Headcount: ~50,000
Revenues: $54,318 (-6%)
Net Income: $4,873 (-59%)
R&D: $7,675 (18%)

In 2023 Abbvie reported a 6% drop in revenue from the previous year due mostly to biosimilar competition for its blockbuster Humira. Once the world’s top-selling drug, sales for the arthritis medicine plummeted 32% to $14.4 billion.

Total revenues for the year of $54.3 billion were primarily driven by Abbvie’s non-Humira growth platform that includes products across immunology, neuroscience, oncology, and aesthetics. Skyrizi and Rinvoq performed exceptionally well. Combined sales of $11.7 billion helped to recoup Humira’s losses. The neuroscience portfolio delivered sales of $7.7 billion, while global sales from the oncology portfolio were $5.9 billion and aesthetics delivered $5.3 billion.

In new product news during the year, AbbVie launched Produodopa in the EU for the treatment of advanced Parkinson’s disease. In other pipeline progress, lutikizumab showed positive results in a Phase 2 trial in adults with moderate to severe acne inversa. Positive results were released from the Phase 2 Luminosity trial evaluating telisotuzumab-vedotin (Teliso-V) in patients with lung cancer. New data was also released for Epkinly (epcoritamab) which showed strong, durable treatment response for patients with lymphoma—the U.S. FDA also granted breakthrough therapy designation to the cancer treatment.

Acquisitions

2023 was quiet on the acquisition front for Abbvie until the end of the year when in December it announced the acquisition of ImmunoGen, expanding its commercial and clinical presence in the solid tumor space. The $10.1 billion deal brings with it access to the flagship cancer therapy Elahere, a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC). Elahere received U.S. FDA accelerated approval in 2022 and is the first targeted medicine to show meaningful survival benefit in PROC.

ImmunoGen’s follow-on pipeline of next-gen ADCs complements AbbVie’s ADC platform and existing programs. Its pipe includes a Phase 1 asset, IMGN-151, a next-gen anti-FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications. Pivekimab sunirine, in Phase 2 at the time of the deal, is an anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.

About a week after the ImmunoGen deal was announced, AbbVie inked another agreement to acquire Cerevel Therapeutics and its neuroscience pipeline of multiple clinical-stage and preclinical candidates with potential across schizophrenia, Parkinson’s, and mood disorders, for approximately $8.7 billion. The acquisition complements AbbVie’s neuroscience portfolio, adding a wide range of potentially best-in-class assets that may transform standards of care across psychiatric and neurological disorders where significant unmet needs remain for patients. Cerevel’s late-stage asset emraclidine is a potential best-in-class, next-generation antipsychotic that may be effective in treating schizophrenia. In addition, emraclidine has potential in dementia-related psychosis in Alzheimer’s disease and Parkinson’s.

In another smaller deal, AbbVie acquired Mitokinin, a biotechnology company developing a potentially first-in-class treatment for Parkinson’s Disease for $110 million at closing and up to $545 million upon the achievement of certain development and commercial milestones, plus royalties on sales. Mitokinin’s lead compound, a selective PINK1 activator, is designed to address mitochondrial dysfunction that is believed to be a major contributing factor to Parkinson’s disease pathogenesis and progression.

Collaborations

During the year, Abbvie continued to push its R&D initiatives forward through several collaborations. With Immunome, a clinical-stage biotech that utilizes its human memory B cell platform to develop first-in-class antibody therapeutics, it entered a worldwide collaboration and option agreement to discover up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome’s Discovery Engine. Immunome gave AbbVie the option to purchase worldwide rights for up to 10 novel target-antibody pairs arising from the selected tumors.

AbbVie and Anima Biotech entered a collaboration to discover and develop mRNA biology modulators for three targets across oncology and immunology. Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs.

Capsida Biotherapeutics and Abbvie expanded their strategic collaboration to develop genetic medicines for eye diseases with high unmet need. AbbVie’s capabilities will be paired with Capsida’s novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs. The collaboration builds upon the neurodegenerative disease partnership announced in 2021.

The Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the Emirate, signed a Memorandum of Understanding with AbbVie and M42 for collaborative efforts in tailoring personalized medicine and genomics in Abu Dhabi. M42 is a tech-enabled, integrated healthcare company comprised of G42 Healthcare and Mubadala Health. The three parties aim to advance precision medicine in the diagnosis and treatment of multiple myeloma and non-small cell lung cancer. DoH aims to drive research that will contribute to policy changes and guideline implementation which will enable broader patient access to innovative approaches in healthcare.

In another partnership, AbbVie and Calibr expanded their collaboration to advance several innovative preclinical and early-stage assets across AbbVie’s core therapeutic areas including immunology, oncology, neuroscience, and other areas of interest. The partnership with AbbVie and Scripps Research was formed in 2019 to develop a broad range of potential new therapeutics.

AbbVie and Umoja Biopharma, an early clinical-stage biotechnology company, announced two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology using Umoja’s proprietary VivoVec platform. The first agreement provides AbbVie an exclusive option to license Umoja’s CD19 directed in-situ generated CAR-T cell therapy candidates including UB-VV111, Umoja’s lead clinical program for hematologic malignancies. Under the terms of the second agreement, AbbVie and Umoja will develop up to four additional in-situ generated CAR-T cell therapy candidates for discovery targets selected by AbbVie.

Lastly, AbbVie and BigHat Biosciences formed a research collaboration to leverage artificial intelligence (AI) and machine learning to discover next-generation therapeutic antibodies. Working closely with AbbVie, BigHat will utilize its Milliner platform, a suite of machine learning technologies integrated with a high-speed wet lab, to guide the design and selection for high quality antibodies for multiple therapeutic targets.

Headcount: ~50,000
Revenues: $58,054 (+14%)
Net Income: $11,845 (+3%)
R&D: $6,510 (-6%)

In 2022, AbbVie reported revenues of more than $58 billion, reflecting a 3% increase over 2021. In addition to the $21 billion of revenues reported for blockbuster Humira, growth was driven by the neuroscience portfolio and the performance of immunology growth drivers, Skyrizi and Rinvoq, which generated nearly $7.7 billion last year combined.

The company’s full-year worldwide revenues from the Hematologic Oncology portfolio stood at $6.6 billion, a 9% decline. Imbruvica and Venclexta net revenues worldwide were $4.6 billion and $2.0 billion, respectively. The Neuroscience portfolio reported full-year global net revenues of $6.5 billion, which represented a 10% rise on a reported basis. Global Skyrizi and Rinvoq revenues were $5.2 billion and $2.5 billion, respectively.

In June 2022, U.S. FDA approved Skyrizi as the first and only specific interleukin-23 (IL-23) to treat moderately to severely active Crohn’s disease in adults. Later in the year, the drug also received European Commission (EC) approval for this indication.

During the year, FDA also approved Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval marks the fourth indication for Vraylar.

AbbVie also announced that the U.S. FDA accepted, for priority review, the Biologics License Application (BLA) for epcoritamab, an investigational subcutaneous bispecific antibody for the treatment of adult patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL).

Drug discovery and development partnerships

In March 2022, Abbvie acquired Belgium-based company Syndesi Therapeutics in a deal worth up to $1 billion, expanding its neuroscience portfolio. Syndesi received an upfront payment of $130 million and is entitled to get further contingent payments of up to $870 million on meeting specific milestones.

Established in 2017, Syndesi focuses on developing new treatments that regulate synaptic activity to alleviate cognitive impairment symptoms. With the acquisition, AbbVie gains ownership of Syndesi’s portfolio of new synaptic vesicle protein 2A (SV2A) modulators, including its lead small molecule, SDI-118. The mechanism is being studied to potentially treat cognitive impairment and other symptoms linked to various neurodegenerative and neuropsychiatric diseases such as major depressive disorder and Alzheimer’s disease.

