5689432326001 Headquarters: New York, NY
Year Established: 1849
Revenues: $52,824 (+8%)
Net Income: $7,215 (+4%)
R&D: $7,872 (+2%)
TOP SELLING DRUGS
|Prevnar||family pneumoccal vaccine||$5,718||-8%|
Headquartered in New York City, Pfizer jumped past Novartis to reclaim its spot as the largest pharmaceutical company in the world by revenue. The company reported an 8% growth to $52.8 billion for 2016 as compared to $48.9 billion in 2015. Pfizer’s portfolio includes medicines, vaccines, and consumer healthcare products separated into two businesses: Innovative Health and Essential Health.
The Innovative Health segment includes the global innovative pharmaceuticals segment and the global vaccines, oncology, and consumer healthcare segment and accounts for more than half of the company’s total revenues. The revenue contribution from the segment rose to 55% of total revenues for 2016. The Innovative Health revenues increased 11% to $29.2 billion in 2016 primarily due to an increase in sales of Lyrica, Ibrance, Eliquis, Xeljanz, Xtandi, and the strong performance of new products.
Pfizer Essential Health, formerly known as the Global Established Pharma segment, is focused on non-viral anti-infectives, biosimilars and sterile injectable medicines. The Essential Health business also includes legacy Hospira products. In September 2015, Pfizer acquired Hospira to create a leading provider of global sterile injectables that now encompasses one of the broadest and most diverse portfolios of sterile injectable medicines in the industry. The Essential Health segment revenue’s rose 11% to $23.6 billion in 2016, driven by increased sales of legacy Hospira products.
Many of Pfizer’s R&D pipeline’s new molecular entities are aimed at a range of cancers, including kidney, breast, prostate, lung and blood cancers, and include biologics, chemicals, immunotherapies, gene therapies and biosimilars.
In 2016, Pfizer achieved several regulatory milestones. Its breakthrough oncology product Ibrance, which was approved by the FDA in the U.S. in 2015 for the initial treatment of the most common form of advanced breast cancer, received a new U.S. indication for recurrent disease. Ibrance also was approved in 2016 by the European Medicines Agency (EMA) for both initial and recurrent disease. There are 77 ongoing or completed collaborative Ibrance studies with investigators, 43 of which are in breast cancer and 34 in non-breast tumors including pancreatic and head and neck cancers.
Xalkori, Pfizer’s treatment for non-small cell lung cancer, was approved by the FDA for a certain type of lung cancer known as ROS-1.
Two therapies in development for cancer were accepted for regulatory review in 2016. Inotuzumab for acute lymphoblastic leukemia is now in registration in the EU, and avelumab for metastatic Merkel cell carcinoma is being reviewed in the U.S. and EU.
Together with its partner Merck KGaA, Pfizer is expanding its foothold in immuno-oncology where it currently has 30 avelumab clinical programs in the clinic and in 2016, launched four “first-in-patient” studies and now has eleven immuno-oncology entries in the clinic. Pfizer is now well positioned to capitalize on what many believe will be the future of cancer treatment—immuno-oncology agents combined with more conventional therapies.
Driving progress in the biosimilars market
As the leading global biosimilars company, Pfizer currently has three marketed biosimilars as part of its acquisition of Hospira—Inflectra (infliximab-dyyb), Retacrit (epoetin zeta) and Nivestim (filgrastim)—available to patients in several markets. Inflectra, which is marketed under other brand names in some countries, is approved in more than 70 countries. Pfizer’s robust biosimilars pipeline consists of eight distinct molecules in mid-to-late stage development, and six in early-stage development. Three of its late-stage pipeline products have reported positive top-line data from Phase III studies, and full data results are anticipated in 2017-2018.
Over the past year, the company has also worked to advance the U.S. biosimilars marketplace. In 2016, Pfizer launched Inflectra, a biosimilar for Remicade in the U.S. It marks the first monoclonal antibody (mAb) biosimilar to be both approved and launched in the U.S. It received FDA clearance in November 2016 and will treat difficult conditions including rheumatoid arthritis (RA), Crohn’s disease, plaque psoriasis and ulcerative colitis (UC).
Pfizer’s 14 biosimilars in the pipeline are expected to compete in a global market that may grow to $17-20 billion over the next five to 10 years. To offer support to patients and providers in the U.S., Pfizer launched the Pfizer enCompass Program, a comprehensive reimbursement and patient support program for biosimilars.
