Miami, FL, July 10, 2002
Noven Comments On Women's Health Initiative HRT Study
NIH Study States Risk/Benefits of Transdermal HRT May Differ From Oral Therapy
-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), a leading developer of transdermal hormone replacement therapy (HRT) products, today commented on the release of data from the Women's Health Initiative (WHI) study sponsored by the National Institutes of Health.
The WHI study was designed to evaluate the risks and benefits associated with long-term use of oral HRT by healthy women. The NIH recently announced that it is discontinuing the combination oral HRT arm of the study after an average follow-up period of 5.2 years because Prempro™, the combination oral HRT product used in the study, caused an increase in the risk of invasive breast cancer.
"It is important to clarify the scope of the WHI study and to understand whether or not its findings apply to Noven's transdermal HRT products," said Karen A. Frank, M.D., Noven's Vice President – Clinical Research and Regulatory Affairs.
In their report, the WHI study investigators specifically state: "The [study] results do not necessarily apply to lower dosages of these drugs, to other formulations of oral estrogens and progestins, or to estrogens and progestins administered through the transdermal route. It remains possible that transdermal estradiol with progesterone, which more closely mimics the normal physiology and metabolism of endogenous sex hormones, may provide a different risk-benefit profile." Noven developed and manufactures the only FDA-approved transdermal estrogen/progestin patch in the United States – CombiPatch®.
Both the estrogen and progestin components of Prempro are different chemical entities than those used in Noven's CombiPatch, and the means of delivery into the system are significantly different. Prempro is an oral tablet formulation consisting of conjugated equine estrogens and medroxyprogesterone acetate as active ingredients. CombiPatch® is a transdermal delivery system containing estradiol, which is identical to the estrogen produced naturally by a woman's ovaries, and norethindrone acetate.
Dr. Frank added: "Women generally begin HRT to treat menopausal symptoms such as hot flashes, vaginal dryness and sleep disturbances, that can disrupt normal daily activities. Most of these patients remain on therapy for well under one year, and in most cases patients terminate therapy when their menopausal symptoms subside." According to the NIH, the WHI study did not address the short-term risks and benefits of hormones for the treatment of menopausal symptoms. HRT is the only therapy proven to relieve menopausal symptoms.
In addition, the WHI study includes an arm evaluating the long-term use of estrogen replacement therapy (ERT), and this portion of the study was not terminated. The acting director of the study stated that the estrogen arm will continue because at this point there is no evidence that the risks of ERT exceed its benefits. Noven's best selling and fastest growing product, Vivelle-Dot (estradiol transdermal system), is an estrogen-only transdermal delivery system indicated for the treatment of menopausal symptoms.
"Millions of women annually struggle with hot flashes, sleepless nights and other symptoms of menopause," added Dr. Frank. "Transdermal HRT, when used as indicated, remains a safe and effective treatment for menopausal women."
Robert C. Strauss, Noven's President, Chief Executive Officer & Chairman, added: "As the developer of the nation's only FDA-approved transdermal combination HRT therapy, we are hopeful that the observations of the WHI study investigators will lead to greater interest in the benefits of our transdermal HRT products."
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Together with Novartis Pharmaceuticals Corporation, Noven owns a highly profitable women's health products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen transdermal delivery systems (including Vivelle-Dot®, licensed to Novogyne, and Estradot®, licensed to Novartis Pharma AG) and combination estrogen/progestin transdermal delivery systems (including CombiPatch®, licensed to Novogyne, and Estalis®, licensed to Novartis Pharma AG). With a range of additional products in development, including MethyPatch®, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal drug delivery systems. For additional information, visit Noven's website at www.noven.com.
This release contains forward-looking statements related to the business of Noven that can be identified by the use of forward-looking terminology such as "are hopeful", "will" and similar words and phrases. Such statements are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission and in this press release, including the risk that physicians and patients will extrapolate the study results to transdermal HRT products and that prescription growth of Noven's products will be adversely affected.
Vice President & Chief Financial Officer
Noven Pharmaceuticals, Inc.