In another deal, AbbVie acquired the UK-based biotech DJS Antibodies for $255 million. DJS focuses on the discovery and development of antibody therapies that act on difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs). The company leverages its HEPTAD platform to facilitate the antibody discovery of GPCRs and other difficult targets. Its lead program, DJS-002, is a potential first-in-class lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody. The antibody is being analyzed in investigational preclinical studies to treat idiopathic pulmonary fibrosis (IPF) and other fibrotic ailments.

With the takeover, AbbVie gains access to the HEPTAD platform. Leveraging HEPTAD, DJS generated an exclusive pipeline that comprises DJS-002. Apart from the acquisition price, the shareholders of DJS are entitled to receive potential further payments on meeting specific development milestones linked to the success of the DJS-002 program.

Collaborations

During the year Abbvie tightened ties with Sosei Heptares when it entered a new multi-target collaboration to discover, develop and commercialize novel medicines targeting neurological diseases. The new strategic collaboration leverages Sosei Heptares’ StaR technology and SBDD platform and AbbVie’s extensive neuroscience expertise. It is the second collaboration between the two companies and following a 2020 agreement focused on inflammatory and autoimmune diseases. Sosei Heptares is eligible to receive up to $80 million in upfront and near-term milestone payments and has potential to receive further downstream payments totaling up to $1.2 billion, plus royalties.

In another collaboration, AbbVie and HotSpot Therapeutics, a biotech developing small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, entered an exclusive worldwide collaboration and option to license agreement for HotSpot’s discovery-stage IRF5 program for the treatment of autoimmune diseases. HotSpot received $40 million upfront and may be eligible to receive as much as $295 million in option fees and R&D milestones, as well as royalties on sales.

IRF5 is a transcription factor that acts as a key regulator of certain types of immune responses, and its dysregulation is strongly implicated in several poorly treated autoimmune disorders. Efforts to modulate IRF5 using conventional small molecule approaches have been unsuccessful because IRF5 lacks a traditional active site. Leveraging the Smart Allostery platform, HotSpot discovered what it believes to be the first and only disclosed small molecule IRF5 inhibitor that targets a previously unknown allosteric pocket on the protein that is critical for its endogenous regulation—a “natural hotspot.” Should AbbVie exercise its option to license, AbbVie will conduct all future development and commercialization activities for the IRF5 inhibitor program.

Dragonfly Therapeutics, a biotechnology company developing novel immunotherapies that harness the immune system to treat disease, expanded its research collaboration with AbbVie to develop Dragonfly’s novel immunotherapies for new targets in autoimmune and fibrotic diseases. AbbVie successfully licensed its first TriNKET drug candidate from Dragonfly, part of a multi-target collaboration initiated in November 2019, in January 2021.

Gedeon Richter and Abbvie entered a new co-development and license agreement to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. The collaboration is based on the results of preclinical research carried out by Richter and includes several new chemical entities selected for development. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as cariprazine (Vraylar/Reagila).

AbbVie and Cugene, a clinical-stage biotech focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer, entered an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases.

In December 2022, Vancouver, British Columbia-based AbCellera entered a multi-year, multi-target strategic collaboration with Abbvie, leveraging its antibody discovery and development engine to deliver optimized development candidates for up to five targets selected by AbbVie across multiple indications. Under the terms of the agreement, AbbVie has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive downstream clinical and commercial milestone payments and royalties on net sales of products.

AbbVie and Immunome, a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, formed a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome’s Discovery Engine.

Lastly, AbbVie and Anima Biotech partnered to discover and develop mRNA biology modulators for three targets across immunology and oncology. Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs.

Headcount: 50,0000
Revenues: $56,197 (+23%)
Net Income: $11,542 (+150%)
R&D: $7,084 (+8%)

TOP SELLING DRUGS

Operating as a single global business segment dedicated to research and development, manufacturing, and commercialization of innovative medicines and therapies, AbbVie’s portfolio of products include therapies that address complex and serious diseases. Key among its products are immunology therapies, namely Humira, which is sold in markets globally and accounted for approximately 37% of AbbVie’s total revenue in 2021, despite biosimilar competition in numerous markets.

Recently Abbvie resolved all U.S. Humira litigation with Alvotech, under which, AbbVie will grant Alvotech a non-exclusive license to its Humira-related patents in the U.S., which will begin on July 1, 2023. AbbVie will make no payments to Alvotech, and Alvotech will pay royalties to AbbVie for licensing its patents. The resolution includes dismissal of the patent and trade secret litigation between the two companies.

Fast becoming another flagship product, Skyrizi (risankizumab), a biologic therapy for psoriasis administered as a quarterly injection following two induction doses, achieved sales nearing $3 billion, up 85% in 2021 and becoming third in line in sales. Meanwhile, Rinvoq (upadacitinib), an oral, once-daily selective and reversible JAK inhibitor to treat inflammatory diseases, with recent approvals and expanded indications saw sales up over 100%.

Abbvie’s next top seller Imbruvica, a hematologic oncology treatment developed and commercialized in partnership with Janssen Biotech, Inc., recently demonstrated significant survival outcomes in older adults. Primary seven-year data from Janssen’s Phase III trial of Imbruvica in lymphoma demonstrated the drug’s ability to reduce the risk of disease progression by 25% when combined with bendamustine-rituximab and rituximab. Abbvie is currently seeking approval for the treatment of pediatric and adolescent patients with chronic graft versus host disease. Results from Phase 1/2 iMAGINE trial showed an overall response rate of 78% with Imbruvica and after 20 weeks, sustained response rates were observed in 70% and 58% of treatment-naive and relapsed/refractory responders, respectively.

Additionally, legacy Allergan products continue to contribute to Abbvie’s momentum. Significant growth drivers in neuroscience include Vraylar and Botox Therapeutic. Vraylar (cariprazine) is a dopamine D3-preferring D3/D2 receptor partial agonist and a 5-HT1A receptor partial agonist. Its D3 binding profile may be linked to observed improvements in the negative symptoms of schizophrenia and to antidepressant effects in bipolar I disorder. Abbvie is seeking FDA approval of Vraylar for the adjunctive treatment of major depressive disorder, supported by a recent study that met its primary endpoint of statistically significant improvement in patients compared with placebo.

Meanwhile, Botox Therapeutic (onabotulinumtoxinA injection), a neuromuscular blocking agent that is injected into muscle tissue, is approved to treat numerous indications from headaches and urinary incontinence to spasticity.

Also, bolstering 2021 results, global revenues from the aesthetics portfolio were up 23% to $1.4 billion, with Botox Cosmetic revenues of $626 million, an increase of 27% and global Juvederm revenues of $432 million, an increase of 31%.

Acquisitions and Alliances

For $130 million upfront and potential additional payments of as much as $870 million based on certain milestones, AbbVie recently acquired Syndesi Therapeutics SA, expanding its neuroscience portfolio with novel modulators of the synaptic vesicle protein 2A. The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder.

Syndesi’s lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. Synaptic dysfunction is believed to underlie the cognitive impairment seen in multiple neuropsychiatric and neurodegenerative disorders.

In another recent acquisition, Allergan Aesthetics, an AbbVie company, acquired Soliton, Inc. complementing Allergan Aesthetics’ portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.

Meanwhile, several alliances and investments aim to address autoimmune, inflammatory and neuropsychiatric diseases. An exclusive worldwide license option agreement with Cugene Inc., aims to advance CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases. AbbVie paid $48.5 million upfront and has an option to obtain an exclusive license for certain IL-2 muteins, including CUG252. Currently in Phase 1, CUG252 is designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 activity on other IL-2 receptor expressing cells for the treatment of autoimmune diseases.

Additionally, a new co-development and license agreement with Gedeon Richter Plc. will research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. Richter will receive an upfront cash payment, along with potential development, regulatory and commercialization milestones. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as Vraylar.

