Healthcare Industry News: dementia
News Release - October 18, 2006
Depomed Obtains Exclusive License to Gabapentin Use in Hot FlashesCompany to Seek Labeling for Gabapentin GR as a New, Non-Hormonal Hot Flash Therapy
MENLO PARK, Calif.--(HSMN NewsFeed)--Depomed, Inc. (NASDAQ:DEPO ) today announced that it has obtained an exclusive sublicense from PharmaNova, Inc. to a U.S. patent held by the University of Rochester covering the use of gabapentin for the treatment of menopausal hot flashes. The company currently has an ongoing Phase III clinical trial for the use of Gabapentin GR to treat post-herpetic neuralgia and a Phase II clinical trial in diabetic peripheral neuropathy. The formulation, manufacturing and clinical data from these late-stage programs will be used to accelerate a clinical program for hot flashes, which will significantly expand the company's evolving Gabapentin GR franchise. The company's goal is to develop one of the first non-hormonal treatments for hot flashes, a prevalent and often debilitating menopausal symptom.
"This license allows us to develop and seek marketing approval for Gabapentin GR for the treatment of hot flashes, while affording us marketplace protection for the use of gabapentin in this indication," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "We feel this patent is a valuable asset, as several scientific publications have demonstrated gabapentin's potential as an effective therapy for reducing menopausal hot flashes. To date, there is no single entity FDA approved non-hormonal treatment for this indication."
Carl Pelzel, executive vice president and chief operating officer of Depomed added, "We are excited about our late stage franchise in pain and believe the hot flash indication has the potential to be developed quickly by leveraging data already generated on our compound in other programs and by referring to the many publications supporting gabapentin use in treating hot flashes."
The exclusive sublicense agreement with PharmaNova relates to the use of gabapentin for the treatment of menopausal hot flashes covered by U.S. Patent Number 6,310,098. Depomed has paid PharmaNova an upfront license fee of $500,000 and has committed to milestone fees and royalties on sales of Gabapentin GR for the hot flash indication.
Mr. Pelzel continued, "The market for hot flashes is sizeable and characterized by a significant unmet need because women and their doctors have increasingly shied away from traditional hormonal, or estrogen, therapies. We believe our Gabapentin GR product may prove in clinical trials to be a safer, effective alternative to hormonal therapies in the treatment of hot flashes."
The use of estrogen for hot flashes was challenged when results of an NIH-sponsored Women's Health Initiative trial were published in the July 2002 issue of JAMA, demonstrating that hormone replacement therapy significantly increased risk of coronary heart disease and stroke. The results of this trial caused the $2 billion hormone replacement market to decline by over $800 million in just over six months, representing a loss of over 34 million prescriptions. Published data on the use of gabapentin in menopausal women support the efficacy of the compound to address hot flash symptoms. A recent study published in the July 2006 issue of Obstetrics and Gynecology reported that gabapentin is as effective as estrogen in treating hot flashes.
Sireesha Y. Reddy, M.D., assistant professor of Obstetrics and Gynecology at the University of Rochester Medical Center and lead author of the comparative trial published in the July 2006 issue of Obstetrics and Gynecology stated, "I applaud efforts to develop non-hormonal therapeutic options for the treatment of hot flashes given the serious healthcare risks associated with high doses and long term usage of hormones such as estrogen. Our findings showed that indeed gabapentin was as effective as estrogen in reducing hot flash symptoms with significantly reduced associated side effects."
"We are delighted that Depomed will pursue a program for Gabapentin GR to treat hot flashes," said Rodney A. Brown, president of PharmaNova. "Based on existing data for their technology and product, we believe that Gabapentin GR will be a welcomed alternative to hormonal therapies and a successful product in the women's health arena."
About Hot Flashes
Approximately 70 percent of North American women have hot flashes at some level of intensity during perimenopause. Hot flashes are sudden waves of heat that can start in the waist or chest and work their way to the neck and face and sometimes over the rest of the body. They are characterized by a sudden temporary onset of body warmth, flushing and sweating. Depending on the intensity of the hot flash, some women may experience headaches, fatigue, dizziness, or heart palpitations. The only government-approved single agent therapy in both the United States and Canada for treating this menopause-related symptom is prescription estrogen, which has been associated with increased risk of breast cancer, coronary heart disease, thromboembolism, stroke and dementia.
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm(TM) drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. ProQuin® XR (ciprofloxacin hydrochloride) extended-release tablets have been approved by the FDA for the once daily treatment of uncomplicated urinary tract infections and are currently being marketed in the United States. In addition, once daily Glumetza(TM) (metformin hydrochloride extended release tablets) has been approved for use in adults with type 2 diabetes and is currently being marketed in the United States and Canada. The company is conducting a Phase III trial in post-herpetic neuralgia and a Phase II trial in diabetic peripheral neuropathy with its product candidate, Gabapentin GR(TM). Additional information about Depomed may be found at its web site, www.depomedinc.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to those related to our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and its most recent quarterly report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.