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P&G and TheraTech Form Alliance to Develop Patented Testosterone Patch for Women
Companies Agree To Develop And Market First-Ever Testosterone Patch Designed For Women
CINCINNATI, and SALT LAKE CITY, Dec. 3 /PRNewswire/ -- The Procter & Gamble Company (NYSE: PG - news) and TheraTech, Inc. (Nasdaq: THRT -
news) said today they have entered into an agreement to develop transdermal testosterone and combination estradiol/testosterone hormone replacement patches for
women.
Industry experts estimate there are over one million women in the U.S. and Europe being treated for symptoms of testosterone deficiency, and millions more are
expected to be at risk as a result of reduced hormone production which occurs for many women in their postmenopausal years. Medical experts say benefits of
testosterone replacement therapy in women may include restoration of libido, increased energy, an enhanced sense of well-being, prevention and treatment of
osteoporosis, and improved memory.
Under the agreement, the companies will work together on the clinical development of these novel testosterone and combination estradiol/testosterone products.
P&G will fund the development of both products. In addition to on- going research and development payments, TheraTech also will receive milestone payments up
to $35 million contingent upon these products successfully meeting a number of development and commercial milestones. TheraTech will manufacture these
products and retain certain co-promotion rights. In addition, P&G will pay TheraTech royalties on future sales of these products in countries covered by this
agreement.
In return, P&G will have marketing rights for these products globally when cleared by regulatory authorities, with the exception of Asia. However, the companies
may expand the agreement to include selected Asian countries.
The companies said the testosterone patch product is currently being evaluated in a multi-center phase II clinical study being conducted by TheraTech for the
treatment of diminished libido in women with testosterone deficiency resulting from surgical menopause. Testosterone deficiency in women also can result from
natural menopause, premature ovarian failure, chemotherapy, adrenal insufficiency or long-term corticosteroid treatment.
An Unmet Medical Need
Many physicians believe testosterone deficiency is one of the most overlooked medical problems facing women today. According to many medical experts,
testosterone replacement therapy could play a role in restoring the physical energy, sense of well-being and libido which can diminish as women experience
menopause. It also may play a role in the prevention and treatment of osteoporosis by building bone mass. In addition, according to medical literature reports,
testosterone replacement therapy may have a positive effect on memory skills in women experiencing symptoms of testosterone deficiency.
There are very few therapeutic choices today that deliver natural testosterone at levels which normally occur in healthy young women for physicians to discuss with
their patients. Healthy young women produce testosterone at rates significantly less than amounts produced by healthy young men. The goal of placing a patient on
testosterone replacement therapy is to restore testosterone to normal physiological levels. In contrast, abnormally high levels of testosterone replacement dosed over
time, can lead to acne, increased facial hair and in extreme cases, lowering of voice.
''For these reasons, many women are naturally very reluctant to consider using some testosterone replacement therapy products,'' said Dr. Malcolm Whitehead,
director of the Menopause Clinic at King's College Hospital, London. ''We need tailor-made treatment options for women who exhibit symptoms of testosterone
deficiency so physicians can adjust the hormone replacement therapy to the individual patient.''
Phase I clinical studies in women with testosterone deficiency due to surgical menopause have indicated TheraTech's testosterone patch can restore testosterone
levels to the normal physiological range. Current phase II trials are evaluating the testosterone patch for the treatment of sexual dysfunction as well as its effects on
bone metabolism markers in this population.
Marianne Legato, M.D., founder/director of the Partnership for Women's Health at Columbia University, said, ''More research is needed to deepen our
understanding of the role that testosterone levels play in maintaining the optimal health of women. We also need answers to the medical issues associated with
insufficient or excess levels of testosterone, and better insights into how women experience and describe their symptoms. In addition, we also need a more diverse
range of therapeutic options to treat symptoms associated with testosterone imbalances.''
''Pioneering Effort'' In Women's Healthcare
Bruce L. Byrnes, president of P&G's health care business, said, ''For millions of women, testosterone deficiency may diminish their quality of life. We believe the
global market for this therapeutic area will grow significantly because of increasing interest in the medical community in the benefits of testosterone replacement
therapy in women.