Finally, for $40 million upfront, an equity investment, and as much as $300 million in future development and regulatory milestones, a collaboration and license agreement with Caribou Biosciences will research and develop chimeric antigen receptor (CAR)-T cell therapeutics. Although CAR-T cell therapies have shown early promise in some cancer patients, overcoming the rejection of allogeneic CAR-T cells by the host immune system remains a key challenge. Employing Caribou’s CRISPR genome editing platform to engineer CAR-T cells to withstand host immune attack aims to enable the development of next-generation of “off-the-shelf” cell therapies for a broader patient population. AbbVie is responsible for all clinical development, commercialization, and manufacturing efforts.

R&D Pipeline

Abbie anticipates the approval of more than dozen new products or indications in its key therapeutic franchises over the next couple of years. Among recent approvals are additional indications for key products as well as approvals for new products in eye care and migraine. Rinvoq has been approved by the FDA for the treatment of moderate to severe atopic dermatitis and adults with active psoriatic arthritis (PsA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers, and for the treatment of adults with active ankylosing spondylitis and moderate to severe ulcerative colitis. Additionally, the FDA approved Skyrizi for the treatment of adults with active PsA after demonstrating significant improvement in joint symptoms, including swollen, tender and painful joints, compared to placebo, marking the drug’s second FDA-approved indication.

The company’s latest eye care innovation VUITY (pilocarpine HCl ophthalmic solution) was approved by the FDA for presbyopia or age-related blurry near vision, in adults. This is a first-of-its-kind treatment for this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. The daily eye drop works in as early as 15 minutes and lasts up to 6 hours, to improve near and intermediate vision without impacting distance vision.

The FDA also approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. This is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of migraine. Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days in adults with episodic migraine compared to placebo, with the majority of patients experiencing between a 50-100% reduction in the 12-week treatment period. This is AbbVie’s third treatment across the full spectrum of migraine.

In recent pipeline news, AbbVie submitted a New Drug Application to the FDA for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. The submission is based on Phase 3 results demonstrating statistically significant improvement in “On” time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). ABBV-951 is designed to provide a first-of-its-kind, 24-hour, continuous subcutaneous delivery of CD/LD, offering the potential for improvement in motor fluctuations in patients with advanced Parkinson’s disease.

Finally, Teliso-V, an antibody-drug conjugate, is being studied in patients with previously treated non-small cell lung cancer (NSCLC) with c-Met overexpression. Earlier this year the FDA granted the drug Breakthrough Therapy Designation supported by data from an ongoing Phase 2 study. The primary endpoint of overall response rate was 53.8% in the c-Met high group and 25% in the c-Met group at reported interim analysis.

Headcount: 47,000
Revenues: $45,804 (+38%)
Net Income: $4,616  (-41%)
R&D: $6,557 (+2%)

TOP SELLING DRUGS

Moving up the ranks to #4, in May 2020 AbbVie completed its $63 billion acquisition of Allergan, significantly adding scale and cash flow for further investment in R&D and business development. The two companies bring together $45.8 billion in global sales, with Allergan’s aesthetics portfolio significantly diversifying AbbVie’s revenue base. Having invested $5.8 billion in R&D last year to support its pipeline across key therapeutic areas, AbbVie picked up several key approvals and anticipates the approval of more than a dozen new products or indications over the next two years.

Second only to Humira, top seller IMBRUVICA (ibrutinib) was recently approved by the FDA in combination with rituximab for the treatment of previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marking the 11th FDA approved indication for IMBRUVICA since it was first approved in 2013, and the sixth in CLL, the most common form of leukemia in adults.

A testament to its success in hematologic oncology, results from long-term, integrated analysis of two Phase III studies evaluating IMBRUVICA-based therapies for the first-line treatment of CLL/SLL up to 6.5 years of follow-up, showed similar progression-free survival (PFS) and overall response rates. Additionally, pooled analysis across four trials with up to eight years of follow-up showed that first-line treatment with IMBRUVICA-based therapies resulted in sustained, long-term efficacy with high four-year PFS rates in high-risk CLL patients.

Financial highlights
While the 38% growth in 2020 includes Allergan product revenues from the date of the acquisition May 8, 2020, and acquisition and integration costs are reflected in earnings, AbbVie’s comparable operational results showed significant growth across its immunology, oncology and neuroscience franchises.

The company’s flagship immunology portfolio sales were up 13% for the year to $22.2 billion, with Humira sales up 3.5% to $19.8 billion, despite biosimilar competition, and newer products Skyrizi and Rinvoq revenues reached $1.6 billion and $731 million, respectively. Hematologic oncology portfolio sales were up an impressive 22% to $6.7 billion, with Imbruvica sales of $5.3 billion, up 14%, and Venclexta sales of $1.3 billion. Also pulling its weight, the neuroscience portfolio had sales of $3.5 billion with Botox Therapeutic sales reaching $1.4 billion and Vraylar revenues of $951 million.

Of note, full-year revenues from the acquired aesthetics portfolio contributed $2.6 billion, with Botox Cosmetic accounting for $1.1 billion. During the course of the year, Allergan Aesthetics, an AbbVie company, expanded its portfolio of toxins and dermal fillers, plastics and regenerative medicine, body contouring and skincare products, which hold market-leading positions in the U.S. and other key markets.

Advancing assets
Key assets advancing within AbbVie’s pipeline include post-Humira hopefuls Rinvoq and Skyrizi, and migraine candidate atogepant, all of which are filed and pending approval for new or expanded indications. The following also highlights recent progress among other late stage programs.

Rinvoq (upadacitinib), a selective and reversible JAK inhibitor, is being studied in several immune-mediated inflammatory diseases and shows a lot promise. Recent results from a Phase III study show that Rinvoq achieved superiority to Sanofi’s Dupixent in treating Eczema for the primary endpoint, the proportion of patients with at least a 75 percent improvement in Eczema in adults with moderate to severe atopic dermatitis. Rinvoq also showed superiority versus Dupixent for all ranked secondary endpoints.
Also, results from a Phase III induction study showed Rinvoq met the primary endpoint of clinical remission in adults with moderate to severe ulcerative colitis, along with all ranked secondary endpoints. Results from the Phase III maintenance study and regulatory submissions are expected in 2H21.

First approved in April 2019 for moderate to severe plaque psoriasis, Skyrizi is among AbbVie’s fastest growing immunology products. Recent Phase III studies evaluating interleukin-23 inhibitor Skyrizi (risankizumab), in moderate to severe Crohn’s disease (CD), met the co-primary endpoints of clinical remission and endoscopic response, demonstrating superiority versus placebo. Additionally, key secondary endpoints showed significant clinical and endoscopic outcomes with symptom improvement. Additionally, Phase III studies evaluating Skyrizi in Active Psoriatic Arthritis (PsA) demonstrated strong levels of response on both joint and skin endpoints, with significantly more patients treated with Skyrizi achieving the primary endpoint.

Another key asset, Atogepant, is among AbbVie’s migraine therapeutics projected to be worth of $766 million in 2026 following FDA approval. Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist, a class of potent vasodilators, particularly in the cerebral circulation. A Phase III trial evaluating atogepant met its primary endpoint of statistically significant reduction in mean monthly migraine days, compared to placebo, for all doses evaluated across a 12-week treatment period. The trial also demonstrated statistically significant improvements in all six secondary endpoints. Regulatory submissions are pending in the U.S. and other countries.

In other late stage news, Phase III results evaluating Allergan’s AGN-190584 (pilocarpine) ophthalmic solution for the treatment of symptoms associated with presbyopia, met the primary efficacy endpoint. Presbyopia is a common, progressive condition that reduces the aging eye’s ability to focus on near objects and affects nearly four out of 10 people in the U.S.

Alliances
Several significant investments in early stage asset alliances aim to overcome challenges associated with antibodies and cell therapies. AbbVie will pay Genmab $750 million upfront, and a potential for up to $3.15 billion in additional milestones, to jointly develop and commercialize Genmab’s next-gen bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 in hematological cancers.

