Headcount: 44,000
Revenues: $38,609 (+3%)
Net Income: $8,587 (+5%)
R&D: $7,922 (+13%)

Following the successes of 2023, GSK continues to face Zantac litigation and recent headlines point to potential impinged growth for runaway RSV vaccine Arexvy.

In 2023, vaccines sales were up 24% driven by Shingrix success and the launch of Arexvy, the first approved respiratory syncytial virus (RSV) vaccine for older adults, which raked in nearly $1.6 billion in sales.

In early June, a label expansion for Arexvy was approved by the FDA in adults 50 through 59 years who are at increased risk for RSV, however, the market leading RSV vaccine faces limitations as the U.S CDC narrows the age recommendation and limits it to only at-risk patients in the 60-74 age range, reducing the number of potential patients – at least until additional data are available. The vaccine was first approved in May 2023 for patients 60 and above.

In other financial highlights, growth was adversely impacted by a 98% drop in sales for COVID-19 drug Xevudy, while growth momentum in HIV sales for the year was primarily driven by patient demand for oral combination drugs Dovato and Juluca, and long-acting medicines Cabenuva and Apretude.

During the year GSK won four major product approvals, inlcuding Arexvy, Apretude for HIV prevention, Ojjaara for myelofibrosis, and Jemperli in first line endometrial cancer.

Continued investments in expanding its pipeline, GSK’s business development efforts include the acquisition of Bellus Health and Aiolos Bio, and license agreements with Arrowhead Pharmaceuticals and Hansoh Pharma, adding assets in respiratory, infectious diseases, and oncology.

R&D Efforts

GSK has 71 vaccines and specialty medicines in clinical development, including 18 in Phase III/registration. Further expanding its pipeline, GSK licensed two drugs, one being explored in cancers, and the other for hepatitis B.

Building on its oncology portfolio of clinical-stage antibody-drug conjugates (ADCs), GSK licensed Hansoh’s HS-20089, a B7-H3 targeted ADC utilizing a clinically validated topoisomerase inhibitor (TOPOi) payload, which has shown promise in lung cancer with potential to address broader solid tumor indications.

Additionally, under an agreement with Arrowhead Pharmaceuticals Inc., a Johnson & Johnson company, GSK gains exclusive worldwide rights to further develop and commercialize JNJ-3989, an investigational hepatitis B virus-targeted small interfering ribonucleic acid (siRNA) therapeutic. GSK plans to evaluate the drug in a sequential regimen with bepirovirsen, GSK’s investigational antisense oligonucleotide, for the treatment of adult non-cirrhotic patients with chronic hepatitis B (CHB) on nucleos(t)ide analogue (NA) therapy.

Bepirovirsen is the only single agent in Phase III development that has shown clinically meaningful functional cure response for patients with CHB receiving oral NAs, following positive results demonstrated in clinical trials.

Acquisitions

With several strategic acquisitions throughout the year, GSK adds development capabilities for Oligonucleotide therapies, monoclonal antibodies for respiratory and inflammatory conditions, and a late-stage asset camlipixant for the treatment of chronic cough.

Most recently, GSK acquired Elsie Biotechnologies, a San Diego-based biotechnology company exploring the full potential of oligonucleotide therapeutics, for up to $50 million.

Oligonucleotides have a unique ability to modulate gene expression, with the potential to address a significant number of therapeutic targets that are not responsive to small molecules or biologics.

This acquisition allows GSK to integrate Elsie’s oligonucleotide discovery, synthesis, and delivery technologies to enhance its platform R&D capabilities. This follows a successful research collaboration with Elsie back in July 2023, in which GSK was able to explore and validate the technology.

Earlier this year, GSK completed the acquisition of Aiolos Bio, Inc., a clinical-stage biopharmaceutical company focused on treatments for respiratory and inflammatory conditions, for a $1 billion upfront and as much as $400 million in success-based regulatory milestones.

Here GSK gains access to Aiolos’ AIO-001, a potential best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody in development for the treatment of asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps. Targeting the TSLP pathway addresses a key driver of the inflammatory response in major allergic and inflammatory diseases.

Meanwhile, the acquisition of Bellus Health for approximately $2 billion provides GSK with access to camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in Phase III development for the first-line treatment of adults with refractory chronic cough (RCC).

Current clinical data show that by selectively inhibiting P2X3 receptors camlipixant may reduce cough frequency with a relatively low incidence of taste disturbance, which frequently leads to patients discontinuing treatment. Regulatory approval and launch of camlipixant is anticipated in 2026.

Alliances

Additional R&D alliances focus on treatments for tuberculosis and invasive candidiasis, and access to a cell-free DNA manufacturing technology. In May, GSK expanded its strategic collaboration with BioVersys AG to accelerate the clinical development of alpibectir for the treatment of tuberculosis (TB).

Alpibectir, a small molecule acting through a novel mode of action, was developed in a public-private collaboration and is currently being evaluated in combination with ethionamide in a Phase 2a study in pulmonary TB in South Africa. The compound represents a new concept of overcoming resistance and significantly potentiating the activity of an existing antibiotic, ethionamide.

GSK and BioVersys will continue development of alpibectir beyond Phase 2 in both TB pulmonary and TB meningitis programs. GSK will also take an equity stake in BioVersys’ latest investment round, which will enable the further clinical development of BioVersys’ portfolio, this includes BV100, a potential breakthrough hospital antibiotic with a new mode of action targeting Acinetobacter baumannii, the most drug-resistant bacterial pathogen.

Under an exclusive license agreement with SCYNEXIS, Inc., a company developing medicines to overcome and prevent difficult-to-treat and drug-resistant infections, GSK gains rights to ibrexafungerp. SCYNEXIS recently achieved a development goal in a Phase 3 study for ibrexafungerp in invasive candidiasis.

The exclusive license agreement gives GSK rights to commercialize BREXAFEMME (ibrexafungerp tablets) for vulvovaginal candidiasis while continuing to develop ibrexafungerp for the potential treatment of invasive candidiasis, a life-threatening fungal infection. Under the agreement, SCYNEXIS received $90 million upfront and is eligible for additional milestones totaling as much as $503 million, as well as royalties on sales.

Lastly, Elegen and GSK entered a collaboration and licensing agreement for the use of Elegen’s cell-free DNA manufacturing technology in the development of GSK’s vaccines and medicines.

GSK will leverage Elegen’s ENFINIA DNA to support development of medicines and vaccines, including RNA vaccines. In addition to an upfront payment, Elegen is eligible to receive milestones relating to the development of new product features and a potential equity investment in Elegen by GSK.

ENFINIA DNA delivers NGS-verified, high-complexity, clonal-quality, linear DNA up to 7kb in as fast as seven business days, according to the company. Unlike conventional synthesis of mRNA from linearized plasmid DNA, Elegen’s DNA is produced entirely cell-free, with the potential to enable a seamless transition from discovery to clinical scale-up under GMP.

Headcount: 69,400
Revenues: $35,360 (+19%)
Net Income: $18,836 (>100%)
R&D: $6,618 (+9%)

It was an eventful year for GlaxoSmithKline, with high growth top sellers, key approvals, acquisitions, and alliances. Fiscal growth for year was largely attributed to record Shingrix sales of nearly $3.6 billion, and COVID-19 treatment, Xevudy, with sales topping $2.8 billion. Meanwhile, within the company’s three segments, Specialty Medicines sales were up 37% to $13.6 billion, Vaccines sales were $9.5 billion, up 17% thanks to Shingrix, and General Medicines accounted for $12.2 billion, up 5%. Earnings for the year primarily reflect the gain from discontinued operations arising from the demerger of the Consumer Healthcare business, which took place in July.

In a big win for GSK, Arexvy the company’s respiratory syncytial virus vaccine, was recently approved in by the FDA in May and the European Commission in June, becoming the world’s first RSV vaccine for older adults. Regulatory reviews in Japan and other counties underway. At press time, phase III trial results showed vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons. U.S. launch is planned before the 2023/24 RSV season.

In corporate news, GSK announced that its new global headquarters will be in central London. The company will move to the new headquarters in 2024 from its current location in Brentford, West London. The site, known as the Earnshaw, is under construction and offers close proximity to the fast-growing global Life Sciences hub, London’s Knowledge Quarter, and GSK’s existing collaboration partners including the Francis Crick Institute and King’s College London.

Acquisitions

GSK spent more than $6 billion on several acquisitions over the course of the year, adding late-stage assets to its vaccines, oncology, and general medicines portfolio. Complementing its respiratory medicines, GSK recently acquired Bellus Health, a Canada-based biopharmaceutical company focused on treating refractory chronic cough (RCC), for approximately $2 billion, gaining camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the treatment of adults with RCC. Current clinical data show that by selectively inhibiting P2X3 receptors, camlipixant may reduce cough frequency. Regulatory approval and launch of camlipixant is anticipated in 2026.

For approximately $1.9 billion, GSK acquired Sierra Oncology, a CA-based biopharmaceutical company focused on targeted therapies for rare forms of cancer, adding Momelotinib, a treatment for Myelofibrosis, and building on its commercial and medical expertise in hematology. Momelotinib has a differentiated mode of action that may lead to beneficial treatment effects on anemia and reduce the need for transfusions while also treating symptoms. The MOMENTUM phase III trial met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anemia.

Additionally, GSK acquired Affinivax, Inc., a clinical-stage biopharmaceutical company based in Cambridge, MA, for $2.1 billion upfront and as much as $1.2 billion in potential development milestones. Affinivax is developing a new class of vaccines, the most advanced of which are next-generation pneumococcal vaccines, and its Multiple Antigen Presenting System (MAPS) technology supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent strains and potentially creating higher immunogenicity than current vaccines.

Its most advanced candidate, AFX3772, includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus valent pneumococcal candidate vaccine is also in preclinical development.

In the phase I/II clinical trials, AFX3772 was well tolerated and demonstrated good immune responses compared to the current standard of care. In July 2021, the U.S. FDA granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and above.

Alliances

GSK partnered with Scynexis to develop Brexafemme (ibrexafungerp) in drug-resistant fungal infections, for which the CDC recently issued a warning citing an increase of drug-resistant Candida auris infections. GSK paid $90 million upfront and Scynexis is eligible for additional milestone-based payments totaling a potential $593 million plus royalties.

Ibrexafungerp first received FDA approval in September 2021 to treat vaginal yeast infections, and in December 2022, it was approved for vulvovaginal candidiasis and the reduction in recurrence. Ibrexafungerp is currently in Phase III trials for the treatment of invasive candidiasis. Successful development of the therapy for this indication will trigger up to $245.5 million in payments from GSK. Scynexis recently achieved a $25 million performance milestone following a development goal for the Phase 3 MARIO study for ibrexafungerp in invasive candidiasis.

Meanwhile, a strategic alliance with Wave Life Sciences aims to advance oligonucleotide therapeutics, including Wave’s preclinical RNA editing program targeting alpha-1 antitrypsin deficiency (AATD), WVE-006. AATD is an inherited genetic disease that affects both the lungs and liver with limited treatment options. WVE-006 is a first-in-class RNA editing therapeutic that is designed to address both liver and lung manifestations of the disease.

The four-year collaboration combines GSK’s insights from human genetics with Wave’s discovery and drug development platform, PRISM. Wave received $170 million upfront and is eligible to receive as much as $225 million and $300 million in development and launch milestones, as well royalties. Wave anticipates submitting clinical trial applications for WVE-006 this year. Once a phase 1 trial is complete, GSK will take over development.

Oligonucleotides are short strands of DNA or RNA that can reduce, restore, or modulate RNA through several different mechanisms with the capability to address a wide range of genomic targets in multiple therapeutic areas. Wave’s PRISM platform offers three RNA-targeting modalities (editing, splicing, and silencing, including siRNA and antisense). Importantly, these modalities incorporate novel chemistry to optimize the pharmacological properties of oligonucleotides. The discovery collaboration enables GSK to advance up to eight programs and Wave to advance up to three programs.