Pfizer is also developing new therapies for improving the quality of life of people who live with debilitating conditions such as RA, lupus, psoriatic arthritis and inflammatory bowel disease (IBD), including UC. It’s expertise in Janus kinase inhibitors (JAK), which interfere with the inflammation process in autoimmune diseases, is enabling it to advance several other potential anti-inflammatory therapies beyond the marketed product Xeljanz. Pfizer anticipates initiating approximately six JAK studies in 2017.
In addition, Pfizer has a rich history in vaccine research and development, and in 2016 continued to improve and expand its portfolio of potentially life-saving vaccines. The European Commission approved an expanded indication for its Nimenrix vaccine making it the first and only conjugate vaccine in the EU for immunizing infants six weeks of age and older against invasive meningococcal disease caused by a certain group of bacteria. In addition, Pfizer’s Meningococcal Group B (MenB) vaccine, Trumenba, was approved by the FDA for a new two-dose schedule designed to help prevent MenB in healthy adolescents and young adults. Pfizer also continued to advance its Staphylococcus aureus (S. aureus) and Clostridium difficile (C. difficile) vaccine candidates, designed to prevent widespread and increasingly drug-resistant infections.
Collaborations and Acquisitions
Collaboration is an important element of Pfizer’s overall discovery and early development process. In 2016, it received breakthrough therapy designation from the FDA for a hemophilia gene therapy being developed in partnership with SPARK Therapeutics. It also acquired Bamboo Therapeutics, a privately held biotech based in Chapel Hill, NC, focused on developing gene therapies for the potential treatment of patients with certain rare diseases including Duchenne muscular dystrophy (DMD) and Friedreich’s ataxia (FA). Through this acquisition Pfizer acquired a number of novel assets, key technology and manufacturing capabilities that position it to be ahead of the curve in this developing area of research that the company says has the potential to be game-changing.
In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, primarily outside the U.S., including the commercialization rights and development rights in certain markets to the newly approved EU drug Zavicefta (ceftazidime-avibactam), the marketed agents Merrem/Meronem (meropenem) and Zinforo (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and ceftaroline-avibactam (CXL).
Zavicefta specifically addresses certain multi-drug resistant Gram-negative infections, including those resistant to carbapenem antibiotics, one of the largest threats to global health in the field of infectious disease.
Pfizer also advanced its collaboration with Merck & Co. on ertugliflozin, which is in a new class of treatments for type 2-diabetes, the world’s most prevalent type, and expects regulatory action in 2017. Through a partnership with Eli Lilly & Co., Pfizer has initiated six new Phase III trials to continue the development of tanezumab, a novel potential treatment option for chronic, debilitating pain in patients with osteoarthritis, lower back pain and cancer.
Pfizer also entered into several research collaborations and business relationships. They include collaborations with Biolnvent International AB to develop antibodies targeting tumor-associated myeloid cells and Western Oncolytics to advance their novel oncolytic vaccinia virus, WO-12, adding another novel technology platform to its cancer vaccine efforts, as well as a relationship with IBM where it will utilize IBM Watson for Drug Discovery to help accelerate research in immuno-oncology by identifying potential new targets and combination therapies.
Domain Therapeutics, a biopharma company specializing in new drug candidates that target G protein-coupled receptors (GPCRs), entered a collaboration agreement with Pfizer to assess the impact of mutations on different signaling pathways engaged by GPCRs. Domain will use its bioSensAll technology to define signaling signatures for each of the wild-type and mutant receptors. The bioSensAll technology allows for easier understanding of signaling pathways activated by each candidate molecule, predicting its pharmacological profile. This makes it possible to choose at an early stage molecules that have the required activity but do not present side effects or induce tolerance to treatment. The collaboration aims to validate potential targets across a range of therapeutic indications.
Pfizer also entered a new therapeutic antibody discovery collaboration with AbCellera Biologics to apply its mAb screening platform to discover function-modulating antibodies against undisclosed membrane protein targets. AbCellera’s platform allows it to screen natural immune repertoires with unparalleled depth to unlock challenging discovery programs.
Lastly, Pfizer gained an eczema asset when it paid $5.2 billion for Anacor Pharmaceuticals. The company’s lead asset, crisaborole, is a non-steroidal topical PDE4 inhibitor with anti-inflammatory properties for the treatment of mild-to-moderate atopic dermatitis, or eczema. In two Phase III studies, crisaborole achieved statistically significant results on all primary and secondary endpoints. Pfizer received FDA approval at the end of the year and said it believes peak sales for crisaborole could potentially reach $2.0 billion annually.