The alliance will combine antibodies from both companies along with Genmab’s DuoBody technology and AbbVie’s payload and ADC technology to select and develop up to four additional differentiated next-gen antibody-based product candidates, potentially across both solid tumors and hematological malignancies. In an effort to provide a more targeted, less toxic treatment approach, Genmab’s DuoBody-CD3 technology engages and directs cytotoxic T cells selectively to tumors and AbbVie’s ADC technology allows the delivery of therapeutic toxin directly to cancer cells while sparing healthy cells.

In another global research alliance, AbbVie will pay $180 million upfront and as much as $1.74 billion in milestones to advance I-Mab’s lemzoparlimab (TJC4), an anti-CD47 monoclonal antibody for the treatment of multiple cancers. Lemzoparlimab is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development.

An equity investment in Caribou Biosciences will leverage Caribou’s next-gen Cas12a CRISPR hybrid RNA-DNA (chRDNA) genome editing and cell therapy technologies to develop two new chimeric antigen receptor (CAR)-T cell therapies directed to targets specified by AbbVie in exchange for $40 million upfront and up to $300 million in future milestones. While allogeneic, “off-the-shelf” CAR-T cell therapies have shown early promise in some cancer patients, this alliance aims to overcome the rejection of allogeneic CAR-T cells by the host immune system, a key challenge to their broader development.

Additionally, a global collaboration with Jacobio Pharmaceuticals aims to develop and commercialize SHP2 inhibitors targeting a key node in cancer and immune cells. Many tumors have genetic mutations, driving abnormal cancer cell growth which relies on SHP2 activity.

SHP2 also plays a key role in controlling cytokine production and immune cell response. Inhibition of SHP2 is believed to potentially reduce cancer cell growth and modulate immune responses to generate anti-tumor activities. AbbVie has an exclusive license to Jacobio’s early clinical stage SHP2 assets, JAB-3068 and JAB-3312, oral small molecules designed to specifically inhibit SHP2activity.

Finally, AbbVie and Frontier Medicines Corp., a precision medicine company drugging challenging protein targets, partnered to develop and commercialize a pipeline of small molecule therapeutics against high-interest, difficult-to-drug protein targets using Frontier’s chemoproteomics platform to identify small molecules for programs directed to novel E3 ligases and certain oncology and immunology targets.

Headcount: 30,000
Revenues: $33,266 (+2%)
Net Income: $7,882 (+39%)
R&D: $6,407 (-38%)

TOP SELLING DRUGS

In looking at AbbVie’s foreseeable growth drivers, in the first quarter of 2020 IMBRUVICA, VENCLEXTA, SKYRIZI continued to make strides. Revenues were up 10% in the quarter to $8.6 billion, despite a 15% decline in International Humira sales and a 29% drop in Mavyret sales, the company’s top sellers.

AbbVie’s investments in its hematologic oncology portfolio are paying off, with global revenues of $1.5 billion in 1Q20, up 32% with IMBRUVICA revenues of $1.2 billion, up 21% and VENCLEXTA sales reaching $317 million. We’re also keeping an eye on new immunology assets SKYRIZI, with sales of $300 million, and RINVOQ, which had sales of $86 million in 1Q20.

The company is recouping some of the lost Humira revenues with improved treatment options in rheumatoid arthritis and psoriasis. SKYRIZI, an IL-23 inhibitor boasts a 75% improvement rate at week 16 in moderate to severe plaque psoriasis and RINVOQ, a new oral selective and reversible JAK inhibitor, improves signs and symptoms in rheumatoid arthritis patients through 72 and 84 weeks, as well as inhibits structural joint damage in rheumatoid arthritis patients.

Strategic Moves
Last June AbbVie made a bold strategic move to buy Allergan for approximately $63 billion in an effort to diversify its portfolio, as the world’s best-selling drug, AbbVie’s flagship Humira, begins to feel the impact of biosimilar competition. Allergan brings the biggest name in medical aesthetics, Botox. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care and virology.

The companies recently got the go ahead from the U.S. Federal Trade Commission (FTC) for AbbVie’s pending acquisition of Allergan. AbbVie agreed to sell several assets to settle objections to its purchase Allergan, divesting Brazikumab and Zenpep.

AstraZeneca will acquire brazikumab, an investigational IL-23 inhibitor in Phase IIb/III development for Crohn’s Disease, and Phase II for ulcerative colitis. Nestle will acquire and take full operational ownership of Zenpep, a treatment available in the U.S. for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the deal.

In another, albeit less sensational acquisition, AbbVie enhanced its early stage oncology pipeline with Seattle-based Mavupharma, a privately held biopharma company focused on new approaches to target the STING (STimulator of INterferon Genes) pathway to treat cancer. Mavupharma’s lead candidate MAVU-104, is a first-in-class, orally active, small molecule inhibitor of ENPP1, an enzyme involved in the regulation of the STING pathway. Inhibiting ENPP1 with MAVU-104 allows for highly controlled enhancement of STING signaling in tumors without the need for injections. Enhancing STING signaling has shown promise in a variety of tumor models.

R&D
AbbVie gained several significant approvals for key growth products. The FDA and EMA approved RINVOQ (upadacitinib), a once-daily oral Janus kinase (JAK) inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to methotrexate.

Patients taking RINVOQ achieved clinical remission, a state characterized by almost no disease activity and symptoms, even without methotrexate.

AbbVie also has applications under review for RINVOQ for the treatment of active psoriatic arthritis supported by studies demonstrating RINVOQ met the primary endpoint of response at week 12 versus placebo, as well as non-inferiority versus Humira in terms of response at week 12.

In another big win, ORIAHNN recently became the first non-surgical, oral treatment option approved by the FDA for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women, with a treatment duration of up to 24 months. Uterine fibroids are estrogen and progesterone-dependent non-cancerous tumors and are the most common type of benign tumor in women of reproductive age.

Oncology Assets
IMBRUVICA, in combination with rituximab, was approved by the FDA for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This milestone marks the 11th FDA approval for IMBRUVICA since it was first approved in 2013 and the sixth in CLL, the most common form of leukemia in adults.

Also, the European Commission recently approved VENCLYXTO (venetoclax) in combination with obinutuzumab for patients with previously-untreated Chronic Lymphocytic Leukemia. Further, positive results from Phase III trial of VENCLEXTA (venetoclax) in combination with Azacitidine in patients with Acute Myeloid Leukemia (AML) demonstrated statistically significant improvement in the primary endpoints of overall survival and composite complete remission rate. AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate and few treatment options.

Oncology Alliances
AbbVie and Genmab recently partnered to develop and commercialize three of Genmab’s early-stage investigational bispecific antibody product candidates, and to research future differentiated antibody therapeutics for cancer. The companies will partner to develop Genmab’s next-gen bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 leveraging AbbVie’s clinical expertise, antibody-drug conjugate (ADC) platform and global commercialization in hematological cancers.

AbbVie is paying $750 million upfront and Genmab has the potential to receive as much as $3.15 billion in additional development, regulatory and sales milestones for all programs as well as royalties on sales for epcoritamab outside the U.S. and Japan. Except for these royalty-bearing sales, the companies will share profits on a 50:50 basis.

A global, exclusive collaboration with Jacobio Pharmaceuticals aims to develop and commercialize SHP2 inhibitors targeting a key node in cancer and immune cells. SHP2 is a key protein mediator of cell signaling and many tumors have genetic mutations, driving abnormal cancer cell growth which rely on SHP2 activity. Jacobio’s early clinical stage assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity.

SHP2 also plays a key role to control cytokine production and immune cell response and is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities.

Expanding an alliance with Harpoon Therapeutics for HPN217, a B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC), the companies added up to six additional targets. These agreements are expected to advance and broaden the use of Harpoon’s TriTAC platform, which produces novel T cell engagers targeting both solid tumors and hematologic malignancies.  In a transaction valued at a potential $510 million in upfront, milestone payments, and royalties, AbbVie has an option to exclusive rights to HPN217.