Advancing assets

GSK’s pipeline is comprised of 69 vaccines and specialty medicines based on science of the immune system, with 18 in phase III/registration. This year, the FDA granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a FDA-approved test, that has progressed on or following a prior platinum-containing regimen and are not candidates for surgery or radiation. Additional approvals by the FDA for Jemperli in first line endometrial cancer, and momelotinib, in myelofibrosis, are anticipated in 2023.

Among several key late-stage assets that are advancing are gepotidacin, bepirovirsen, tebipenem, and depemokimab. Pivotal phase III trials for gepotidacin, an antibiotic for uncomplicated urinary tract infections (UTIs), were stopped early for efficacy. The company also achieved positive phase IIb data for bepirovirsen, a potential functional cure for chronic hepatitis B. GSK entered an exclusive license agreement with Spero Therapeutics for tebipenem Hbr, a late-stage antibiotic for complicated UTIs. Also, GSK expanded the depemokimab phase III program with trials for long-acting IL-5 inhibitor in three additional eosinophil-driven diseases.

Lastly, the FDA granted Orphan Drug Designation for Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. Plans to initiate a phase II/III trial in systemic sclerosis associated interstitial lung disease is on track for the first half of 2023.

Headcount: 90,096
Pharma Revenues: $33,059 (+1%)
Net Income: $6,874 (-20%)
R&D: $7,120 (+4%)

TOP SELLING DRUGS

Driving GlaxoSmithKline’s modest growth in 2021, sales of Xevudy (sotrovimab), the monoclonal antibody treatment for Covid-19, reached $1.3 billion contributing approximately 6 percentage points to Pharmaceuticals growth for the year. However, as of April 5, 2022, the FDA suspended use of sotrovimab for Covid-19 treatment in the U.S., saying the antibody is unlikely to be effective against the Omicron BA.2 sub-variant. Meanwhile sales of Established Pharmaceuticals for the year were down 11% to $10.5 billion, and Vaccines turnover was down 3% to $9.1 billion, as a result of lower demand for routine adult vaccination.

In addition to Pandemic revenues, up 31% reflecting the ongoing fulfilment of Xevudy contracts, growth drivers in Respiratory, Immuno-inflammation, and Oncology also helped offset declines for several of GSK’s top selling products. Offsetting losses for legacy products, namely Advair and Ventolin, Respiratory sales were up 21% with sales of Trelegy and Nucala each exceeding $1.5 billion in annual sales for the first time. Sales of Nucala grew 15%, while Trelegy sales were up 49%. Immuno-inflammation sales were up 22% driven by Benlysta with $1.2 billion in sales and benefitting from lupus nephritis launches in U.S. and Japan in 2H20. Oncology sales were up 22% were driven by Zejula, a PARP inhibitor treatment for ovarian cancer, with sales of $532.8 million, up 17%. Also, Blenrep for the treatment of patients with relapsed or refractory multiple myeloma was approved and launched in the U.S. and Europe 3Q20, with ongoing launches throughout Europe in 2021. Blenrep sales globally totaled $120 million.

Corporate news

In the most significant corporate change for the company in the last 20 years, on June 23, 2021 GSK confirmed its intention to separate its Consumer Healthcare business from the GSK Group to form Haleon plc, an independent consumer healthcare company. It’s proposed that the separation will be effected by way of a demerger of at least 80 percent. The Consumer Healthcare business is currently a joint venture between GSK and Pfizer Inc., with GSK holding a majority controlling interest of 68 percent and Pfizer holding 32 percent.

Following the demerger, GSK plans to focus purely on biopharmaceuticals, prioritizing investments in development of vaccines and specialty medicines. The company’s R&D approach will focus on the science of the immune system, use of human genetics, and advanced technologies.

Expanding its vaccines and oncology assets, GSK is spending more than $3.1 billion with two recent acquisitions. GSK recently entered an agreement to acquire Affinivax, Inc., a clinical-stage biopharmaceutical company based in Cambridge, MA for $2.1 billion upfront and up to $1.2 billion in potential development milestones. The acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase 2 development and highly innovative MAPS technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines.

GSK also agreed to acquire Sierra Oncology, Inc., a CA-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare cancers, for approximately $1.9 billion. Sierra Oncology’s differentiated momelotinib has the potential to address the critical unmet needs of myelofibrosis patients with anaemia. Myelofibrosis is a fatal cancer of the bone marrow impacting the normal production of blood cells. Momelotinib complements GSK’s expertise in hematology, and Sierra Oncology anticipates U.S. regulatory submission in 2Q22 and EU submission in the 2H22.

Advancing R&D assets

GSK’s R&D pipeline currently includes 64 vaccines and specialty medicines in its four core therapeutic areas of infectious diseases, HIV, oncology and immunology/respiratory. The company’s late-stage R&D pipeline includes assets with the potential to be first-in-class or best-in-class, as well as offering strategic lifecycle opportunities, to help deliver sales through 2026 and beyond.

Most recently, the U.S. FDA approved Priorix for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older. Also, the FDA accepted GSK’s New Drug Application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anemia in chronic kidney disease (CKD). Daprodustat was developed based on the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The FDA has assigned a Prescription Drug User Fee Act action date of February 1, 2023.

The daprodustat NDA is based on positive results from the ASCEND phase III clinical trial, which included five pivotal trials assessing the efficacy and safety of daprodustat for the treatment of anemia across the spectrum of CKD.

In the way of ongoing efforts to battle Covid-19, while GSK and development partner Vir Biotechnology, Inc. face uncertainty advancing sotrovimab, GSK’s partnered Covid-19 vaccine and booster remain on track. Sotrovimab, which was previously granted Emergency Use Authorization (EUA) by the U.S. FDA in May 2021, is an investigational single-dose intravenous infusion SARS-CoV-2 monoclonal antibody. Under the EUA, sotrovimab was authorized to treat mild-to-moderate Covid-19 in adults and pediatric patients. The companies planned to manufacture approximately two million doses globally in the first half of 2022 and additional doses in the second half of the year.

The U.S. distribution of the Covid-19 antibody has been on hold since the FDA pulled authorization in April. GSK previously announced that preclinical studies demonstrated sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron variant.

In January, the U.S. Government had purchased an additional 600,000 doses of sotrovimab to be delivered throughout the first quarter of 2022. This agreement was an amendment to an earlier commitment with the U.S. Government in November 2021.

While currently on hold, an application to the FDA was submitted for sotrovimab in the fourth quarter requesting an amendment to the EUA to include intramuscular administration. Also in the fourth quarter, the European Commission approved sotrovimab for the early treatment of Covid-19 in adults and adolescents 12 years and over who do not require supplemental oxygen and who are at increased risk of progressing to severe infection.

To date, GSK had received binding agreements for the sale of approximately 1.7 million doses worldwide. Separately, Vir and CDMO WuXi Biologics terminated their Covid antibody alliance as U.S. rollout faces an uncertain future.

GSK and partner Medicago, a biopharmaceutical company headquartered in Quebec, received approval from Health Canada for COVIFENZ, Covid-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted) for active immunization to prevent Covid-19 caused by SARS‑CoV‑2 in individuals 18 to 64 years of age.

Additionally, GSK and Sanofi plan to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for their Covid-19 vaccine. The Sanofi-GSK vaccine is supported by robust immune responses and a favorable safety profile. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels.

In the Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: 100% efficacy against severe Covid-19 disease and hospitalizations; 75% efficacy against moderate or severe Covid-19 disease; and 57.9% efficacy against any symptomatic Covid-19 disease, in line with effectiveness in dominated by variants of concern.

Finally, SK bioscience and GSK submitted a biologics license application for SKYCovione, a recombinant protein-based Covid-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety following positive Phase III clinical data. The vaccine candidate demonstrated superior neutralizing antibody titers over AstraZeneca’s Vaxzevria (control vaccine), a currently authorized Covid-19 vaccine, along with a clinically favorable safety profile.

Headcount: 99,437
Pharma Revenues: $32,637 (flat)
Net Income: $8,673 (+26%)
R&D: $6,922 (+17%)

TOP SELLING DRUGS

In early 2020, GlaxoSmithKline (GSK) started a two-year plan to separate into two new companies: New GSK, a biopharma company focused on specialty medicines and vaccines with an R&D approach targeting the immune system, the use of human genetics and new technologies; and a new consumer healthcare organization. The company said it is on track for separation into new standalone Biopharma and Consumer Healthcare entities in 2022.

Together, GSK’s Pharmaceutical and Vaccines segments generated $32.6 billion of revenue in 2020, which was flat compared to the year prior. New and specialty products drove growth with sales of $13.4 billion, up 11%—this group of products now account for more than half of pharmaceutical sales. Strong sales performance from key growth drivers in HIV, respiratory, oncology helped offset disruption from COVID-19 to adult vaccinations.

Pharmaceuticals segment turnover in the year was $23.5 billion, down 3%. Respiratory sales were up 22% to $5.2 billion, on growth of Trelegy, Nucala and Relvar/Breo. HIV sales were flat at $6.7 billion, with growth in Juluca and Dovato partly offset by declines in Tivicay and Triumeq. Sales of established pharmaceuticals declined 16% to $10 billion.

In the vaccines segment, turnover declined 2% to $9.2 billion, primarily driven by the adverse impact of the COVID-19 pandemic on Hepatitis vaccines, DTPa-containing vaccines, Synflorix and Bexsero, together with the divestment of Rabipur and Encepur. This decline was partly offset by higher sales of Influenza vaccines across all regions and by Shingrix growth in Europe, China and the U.S. together with a strong performance from Cervarix in China.

Covid-19 vaccine
In August 2020, GSK and Sanofi entered an agreement with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.

The U.S. government through its Operation Warp Speed is providing up to $2.1 billion, more than half of which is to support development of the vaccine, including clinical trials, with the remainder used for manufacturing scale up and delivery of an initial 100 million doses of the vaccine.

As of May 2021, Sanofi and GSK initiated a global Phase III clinical efficacy study of the vaccine candidate. The two-stage trial design is evaluating vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants. A booster study program has also begun to complement the Phase III trial. Pending positive Phase III outcomes and regulatory reviews, the vaccine could be approved in the fourth quarter of 2021. Manufacturing started within weeks of the Phase III trial announcement to enable rapid access to the vaccine if approved.

The Phase III study follows the interim Phase 2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates. After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.

In another Covid deal, GSK and CureVac entered €150 million collaboration to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK is supporting the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021. The goal is to offer broader protection against a variety of different SARS-CoV2 variants, and to enable a quick response to new variants potentially emerging in the future. The development program started in February 2021, with the target of introducing the vaccine in 2022.

Pipeline approvals
GSK made significant progress across its biopharma portfolio, with nine major GSK drug candidates gaining regulatory approval. In the infectious disease portfolio, GSK received approvals in HIV for a first-in-class attachment inhibitor, Rukobia, in the U.S. and Europe, and for the long-acting regimen, Cabenuva, in Canada, the U.S. and Europe, where it is licensed as Vocabria + Rekambys.

The firm also received European regulatory approval to extend the use of several of its vaccines against infectious diseases: Shingrix, to expand its use from people aged over 50 to those over 18 who are at increased risk of shingles; Boostrix, a tetanus, diphtheria, and pertussis vaccine, received an expanded indication to include maternal immunization; and for Bexsero, a Europe-wide label update for its 2+1 schedule starting with infants of two months.

In oncology GSK received significant U.S. and European approvals, first for Zejula, which was approved for an expanded indication in ovarian cancer, and secondly for Blenrep, a first-in-class anti-BCMA (B-cell maturation antigen) treatment for multiple myeloma. In respiratory, Nucala, a first-in-class, anti-IL5 biologic, was approved in the U.S. for hypereosinophilic syndrome, and Trelegy Ellipta, a once-daily single inhaler triple therapy, was approved in the U.S. for asthma. Also, Duvroq, for chronic kidney disease-related anaemia, was approved in Japan while Benlysta was approved in the U.S. for an expanded indication in lupus nephritis.

