MADISON, N.J., Oct. 5 /PRNewswire-FirstCall/ -- Wyeth showcased a robust pipeline of late-stage research and development (R&D) programs, as well as several innovative early-stage compounds during its R&D presentation to analysts and investors today in New York.
While reviewing its pipeline, Wyeth highlighted seven new drugs and 11 indications in late-stage clinical development, including new products spanning a variety of therapeutic areas, notably women’s health, vaccines and neuroscience.
“With seven new products on the horizon and 11 major late-stage clinical programs rapidly moving forward, Wyeth is leading the way in bringing new solutions for patients and physicians,” said Robert Essner, Wyeth Chairman and Chief Executive Officer. “We believe these new treatments will help continue the strong growth generated by our broad portfolio led by Enbrel(R) and Prevnar(R) and could potentially be among Wyeth’s top products by 2010.”
The Company also presented new data on its early-stage R&D pipeline with special emphasis on programs for oncology and Alzheimer’s disease. Currently, Wyeth features nine oncology programs utilizing three different therapeutic strategies. In addition, Wyeth’s Alzheimer’s program is utilizing three platforms -- small molecules, antibodies and therapeutic vaccines. There currently are 10 Alzheimer’s programs in development at Wyeth.
“Since 2004, Wyeth has submitted 11 new drug applications in the United States,” said Robert R. Ruffolo, Jr., Ph.D., Senior Vice President of Wyeth and President of Wyeth Research. “We have delivered on an ambitious goal to submit two New Drug Applications (NDA) for new molecular entities per year, and, with 68 projects now in development, we believe that we can continue at that pace.”
Near-Term Pipeline Highlights
Prevnar 13 (13-Valent Pneumococcal Conjugate Vaccine)
Since the introduction of Prevnar, pneumococcal 7-valent conjugate vaccine (diphtheria protein), in the United States, the rate of antibiotic-resistant invasive pneumococcal disease has substantially decreased in infants and young children and adults over age 65.
Building on this success, Wyeth is developing a 13-valent pneumococcal conjugate vaccine that targets additional pneumococcal serotypes. This new vaccine currently is undergoing worldwide Phase 3 studies in both children and adults with submissions beginning in early 2009. If approved, Prevnar 13 would be the most complete vaccine available for the prevention of pneumococcal disease and otitis media.
Pristiq (Desvenlafaxine Succinate) (Major Depressive Disorder and Vasomotor Symptoms)
Pristiq(TM), a serotonin/norepinephrine reuptake inhibitor (SNRI) now is being studied with a specific focus on women. It initially was developed for two indications that currently are pending approval from the U.S. Food and Drug Administration (FDA) -- the treatment of major depressive disorder (MDD) and vasomotor symptoms (VMS) associated with menopause.
In the area of depression, Pristiq is expected to improve the balance of serotonin and norepinephrine as compared with serotonin reuptake inhibitors (SSRI) because of its pharmacologic profile as a dual reuptake inhibitor. This balance is thought to be important in depressed women who are transitioning through menopause and often are experiencing a fluctuation or decline in estrogen that may directly or indirectly diminish both serotonin and norepinephrine functioning.
Clinical studies confirm that Pristiq is effective in both men and women. However, women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology.
Pristiq also may be a treatment option for patients who are on multiple medications. The compound has a low risk of drug-drug interactions. This is important when considering that depression often is a co-morbid condition in medically ill patients and that these patients frequently are taking multiple medications. The Company expects FDA action for the MDD indication in January 2007.
FDA action for the second application for Pristiq for vasomotor symptoms (VMS) associated with menopause is anticipated in April 2007. Pristiq is expected to provide significant relief of hot flushes (decrease in number and severity) associated with menopause.
If approved, Pristiq will be the first non-hormonal treatment indicated for relief of VMS.
The dual indications represent the beginning of Wyeth’s optimization of this promising compound. The Company also plans to pursue indications for Pristiq that would include fibromyalgia syndrome and diabetic neuropathic pain.
Viviant (Bazedoxifene) (Osteoporosis)
Viviant(TM) is a selective estrogen receptor modulator (SERM) that has been submitted for prevention of postmenopausal osteoporosis and currently is in Phase 3 clinical trials for the treatment of postmenopausal osteoporosis.
According to the National Osteoporosis Foundation, approximately 8 million U.S. women are estimated to have osteoporosis and another 22 million are at risk for developing the disease. Each year, osteoporotic fractures cost the U.S. health system an estimated $17.9 billion.
The FDA accepted the Viviant NDA for the prevention of osteoporosis on August 23, 2006. In 2007, Wyeth plans to submit an additional NDA for Viviant for the treatment of osteoporosis.
Aprela (Bazedoxifene/Conjugated Estrogens) (Vasomotor Symptoms)
The addition of conjugated estrogens to bazedoxifene for the relief of a wide range of menopausal symptoms is expected to add significant value to this product line, potentially making the bazedoxifene family a comprehensive approach to postmenopausal treatment.