COVID-19 Efforts
AbbVie is collaborating with select health authorities and institutions globally supporting the experimental use of the HIV medicine, Kaletra/Aluvia (lopinavir/ritonavir) to determine antiviral activity as well as efficacy and safety of lopinavir/ritonavir in treating COVID-19.

AbbVie is supporting clinical studies with lopinavir/ritonavir, working closely with European health authorities and the U.S. FDA, Centers for Disease Control and Prevention, National Institutes of Health and Biomedical Advanced Research and Development Authority to coordinate on these efforts. The company has also joined the Innovative Medicines Initiative to support research and discovery of targeted medicines against COVID-19.

Headcount: 30,000
Revenues: $32,753 (+16%)
Net Income: $5,687 (+7%)
R&D: $10,329 (+106%)

TOP SELLING DRUGS

AbbVie’s revenues grew 16% to $32.8 billion in 2018 driven primarily by sales growth related to Mavyret, Imbruvica and Venclexta and the continued strength of Humira. The arthritis blockbuster again topped the 2018 list of top selling drugs, raking in $19.9 billion in sales—an increase of 8.2%. Biosimilar competition is expected to hurt Humira sales in 2019, but is not expected to be an issue in the U.S. until 2023.

Cancer drugs Imbruvica and Venclexta both reported positive growth. Imbruvica revenue was $3.6 billion, an increase of 39.5%, driven by market share growth in front-line chronic lymphocytic leukemia (CLL) and other approved indications. Venclexta increased its sales by more than 100% in 2018 primarily due to market share gains following FDA and EMA approvals in combination with Rituxan. Hep C drug Mavyret’s sales increased by more than 100% in 2018 after its approval by FDA and EMA in the second half of 2017 as well as further geographic expansion in 2018. Mavyret’s penetration into the market hurt revenues of fellow hep C drug Viekira, whose sales decreased by 76% in 2018.

Growth catalysts
AbbVie’s pipeline includes more than 60 compounds or indications in development across immunology, oncology and neuroscience, with additional targeted investments in cystic fibrosis and women’s health.

AbbVie achieved a number of regulatory milestones for several key products in 2018, including regulatory approvals for cancer drug Venclexta in combination with Rituxan (rituximab) and in combination with azacitidine or decitabine; Imbruvica was also approved in combination with rituximab for cancer treatment. In addition, the company introduced Orilissa, the first FDA-approved oral treatment in over a decade for the management of moderate to severe pain associated with endometriosis.

With more than 30 programs in mid- and late-stage development, some highlights from AbbVie’s pipeline advancements in 2018 including having completed registrational studies and submitted regulatory applications for the company’s next-generation immunology assets, upadacitinib and risankizumab, in rheumatoid arthritis and psoriasis, respectively. In addition, the company initiated several Phase 3 programs for these assets including studies for upadacitinib in atopic dermatitis and ulcerative colitis, as well as risankizumab in Crohn’s disease.

Extends R&D alliance with Calico
AbbVie and Calico  extended their collaboration to discover, develop and market new therapies for patients with age-related diseases, including neurodegeneration and cancer.

Calico is the Alphabet-backed life sciences company that is led by former Genentech chairman and chief executive officer Arthur D. Levinson, Ph.D.  Calico has a research and development facility in the San Francisco Bay Area and more than 150 employees.

The collaboration has been extended for an additional three years. Calico will be responsible for research and early development until 2022 and will advance collaboration projects through Phase IIa through 2027. AbbVie will continue to support Calico in its early R&D efforts and, following completion of Phase IIa studies, will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits. AbbVie and Calico will each commit to contribute an additional $500 million to the collaboration.

Since 2014, the collaboration has produced more than two dozen early-stage programs addressing disease states across oncology and neuroscience and yielded new insights into the biology of aging.

In other R&D tie-ups, AbbVie and Calibr entered a collaboration to develop T-cell therapies aimed primarily at cancer, including solid tumors, leveraging advanced precision medicine technology. AbbVie gains exclusive access to Calibr’s switchable CAR-T platform for up to four years. The companies will work together to develop T-cell therapies directed to solid tumor targets identified by AbbVie.
AbbVie also has the option to develop additional cell therapies toward AbbVie-nominated targets and license existing Calibr cell therapy programs under development for hematological and solid cancers, including Calibr’s lead program.

Calibr plans to enter this lead candidate into clinical studies for lymphoma in 2019. In addition, the agreement provides AbbVie with an option to acquire an exclusive license to Calibr’s switchable CAR-T platform and programs within the first four years of the collaboration. The companies will share responsibility for preclinical development, and AbbVie is responsible for clinical development and commercialization. Calibr is eligible to receive success-based milestone payments and royalties.

Calibr’s cell therapy program is designed to enhance safety, versatility and efficacy through a proprietary modular “switchable” CAR-T cell that uses antibody-based switch molecules to control the activation and antigen specificity of CAR-T cells. Calibr’s technology may enable the development of universal CAR-T-based treatments across several types of hematological and solid tumor indications.

With Voyager Therapeutics, AbbVie entered an exclusive strategic collaboration and option agreement to develop and commercialize vectorized antibodies directed against tau for the treatment of Alzheimer’s disease and other neurodegenerative diseases. The collaboration combines AbbVie’s monoclonal antibody expertise, global clinical development and commercial capabilities with Voyager’s gene therapy platform that enables generating adeno-associated viral (AAV) vectors for the treatment of neurodegenerative diseases.

In healthy individuals, tau is an abundant protein in the brain that promotes cellular stability and function. In the diseased brain, altered tau accumulates, resulting in impaired brain function and neuronal cell loss. One of the limitations with current biologic therapies for neurodegenerative diseases is that only a small amount of drug makes it into the brain. This collaboration aims to develop a potential one-time treatment using Voyager’s gene therapy platform to reduce tau pathology through the delivery of an AAV vector antibody that encodes the genetic instructions to produce anti-tau antibodies within the brain.

Lastly, AbbVie took over full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF). The investigational program comprises several clinical and preclinical compounds originally discovered and developed jointly by AbbVie and Galapagos. Galapagos will not pursue further research and development in CF, but is eligible for future milestones and royalties on commercialized programs. Galapagos retains the right to future development of GLPG-2737 in non-CF indications. AbbVie is eligible to receive undisclosed future milestones and royalties in non-CF indications.

Headcount: 29,000
Revenues: $28,216 (+10%)
Net Income: $5,309 (-11%)
R&D: $4,982 (+14%)

TOP SELLING DRUGS 

Last year marked Abbvie’s fifth in operation and proved to be its most successful since it launched in 2013. Revenues grew by 10 percent to $28.2 billion, marking the third consecutive year of double-digit growth driven by blockbuster Humira.

With 15% growth year-over-year and $18.4 billion in 2017 sales, Humira is the world’s best-selling drug and accounted for approximately 65% of AbbVie’s total 2017 revenue. As the most widely prescribed autoimmune biologic therapy, Humira will continue to be an important growth driver for several years. EvaluatePharma says the rheumatoid arthritis drug will continue to top the revenue charts through 2022.

AbbVie’s positive growth can also be attributed to cancer drug Imbruveca’s 40% jump in sales to $2.5 billion. Other key products include Creon and Duodopa and the launch of HCV product Mavyret. These increases were partially offset by a decline in net revenues of HCV product Viekira due to heavy competition.

Pipeline approvals

With regards to its pipeline, AbbVie has more than 60 programs exploring new technologies and approaches to treatment in active clinical development across key therapeutic areas and remains on track to launch more than 20 new products or indications by 2020.

In January 2017, the FDA approved Imbruveca for patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. This indication was approved under accelerated approval based on overall response rate (ORR) and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. MZL is a slow-growing form of non-Hodgkin’s lymphoma.