Advanced technologies partnerships
In 2020 GSK sharpened its advanced technologies initiatives by establishing a London AI hub and forming two new collaborations in human genetics and genomics. The AI hub team will use biomedical information, AI methods and advanced computing platforms to unlock new potential from GSK’s genetic and clinical data. They will use the dedicated hub to work and partner with leading companies and AI institutions, including NVIDIA and Silicon Valley start-up Cerebras.

On the AI front GSK is also supporting PhD students at the University of Cambridge’s new Center for AI and Medicine, which will provide GSK with a talent pipeline for the coming five years and will shape the next generation of practitioners.

During the year GSK also formed a new five-year research collaboration with one of the world’s leading genetics and functional genomic centers, the Broad Institute, in Cambridge, MA. Additionally, in December 2020, the firm announced with Ahren Innovation Capital that it will co-lead a Series A investment in Adrestia Therapeutics, a UK-based biotechnology company using cutting-edge molecular biology to develop precision medicines. Adrestia’s Disease Rebalancing Platform uses synthetic viability to identify phenotypic and molecular imbalances of disease as the basis of novel drug discovery. GSK is also entering into a multi-year agreement with Adrestia on up to five projects.

CDMO deals
During 2020 GSK reduced its manufacturing footprint when it parted ways with sites in Poland and Canada. With the contract development and manufacturing organization (CDMO) Delpharm, GSK struck a deal in October under which Delpharm acquired the Poznan manufacturing facility in Poland. The transaction includeds ownership of GSK’s Poznan manufacturing site, including all facilities and around 700 manufacturing employees, transfer over to Delpharm. Delpharm will continue to manufacture, under contract, the existing GSK product line for a minimum of five years, while GSK will remain the owner and marketing authorization holder of these products.

Earlier in the year, in March 2020, GSK entered an agreement under which the CDMO Bora Pharmaceuticals acquired GSK’s Mississauga, Ontario (Canada) facility. The GSK facility produces approximately 50 different products for over 100 markets worldwide and employs approximately 400 manufacturing staff. Bora Pharmaceuticals will continue to manufacture, under contract, the existing GSK product line for a minimum of five years.

In another CDMO deal, GSK inked a deal with Samsung Biologics to secure additional manufacturing capacity for its biopharmaceutical portfolio. Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK’s future needs and will supplement GSK’s existing manufacturing network. The agreement is worth more than $231 million over the next eight years. It will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022. The intention is to expand to additional specialty-care products in the future.

Headcount: 99,437
Pharma Revenues: $32,411 (+5%)
Net Income: $6,910 (+30%)
R&D: $5,991 (+17%)

TOP SELLING DRUGS

GlaxoSmithKline (GSK) reported combined revenues from its Pharmaceuticals and Vaccines units of $32.4 billion, a 5% increase from the year before. In 2019, GSK closed its deal with Pfizer to combine their two consumer healthcare businesses, making GSK number one globally in over-the-counter (OTC) medicines and therapeutic oral health. Consumer OTC sales are not included in GSK’s ranking in this report.

Pharmaceuticals turnover in the year was up 2% to $21.8 billion. HIV sales were up 3% to $6 billion, with growth in Juluca and Dovato partly offset by declines in Triumeq and Tivicay. Respiratory sales were up 18% to $3.8 billion, on growth of Trelegy Ellipta and Nucala. Sales of Established Pharmaceuticals were $10.8 billion, down 7% partly due to the impact of loss of exclusivity of Advair.
Vaccines turnover grew an impressive 21% to $8.8 billion driven by the strong growth of shingles vaccine Shingrix, with sales of $2.2 billion. Meningitis vaccines also contributed significantly to growth.

In 2019, GSK strengthened its pipeline with eight filings, six positive pivotal trial results, and four priority assets accelerating to Phase II/III. It also accelerated its oncology pipeline with regulatory submissions for Zejula, an oral poly ADP-ribose polymerase (PARP) inhibitor, in first-line ovarian cancer, belantamab mafodotin in relapsed/refractory multiple myeloma, and dostarlimab in endometrial cancer.

GSK received approvals for three medicines: Dovato, an HIV treatment; Dectova, a treatment for influenza A or B; and new self-administration options for its respiratory biologic, Nucala. Expanded indications were also received for Zejula for ovarian cancer and Benlysta, the world’s first biologic treatment for systemic lupus erythematosus.

Oncology and vaccine partnerships
GlaxoSmithKline bolstered its cancer drug development pipeline during the year when it agreed to pay up to $4.2 billion to Germany’s Merck KGaA for the rights to a next-generation immunotherapy.
Merck received an upfront payment of $336 million for the drug, known as M7824, or bintrafusp alfa. Merck is eligible for potential payments of up to $560 million depending on development milestones in lung cancer. Merck could also get up to a further $3.2 billion, depending on commercial milestones. With this alliance, both companies have the leadership position in this new class of immunotherapies, specifically leveraging TGF-β biology.

For GSK, this alliance is a further step in the company’s priority to strengthen its pharmaceuticals pipeline and follows the company’s $5.1 billion acquisition of Tesaro, an oncology-focused company based in Waltham, MA, at the end of 2018.

GSK also established several partnerships during the year to bolster its vaccine capabilities, including one to develop a new vaccine to prevent cervical cancer, with Innovax and Xiamen University in China. It also established a collaboration with VBI, a biotech company, to facilitate development of a specialized therapeutic vaccine candidate for patients with recurrent glioblastoma. GSK also teamed up with Viome, a company with deep expertise in understanding the gut microflora and its role in chronic diseases, to facilitate vaccine development to prevent or even treat such conditions.

In another partnership, GSK entered a five-year collaboration with the University of California to establish a state-of-the-art laboratory for CRISPR technologies, the Laboratory for Genomics Research (LGR). The new laboratory will explore how gene mutations cause disease and develop new technologies using CRISPR, the most powerful tool in functional genomics, to rapidly accelerate the discovery of new medicines.

Expanding manufacturing capabilities
In 2019, GSK opened a $120 million next-generation biopharmaceutical manufacturing facility at its Upper Merion, PA, site. The investment at Upper Merion creates a technologically-advanced manufacturing hub that offers the flexibility and speed necessary when making today’s complex specialty medicines.

The newly-outfitted manufacturing space is made to be more flexible than traditional pharmaceutical manufacturing equipment. Upper Merion uses emerging technologies in bioreactors, such as single-use and disposable components, which eliminates the need for complex retrofitting and sterilizing that is typical in most manufacturing plants. This simplifies and accelerates the process of changing from manufacturing one medicine to another medicine.

A new analytical lab is also part of the facility, which brings together the R&D and manufacturing teams at Upper Merion. The processes associated with quality and commercial testing have been streamlined to ensure medicines are ready for patient use as soon as possible.

In other projects, GSK completed a $139 million expansion of its Rockville, MD site, which will increase manufacturing capacity for Benlysta by 50%. In Singapore, it opened a new state-of-the-art pharmaceutical manufacturing facility at its Jurong site. The $96 million development included the creation of two continuous manufacturing facilities, and the expansion and modernization of an existing production unit. The transformation is expected to significantly improve efficiency, expand capacity for manufacturing its assets, including daprodustat and dolutegravir, and reduce medicine production times.

GSK also established a partnership with The Center for Process Innovation (CPI) and AstraZeneca to establish a bespoke, continuous wet granulation manufacturing facility for small-scale development of oral solid dosage pharmaceuticals.

To expand its vaccines production capabilities, GSK unveiled plans to invest $100 million in its manufacturing site in Hamilton, MT to expand the production capacity of key components of the adjuvant system used in several of GSK’s vaccines, including Shingrix.

The Hamilton vaccines facility currently manufactures components of GSK’s essential adjuvant technologies, which this investment will expand further. GSK’s adjuvant systems help achieve a stronger immune response.

In 2019, GSK completed exits of the Guarulhos, Brazil, Cork, Ireland and Suzhou, China sites from its network, and initiated the exit of the Verona, Italy site, which is expected to be completed in 2020. On the vaccines side, GSK divested two of its sites, in Ankleshwar, India and Tianyuan, China.

Headcount: 95,490
Revenues: $40,992 (+1%)
Pharma Revenues: $30,807 (+2%)
Net Income: $5,381  (-2%)
R&D: $5,178  (-14%)

TOP SELLING DRUGS 

GlaxoSmithKline (GSK) reported revenue of $40.9 billion, up just 1% from the year before. The standout was Shingrix, GSK’s vaccine for shingles, which had sales of $1.0 billion in its launch year. HIV medicines also continued to grow with $3.5 billion in sales for Triumeq, GSK’s new top seller, and $2.2 billion for Tivicay.

With the decline if its flagship product Advair, GSK continues to build its new respiratory portfolio with Trelegy Ellipta, the new three-in-one medicine for chronic obstructive pulmonary disease (COPD), and Nucala, GSK’s biologic medicine for severe asthma. In addition to the positive launches of Shingrix and Trelegy Ellipta, GSK reported a strong start to sales of HIV drug Juluca.

During the year GSK implemented a new R&D approach to focus on science of the immune system, human genetics and advanced technologies. In fact, it made significant progress in reshaping its pharmaceuticals R&D portfolio to reflect this new strategy with 33 of 46 new medicines now targeting modulation of the immune system.

As part of the its ongoing prioritization and strengthening of its pharmaceuticals pipeline, GSK transferred its portfolio of approved and investigational rare disease gene therapies to Orchard Therapeutics. GSK became an investor in Orchard as a result, receiving a 19.9% equity stake along with a seat on the company’s board. GSK and Orchard will exchange manufacturing, technical and commercial insights and learnings on the development of gene therapy medicines to ensure the success of the assets.

In other business news, GSK entered a deal to create a consumer healthcare joint venture with Pfizer and bought out Novartis’ stake in GSK Consumer Healthcare. The combination of the iconic brands of GSK and Pfizer will create one of the largest consumer healthcare players in key geographies including the U.S., Europe, China, India and Australasia. Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion. Pfizer receives a 32% equity stake in the joint venture.

The joint venture will be a category leader in pain relief, respiratory, vitamin and mineral supplements, digestive health, skin health and therapeutic oral health.

Following the integration, GSK said it intends to separate the joint venture as an independent company. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO.

Pumped up pipeline
GSK strengthened its pipeline through business development initiatives with 23andMe and Tesaro. First, bolstering its cancer assets, GSK added the ovarian cancer drug Zejula to its portfolio when it paid $5.1 billion for Tesaro. The deal significantly strengthens GSK’s pharmaceutical business, accelerating the build of its pipeline and commercial capability in oncology. Zejula (niraparib), a major marketed product, is an oral poly ADP ribose polymerase (PARP) inhibitor that is currently approved in the U.S. and Europe. Clinical trials to assess the use of Zejula in “all-comers” patient populations, as a monotherapy and in combinations, for the significantly larger opportunity of first line maintenance treatment of ovarian cancer are also underway.

With 23andMe, GSK entered a multi-year collaboration expected to identify novel drug targets, tackle new subsets of disease and enable rapid progression of clinical programs. The four-year collaboration will focus on research and development of innovative new medicines and potential cures, using human genetics as the basis for discovery. The collaboration will combine 23andMe’s large-scale genetic resources and advanced data science skills, with the scientific and medical knowledge and commercialization expertise of GSK. The goal of the collaboration is to gather insights and discover novel drug targets driving disease progression and develop therapies for serious unmet medical needs based on those discoveries.

With over 5 million customers, 23andMe offers those with an interest in genetics the opportunity to learn more about their personal genetic profile. 23andMe customers can also choose to participate in research and contribute their information to a unique and dynamic database, which is now the world’s largest genetic and phenotypic resource.

GSK brings extensive drug discovery and development capabilities across a broad range of diseases and modalities, including small molecule, biopharmaceuticals and cell and gene therapies. It will apply its technologies, including access to additional data sources, in-house target validation and genetics expertise, and utilize its manufacturing, commercial operations and scale to support partner activities across research and development.

R&D alliances
GSK entered several research collaborations during the year, some of which are highlighted here. A research pact with Fimbrion Therapeutics led to the identification of an orally available, small molecule development candidate for the treatment and prevention of urinary tract infections. The discovery partnership began its joint research efforts in July 2016.