Aprela(TM) has the potential to provide improved bone health while also reducing vasomotor symptoms without stimulating breast or uterine tissues. In 2007, Wyeth is planning to file an NDA for Aprela for treatment of vasomotor symptoms, vaginal atrophy and prevention of osteoporosis.
Lybrel (Levonorgestrel/Ethinyl Estradiol Tablets)
Lybrel(TM) is an investigational oral contraceptive that contains a low dose of levonorgestrel and ethinyl estradiol, a well-studied combination. It is expected to be the only combination oral contraceptive approved that is designed to be taken daily, 365 days a year, without a placebo phase or pill- free interval. If approved, this product also will allow a woman to reduce symptoms that often accompany the hormonal fluctuations associated with the menstrual cycle.
In addition to the FDA, the NDA for Lybrel is under review in the European Union.
Torisel (Temsirolimus)
Torisel(TM) is a specific inhibitor of mTOR (mammalian target of rapamycin), a signaling protein that regulates cell growth and angiogenesis or new blood vessel formation. It currently is in Phase 3 trials for several cancers, including renal cell carcinoma (RCC) and mantle cell lymphoma.
In June 2006, Wyeth announced preliminary results of an ongoing study of Torisel for the treatment of advanced renal cell carcinoma. RCC accounts for about 85 percent of all renal cancers. Patients with the most advanced form of the disease have a five-year survival rate of 20 percent.
At today’s meeting, Wyeth reviewed previously reported data showing that patients who were treated with temsirolimus alone experienced a 3.6-month, or 49 percent, increase in median overall survival time compared with patients treated with interferon-alpha alone.
Bifeprunox (Schizophrenia)
Bifeprunox, a dopamine partial agonist, is an investigational atypical antipsychotic for the treatment of schizophrenia. Clinical data were presented from safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia in both acutely psychotic patients and patients who have stabilized disease.
While bifeprunox has been shown to have a smaller mean effect in acute psychosis when compared with older atypical antipsychotics that have some well-known side effects, it may be particularly well-suited for patients who are experiencing side effects with their current therapy. The safety data for bifeprunox have consistently shown a favorable weight and metabolic profile in both short- and long-term studies, which is a common and serious side effect that can cause patients to stop taking their medication.
An NDA for bifeprunox for the treatment of schizophrenia will be submitted to the FDA in October 2006. Wyeth will co-market and co-promote bifeprunox in the United States, Canada and Mexico with Solvay Pharmaceuticals, which will hold the license and record the sales.
Methylnaltrexone
Methylnaltrexone is an investigational drug that is being studied as a treatment for the peripheral side effects of opioid analgesics, without interfering with pain relief. It is being developed in three dosage forms: subcutaneous and oral forms as treatment platforms for opioid-induced constipation (OIC) and an intravenous (I.V.) form for post-operative ileus, a potentially serious impairment of gastrointestinal function that can delay recovery and can prolong hospitalization.
Opioid analgesics, such as morphine, are widely used to treat patients with moderate to severe pain. However, opioid use often results in OIC. An estimated 5 million patients suffer from OIC annually.
Wyeth is developing methylnaltrexone in collaboration with Progenics Pharmaceuticals. The companies plan to submit NDAs for subcutaneous methylnaltrexone in early 2007, I.V. methylnaltrexone in late 2007 or early 2008 and oral methylnaltrexone in late 2008 or early 2009.
Early-Stage Pipeline Programs
Alzheimer’s Disease
Wyeth’s Alzheimer’s program utilizes three platforms: small molecules, antibodies and vaccines to interact with different targets than presently available medications for this disease. In total, Wyeth has 10 development programs under way for Alzheimer’s disease.
Among these programs, the monoclonal antibody, bapineuzumab, and the peptide-CRM conjugate ACC-001, both in development in collaboration with Elan Pharmaceuticals, are intended to clear the formation of amyloid plaques in the brain. In addition, lecozotan, a small molecule drug currently in Phase 2 testing, is designed to enhance the levels of critical neurotransmitters in the brain.
Oncology
Wyeth also discussed a number of early-stage programs across its three strategies for oncology: cell cycle inhibitors, cell signaling inhibitors and anti-body targeted chemotherapy. The Company discussed nine oncology programs in either Phase 0, Phase 1 or Phase 2. These include four different antibody targeted chemotherapies for acute myelogenous leukemia, non-Hodgkin’s lymphoma, and a variety of solid tumors, including breast, colon and lung cancer.
Webcast Information
The information contained in this press release is a brief summary of the material and clinical data presented at today’s investor conference. For more complete information, investors and other interested parties are directed to the archived audio webcast of the R&D presentations that will be available on Wyeth’s Web site for the next 90 days. Slides from the day’s presentation also will be made available on the Company’s Web site, www.wyeth.com.
About Wyeth
Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third-party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, including the ability of any particular patent to provide market exclusivity, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, Risk Factors.” We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Wyeth
CONTACT: Media: Douglas Petkus, +1-973-660-5218, or Investors: JustinVictoria, +1-973-660-5340, both of Wyeth
Web site: http://www.wyeth.com/