In August 2017, the FDA also approved Imbruveca for the treatment of adult patients with chronic graft- versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. Imbruveca is the first therapy specifically approved for adults with cGVHD, a severe and potentially life-threatening consequence of stem cell or bone marrow transplant. This marked the sixth U.S. disease indication for Imbruveca since the medication’s initial approval in 2013 and the first approved indication outside of cancer.

In the same month, the FDA approved Mavyret for the treatment of patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). Mavyret is also indicated for the treatment of adult patients with HCV genotype 1 infection.

Advancing early stage research

After acquiring Stemcentrx and its lead late-stage asset Rova-T for $5.8 billion in 2016, AbbVie was not active in M&A in 2017. The company instead focused on developing new collaborations to advance early-stage research in key therapeutic areas such as oncology and immunology.

With WuXi NextCODE, a global contract genomics organization, AbbVie entered a 15-year strategic alliance to conduct population genomics research in Ireland aimed at advancing the discovery and development of new therapeutic approaches for serious diseases within oncology, neuroscience and immunology. The alliance will result in the sequencing of 45,000 genomes from volunteers across Ireland to seek novel insights into the biological processes that underlie complex disease. AbbVie will use the research database developed by GMI to identify new molecular approaches for drug discovery and development as well as companion diagnostics.

AbbVie and Pure MHC entered a research and license agreement to discover and validate peptide targets for use with T-cell receptor therapeutics in several types of cancers.Pure MHC has developed technology to identify novel, tumor-associated peptides based on innovation licensed from the University of Oklahoma. The collaboration aims to identify a library of peptide targets for further research across multiple tumor types and advance AbbVie’s next-gen immuno-oncology therapies.

AbbVie also entered into an exclusive license with Dong-A-ST, a specialty healthcare company in South Korea, for MerTK inhibitors in preclinical development for use in conjunction with immuno-oncology therapies. MerTK is a protein that is believed to contribute to the promotion of immunosuppressive tumor microenvironment. The collaboration will explore the combination of MerTK inhibitors in conjunction with AbbVie’s portfolio of anti-cancer agents across multiple types of solid tumors.

In addition, a partnership with Zebra Biologics aims to discover agonist antibody therapeutics for inflammatory diseases. Zebra will use its function-based antibody discovery platform to generate antibodies that activate biological pathways associated with AbbVie targets. The companies will collaborate on the identification and preclinical validation of emerging, undisclosed candidates. Zebra will lead the discovery of candidate agonist antibodies and will collaborate with AbbVie in preclinical validation of select clinical candidates. AbbVie would be responsible for clinical development, manufacturing, regulatory approval and commercialization.

Lastly, AbbVie and Turnstone Biologics entered a research, option and license agreement under which AbbVie obtained an exclusive option to license as many as three of Turnstone’s next-generation oncolytic viral immunotherapies. Oncolytic viruses take advantage of defective pathways in tumors to selectively replicate in and destroy cancer cells, while cancer vaccines create killer (CD8+) T cell immune responses against tumor antigens.

AbbVie has an option to obtain all global development and commercialization rights to Turnstone’s Ad-MG1-MAGEA3 therapy, in two Phase 1/2 trials for multiple solid tumor indications. Each of the three therapies leverages Turnstone’s platform based on an engineered Maraba virus. In the event AbbVie exercises one or more of its options, AbbVie expects to pursue this immunotherapeutic technology across several types of solid tumors.

Headcount: 29,000
Revenues: $25,638 (+12%)
Net Income: $5,953 (+16%)
R&D: $4,366 (+2%)

TOP SELLING DRUGS  

In 2016 AbbVie delivered its best year yet since it launched in 2013 after separating from Abbott Laboratories. With strong growth performance, new product launches and the addition of Stemcentrx to advance its work within oncology, AbbVie delivered revenue growth of more than 13% to $25.6 billion, placing it as the ninth largest pharma company in the world.

AbbVie operates in one business segment—pharmaceutical products. Its blockbuster biologic Humira (adalimumab), which is used to treat a range of autoimmune diseases, continues to anchor the company accounting for more than 60% of total revenues. The rising star in AbbVie’s portfolio is the cancer drug Imbruvica, whose sales shot up 143% to $1.8 billion in 2016. The company also offers products for Virology, Metabolics/Hormones, Endocrinology.

In 2016, AbbVie launched several new products and expanded indications across immunology, oncology, virology and neuroscience. The company also advanced its research in oncology with Stemcentrx and its novel compound, rovalpituzumab tesirine (Rova-T), which is currently in late-stage clinical trials for solid tumor cancers.

AbbVie made the mega deal to acquire Stemcentrx and its lead late-stage asset Rova-T for $5.8 billion in April 2016. The company says Rova-T is a novel biomarker-specific therapy that is derived from cancer stem cells and targets delta-like protein 3 (DLL3) that is expressed in more than 80% of SCLC patient tumors and is not present in healthy tissue. AbbVie boasts an oncology development program of more than 200 clinical trials across more than 20 tumor types.

At the beginning of the year, MD Anderson Cancer Center and AbbVie entered a three-year immunotherapy collaboration to select and conduct preclinical and clinical studies evaluating new ideas in the area of immuno-oncology. AbbVie’s research efforts in immunotherapy leverage the company’s strengths in biology, protein engineering and chemistry. MD Anderson’s immunotherapy platform includes technology for preclinical modeling, clinical trials and immune monitoring before, during and after treatment to better understand drug mechanisms and identify biomarkers to guide treatment. AbbVie and MD Anderson will each assign two scientists to a joint scientific committee to decide on projects to pursue. The collaboration will initiate with projects driven by AbbVie Biotherapeutics, AbbVie’s center of innovation in the biotech hub of the San Francisco Bay Area. Future projects will draw from AbbVie’s portfolio of oncology programs.

At the end of the year, AbbVie and Northwestern University signed a five-year collaboration agreement to advance research and discovery in oncology. AbbVie and the Robert H. Lurie Comprehensive Cancer Center of Northwestern will work in several areas of oncology research, including, lung, colorectal, breast, prostate and hematological cancer.

The collaboration provides Lurie Cancer Center scientists with the opportunity to access new therapies developed by AbbVie for preclinical research funded under the agreement, as well as AbbVie’s research teams. AbbVie has the option to obtain an exclusive license of certain Lurie Cancer Center discoveries made under the five-year collaboration.

AbbVie set up additional collaborations with several other companies. One with Boehringer Ingelheim aims to develop and commercialize BI 655066, an anti-IL-23 monoclonal antibody in Phase III development for psoriasis. The companies are also evaluating the drug’s potential in Crohn’s disease, psoriatic arthritis and asthma. In addition to the anti-IL-23 antibody, AbbVie gains rights to an anti-CD-40 antibody, BI 655064, currently in Phase I development. Boehringer will retain responsibility for further development of BI 655064, and AbbVie may elect to advance the program after certain undisclosed clinical achievements.

AbbVie also formed a collaboration with Argenx, a clinical-stage biopharmaceutical company, to develop and commercialize ARGX-115, Argenx’ preclinical human antibody program targeting the novel immuno-oncology target GARP, a protein believed to contribute to immuno-suppressive effects of T-cells. Argenx will conduct research and development through IND-enabling studies. Upon successful completion of these studies, AbbVie may exercise an exclusive option to license the ARGX-115 program and assume responsibility for further clinical development and commercialization. In addition to the ARGX-115 program, and upon reaching a predetermined preclinical stage milestone, AbbVie will fund further GARP-related research by Argenx for an initial period of two years.

CytomX Therapeutics teamed up with AbbVie to co-develop and commercialize Probody Drug Conjugates against CD71, which is highly expressed in a number of solid and hematologic cancers and has molecular properties for efficient delivery of cytotoxic payloads to tumor cells. Probody therapeutics are designed enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues. CytomX has generated preclinical data that demonstrates that Probody drug conjugates can safely and effectively target tumor antigens, such as CD71, that are not addressable by conventional antibody-drug conjugates.