A three-year extension was made to a tie-up with Neomed-Labs. Under the terms of this renewed agreement, Neomed-Labs will develop immunotools (antigens), immunochemical assays as well as functional assays and undertake the clinical testing for several GSK vaccine projects at the clinical stage.

Neomed-Labs is a spin-out from GSK’s Clinical Laboratory Services since April 2015 with a three-year original agreement. Following a successful transition from GSK, Neomed-Labs became a fully independent CRO in 2017 and is now collaborating with major global vaccine manufacturers.

With Syngene International, another global contract research services company, GSK formed a multiyear R&D agreement that will focus on accelerating the discovery of new drug candidates using Syngene’s discovery services platforms. Syngene will set-up a customized discovery research laboratory to support projects across several therapeutic areas. A team of Syngene scientists will work closely with GSK’s global R&D teams on discovery research projects to identify new drug candidates with the potential to address some of the world’s most pressing healthcare needs.

Lastly, GSK entered a technology agreement with LabCorp’s Covance Drug Development business. GSK will use Covance’s Xcellerate Monitoring, Xcellerate Insights, and Xcellerate Clinical Data Hub solutions in a software-as-a-service (SaaS) model. A key component of the technology licensed by GSK is Xcellerate Monitoring, Covance’s implementation of risk-based monitoring, which enables assessment and mitigation of risk at the study, site and patient level. It also allows sponsors to strategically guide site monitoring resources and build quality and efficiency into their clinical trials, from commencement to completion.

Headcount: 99,300
Revenues: $40,725 (+7%)
Pharma Revenues: $30,270 (+8%)
Net Income: $5,514  (+57%)
R&D: $6,039  (+23%)

TOP SELLING DRUGS

GlaxoSmithKline (GSK) reported pharma revenues of $30 billion in 2017. This is an 8% growth over the previous year driven by strong performances from HIV medicines Tivicay and Triumeq, the Ellipta portfolio and Nucala, a biologic medicine for respiratory conditions.

In terms of pipeline progress, towards the end of 2017 GSK received approvals for three key new products: Shingrix, a new vaccine which represents a new standard for the prevention of shingles; Juluca, the first in a series of 2-drug regimens for HIV that reduces the number of drugs patients take as they are now living longer with what is becoming a more chronic disease; and Trelegy Ellipta, which is the first once a day inhaler to combine three medicines in one device to treat chronic obstructive pulmonary disease (COPD).

Manufacturing network facelift

GSK has made several moves recently designed to improve its manufacturing network. These include both investments for respiratory and HIV medicines manufacturing in the UK, the sale of several products and the closure of a UK manufacturing site.

Between now and 2020, the company said it plans to invest more than $185 million at its Ware, Hertfordshire, Barnard Castle, Co. Durham and Montrose, Scotland sites. The investments will support expansion of manufacturing for respiratory and HIV medicines. This new investment is in addition to the $360 million announced last year and an investment of more than $1.6 billion in UK manufacturing since 2012.

As part of the initiative, GSK is reviewing its cephalosporins antibiotics business, with an option to sell the business including the associated manufacturing facilities. These medicines are produced at GSK sites in Ulverston, Cumbria, Verona in Italy and part of its Barnard Castle site. The company has also decided to outsource some manufacturing activity at its Worthing site in the UK. GSK will continue to manufacture other antibiotics such as Augmentin and will continue to research new antibiotics. The company has also decided not to proceed with a previously planned investment to build a biopharmaceutical facility in Ulverston as it no longer needs the additional capacity.

In its consumer healthcare business, GSK reached an agreement in March 2018 with Novartis for the buyout of Novartis’ stake in their consumer healthcare joint venture for $13 billion. GSK is looking to possibly sell its Horlicks and its other consumer healthcare nutrition products to support funding of the transaction.

The majority of Horlicks and other nutrition product sales are generated in India, with the Horlicks range is widely recognized as a portfolio of premium nutrition products. On the heels of the Novartis deal, GSK said it was planning to close its Horlicks factory in Slough, UK.

GSK expects the outcome of the strategic review to be concluded around the end of 2018. It says India remains a priority market for GSK investment and growth. For the pharmaceutical and vaccines businesses, GSK is looking to build new manufacturing capacity in Vemgal, Karnataka and Nashik.

During the year GSK also divested its anaesthesia portfolio to Aspen Pharmacare, a move also aligned with GSK’s strategy of simplification through focusing on core therapeutic areas. It also sold a consumer healthcare manufacturing facility in Aiken, SC to contract development and manufacturing organization (CDMO) Avara Pharmaceutical Services.

Drug discovery driven

Plasticell, a biotechnology company specializing in stem cell screening and cell therapies, entered into a collaboration with GSK for the use of its stem cell screening technology, CombiCult, to optimize induced pluripotent stem cells (iPSCs) to specific blood cell lineages for GSK’s therapeutic research. Plasticell will use its CombiCult technology to screen combinations of molecules provided by GSK to identify and optimize iPSC differentiation protocols.

Also, UK Biobank announced a major research initiative with GSK and the Regeneron Genetics Center (RGC) to generate genetic sequence data from the 500,000 volunteer participants in the UK Biobank resource. The initiative will enable researchers to gain valuable insights to support advances in the development of new medicines for a wide range of serious and life threatening diseases. The groundbreaking UK/US initiative will deliver first data within a year.

GSK selected a third target under its ongoing oncology discovery collaboration with Immunocore for multiple novel targets not addressable with antibody-based technologies. Immunocore will generate a novel ImmTAC molecule against the selected target which is relevant in multiple cancers. This is the third program to be initiated as part of the discovery collaboration from 2013. Immunocore is currently working on two other ImmTAC programs under the agreement. The lead program is on track for an investigational new drug (IND).

Finally, a strategic drug discovery collaboration with Exscientia will apply its AI enabled platform to discover novel and selective small molecules for up to 10 disease-related targets nominated by GSK across multiple therapeutic areas. Exscientia will apply both its Big Data resources comprising medicinal chemistry and large-scale bioassays, and its AI-driven algorithms to design novel molecules that fulfill the requirements of the lead and candidate criteria.

Headcount: 99,300
Revenues: $37,929 (+7%)
Net Income: $1,240 (-98%)
R&D: $4,934 (-6%)

TOP SELLING DRUGS

GlaxoSmithKline (GSK) moved up a spot from number six last year to round out the 2016 top five pharma companies. The UK-based drug maker’s revenue grew to $37.9 billion from $35 billion last year, driven by strong sales of HIV drugs in the Pharmaceuticals segment.

The Pharmaceuticals segment is focused on providing medicines to treat a range of acute and chronic diseases. The broad portfolio includes medicines for respiratory and HIV, in which GSK are global leaders. Segment sales were approximately $20 billion. The respiratory business grew 2% driven by new products launched over the last four years, including Ellipta-based products Breo, Anoro, Arnuity and Incruse as well as biologic Nucala. HIV sales increased 37% driven primarily by strong performances from both Triumeq, a single-pill treatment combining dolutegravir, abacavir and lamivudine, and Tivicay (dolutegravir), an innovative integrase strand transfer inhibitor. The global HIV business is managed through ViiV Healthcare, a company 78.3% owned by GSK, with Pfizer and Shionogi the other shareholders. ViiV Healthcare is growing rapidly, and accounts for over 20% of Pharmaceutical sales.

GSK’s Vaccines business has a broad portfolio with vaccines for people of all ages from babies and adolescents to adults and older adults. The company delivers over two million vaccine doses per day to people living in over 160 countries. Vaccines sales grew 26% roughly $4.6 billion during 2016. Performance was driven by sales of new products including meningitis vaccines Bexsero and Menveo, and there was also strong demand for Fluarix /FluLaval.

The Consumer Healthcare business, which develops and markets products in Wellness, Oral health, Nutrition and Skin health categories, includes GSK’s seven global power brands—Otrivin, Panadol, parodontax, Poligrip, Sensodyne, Theraflu and Voltaren. Segment sales grew 19% to approximately $10 billion. At a brand level, Sensodyne, Panadol and Otrivin performed strongly with Sensodyne passing the $1 billion mark for the first time.

GSK reported balanced growth across its three global geographies. U.S. sales grew 9% while in Europe sales grew 12% and international market sales grew 8% for the year.

Research collaborations

During the year GSK reported progress on several research collaborations. It exercised its option for an exclusive license to a target under the respiratory diseases research collaboration with Five Prime Therapeutics, triggering a $1.5 million payment to Five Prime. The collaboration, established in 2012, aims to identify new therapeutic approaches to treat refractory asthma and chronic obstructive pulmonary disease (COPD), with a focus on identifying novel therapeutic targets. The collaboration was expanded in April 2014 to include two additional respiratory discovery programs and the research term was extended through July 2016, which GSK committed to fund.

GSK has responsibility for further development and commercialization of products that incorporate or target the licensed protein target. Five Prime is eligible to receive as much as $93 million in milestone payments for each product incorporating the licensed protein. Five Prime is also eligible to receive royalties on sales. The Five Prime discovery platform includes a library of more than 5,700 extracellular proteins believed to encompass all of the body’s medically important targets for protein therapeutics.

In another joint research effort, Adaptimmune Therapeutics and GSK expanded the terms of their collaboration agreement to accelerate Adaptimmune’s lead clinical cancer program, an affinity enhanced T-cell immunotherapy (GSK3377794) targeting NY-ESO-1, toward pivotal trials in synovial sarcoma. Adaptimmune and GSK formed a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program through clinical proof of concept and, on exercise, will assume full responsibility for the program. The companies will accelerate the development of Adaptimmune’s NY-ESO therapy into pivotal studies in synovial sarcoma and will explore development in myxoid round cell liposarcoma. Additionally, the companies may initiate up to eight proof-of-principle studies exploring combinations with other therapies, including checkpoint inhibitors. According to the expanded development plan, the studies will be conducted by Adaptimmune with GSK effectively funding the pivotal studies and sharing the costs of the combination studies via a success based milestone structure.

VBI Vaccines entered into a research collaboration with GSK Biologicals SA to evaluate VBI’s LPV Platform. VBI’s LPV Platform is a proprietary formulation and process that enables the development of vaccines and biologics with improved stability and preserved potency. GSK has the option to negotiate an exclusive license to VBI’s LPV Platform for use in a defined field. Stability is a critical issue potentially affecting vaccine potency, safety and ultimately patient access. The LPV Platform uses a proprietary formulation and process to enclose and protect the antigen (active component) of a vaccine or biologic. VBI has completed proof of concept studies on a number of vaccine and biologic targets that demonstrate the LPV Platform’s ability to preserve potency under stress conditions.

Lastly, Codexis, a protein engineering company, completed the third and final wave in the transfer of its CodeEvolver protein engineering platform technology to GSK, which paid $7.5 million for completion of this milestone in the second quarter of 2016. The agreement grants GSK a license to use Codexis’ CodeEvolver platform technology to develop novel enzymes for use in the manufacture of GSK’s pharmaceutical and health care products. Codexis has the potential to receive additional milestone payments ranging from $5.75 million to $38.5 million per project based on GSK’s successful application of the licensed technology. Codexis is also eligible to receive royalties based on sales for products using Codexis’ CodeEvolver technology. The CodeEvolver platform technology is operational at a GSK R&D facility in Pennsylvania.

In other news during the year, GSK opened a $90 million expansion at an antibiotics factory, enabling the pharma giant to make antibiotics for an extra 100 million patients each year at the plant in Irvine, North Ayrshire. The site has been expanded to meet growing demand from the developing world and emerging markets and the investment creates 55 new jobs with a 35% boost in capacity. The expansion is part of GSK’s roughly $360 million investment in Scotland since 2013 between its sites in Irvine and Montrose, Angus. Also, an additional $260 million of investment funding was announced at the opening.

