Healthcare Industry News: Lyrica
News Release - August 6, 2007
Pfizer Says Growth in Phase II Portfolio Supports Goal of Tripling Phase III Portfolio by 2009Company Focused on Areas of High Medical Need Including Cancer, Heart Disease, Pain, Neurological Disorders and Infectious Diseases
Update Posted Online Today Shows 99 Programs Across 11 Therapeutic Areas, With 47 in Phase II and Significant Growth in Biologics
NEW YORK--(HSMN NewsFeed)--Pfizer said today that it now has a total of 47 programs in its Phase II Research and Development pipeline, which is the largest Phase II cohort in its history and represents continued progress toward its target of tripling the company's Phase III portfolio by 2009. "The growth of our Phase II cohort is encouraging progress toward meeting our target for our Phase III portfolio by 2009," said Pfizer's Chairman and Chief Executive Officer Jeff Kindler. "With the progress we are seeing in our pipeline -- as well as our efforts in reducing our attrition rates - we are also continuing to target having a steady stream of new medicines from our internal R&D, four a year, starting in 2011. Our portfolio is very promising and focused on markets where we see substantial opportunities to meet unmet medical needs with innovative science and technology. We will continue to sharpen the focus and simplify the structure of our R&D organization so that we bring our pipeline forward to commercialization as rapidly as possible and enhance our productivity in all aspects of our clinical work."
The pipeline update, posted today at http://www.pfizer.com/pipeline, provides information on progress of candidates since the posting last December:
- There are now 99 total programs, with 38 in Phase I, 47 in Phase II, 11 in Phase III and three in registration, awaiting action from regulatory authorities.
- Three compounds have entered Phase III, 14 have entered Phase II, and seven have entered Phase I.
- Phase II now includes 47 programs, reflecting the success of the company's ongoing efforts to increase R&D productivity and reduce attrition at this key phase of development - 14 compounds were added while only four were discontinued. Phase II covers a wide range of therapeutic areas, and it is advancing potential new and innovative treatments across a broad spectrum of unmet medical needs.
- The pipeline includes 20 potential treatments for cancer; 16 for cardiovascular, metabolic and endocrine diseases; 17 for pain and inflammation; 17 for neurological disorders and 10 for infectious diseases. Others areas represented include gastrointestinal, genitourinary, ophthalmology, dermatology and allergy/respiratory. Overall a total of 13 programs were discontinued.
- The development pipeline now has a total of 14 biologic compounds, including vaccines and antibodies designed to treat cancer, rheumatoid arthritis, influenza and other serious medical conditions. Pfizer is making significant internal and external investments to further expand its presence in biologics and capitalize on attractive development opportunities.
- While the total number of Phase I compounds has declined since the December, 2006 update and now stands at 38, reflecting both transfers to Phase II and some attrition, the majority of Pfizer's Phase I starts are targeted for the second half of 2007.
- The update includes 85 New Molecular Entities plus 14 potential new indications or enhancements for medicines including Lyrica, Geodon, maraviroc, and Eraxis and Vfend, among others.
"In the last eight months, we have advanced 27 programs, with the loss of just 13. Our progress is especially gratifying since we are continuing to make major structural and organizational changes while we pursue all of these opportunities. We are revising the allocation of our capital so that we target the areas of greatest medical and commercial promise, and I am confident that you will see Pfizer bring forward significant new therapies to fight cancer, cardiovascular disease, neurological disorders, infections and many other conditions. This performance is remarkable in a period of profound change and is a testament to the commitment and dedication of my colleagues in Pfizer Global Research & Development," he added.
Research focus continues on areas of high medical need
Highlights of today's update include new information on five of Pfizer's 11 therapeutic areas: 1) oncology; 2) cardiovascular, metabolic and endocrine disease; 3) pain; 4) the neuroscience portfolio; and 5) infectious diseases.
Oncology is a major focus of Pfizer's medical research. The company invests more than 20% of its development budget in this area with 20 active programs in immunotherapy, angiogenesis inhibition and signal transduction inhibition. The pipeline includes potential treatments across numerous tumor types, underscoring the company's multidimensional approach to cancer treatment. The company now has compounds either in or nearing Phase III that, in total, address more than 70 percent of deaths due to various cancer types.