Lastly, Galapagos NV and AbbVie expanded their agreement in cystic fibrosis (CF) to reflect the successful expansion of their CF portfolio. The companies aim to develop a triple CFTR combination therapy to address 90% of patients with CF. In order to bring a more effective therapy to patients, the companies have developed multiple candidates and backups for each of the three components of a potential triple combination.

Headcount: 28,000
Revenues: $22,859 (+15%)
Net Income: $5,144 (+190%)
R&D: $4,285 (+30%)

TOP SELLING DRUGS   

AbbVie’s revenues increased more than 22%, to $22.8 billion in 2015. The biopharma company has continued to drive significant growth from its leading product Humira, with 2015 sales of $14 billion, an increase of 19% compared to 2014. The company also expanded its flagship therapies to include the HCV franchise and oncology product Imbruvica, a first-in-class BTK inhibitor, which positions AbbVie as an oncology leader. Additionally, during the year AbbVie received FDA approval of Duopa for patients with Parkinson’s disease in the U.S.

AbbVie has a growing number of programs in mid- and late-stage development, and it continues to make significant pipeline advancements. During the year, it submitted regulatory submissions for Venetoclax for relapsed/refractory chronic lymphocytic leukemia (CLL); Imbruvica for first-line CLL; Zynbryta for multiple sclerosis; and Humira for uveitis. The company also successfully transitioned several mid-stage pipeline assets into late-stage development, including its JAK-1 inhibitor, ABT-494, in rheumatoid arthritis; a pan-genotypic, next-generation HCV combination therapy; elagolix for uterine fibroids; and ABT-414, an antibody drug conjugate for glioblastoma multiforme.

The big news during the year occurred in March when AbbVie announced it was buying Pharmacyclics, a biopharmaceutical company that develops and commercializes novel therapies for cancer treatment. The $21 billion deal closed in May 2015 and expands AbbVie’s clinical and commercial presence in oncology, giving it ownership of Pharmacyclics’ flagship asset Imbruvica, a highly effective treatment for hematologic malignancies.

Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor approved for four indications to treat three different types of blood cancers including chronic lymphocytic leukemia, mantle cell lymphoma and Waldenstrom’s macroglobulinemia. Imbruvica received FDA approval in 2013 and is the only therapy to have received three Breakthrough Therapy designations by the FDA. It is currently approved in more than 40 countries. Potential further Imbruvica indications include solid tumors, as well as the potential to leverage AbbVie’s immunology expertise for the development of Pharmacyclics’ immunology program, and advance AbbVie’s efforts in hematologic malignancies.

Expanding its manufacturing capabilities, AbbVie announced during the year the expansion of one of its existing sites in Puerto Rico with an estimated investment of $30 million. This expansion will add to Puerto Rico’s capabilities as a manufacturing destination for biotechnology and is expected to create as many as 100 new jobs during the next two years. The expansion will take place at AbbVie’s site located in the northern municipality of Barceloneta. This site is already home to two of the company’s state-of-the-art facilities.

At the tail end of 2014, AbbVie expanded capacity to support its immunology and oncology pipelines when it acquired a small molecule API manufacturing site in Singapore’s Tuas Biomedical Park. AbbVie’s first manufacturing facility in Asia, the 120,000 square meter site increases capacity for compounds in its immunology and oncology pipelines. It includes a contained API facility, additional buildings, and ancillary equipment.

AbbVie will also construct a bulk biologics manufacturing facility on the property, which is expected to be operational in 2019. The combined facilities will add more than 250 new employees, including positions across manufacturing, technical operations, administration, quality, IT and supply chain. The company is also renovating its small molecule facility.

On the research front, AbbVie and Calico entered an R&D collaboration to discover, develop and market new therapies for age-related diseases, including for neurodegeneration and cancer. Calico is funded by Google and led by former Genentech executives Arthur Levinson and Hal Barron. Calico will establish a new R&D facility in the San Francisco Bay Area with a focus on drug discovery and early drug development and AbbVie will provide scientific and clinical development support, as well as its commercial expertise. Together, the firms will initially contribute as much as $250 million to fund the collaboration with the potential for an additional $500 million each.

Calico will be responsible for research and early development for the first five years and to advance collaboration projects through Phase IIa for a 10-year period. AbbVie will support Calico in its early R&D efforts and, following Phase IIa studies, will have the option to manage late-stage development and commercial activities.

At the start of 2015 AbbVie opened an Innovation Center on the campus of the University of Illinois Research Park in Urbana-Champaign. The Innovation Center plans to employ more than 18 undergraduate and graduate students on a part-time basis. Eight students have begun working on several AbbVie R&D Information Technology projects, which is the initial focus of work at the center.

Students will work on real-world projects ranging from utilizing visualization software in clinical trial research, to harnessing the power of reporting tools for the identification of additional areas of research, to using informatics, text mining and other analytics software in medical research. An AbbVie site manager will oversee the students and serve as liaison between the AbbVie Innovation Center and the University.

In other news, AbbVie entered a global collaboration and license agreement with Halozyme Therapeutics to develop and commercialize products combining AbbVie compounds with Halozyme’s Enhanze platform. Halozyme received $23 million upfront and milestone payments totaling approximately $130 million for as many as nine collaboration targets, as well as royalties if products under the collaboration are commercialized. The Halozyme Enhanze platform is based on a recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan, a chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs. For AbbVie, this technology may allow for more rapid delivery of injectable medications through subcutaneous delivery.

Another collaboration saw AbbVie enter into an exclusive worldwide license agreement with C2N Diagnostics to develop and commercialize a portfolio of anti-tau antibodies for the treatment of Alzheimer’s Disease and other neurological disorders. Tau stabilizes proteins that are responsible for the structure and transport in neuronal cells. Abnormal accumulation of altered tau protein is a leading indicator in a variety of neurodegenerative conditions including Alzheimer’s Disease, Progressive Supranuclear Palsy and Corticobasal Degeneration. In these conditions, the development of tau pathology strongly correlates with clinical disease progression.

At the very beginning of 2016, AbbVie and MD Anderson Cancer Center entered a three-year immunotherapy collaboration to efficiently select and conduct preclinical and clinical studies evaluating new ideas in the area of immuno-oncology.

AbbVie’s research efforts in immunotherapy leverage the company’s strengths in biology, protein engineering and chemistry. MD Anderson’s immunotherapy platform includes technology for preclinical modeling, clinical trials and immune monitoring before, during and after treatment to better understand drug mechanisms and identify biomarkers to guide treatment. AbbVie and MD Anderson will each assign two scientists to a joint scientific committee to decide on projects to pursue. The collaboration will initiate with projects driven by AbbVie Biotherapeutics, AbbVie’s center of innovation in the biotech hub of the San Francisco Bay Area. Future projects will draw from AbbVie’s portfolio of oncology programs.

Headcount: 28,000
Revenues: $19,960 (+6%)
Net Income: $1,774 (-57%)
R&D: $3,297 (+15%)

TOP SELLING DRUGS

In 2014, AbbVie grew worldwide net sales by 6% to $20 billion, driven primarily by the continued strength of Humira and double-digit sales growth from other key products including Creon, Duodopa and Synthroid. Sales growth in 2014 continued to reflect the impact of the loss of exclusivity in the company’s lipid franchise, which resulted in the loss of $748 million of revenue in 2014 over the prior year. Generic competition began in November 2012 for TriCor, July 2013 for Trilipix and September 2013 for Niaspan.

AbbVie has major leading franchises in immunology, virology and a strong emerging franchise in oncology. Products are focused on treating conditions such as chronic autoimmune diseases, including rheumatoid arthritis, psoriasis, and Crohn’s disease; hepatitis C (HCV); human immunodeficiency virus (HIV); endometriosis; thyroid disease; Parkinson’s disease; complications associated with chronic kidney disease and cystic fibrosis; and other health conditions such as low testosterone.