In terms of divestitures, GSK sold to Mayne Pharma a portfolio of marketed dermatology Foam Assets from for $50.1 million. The assets include U.S. rights to Fabior and Sorilux, Canadian rights to Luxiq and Olux-E and Mexican rights to betamethasone foam. Mayne Pharma acquired the approved regulatory filings, trademarks, marketing materials, select product inventory, and will acquire or obtain licenses for related patents.

Headcount: 101,255
Revenues: $35,463 (-7%)
Net Income: $12,410 (+166%)
R&D: $5,277 (-7%)

TOP SELLING DRUGS  

In 2015 GlaxoSmithKline (GSK) reported sales of $35.5 billion. The key event was the completion of its three-part deal with Novartis that was announced the year before. As a result of this transaction, GSK acquired Novartis’s global vaccines business, excluding influenza vaccines, for $5.25 billion. As part of the deal, GSK has also created a new leading consumer healthcare joint venture with Novartis in which GSK has majority control of 63.5%. Finally, GSK divested its oncology business to Novartis for $16 billion.

Following the Novartis deal, GSK further expanded its vaccines presence in the U.S. by establishing a new global center for vaccines research and development (R&D) in Rockville, MD. The site will become one of three global vaccines R&D centers for GSK, complementing the company’s existing global R&D centers in Rixensart, Belgium and in Siena, Italy, a site GSK recently acquired as part of the Novartis deal.

The new U.S. vaccines R&D center will expand GSK’s efforts to discover and develop novel vaccines and it will consolidate vaccines R&D activities currently conducted at other GSK sites including in Philadelphia, PA and Cambridge, MA, into one centralized location. Key late stage development programs, as well as vaccine discovery and new platform technology development will be led from Rockville.

Also on the research front, GSK unveiled plans to become a key partner, with an investment of $25 million, in a pioneering new global fund for dementia research. The Dementia Discovery Fund, established by the UK government with initial commitments totaling $100 million, brings together leading pharmaceutical companies, the UK government and Alzheimer’s Research UK to address the rising threat posed by dementia by supporting research into future treatments. The fund aims to identify and nurture promising new avenues of research from around the world in the field of dementia and supports GSK’s commitment to explore novel, collaborative approaches in challenging areas of research.

In a unique public-private collaboration formed to create an HIV Cure center and a new company to bring together academic and pharmaceutical research scientists, The University of North Carolina at Chapel Hill and GSK, unveiled plans to create a dedicated HIV Cure center and a jointly owned new company that will focus on discovering a cure for HIV/AIDS. The HIV Cure center will be located on the UNC-Chapel Hill campus and will focus exclusively on finding a cure for HIV/AIDS. The new company, Qura Therapeutics, will handle the business side of the partnership, including intellectual property, commercialization, manufacturing and governance. Together, the HIV Cure center and Qura Therapeutics will serve as a catalyst for additional partners and public funding.

Through the new company, GSK will invest $4 million per year for five years to fund the initial HIV Cure center research plan, and a small research team from GSK will move to Chapel Hill to be co-located with UNC researchers. The University will provide world-class laboratory space on its medical campus for the HIV Cure center and the new company.

Further strengthening its HIV pipeline and outlook, GSK, through its global HIV business, ViiV Healthcare, reached two separate agreements with Bristol-Myers Squibb (BMS), to acquire its late-stage HIV R&D assets and to acquire its portfolio of preclinical and discovery stage HIV research assets.

Late stage assets, including fostemsavir (BMS-663068), an attachment inhibitor, currently in Phase III development for heavily treatment experienced patients that has received a breakthrough designation from the FDA and is expected to be filed for regulatory approval in 2018. The second late stage asset is a maturation inhibitor (BMS-955176), currently in Phase IIb development for both treatment-naive and treatment experienced patients. A back-up maturation inhibitor candidate (BMS-986173) is also included in the purchase.

Assets in preclinical and discovery phases of development include a novel biologic (BMS-986197) with a triple mechanism of action, a further maturation inhibitor, an allosteric integrase inhibitor and a capsid inhibitor.

Also on the research front, during the year GSK teamed up with Merck to initiate a Phase I clinical trial designed to evaluate GSK’s investigational immunotherapy GSK3174998 as monotherapy and in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumor(s) that have progressed after standard treatment.

In terms of acquisitions, in February GSK acquired GlycoVaxyn AG, a specialist vaccine biopharmaceutical company based in Switzerland. Since forming a scientific collaboration in 2012, GSK has held a minority stake in GlycoVaxyn. It acquired the remaining shares for $190 million to take full ownership of the company.

GlycoVaxyn has developed an innovative biological conjugation platform technology, which has the potential to play an important role in the development of new prophylactic and therapeutic vaccines for a range of bacterial diseases. This proprietary technology also has the potential to enable GSK to develop a simplified conjugate vaccine manufacturing process.

As part of the deal, GSK also acquired a small number of early stage vaccines in development against bacterial infections such as pneumonia, pseudomonas, staphylococcus aureus andShigellosis, supplementing the company’s existing vaccines pipeline.

Also of note in 2015, GSK started building its largest Indian tablet manufacturing pharmaceutical factory. When fully operational in 2017, the $140 million factory will make more than 8 billion tablets and 1 billion capsules a year in the areas of gastroenterology and anti-inflammatory medicines for the Indian market. The facility will be built on a 50-acre site in Vemgal, Karnataka. The facility will also include a warehouse, site infrastructure, employee welfare center and utilities to support the manufacturing and packing of the medicines.

During the year GSK also established a new global headquarters for Asia in Singapore. The eight-story, nearly 15,000 square meter facility will have capacity for up to 1,000 employees across GSK’s pharmaceuticals, vaccines and consumer healthcare businesses. Key leadership is already transitioning into the region with almost 150 global or regional roles moving to Singapore in the last year. Construction is expected to be complete by the end of 2016 and all employees will be situated at the new site during the second half of 2017.

Headcount: 98,000
Revenues: $37,960 (-9%)
Pharma Revenues: $30,806 (-8%)
Net Income: $4,671 (-47%)
R&D: $5,693 (-8%)

TOP SELLING DRUGS

GlaxoSmithKline (GSK) said challenging trading conditions, particularly in the U.S. primary care market led to sales declining 8% for the year to $30.8 billion.

The standout event of the year for GSK was the major three-part transaction with Novartis involving its consumer healthcare, vaccines, and oncology businesses. The two companies will create a new consumer healthcare business, for which GSK will have majority control with an equity interest of 63.5%.

GSK will acquire Novartis’ global vaccines business—excluding influenza vaccines—for an initial cash consideration of $5.25 billion and subsequent potential milestone payments of as much as $1.8 billion, as well as royalties on sales.

Finally, Novartis will acquire GSK’s marketed oncology portfolio, related R&D activities, and rights to its AKT inhibitor and future products, for approximately $16 billion.

The Novartis OTC portfolio is highly complementary to GSK’s and has many well-known brands such as Voltaren, Excedrin, Otrivin and Theraflu.

Also during the year, Avalon Ventures launched two new companies through its collaboration with GSK—Silarus Therapeutics and Thyritope Biosciences. Each will receive as much as $10 million in financing and R&D support from Avalon and GSK. Both companies will be located at COI Pharmaceuticals in San Diego, an innovation center established by Avalon to provide an R&D facility and operational support to its life science portfolio companies.

Clovis Oncology entered into a clinical trial collaboration with GSK to evaluate a novel combination therapy targeting mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC). The Phase 1/2 trial of rociletinib in combination with trametinib is planned for 1H15. The trial will assess the safety and activity of the combination in patients with EGFR mutant NSCLC who were previously treated with an EGFR tyrosine kinase inhibitor (TKI).

Roivant Neurosciences Ltd. entered into an agreement with GSK to acquire SB742457, a selective 5-HT6 receptor antagonist with the potential to improve cognition and function in multiple central nervous system disorders.

Following approvals received in 2013 for respiratory products Breo Ellipta and Anoro Ellipta, Tafinlar and Mekinist in oncology and Tivicay in HIV, GSK received four further approvals in 2014: Incruse Ellipta and Arnuity Ellipta in respiratory, Triumeq in HIV and Tanzeum for type 2 diabetes. GSK is awaiting FDA decisions on Breo Ellipta for use in asthma and mepolizumab, a first-in-class anti-IL5 treatment for severe eosinophilic asthma. GSK says this year it expects as many as 25 Phase II or III starts.

In its advanced pipeline GSK sees significant potential, for example, from its vaccine to prevent shingles, a triple combination therapy for COPD and a new long acting HIV treatment, cabotegravir. In addition to these GSK has a number of exciting early stage assets in therapy areas such as immuno-inflammation, immuno-oncology and cardiovascular disease and a number of prophylactic and therapeutic vaccine candidates.

GSK may have dropped a place in the Top 25 this year but it has certainly been busy in terms of acquisitions, collaborations and divesting parts of its business. GSK began the year acquiring the rest of GlyconVaxyn for the sum of $190 million. This was followed in March by a deal with Novartis acquiring most of its vaccine division, creating a new consumer health care joint venture, and selling off its oncology business. Around the same time GSK sold its opiates business to India-based Sun Pharma. Finally, Irish-based Perrigo recently announced that it has acquired a portfolio of GSK’s well-known OTC brands.

The end of 2014 wasn’t kind to GSK after the whopping fine and bad publicity that followed the China bribery scandal, but the company is working hard to move on in 2015. With the filing of applications in the U.S. and Europe late last year for mepolizumab, its injectable for the treatment of severe asthma, it may have another blockbuster in the making. Having made a very public announcement to illustrate improvements to its modus operandi it is still going to have to do some polishing to shine up its corporate image.

—Adele Graham-King

Headcount: 99,451
Pharma Revenues: $41,61 (31%)
Net Income: $9,350 (-1%)
R&D BUDGET: $6,46 (83%)

TOP SELLING DRUGS

The past few years have been good for GSK, which boasts a record number of new drug approvals. However, they haven’t been without their challenges. Last month, GSK received a Warning Letter from FDA for some problems with cGMPs at its flu vaccine manufacturing plant in Ste. Foy, Quebec. The company continues to investigate allegations of physician bribery and worse, which began in China two years ago, but have since extended to other parts of the world.

GSK leaders have reportedly pledged to stop paying outside doctors to promote its products and end other incentives, and plan to step up recruitment of in-house physicians by up to 20%.

These goals jibe well with the company’s overall goal of increasing transparency. GSK has made great progress in creating a more transparent culture, and has led the industry in improving patient access to medicines, as measured by Wim Leereveld’s Access to Medicines index. The new index will be released later this year, but GSK has held the number one position for several years.

The company has committed to make more of its clinical research data transparent. In 2013, GSK publicly supported the AllTrials campaign, and became the first company to commit to publishing detailed clinical study reports for its medicines. The company also launched an online system allowing researchers access to anonymous patient level data from clinical trials.

To avoid any suggestions of conflicts of interest, company managers plan to stop direct payments to healthcare professionals for speaking engagements and for attendance at medical conferences, and to separate sales team remuneration from prescription generation.

In the past few years, GSK has begun to insource, or take more key operations back inhouse, to help simplify its supply chain. It has also sold off some product lines that didn’t seem to fit, including anticoagulants and consumer healthcare drinks.

CEO Andrew Witty has bucked the industry trend of blaming high drug costs on R&D costs by arguing that R&D needs to become more efficient. The company has also developed some innovative approaches to R&D that appear to be paying off.

Witty was quoted in the UK press as saying that the company’s rate of return on R&D investment has increased by roughy 30% over the past four years because fewer drugs are failing.

GSK has reorganized its research into hubs or centers of excellence called discovery performance units. Each unit is staffed with a crossfunctional team of scientists focusing on one specific research area and functions, like a biotech company.

Making R&D more competitive
Ideas for funding are pitched to a discovery investment board headed by a R&D chief, a biotech CEO, senior public health official, and executives running the company’s discovery, development and business development divisions. Each DPU receives initial funding with additional money coming once project goals are met.

To encourage academic partnerships, the company started a Discovery Fast Track Challenge to help speed the transformation from early stage research into new product development.  Scientists submit details on their research and those selected collaborate on early stage research with GSK’s Discovery Partnerships with Academia, to test hypotheses and targets. If they come up with a winning compound, the winning investigators could be offered a formal DPAc partnership and opportunity to work together on the development of a potential new medicine.