''This new arrangement with TheraTech builds on our successful history of working together, which includes developing and introducing Alora(R), an estrogen
replacement patch, and our estrogen/progestin patch, which is currently in phase III clinical trials. Furthermore, this allows us to combine our expertise in conducting
world-class clinical studies and marketing pharmaceutical products in key geographies globally with TheraTech's experience and expertise in drug delivery and
hormone replacement patch development.''
Dinesh C. Patel, Ph.D., chairman, president and chief executive officer of TheraTech, said, ''We are delighted to expand our relationship with P&G in this new
collaboration. This represents an exciting pioneering effort in women's healthcare. P&G's marketing prowess and exceptional R&D capabilities are a terrific match
with TheraTech's patent position and advanced transdermal technology. We believe this arrangement provides excellent commercial opportunities for both
companies.''
Background information: P&G, TheraTech, Inc.
In prescription drugs, P&G is focusing on cardiovascular, musculoskeletal, anti-infective therapies and women's health. Some of P&G's leading prescription
products include Alora(R), Macrobid(R), Didronel(R), Asacol(R), and Helidac(TM) Therapy. In over-the-counter health care, P&G's leading brands include
Metamucil(R), Pepto-Bismol(R), Crest(R), Scope(R) and the Vicks(R) line of cold/flu/cough and allergy medicines. Its Internet website is pg.com.
TheraTech, Inc. develops and/or manufactures innovative, controlled- release drug delivery technologies, systems, and products, including: a variety of transdermal
patches; oral transmucosal (OTM) systems for delivery of peptides and other drugs requiring rapid onset (e.g., pain medications); a range of oral controlled-release
systems, pulmonary technologies for local and systemic drug administration; and topical preparations. The Company has over 20 products in its development
pipeline and holds 46 issued and/or pending patents. TheraTech's website is www.thrt.com.
This release contains certain forward looking statements. Any statements released by TheraTech, Inc. and P&G that are forward looking are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Editors and investors are cautioned that forward looking statements involve risk and
uncertainties which may affect TheraTech's and P&G's business prospects and performance. This includes economic, competitive, governmental, technological and
other factors discussed in the Companies filings with the Securities and Exchange Commission on forms 10-K, 10-Q or 8-K.
Background information: testosterone
hormone replacement therapy for women
Traditionally, testosterone has been considered as the male sex hormone and estrogen as the female sex hormone. However, both testosterone and estrogen
play important roles in male and female health and behavior.
Experts believe women need a balance of female hormones (estrogen and progesterone) and androgens (testosterone). In reproductive-aged women, blood
levels of estradiol, progesterone and testosterone fluctuate in accordance with the different menstrual cycle phases.
The ovaries and the adrenal glands of normal women synthesize and secrete testosterone. The level of testosterone produced by females is estimated to be
about 5% of that produced by men. Effects of testosterone deficiency in women may include loss of libido, energy and well-being.
Women are at risk of suffering from testosterone deficiency as a result of removal or non-functioning of their ovaries, natural menopause, chemotherapy,
adrenal insufficiency, and long term corticosteroid treatment. Women who have both of their ovaries removed can experience up to a 50% drop in
testosterone to a level which makes some women clinically symptomatic. These women may experience a significant drop in sex drive, energy and sense of
well-being. Women going through natural menopause may experience up to a 30-40% reduction in testosterone(1). Women with insufficient adrenal
production may experience up to a 50% reduction in testosterone.
Experts in this field believe patient/physician education and clinical research into the role of testosterone in women lag behind other hormones. A recent
survey of 252 members of a major menopause support group found that while 98% of women believe that estrogen is a natural hormone and 67% believe
progesterone is natural in women, only 46% believe that testosterone is natural in women(2).
Like estradiol, testosterone production in women drops significantly after menopause. Yet, the impact of testosterone deficiency in women has been far less
studied than that of estradiol.
Sources:
1. Vermeulen A. Adrenal androgens and aging. In: Gemazzi AR, Thijssen JHH, Siiteri PK, et al (eds). Adrenal Androgens. New York, Raven Press; 1980: p. 207
2. Dr. Phillip Sarrel of Yale University School of Medicine, PR Newswire September 5, 1997
SOURCE: The Procter & Gamble Company
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