New Pfizer Pipeline Shows Progress And Growth In Vaccines, Biologics And High-Priority Disease Areas
Prioritized Pipeline Marks Important Milestone for Company's New Global R&D Organization
Company Meets Key Late-Stage Development Commitments Made to Investors
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. today provided an update to its pipeline for the first time since the close of the acquisition of Wyeth in October, 2009. The new development pipeline, composed of assets from both legacy companies, includes 133 programs from phase 1 through registration, and shows growth and increased diversity in each of the areas where the company invests in research and development.
"This pipeline of investigational medicines represents the strong future of Pfizer," said Martin Mackay, president, PharmaTherapeutics Research and Development. "Since the closing of the Wyeth transaction late last year, we have made strategic decisions about our R&D resources, global footprint and high-priority projects. Our focus now turns to delivery of these health solutions for patients around the world."
Pfizer has identified six "Invest to Win" areas of research where there exist significant opportunities for innovation and market leadership: oncology; pain; inflammation; Alzheimer's disease; psychoses; and diabetes. The new pipeline demonstrates focused investment in these areas of significant unmet medical need as well as growth in the critical technologies of vaccines and biologics.
Following the acquisition of Wyeth, the combined company pipeline had 600 projects ranging from discovery through registration. The new prioritized portfolio contains about 500 projects across a broad range of diseases, with a focus on the "Invest to Win" areas, as well as vaccines and biologics. Approximately 70% of Pfizer's research projects and 75% of the late-stage portfolio are focused on these areas.
The growth in vaccines and biologics is reflective of Pfizer's goal of becoming a top-tier biotherapeutics company by 2015. The company's pipeline now includes a total of 6 vaccines and 27 biologics in development, up from 1 vaccine and 16 biologics at the last pipeline update in March 2009.
"Through the acquisition of Wyeth, Pfizer has become a leading biotherapeutics company, and we are well positioned to pioneer the next generation of high-potential medicines," said Mikael Dolsten, president, BioTherapeutics Research and Development.
Pfizer's portfolio now includes:
30 compounds in development for various oncology indications, including PF-02341066, a c-MET-ALK inhibitor in Phase 3 for the treatment of non-small cell lung cancer, and axitinib, a VEGF inhibitor in Phase 2 for lung, gastrointestinal, thyroid, and breast cancer and Phase 3 studies for renal cell carcinoma (RCC). Pfizer has two pan-HER/erbB targeted agents in Phase 3 studies, including PF-00299804 for non-small cell lung cancer and Neratinib for metastatic breast cancer. In addition, Pfizer has therapeutic targets in hematology with compounds in Phase 3 development, such as bosutinib, for the treatment of chronic myelogenous leukemia (CML), in addition to compounds in earlier development, such as inotuzumab ozogamicin for the treatment of Non-Hodgkin's Lymphoma. Last month, a supplemental new drug application (sNDA) seeking FDA approval for Sutent for the treatment of pancreatic neuroendocrine tumors was filed. Sutent is an oral multi-kinase inhibitor approved for the treatment of advanced / metastatic renal cell carcinoma (RCC) and the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
10 compounds in development for Alzheimer's disease, representing a range of mechanisms Pfizer is evaluating for the treatment of this illness. These include Latrepirdine (Dimebon), being developed by Pfizer and Medivation, and bapineuzumab, being developed by Pfizer and Janssen, both in Phase 3 development for the treatment of Alzheimer's disease.
8 compounds in development for pain, including tanezumab, a novel injectable biotherapeutic compound which targets nerve growth factor. The Phase 3 program studying tanezumab in osteoarthritis initiated in November, 2008, with more than 5,000 patients planned to be treated with this potential new medicine.
11 compounds in development for inflammation, including tasocitinib (CP-690,550), Pfizer's JAK-3 inhibitor in development for the treatment of rheumatoid arthritis (RA). Pfizer initiated a global Phase 3 clinical program in RA for tasocitinib (CP-690,550) in February 2009, with five Phase 3 studies ongoing.
6 vaccines and 27 biologics in the development pipeline, including Prevnar 13, a vaccine designed to prevent pneumococcal disease in infants and young children. Prevnar 13 has been approved for infants and young children in 34 countries, including in the EU and Canada, and is under regulatory review in many other countries, including the U.S. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.
By the end of 2009, Pfizer as a stand-alone company met three late-stage development commitments made to investors in March 2008. It met a commitment to initiate 10-12 Phase 3 starts between March, 2008 and March, 2009, and it met commitments to initiate 15 Phase 3 starts in the 2008-2009 period and to have 24-28 new molecular entities and new indications in the Phase 3 pipeline by the end of 2009. The new combined company pipeline has 34 new molecular entities and new indications in Phase 3.
Pfizer also announced that it has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Lyrica for the adjunctive treatment of generalized anxiety disorder (GAD).
In November, 2009, Pfizer announced that it would reduce its global R&D square footage by 35 percent. Consequently, R&D activities will be conducted at five main sites and nine specialized units around the world as compared with 20 R&D sites upon closing the acquisition of Wyeth on October 15, 2009.
Detailed information about Pfizer's pipeline is available at www.pfizer.com/pipeline. Accompanying information includes compound name, target disease, phase of development and, for late-stage programs, mechanism of action.
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At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com
DISCLOSURE NOTICE: The information contained in this release is as of January 27, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about various products in development and potential additional indications for certain in-line products, including their potential benefits, and about planned regulatory submissions and planned facility reductions, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications and supplemental drug applications that have been or may be filed for any such products in development and additional indications, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products and such additional indications; and competitive developments. -6-
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.