Instead of oncology, the company is focusing on vaccine development and other areas, including consumer healthcare. Earlier this year, the company agreed to sell its oncology drug portfolio to Novartis for about $26 billion, receiving control of Novartis’ non-flu vaccine businesses in return. GSK will also be the majority partner in a consumer healthcare venture with Novartis.

Novartis will benefit from GSK’s approvals this year, which include ofatumumab (Arzerra Injection, for intravenous infusion) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL and  trametinib (Mekinist tablets)), and dabrafenib (Tafinlar) capsules, for use in combination in the treatment of metastatic melanoma.
With Theravance, the company has filed for approval of the COPD and asthma inhaler Breo Elliptica (fluticasone furoate/vilanterol). It is also working with J&J to develop new HIV medications.

Results have been mixed for its cardiovascular drugs. So far, darapladib, acquired when it bought Human Genomic Sciences, has failed to show significant benefits in Phase III. The company is now also evaluating losmapimod, which has been developed to help prevent repeat heart attacks.

Operational Excellence and ERP Investments
The company has launched a Major Change program, aiming to improve supply chain processes, manufacturing and R&D.  GSK expects to see 1 billion pounds of annual savings by 2016.  In 2013, these programs generated 3 billion pounds in savings.
Operational Excellence initiatives launched in 2007 are expected to result in significant savings this year.

GSK is also improving manufacturing and supply efficiency, and has invested in enterprise resource planning (ERP) system, to improve overall efficiency and to allow for better forecasting.

Headcount: 99,488
Pharma Revenues: $33,787 (-5%)
Total Revenues: $41,885 (-5%)
Net Income: $7,518 (-14%)
R&D Budget: $6,042 (-3%)

Top Selling Drugs

Account for 58% of total pharma sales, same as in 2011

GlaxoSmithKline is at a crossroads. Year-in and year-out, GSK is among the biggest of the big, but its overreliance on a single product has made it vulnerable and has left the company searching for the way forward. It’s suffered a boatload of patent expirations, but none have been as damaging as those that beset the competitors ahead of it in our ranks.

GSK is the first company in this year’s list to have an utterly out-of-whack™ ratio between its top seller and its second-best performer. In this case, Advair brought in 6.4 times the revenues of Avodart. In fact, Advair garnered more sales than all of GSK’s other blockbusters combined.

That’s not as bad as some other companies in our ranks, as you’ll see. To be fair, had diabetes treatment Avandia not been reduced to rubble by a super-restrictive REMS program, GSK would have had a little more balance in its portfolio. Still, it sets up a situation where GSK has to rely on Seretide staying ahead of next-generation asthma and COPD treatments (and that its unique delivery method remains difficult to substitute). Can they get their pipeline to pay off in time?

GSK finally completed its hostile(ish) takeover of development partner Human Genome Sciences in August 2013, raising its initial bid by $1.0 billion to top out at $3.6 billion. The move brings lupus treatment Benlysta and HGS’ bio-pipeline under GSK’s aegis. Benlysta posted sales of $110 million in 2012.

In February 2013, decided on an “expansion of our new major change programme,” which is British for “more restructuring.” The move piggybacks the restructuring announced in 2Q12, and is expected to yield $1.5 billion in savings by 2016, at a cost of $2.3 billion. Part of the move entails reducing its presence in Europe due to the “sustained shift . . . in the European reimbursement and pricing environment.” GSK’s sales in Europe dropped 7% in 2012 and fell 3% in 1Q13 as a result of government price cuts.

During its 1Q13 earnings announcement, GSK announced plans to establish a Global Established Products portfolio of “tail” pharma products. The group should include around 50 products with annual sales of $4.5 billion, and will have its own management group. Sales for that segment will be split out beginning in 2014, but there’s no GSK talk (yet) of spinning GEP into its own company. In a conference call, chief executive officer Sir Andrew Witty said the move “opens up optionality for us in the future,” which is British for “maybe.” GSK is also looking to sell its Lucozade and Ribena drink brands, which some analysts contend could bring in around $1.5 billion.

Those structural fixes will help juice earnings, but GSK needs to see pharma growth soon. The company has had a number of FDA approvals recently, including two oral treatments for melanoma, COPD drug BREO Ellipta, a quadrivalent flu vaccine, and an anti-toxin for inhalational anthrax. There are also applications pending in the U.S. and EU for albiglutide, a once-weekly diabetes treatment. The NDA was filed in January 2013, so that might take a while to process.

Peak combined sales estimates for the two melanoma drugs range from $750 million to $2.3 billion, while BREO Ellipta, a new combination treatment co-developed with Theravance, could become the successor to Advair. No one is projecting $8 billion in revenues for the once-daily drug, especially because it hasn’t been cleared to treat asthma, but some estimates do range as high as $4 billion in annual sales.

There’s a multi-billion-dollar question mark at the center of GSK. An FDA advisory panel recently voted to reduce the REMS program on diabetes treatment Avandia, after “reanalysis” of the controversial trial that showed increased risk of heart attacks and strokes. If the FDA acts on the panel’s advice, will GSK be able to benefit? The company hasn’t expressed any interest in widening Avandia’s use, and the drug lost its patent protection 2011. It brought in $3.2 billion in 2006, before evidence arose of its increased risk of heart attacks.

GSK faces some tough headwinds in Europe. Alternatives to Advair, the loss of Vesicare (expired co-marketing pact), and well as generic erosion for a number of products, including Valtrex, Paxil, Lamictal, Combivir, has left the company in a mild decline. For 2012, that puts GSK ahead of the game. If BREO Ellipta and the myeloma drugs can break big in their markets, and abiglutide can get off the launch pad, GSK might be in a good position when its next round of patent expirations hit in 2015.

Acquisition News
Target: Okairos
Price: $325 million
Announced: May 2013
What they said: “Okairos’ technology complements GSK’s existing vaccine technology and expertise and will enable GSK to continue its work developing the next generation of vaccines. The deal also includes a small number of early stage assets.”

—press statement

Outsourcing News
GSK didn’t make any new major outsourcing announcements in the past year, but it did sign a multiyear extension of its drug development services pact with Aptuit. That deal covers work at Aptuit’s Center for Drug Discovery & Development in Verona, Italy, a site that Aptuit bought from GSK in 2010.

GSK also extended its finance and accounting partnership with Genpact for five years. In January 2013, Paul Fry, senior vice president for Finance Services in GSK’s Core Business Services, said, “Our continued partnership with Genpact is a key element in our drive to deliver simpler, more efficient and standardized business processes for GSK.”

Settle Up
Shortly after last year’s issue went to press, GSK pulled a Michael Corleone and settled a whole lot of accounts. In this case, the company made $3 billion in settlements with the feds and the states (and D.C.) regarding Medicaid fraud, Avandia marketing, and improper sales and marketing of numerous products, including Paxil, Wellbutrin, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex, and Advair. As part of the settlement, GSK entered into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services. The CIA also covers some of GSK’s manufacturing operations, because of the fallout from its former manufacturing site in Cidra, PR.

In smaller-scale nuttiness, GSK fired the head of its China R&D unit, Jiangwu Zang, after learning that a study from his unit published in Nature Medicine contained false data. The study didn’t involve patients directly, but did use some blood samples. At press time, there was no word as to whether this was an isolated incident, or if GSK is searching other trials from Mr. Zang and his team for questionable data. [After press time, the China scandal got worse.]

Lowe Down
All year there have been rumors and rumblings about rearrangements inside GlaxoSmithKline. But looking back, that seems fairly normal. They’ve had a number of re-dos in the way that their research departments are set up, each time touted as The Way Things Should Really Be. I’m not sure what they do with all the posters, letterheads, notepads and other stuff that bears the acronyms and logos of the previous systems — if they have a cogeneration plant somewhere, I suppose they could burn it all for fuel.

Some of the big investment firms don’t seem particularly keen on the company, and many of its investors seem fixated on the stock’s dividend, regarding any growth from new drugs as an unexpected bonus. But that dividend will depend on some new drugs coming along (won’t it?), a fact that income investors sometimes seem to lose sight of. GSK has a lot of stuff coming up in front of the FDA, with Breo/Relvar as perhaps the big one. These regulatory hearings will decide GSK’s strategy, their dividend . . . and maybe (if things don’t go so well) another Grand Strategy. Here’s hoping for no new slogans and posters.

—Derek Lowe

Headcount: 96,500
Pharma Revenues*: $36,156 (-2%)
Total Revenues: $43,903 (-1%)
Net Income: $2,865 (-68%)
R&D Budget**: $4,801 (-1%)

* Includes $2.4 billion in revenues from ViiV Healthcare spinoff

** Pharmaceuticals only, not incl. consumer healthcare

Top-Selling Drugs in 2010

Account for 54% of total pharma sales, down from 56% in 2009.

PROFILE

GlaxoSmithKline continued to avoid the mega-merger path to growth, unlike the four companies ahead of it in this year’s ranks. The company has been focused on smaller, market-based buys, continuing its extensive licensing/partnering R&D program, and growing its vaccine business.

Even without a major integration to deal with, GSK still has some big question marks. One-time blockbuster Avandia’s sales plummeted to $680 million in 2010 and will be close to nil in 2011 (a result of being taken off the market in Europe and removed from retail pharmacies in the U.S. (it’ll still be available to a limited set of patients), GSK isn’t quite in the post-Avandia era.

There’s still the pesky problem of class action lawsuits and other litigation to get through. GSK set aside $3.5 billion in January 2011 to cover costs related to Avandia marketing and liability. In 2Q10, the company set aside $2.4 billion for Avandia and other lawsuits. Even if there’s a prompt settlement with the U.S. states and federal government, the liability lawsuits could stretch on for years, although GSK’s been settling large numbers of them in the past year.

GSK is no stranger to years-long litigation. In October 2010, the company paid $750 million to the U.S. Department of Justice and the U.S. Attorney’s Office in Massachusetts following an investigation of the company’s manufacturing plant in Cidra, Puerto Rico. The settlement was the culmination of an eight-year investigation (!) into manufacturing practices at Cidra, first cited by FDA in 2002. The allegations were so egregious and hair-curlingly bizarre that I don’t even want to list them here. (I will, however, direct you to http://bit.ly/9IJPk5 for more, courtesy of Jim Edwards at BNet.)

Every major pharma (sadly) has its share of lawsuits and liabilities, so let’s look at the rest of GSK. While Avandia’s sales kept plummeting, the company took a double-whammy in 2010, as generic Valtrex ate up $1.2 billion in revenues and the previous year’s one-time boost of flu treatment Relenza left a $1.0 billion hole to fill. GSK also dropped nearly $1.0 billion in revenues in 2009 from Lamictal’s patent expiration. It’s a good thing that the British Pound was relatively stable with the previous year’s average; in our last edition, the value of the GBP collapsed from 2008 to 2009, walloping GSK’s results.

In a sense, all those things are minor worries. The big fear at GSK is that someone will market a generic version of Seretide/Advair. The patents for the active ingredients in GSK’s top seller have already expired in the U.S., but the patents for its Diskus delivery system, which is critical for achieving substitutability, are protected for years to come in this market. Generics makers won a key court ruling in Germany in May 2010, but it may not be applicable outside that market.

In May 2011, Swedish regulators approved a generic version of the two active ingredients in a different delivery system than GSK’s Diskus. This version could begin eating away at GSK’s revenues in Europe, but there doesn’t appear to be anything imminent in the U.S. market. A Wall Street Journal report quoted GSK’s chief executive officer, Andrew Witty, as saying, “We have seen all sorts of people stub their toe on what everybody thought was a very easy proposition [copying Advair]. I remain of the view that we are likely to have Advair as a very major product for GSK for a very long time.”

Advair’s sales dropped 2% in 1Q11, caused by retail de-stocking in the U.S., discounts from austerity measures in the EU and price cuts in Turkey and Russia. Except for Pfizer, no company in our list has a bigger gap between the sales of its top two products: Lipitor to Enbrel had a $7.5 billion gap in 2010, while Advair to Flovent had $6.7 billion separating them last year.

