Wyeth: The leader in women's health—yesterday, today, and tomorrow
Forward looking statement
This article includes statements of historical fact as well as projections about the future. Projections about the future are based on the best information available today, but involve significant risks and uncertainties. In the pharmaceutical industry, few products move successfully through all three stages of clinical development, and fewer still achieve regulatory approval. Also, some of the uses for which a product is investigated may not be supported by the clinical data, and/or may not be approved by the regulatory authorities. Therefore, there is no guarantee that pharmaceutical products in development will be approved as projected and introduced commercially. Wyeth Pharmaceuticals (“the Company”) assumes no obligation to update the projections in this article. Individuals are advised to refer to the statements filed by the Company with the Securities and Exchange Commission for the most current information.
As the leader in women's health care for more than 60 years, Wyeth remains committed to developing new and innovative treatments and improving the lives of women worldwide. Wyeth's Women's Health Research Institute® is the only institute in the pharmaceutical industry dedicated solely to research in women's health. The strength of Wyeth's commitment to research and development is evident in its participation in landmark clinical trials and in the depth and breadth of its current and future products. Recently launched products include low-dose conjugated estrogens (CE) and low-dose CE/medroxyprogesterone acetate (MPA) postmenopausal hormone therapies. Wyeth's goal is to develop new products that offer clear clinical advantages over existing therapies in terms of product safety and/or efficacy. The pipeline of women's health products includes several innovative products that have the potential to be either first-in-class or best-in-class. The future product pipeline includes a non-hormonal option for the treatment of hot flushes, a selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis, a new drug paradigm that combines a SERM with conjugated estrogens (CE) for the treatment of conditions related to the menopause, and oral contraceptives (OCs), including a low-dose continuous regimen and the first non-steroidal formulation. Many other innovative women's health products are in earlier stages of development, including a novel treatment for endometriosis.
Wyeth Pharmaceuticals recognizes the importance of women's health care. Since Wyeth developed the first orally active estrogen more than 60 years ago, it has been a pioneer in women's health with continued support and commitment to clinical research and drug development to meet the needs of women worldwide. Over the past decade, Wyeth provided free study drugs for two large hormone therapy (HT) trials conducted by the National Institutes of Health: the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial and the Women's Health Initiative (WHI) Study. Wyeth also fully funded the Heart and Estrogen/Progestin Replacement Study (HERS) and the Women's Health, Osteoporosis, Progestin, Estrogen (HOPE) study.
Wyeth continues to make women's health care a primary focus and invests over $130 million annually in clinical research to develop new therapeutic options to improve the quality of women's lives. Its strong commitment to women's health is evident in the breadth of its established products and the promise of its new products in the pipeline. Figure 1 shows Wyeth's recently approved women's health products and those currently under clinical investigation with estimated launch dates. Wyeth's current drug development for new and innovative products in the field of women's health care involves more than 50 ongoing clinical trials.
Fig 1. Examples of Wyeth's Women's Health Pipeline.
Menopausal health
Conjugated estrogens (CE) (PREMARIN®) and CE/ medroxyprogesterone acetate (MPA) (PREMPROTM) are the most commonly prescribed postmenopausal hormone therapies, and have been studied in some of the largest clinical trials involving women. These studies have provided women and their health care providers with extensive efficacy and safety data to help with clinical decision-making. These product databases are among the most comprehensive in the field of women's health.
Recently, hormone therapy doses have decreased significantly. In mid-2003, Wyeth introduced a low dose of PREMPRO containing 0.45 mg CE /1.5 mg MPA. This product contains 28% less estrogen and 40% less progestin than the standard 0.625 mg CE/2.5 mg MPA, and has been shown to be just as effective. In early 2004, after years of research, Wyeth announced the availability of the lowest dose of PREMPRO: 0.3 mg CE/1.5 mg MPA. It contains 52% less estrogen and 40% less progestin than the standard dose. This new formulation is the lowest clinically proven dose of HT for its approved indications, and is an important addition to Wyeth's already available low-dose hormone therapy options.
The availability of these low-dose options coincides with recent recommendations of the Food and Drug Administration (FDA), Wyeth Pharmaceuticals, and other professional organizations, that women should use the lowest effective dose of HT for the shortest duration consistent with their individual treatment goals and risks.
Not all women who suffer from vasomotor symptoms are appropriate candidates for hormone-based therapies. Thus, there is a need for nonhormonal therapeutic options. Recent data suggest that hot flushes may result from a neurochemical imbalance in the thermoregulatory circuitry. Wyeth is currently investigating the clinical efficacy of a new norepinephrine/serotonin reuptake inhibitor for the treatment of moderate-to-severe hot flushes. This product is currently projected to be available in 2007.
Wyeth is also in Phase III trials with a new SERM for the prevention and treatment of osteoporosis. When used in combination with CE, it creates a new paradigm in the treatment of conditions related to menopause. This combination product, also in Phase III clinical trials, eliminates the need for a progestin in women with a uterus. Wyeth currently projects the SERM monotherapy and combination products will be available in late 2006 and early 2009, respectively.
Contraception
Wyeth has been a leader in the field of contraception for decades. It is currently in Phase III trials with a low-dose continuous oral contraceptive that contains levonorgestrel (LNG)/ethinyl estradiol (EE). In these trials, patients take the product continuously. The continuous regimen should inhibit menses and may prevent the cycle-related symptoms such as dysmenorrhea, irritability, and emotional lability from which many women suffer. This product is currently projected to be available in 2006.
Other contraceptive products in development include the first nonsteroidal oral contraceptive, as well as the first combination of a nonsteroidal progestin with estrogen. The Company currently projects introducing these products in 2008.
Besides menopausal health products and oral contraceptives, Wyeth is also committed to continued research of many other innovative women's health products, including a novel treatment for endometriosis.
Conclusion
Wyeth's commitment to research and goal of developing new, first-in-class and best-in-class women's health products reinforces its role as the world leader in women's health. Researchers at Wyeth and at Wyeth's Women's Health Research Institute, the only such institute in the pharmaceutical industry dedicated solely to research in women's health, will continue the pursuit of innovative products and new therapeutic options to improve the quality of women's lives.
Wyeth Pharmaceuticals, Collegeville, Pennsylvania
Ginger D. Constantine, M.D., Vice President, Women's Health, Clinical Research and Development, Wyeth Research, 500 Arcola Road E-5, Collegeville, PA 19426
Key points
•Wyeth's long standing commitment to research and development in women's health is evident from its history of providing first-in-class and best-in-class products and in the depth of its current and future product pipeline.
•Recently, Wyeth launched several low-dose CE and CE/MPA postmenopausal hormone therapies. In the next 5 years, Wyeth plans to introduce a nonhormonal option for the treatment of hot flushes, a SERM for the prevention and treatment of osteoporosis, and a new product paradigm that combines a SERM with CE for the treatment of conditions related to the menopause.
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