AbbVie also has a pipeline of promising new medicines, including more than 30 compounds or indications in Phase II or Phase III development across such important medical specialties as immunology, virology/liver disease, oncology, renal disease, neurological diseases and women’s health.

AbbVie continued to advance its pipeline during 2014, and has more than 40 programs in clinical development, with 30 of those in Phase II or Phase III development across medical specialties as immunology, virology/liver disease, oncology, renal disease, neurological diseases and women’s health. There are 10 ongoing or recently initiated potential registration programs in oncology; completed late-stage clinical trials in virology, neuroscience and immunology.

During the year, the company secured regulatory approval in the U.S. for its interferon-free HCV treatment, Viekira Pak, as well as submitting its regulatory application in the EU, which was subsequently approved in January 2015. AbbVie also continued to advance its previously submitted regulatory applications in the U.S. for Duopa, which were also approved in January 2015, and completed several late-stage clinical trials, including Zinbryta (daclizumab) for the treatment of the relapsing/remitting form of multiple sclerosis (MS) and registrational programs for an expanded use of Humira for hidradenitis suppurativa. AbbVie also augmented its pipeline through strategic licensing and partnering activities including in-licensing duvelisib, a dual acting PI3 kinase inhibitor currently under investigation for use in a variety of hematological malignancies from Infinity.

The major event during the year for AbbVie was its acquisition of Pharmacyclics for $21 billion, for which it gained the flagship asset Imbruvica (ibrutinib) for hematologic malignancies. The acquisition expands AbbVie’s clinical and commercial presence in oncology.

Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor approved for four indications to treat three different types of blood cancers including chronic lymphocytic leukemia, mantle cell lymphoma and Waldenstrom’s macroglobulinemia. Imbruvica received FDA approval in 2013 and is the only therapy to have received three Breakthrough Therapy designations by the FDA. It is currently approved in more than 40 countries.

Potential further Imbruvica indications include solid tumors, as well as the potential to leverage AbbVie’s immunology expertise for the development of Pharmacyclics’ immunology program, and advance AbbVie’s efforts in hematologic malignancies.

AbbVie, along with Bristol-Myers Squibb (BMS), received Breakthrough Therapy Designation from the FDA for elotuzumab, an investigational humanized monoclonal antibody for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma.

The designation is based on findings from a Phase II study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated MM patients.

In 2014 AbbVie entered into a number of new and innovative collaborations and licensing arrangements, including a partnership with Calico, the Google-based life sciences company. The two companies entered an R&D collaboration to discover, develop and market new therapies for age-related diseases, including neurodegeneration and cancer. Calico is funded by Google and led by former Genentech executives Arthur Levinson and Hal Barron.

As part of the deal, Calico will establish a new R&D facility in the San Francisco Bay Area with a focus on drug discovery and early drug development and AbbVie will provide scientific and clinical development support, as well as its commercial expertise.

AbbVie and Calico will initially contribute as much as $250 million to fund the collaboration with the potential for an additional $500 million each. Calico will be responsible for research and early development for the first five years and to advance collaboration projects through Phase IIa for a 10-year period.

AbbVie will support Calico in its early R&D efforts and, following Phase IIa studies, will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits equally.

In terms of global expansion, AbbVie is investing $320 million to establish manufacturing operations in Singapore for small molecule and biologics active drug substance. Once completed, the facility will provide manufacturing capacity for compounds in AbbVie’s oncology and immunology pipeline to serve global markets. The investment is expected to result in additional headcount of more than 250 new employees. AbbVie anticipates the facility will be fully operational by 2019.

AbbVie’s operations in Asia currently include R&D functions in Tokyo, Japan and Shanghai, China, as well as commercial operations throughout the region. AbbVie currently employs 120 personnel in Singapore, supporting commercial operations, global R&D, and general operations.

AbbVie has been steaming ahead like a train since it departed from Abbott in 2013, planting itself firmly among the top Pharma companies. Whether or not it can sustain this growth will be interesting to see as it faces the impending doom of its massive money making anti-inflammatory drug Humira losing patent protection in the U.S. in December 2016. Humira accounts for more than half of AbbVie’s profits and accounts for more than 60% of its sales, so should it be worried about generic competition?

AbbVie may well have a stay of execution due to the fact that Humira is a biologic, so it’s not easy to manufacture it off a production line. On top of that, most countries in the EU have patents in place until 2018, so this should give them time to fill the hole that the loss of Humira may cause. There is indeed already a biologic ready to jump in the seat of Humira from India’s Cadila Healthcare, but it can’t make it into Europe until probably 2019.

AbbVie isn’t standing still, with a growing drug pipeline and the acquisition of cancer biopharma company Pharmacyclics in March this year, its hopes will be that Imbruvica (Pharmacyclics haematology product) will be able to hold up the financial fort. Also, bringing with it three drugs already in clinical trials, AbbVie looks like it’s going to be among Big Pharma for the long haul.

—Adele Graham-King

Headcount: 25,000
Pharma Revenues: $18,790 (2%)
Net Income: $4,128 (-7%)
R&D Budget: $2,855 (3%)

Top Selling Drugs

AbbVie’s CEO Richard Gonzalez is optimistic about the company’s first year as an independent company.  The Abbott Laboratories spinoff  became its own company on January 1, 2013. That year, it also added to its pipeline, saw sales of its best selling Humira grow by 15%, and moved several late stage compounds into Phase III studies.

FDA recently named AbbVie’s experimental Hepatitis C compound a “breakthrough therapy,” and EU regulators have also validated it, and AbbVie has launched Phase II studies for ABT- 199 for chronic lymphocytic lymphoma, and veliparib for triple-negative breast cancer.

Shire rejects repeated offer
AbbVie recently launched a $46-billion bid for the Ireland-based pharma company, Shire. Both CEO and chief science officer travelled to Europe to make presentations to the shareholders.  However, Shire has so far rejected the bid, Reuters reported last month, citing an inadequate offer price. Acquisition of that company would add to AbbVie’s neurological treatment portfolio, and also provide a potential offshore location for tax-saving “inversion.”

AbbVie currently has more than 20 compounds (or new uses of existing compounds) in Phase II or III development. R&D focuses on immunology, virology, oncology, kidney disease, neurological diseases and women’s health.

The company has extended applications for Humira to 10, including goastroenerology, dermatology and ophthalmology, as the drug is approved for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, juvenile diopathic arthritis, ulcerative colitis, axial spondyloarthritis. Forbes.com columnist Simon King has projected that the drug could overtake Pfizer’s Lipitor as the top-selling pharmaceutical of the past 15 years.

AbbVie is also working on autoimmune treatments, with tregalizumab, in collaboration with Biotest AG, and with GLPG0634, Janus Kinase 1 inhibitor, with Galapagos NV.  Last year, AbbVie formed a collaboration with Ablynx NV to commercialize the anti-IL-6R antibody ALX-0061, to treat rheumatoid arthritis and systemic lupus erythematosus. In May of last year, the company entered into research with Alvine Pharmaceuticals, Inc. to develop ALV003, a new treatment for patients with celiac disease.

Once Monthly Treatment for MS
In its neurological product pipeline, the company and Biogen Idec have developed a once-monthly multiple sclerosis drug, daclizumab, which recently met requirements of Phase III testing. The drug would treat relapse remitting MS.

A levodopa-carbidopa gel for treating Parkinson’s disease has been submitted for FDA approval. AbbVie is starting Phase III clinical trials for its investigational cancer treatment, veliparib (ABT-888), in combination with carboplatin and paclitaxel, for treating patients with advanced breast cancer.

The test will compare the combination of veliparib, carboplatin and paclitaxel to treatment with carboplatin, paclitaxel and placebo in patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally-advanced breast cancer, containing BRCA1 and/or BRCA2 gene mutations.

This year, media report, AbbVie and Abbott Laboratories face patient lawsuits in Chicago alleging failure to warn, via labelling, the potential cardiovascular safety risks of their testosterone supplements, including Abb Vie’s AndroGel.