As I mentioned at the outset, GSK has been aggressive over the years when it comes to partnerships and in-licensing. In fact, of the 10 drugs it moved into Phase III in 2010, eight of them were in-licensed or co-developed. Several of those alliances began to pay off in the past year. GSK and Valeant received approvals for a pair of epilepsy treatments: Trobalt (EU only, in March 2011) and Potiga (U.S. only, in June 2011). Both drugs have estimated peak sales of around $800 million, although Valeant apparently has been projecting sales of $1.5 billion for Potiga.

The approval that got the biggest news was Benlysta, the Lupus treatment that GSK co-developed with Human Genome Sciences. Some analysts think sales could reach $3.5 billion by 2015, and top out at $5 billion.

On the negative side of that scale? GSK’s $720 million acquisition of Sirtris in 2008. The lead compound in that acquisition, a formulation of reservatrol (found in red wine), was cancelled after a trial in multiple myeloma led to kidney damage in patients. According to The Myeloma Beacon, GSK noted that “the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute renal failure.” GSK ended all development of SRT501, which had been studied against diabetes, Alzheimer’s disease, obesity, and cancer treatment and prevention, and opted to try out some earlier phase compounds from Sirtris’ pipeline. (Also, two of the Sirtris executives bizarrely joined a non-profit group that was selling reservatrol supplements online.)

Readers seem to love sports meta-phors (okay, “Some readers”), so in the wake of the 2010-11 NBA Finals, I’m left to wonder whether GSK is the Dallas Mavericks of our top five companies? Instead of being loaded with a roster of huge sellers, GSK has one outsized star (Advair = Dirk Nowitzki) accompanied by a bunch of solid, but not spectacular contributors (with Flovent playing the role of Jason Terry). Maybe it’s not as apt a comparison as the Pacers/Lilly one I made a few years ago, and GSK didn’t exactly plan to have a drug portfolio like this one, but it could be a snapshot of how big pharma will look in the years to come. (This metaphor would’ve held up a lot better if the Mavs had a player who had been inducing heart attacks in fans for years. Like John Starks.)  —GYR

OUTSOURCING NEWS

In July 2010, GSK sold off its Medicines Research Centre in Verona, Italy to Aptuit. Approximately 500 GSK staffers transferred over and Aptuit gained a three-year contract to provide R&D services from the site. The site had been slated for shutdown by GSK in February 2010.

In September 2010, GSK sold off its research center in Zagreb, Croatia to Galapagos. That deal included a $20 million R&D contract. The site had previously served as GSK’s Macrolide Center of Excellence for Drug Discovery and before that as an R&D site for Pliva.

Also in September 2010, GSK signed a biomanufacturing pact with Lonza. Initially, Lonza will manufacture clinical trial substances for five biologics in Phase I or II. “Lonza will also provide access to flexible capacity to enable GSK to respond to future demand, dependent upon progression of molecules through late stage development and commercial launch,” according to a GSK statement. The companies will also “assess options for the design, specification, location and construction of a bespoke biopharmaceutical manufacturing facility within the UK.” Terms weren’t disclosed.

In September 2010, GSK also established long-term strategic CRO partnerships with PPD and Parexel, in a move that mirrors the industry trend of narrowing the number of CRO partners.

ACQUISITION NEWS

Target: Nanjing MeiRui Pharma Co., Ltd.

Price: $70 million

Announced: December 2010

What they said: “GSK will gain access to this portfolio of [urology and allergy] products, as well as MeiRui’s established sales and marketing platform and a manufacturing facility in Nanjing City, Jiangsu Province, China.”

—Company statement

Target: Shenzhen Neptunus

Price: $39 million for 51% it did not previous own in JV

Announced: June 2011

What they said: “This announcement represents an expansion of GSK’s long-term commitment to vaccine supply, manufacturing and development in China.”

—John Lepore, vice president and general manager, Biologicals and Corporate, GSK China

THE LOWE DOWN

The jury’s still out on all the moves that GSK’s been making over the last few years. That’s one of the problems with drug development: the process is so lengthy that the jury stays out for a heck of a long time. The only thing you can be sure of is that your patents are eventually going to run out, and that’s what’s happening soon to Advair, which has been  bringing in (up until now) billions of dollars.

As usual, there’s no convenient multibillion-dollar candidate popping up to replace it. Relovair was supposed to move into that slot in the portfolio, but hasn’t been as impressive in the clinic as it needs to be. GSK does have a lot of interesting stuff earlier in its pipeline, such as some cancer vaccine work and whatever might come out of the Sirtris deal. But those are a ways off, and with Advair disappearing (and Avandia already gone), you have to think it’s going to be pretty lean around the place for a while. But if there’s any more bad news, GSK may go out and do something even weirder than their Sirtris acquisition. —Derek Lowe

Previous Profile: Sanofi // Next Profile: AstraZeneca

Headcount: 99,913
Pharma Revenues: $36,746 (-3%/+15%)
Total Revenues: $44,422 (-2%/+16%)
Net Income: $8,877 (+2%/+20%)
R&D Budget: $6,181 (-6%/+113%)

Revenues converted at average exchange rate / based on reported currency (GBP)

Account for 58% of total pharma sales, same as in 2008.

PROFILE

We’re only up to company #4, and it already sounds like a broken record. But here it is: Glaxo-SmithKline is trying to adjust to the new pharma realities and a massive patent losses and less-than-expected R&D success by increasing its consumer operations, expanding into emerging markets, building its vaccines and biologics franchises, and selling branded generics.

In its 1Q10 financial announcement, GSK noted that its traditional sales model — described as “white pills/ western markets,” which would make a tremendous name for an indie rock band — now comprises only 27% of sales. And how were those sales? Thanks to a 16% drop in the average value of GSK’s reporting currency, the Great Britain Pound (GBP), GSK tumbled out of our top three. At 2008’s exchange rates, the company would have posted pharma revenues of $43.5 billion, a sum that would’ve squeaked it past Sanofi-Aventis for the #2 slot. But if we knew how to guess exchange rates, we’d all be George Soros.

This is one of those instances where the exchange rate really wreaks havoc with the basic results. For instance, Seretide/Advair posted 20% growth in GBP, but that comes out to a mere 2% boost after conversion. However, Lamictal really did get devastated by generic competition, falling 46% in GBP and 54% in dollars, for a billion-dollar drop.

And GSK sure has gotten used to billion-dollar lurches. Relenza added a huge sum to GSK’s bottom line, thanks to H1N1 pandemic panic, while Avandia/Avanda-met, which topped $3 billion in sales in 2006, continued to decline because of safety fears, posting a “mere” $723 million in 2009 revenues.

In February 2010, the New York Times cited an internal — but not unanimous — FDA report that contends Avandia causes more than 500 heart attacks and 300 cases of heart failure every month (and that these could be prevented by switching patients to Takeda’s Actos). This was followed by a staff report from the U.S. Senate Finance Committee, accusing GSK of knowingly covering up safety concerns for several years before Dr. Steve Nissen’s meta-analysis of Avandia trials first raised concerns in 2007.

GSK strenuously objected to those complaints. The company hopes that its new mega-trial, TIDE, will end the debate over Avandia’s safety. However, the trial is scheduled to run until 2020, and Avandia’s U.S. patent expires in 2012, so there’s no chance it’ll bring about a commercial resurgence for the product. (The company hopes to have interim data to show the FDA in 2014.)

R&D: Moving Out

GSK is trying to break out of its traditional mold by restructuring its R&D model. Last year, we covered the company’s finer-grained CEDD/DPU model for discovery and development, which GSK hopes will help reach its goal of around 30 “assets” in late-stage development at all times. In February 2010, the company announced that it was expanding its ongoing $5.6 billion restructuring plan with a new $1.4 billion series of cutbacks that will include R&D. Half of the $750 million annual savings from this round will come from R&D. The company plans to cut development in the depression and pain areas of neuroscience, focusing research on Alzheimer’s, MS and Parkinson’s disease.

In a financial release, chief executive officer Andrew Witty pointed out that 30% of GSK’s drug discovery research is external, generally via option-based deals. The company plans to increase the number of those deals. Paul Trennery, head of Scinovo, GSK’s preclinical development “broker,” told us in our exclusive interview (Contract Pharma January/February 2010), “There’s an expectation that each CEDD should work toward having a proportion of their discovery activity via external partnerships. Some are already doing much, while others are working toward it. . . . Over our whole portfolio, we think that, by 2015, about half of our pipeline will come from external innovator companies.”

GSK filed a BLA for one those externally licensed drugs, Benlysta, a MAb developed by Human Genome Sciences, in June 2010, and may make history with the first new treatment for systemic lupus erythematosus (SLE) in 50 years. Given existing treatments’ failure in SLE trials, Benlysta could become a billion-dollar drug for GSK and HGS.

Drawing a New Map

The company pulled off several deals to move into new geographic regions in the past 12 months, expanding on the previous year’s initiatives:

• July 2009: Acquired BMS’ branded generics business in Lebanon, Jordan, Syria, Libya and Yemen for $23, following 2008 acquisition of BMS’ portfolio in Egypt and Pakistan.
• August 2009: Expands partnership with Fiocruz to develop and manufacture vaccines in Brazil, starting with Synflorix.
• October 2009: Forms JV with Walvax for pediatric vaccines, starting with Priorix, for use in China.
• December 2009: Expanded its deal with Aspen Pharmacare to cover more of sub-Saharan Africa.
• May 2010: Bought 9.9% of South Korea’s top pharma/OTC company, Dong-A, and will co-promote products in that country.
• June 2010: Bought a presence in Argentina via Laboratorios Phoenix (See Acquisition News).

In July 2009, GSK signed a deal with Amgen in July 2009 to help commercialize Prolia in Europe, Australia, New Zealand and Mexico, leveraging its expertise and salesforce in osteoporosis. GSK will also register and sell Prolia in emerging markets where Amgen has no presence, like China, Brazil, India and South Korea.

For all of its marketing expansion into emerging markets, GSK has also been praised for trying to improve health in regions that are too poor to afford most new treatments. GSK handily scored the top rank in the Access to Medicine Index, beating out other major pharmas.

As I noted at the top, GSK is sounding the same notes as other top pharmas. It’s too late for “everything to go right” and enable the company to weather the 2013 loss of Seretide/Advair smoothly. GSK will need to execute outside of white pills/western markets — and it’ll need the GBP to bounce back — to avoid becoming an also-ran.

Return to Top Pharma Report homepage.

Headcount: 99,003
Pharma Revenues: $37,810 (-1%/+6%*)
Total Revenues: $45,177 (-1%/-7%*)
Net Income: $8,742 (-18%/-13%*)
R&D Budget: $6,599 (+3%/+10%*)

* Converted at avg. exch. rate / based on local currency (GBP)

Account for 60% of total pharma sales, same as in 2007.

Profile

One look at GSK’s top-selling drugs tells you that almost all of them are on the downside of their life-cycles. The only products to show significant growth are Advair/Seretide, Valtrex, and vaccines. Unfortunately, Valtrex will start to see generic competition later in 2009, and the original combination patent for Advair/Seretide expires in September 2010.

In local currency (the Great British Pound or GBP), GSK posted a 6% increase in pharma revenues last year. Unfortunately, the average value of the GBP dropped nearly 8% against the dollar during that span, so that pushes GSK out of the #2 slot. Avandia’s freefall continued, with revenues dropping another 46% in 2008 to $950 million (-42% in GBP). In June 2009, the company released findings that show Avandia has no increased CV risk compared to other diabetes treatments, but the damage to the brand has been pretty severe. In the year since our previous report, GSK has put one new product — Promacta for chronic immune (idiopathic) thrombocytopenic purpura (ITP) — on the market.

GSK, to put it bluntly, is running out of time.