- Sutent was launched late last year to treat renal cell carcinoma and gastrointestinal stromal tumors. Pfizer's Phase III study using Sutent in patients with non-small cell lung cancer and breast cancer are progressing well, and Pfizer recently dosed its first patient in its new colorectal Phase III study. Pfizer is also pursuing axitinib for the treatment of thyroid and pancreatic cancers, and there is new data showing that it prolonged overall survival in advanced pancreatic cancer when combined with standard care chemotherapy. The first patient in the Phase III pancreatic cancer trial was dosed in July.
- The investigational compound CP-751871, which works by a novel mechanism of action, represents a new generation of immunotherapy and showed favorable survival outcomes in patients with metastatic melanoma with limited treatments options. CP-675206 continues in Phase III testing for melanoma, with data expected to be available in 2008.
Today's update also reflects Pfizer's intention to resubmit its new drug application for lasofoxifene, a selective estrogen receptor modulator for the treatment of osteoporosis, with new data in December of this year. Other compounds include CP-945598, a potential new treatment for obesity now in Phase III studies, and CP-533536, a compound in Phase II for bone healing, where Pfizer is now consulting with outside experts to develop broader clinical trials and expand its information base.
The updated pipeline shows eight candidates for pain, with an additional nine in the related area of inflammation. The company's scientists are now developing many innovative compounds aimed at novel, recently-discovered biological targets with the potential to alter, reduce or block the transmission of pain signals. For S,S-reboxetine (a selective norepinephrine reuptake inhibitor), Pfizer is encouraged by the data from a Phase II trial in patients with fibromyalgia. Phase II trials have progressed as monotherapy or in combination with Lyrica for post-herpetic neuralgia. A Phase II trial is being planned for painful diabetic neuropathy.
For PF-4383119, Pfizer has completed a Phase IIa trial in osteoarthritis with a positive read-out. As a result, the company will complete a multi-dose trial in osteoarthritis and initiate studies in other settings of pain this year. For PF-592379, a Phase II trial just started comparing against oxycodone in severe osteoarthritis pain.
In neuroscience, Pfizer received approval during the period for Lyrica's fibromyalgia indication, an important line extension in the U.S. Lyrica is currently in Phase III testing for epilepsy monotherapy and Generalized Anxiety Disorder (GAD) in the U.S., as well as Phase II for restless leg syndrome. Geodon is another in-line Pfizer medicine with potential new indications: it is in Phase II for adjunctive bipolar depression and Phase III for bipolar relapse prevention.
Pfizer also continues work on alpha-2-delta compounds for patients with neurological disorders, and it is proceeding with broad confirmatory development of PD-332334, now in Phase II, for the treatment of GAD. Pfizer scientists continue to believe that molecules with this mechanism of action are potentially important new therapies for the treatment of illnesses including insomnia and vasomotor symptoms. Pfizer also has several new approaches to the treatment of Alzheimer's disease in ongoing Phase II clinical trials.
In infectious diseases, Pfizer scientists are working on new treatments for diseases that have a devastating impact of many parts of the world, including malaria, hepatitis C and HIV/AIDS. Today we announced FDA approval for Selzentry(TM) (maraviroc), for the treatment of HIV in treatment-experienced patients. Maraviroc is also in Phase II testing for rheumatoid arthritis.
Pfizer is also currently in Phase III testing for a combination Zithromax/ chloroquine tablet to treat malaria. Its Phase II portfolio includes two potentially new HIV treatments, and it has another Phase II program underway to study two in-line medicines -- Eraxis and Vfend -- in combination to treat fungal infections.
"We will continue to update our pipeline so that investors, doctors, the scientific community, patients and their families can see how our research is advancing," said Mr. Kindler. "These updates are an important part of our commitment to transparency in all aspects of our operations, and we look forward to reporting on our continuing progress."
DISCLOSURE NOTICE: The information contained in this release is as of August 6, 2007. Pfizer assumes no obligation to update any 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 various in-line products, including their potential benefits, as well as targets with respect to the advancement of product candidates within the Company's research and development pipeline, that involve 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 may be filed for such products in development and such additional indications for in-line products 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.
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, 2006 and in its reports on Form 10-Q and Form 8-K.
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