Andrew Witty, who took over as chief executive officer in October 2007, made a formal announcement of GSK’s new strategy in July 2008. He said, “GSK will seek to generate future sales growth through supplementing strength in the core small-molecule pharmaceuticals business, with new investments in fast-growing areas such as vaccines and consumer healthcare and new growth areas such as biopharmaceuticals. At the same time, we are actively seeking to unlock the geographic potential of our different businesses, particularly in emerging economies.”

What does that mean, exactly? Well, one thing it doesn’t appear to mean that GSK is looking to buy another major pharma company in order to bolster its short-term pipeline. Since that announcement a year ago, GSK has continued to make plenty of development collaborations, bought its way into a number of emerging markets, formed a new joint venture with its biggest rival, and cut hundreds of R&D jobs, but it hasn’t made any mention of climbing aboard the major M&A train.

GSK’s biggest splash last year was its $3.6 billion acquisition of Stiefel Laboratories. A post from the WSJ Health Blog by Jacob Goldstein points out, “The acquisition isn’t about some hot new technology, or a promising pipeline. It’s about boring, stable products like acne creams.” The post cited a comment from a USB analyst who contended that Stiefel’s could help boost GSK’s existing dermatology business, while GSK could get Stiefel’s products into more overseas markets.

Speaking of overseas markets, GSK has also made several moves to build its presence in emerging regions around the globe. The same day as Mr. Witty’s new strategy announcement, GSK also signed a deal with Aspen, a South Africa-based pharma company, to commercialize Aspen’s portfolio of branded drugs in emerging markets (Aspen manufactures inexpensively, and GSK pays them a percentage of sales). In May 2009, GSK bought 16% of Aspen and sold a number of specialty meds to the company along with a manufacturing site in Germany. GSK had also sold some brands to Aspen in June 2008. The two companies plan to collaborate on commercializing products in sub-Saharan Africa, not including Aspen’s home country of South Africa. Their combined revenue in that region was $122 million in 2008.

GSK set up a similar deal in June 2009 with Dr. Reddy’s, in which GSK will get access to more than 100 branded drugs that it will market in Africa, the Middle East, Asia and Latin America. The drugs cover CV, diabetes, oncology, gastroenterology and pain management; they’ll be manufactured by Dr. Reddy’s and revenues will be shared. During the year, GSK also acquired rights in emerging markets for several products from UCB and picked up Bristol-Myers Squibb’s Pakistan business and its mature products in Egypt.

I DPU Your CEDD

Of course, GSK isn’t going to get through this period simply by changing itself into a marketing operation for emerging regions. The company still needs to develop (and/or in-license) new drugs. As part of Mr. Witty’s new strategy, GSK has refocused around eight research areas: Immuno-Inflammation, Neuroscience, Metabolic Pathways, Oncology, Respiratory, Infectious Disease, Ophthalmology and Biopharmaceuticals. (I should note that this is GSK’s terminology, as it’s pretty obvious that “biopharmaceuticals” are involved in all of the therapeutic classes that come before it. That said, in GSK’s annual report, the company points out that biopharmaceuticals comprise only 6% of its pipeline, so maybe the DO need to make that its own area of focus.)

The new strategy also granulates the company’s existing Centres of Excellence for Drug Discovery (CEDDs) with Drug Performance Units (DPUs), which will “focus on given biological pathway[s]” and contain between five and 80 scientists. The DPUs will have to compete for investment capital, in an attempt at replicating the entrepreneurial spirit of biopharma startups. They’ll have to develop three-year business plans and convince a Drug Discovery Investment Board that they deserve further funding. The board, according to a GSK statement, “comprises senior GSK R&D leaders and individuals from outside the company operating in the venture capital and Biotech/Pharma investment world.”

Two months after that announcement, the company launched GSK Oncology, which is pretty much what it sounds like: an R&D setup for oncology. The new group “will have the primary goals of identifying new targets and pathways, conducting innovative clinical research and cost-effectively increasing development capacity in order to deliver the unit’s large portfolio of medicines,” said GSK’s chairman of R&D, Moncef Slaoui. That group will contain around a thousand people, which breaks with the DPU model. Evidently, a bigger network is critical for oncology.

GSK hasn’t slowed down its pace of external collaborations, even while trimming its internal R&D. We’ll see if that new model can keep GSK afloat once Advair/Seretide begins its downward slide. Maybe the company will see enough of a revenue boost in 2009 from Relenza — an alternative to Tamiflu to combat the slow-motion swine-flu pandemic — to offset some of its other decliners.

Return to Top Pharma Report homepage.

Headcount: 103,483
Pharma Revenues: $38,501 (+4/-4%*)
Total Revenues: $45,473 (+6/-2%*)
Net Income: $10,630  (+5/-4%*)
R&D Budget: $6,660 (+5/-4%*)

* Decline based on local currency (GBP)

Account for 63% of total pharma sales, same as in 2006.

Profile

Boy, am I glad I’m not in Andrew Witty’s shoes. Sure, the pay must be great; look at the package that his predecessor, J.P. Garnier, received on the way out of GlaxoSmithKline. (The shareholders sure did!) Still, between the patent expirations and the Avandia nightmare, Mr. Witty has some tough times ahead and some thorny decisions to make in his first year as chief executive officer.

Tapped to succeed Mr. Garnier in October 2007, Mr. Witty was in the role of president, Pharmaceuticals Europe at the time of his CEO nomination. Mr. Witty, 43, has been with the company since the age of 21, so he must’ve seen a lot of ups and downs.

It’s currently a “down.” GSK’s 2007 revenues show a 4% uptick in our charts, but that’s only because I insist on converting everything to dollars. In constant currency (the Great Britain pound, in this case), GSK posted a 4% drop in sales. Generic competition for drugs like Coreg (-25% in GBP), Wellbutrin (-41%) and Zofran (-75%) pummeled GSK’s revenues in the U.S. Add (or subtract) a 32% loss in Avandia revenues, and you’ve got the makings of a crisis.

The company posted another 4% drop in GBP in 1Q08, driven by the same factors. The year-to-year drop in Avandia sales was enormous, but that’s an unfair comparison, since Avandia’s heart attack issues hadn’t arisen by 1Q07. A better measure might be comparing 1Q08 to 4Q07: the drug dropped 20% in sales, down to $380 million.

Good thing Advair’s going gangbusters, at $7.0 billion in 2007! I’m nervous about a company’s lead product selling almost 3.5 times more than the #2 product (Lamictal sales were $2.2 billion in 2007), but Avandia would have been slotted right in the low-to-mid-range between the two.

GSK contends that the number of Avandia scrips has stabilized/bottomed out. As outgoing chief executive J.P. Garnier put it in his 1Q07 meeting, “We have stopped the bleeding.” Between that and a June 2008 trial report indicating no increased heart attack risk among Avandia users, GSK is hoping for a rebound for its former #2 drug.

Mixed Results

So, like the rest of the companies on our list, GSK needs to get new products rolling ASAP. The company had several U.S. approvals for new products in the last year, but one was a line extension for a product that went generic (Requip XL) and another was a combo with an existing drug (Treximet for migraines). GSK did get an NCE approved in the past year; Hycamtin capsules (lung cancer) were cleared for marketing in the U.S. in October 2007. GSK is waiting for word on another NCE, Promacta (short-term treatment of chronic idiopathic thrombo-cytopenic purpura (ITP)). On May 2008, an advisory committee did voted 16-0 that Promacta had a favorable risk-benefit profile for the indication, but the FDA bumped its decision of Promacta in June an additional 90 days so it could further review the NDA.

The company has seen several approvals among vaccines. The company gained EU approval for its HPV vaccine Cervarix in September 2007, allowing it to begin competing with Merck’s Gardasil. In June 2008, the UK’s Department of Health selected Cervarix as its vaccine of choice for its national HPV immunization program. GSK submitted the vaccine with the FDA in March 2007 and received a “complete response” letter from the agency nine months later. In June 2008, GSK announced that it will submit new efficacy study data in the first half of 2009, with an FDA decision expected within six months of that submission.

The EU has been kinder to GSK’s vaccine submissions of late. In May, the European Commission approved Prepandrix, GSK’s “bird flu” pre-pandemic vaccine. A pandemic vaccine, which is produced once a pandemic is declared and targets a specific strain of flu, requires four to six months of lead time; a pre-pandemic like Prepandrix is based on currently circulating viruses and can boost immunity before a pandemic can take off.

The company is also awaiting EU approval for Synflorix, a 10-valent vaccine to protect children against invasive pneumococcal disease and bacterial respiratory infections. GSK filed for approval in January 2008.

It’s not like GSK got zero good vaccine news from the FDA this year. In April 2008, the agency approved Rotarix, a two-dose vaccine for prevention of rotavirus gastroenteritis in infants. The product can be given to children earlier than any other treatment for rotavirus, allowing them to complete treatment by four months of age.

Operation

In this year’s recurring storyline, a multi-billion dollar restructuring is one of GSK’s strategies for dealing with its loss in revenues, the slow approval/acceptance of line extensions, and the unpredictability of late-stage trials. The company announced its new Operational Excellence plan in October 2007. It’ll cost $3.0 billion to implement and is intended to yield $1.4 billion in savings by 2010. The announcement didn’t give any specific word on firings, but the company’s financials indicate that the new plan will include some shutdowns:

“In manufacturing, GSK will reduce the overall number of sites operating in its network and simplify processes and site activities to reduce overcapacity. The Group will also continue to seek opportunities to outsource the manufacturing of existing products and for low-cost sourcing of materials, whilst focusing its capability on new products.”

The retooling has also led GSK to shed R&D jobs. I’m somewhat conflicted over that, in general. On one hand, I feel that R&D is the lifeblood of a pharma company and that trimming back that area signifies more serious problems than cuts in manufacturing or sales. On the other hand, I’ve long contended that R&D doesn’t scale; just because your R&D budget is double that of a competitor, it doesn’t mean that you’re going to generate twice as many new compounds.

So, if I’m being intellectually consistent, I have to say it’s fair game to rationalize the R&D budget and look at selective cuts in labs around the world. GSK’s head of drug discovery recently remarked that the company is trying to get more “biotech-like” in its approach.

Every major pharma says this every few years; I’ve concluded that management at major pharmas (I’m not singling out GSK) are either oblivious to the truly endemic problems with scale, or they’re just lying to shareholders. Or both!

I’m not sure what it says about GSK’s faith in R&D, but while those internal cuts have been going on, the company has rolled full-steam ahead on external collaborations. Here’s a partial list of deals in the past year with development companies (note that all deals also include royalties for commercial products):

• Amira Pharmaceuticals — respiratory/CV disease, $425 million in milestones
• Mpex Pharmaceuticals — antibiotics, $15 million upfront, $250 million in milestones per candidate
• Regulus Therapeutics — microRNA for RA and inflammatory bowel disease, $20 million upfront, $144.5 million in milestones for each of four drugs
• Santaris Pharma — viral diseases, $8 million upfront, $140 million in milestones for first four compounds + royalties, $122 million in milestones  for hepatitis C drug
• OncoMed – stem cell treatments for cancer, $1.4 billion in potential milestones
• Galapagos — infectious disease, $7 million upfront, $190 million in development milestones per candidate, $240 in sales milestones (in addition to royalties)
• Anacor Pharmaceuticals — infectious disease, $22 million upfront, $331 million (max.) in milestones per candidate
• Sepracor — Lunivia insomnia (outside North America & Japan), $20 million upfront, $155 million in commercial milestones
• Targacept — CNS, $35 million upfront, $1.5 billion in total milestones for five therapeutic fields
• Tolerx — diabetes, $70 million upfront, $155 million in development costs, $525 million in milestones
• Synta Pharmaceuticals — oncology, $80 million upfront, $885 million milestones for one Phase III candidate

Given these alliances, the recent acquisitions of Sirtris and Reliant (see sidebar), and internal cuts and restructuring in R&D, the new GSK looks like it’s rethinking drug development. I think the biggest factor in staying ahead of #3 Sanofi-Aventis next year is if the GBP beats the Euro in thrashing the U.S. dollar.

Previous Profile: Pfizer // Next Profile: Sanofi-Aventis

Top 20 Pharma Report homepage