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PharmaNova’s U.S. Licensee and Partner, Depomed, Inc., Announces Intent to File NDA for Serada for Treatment of Menopausal Hot Flashes.
PharmaNova, Inc. of Victor, New York announced today that its US licensee and development partner, Depomed, Inc., (DEPO Nasdaq) intends to file a New Drug Application (NDA) with the FDA for Serada™, an investigational extended release gabapentin formulation for the treatment of menopausal hot flashes. The announcement follows Depomed’s recent meeting with FDA to discuss the Serada clinical development program and possible submission of an NDA. Following the meeting, Depomed announced their intent to file the NDA in the second half of 2012. Rodney Brown, President and CEO of PharmaNova, stated “We are delighted that Depomed have maintained their commitment to this important program and congratulate the team on this critical achievement. With product launch potentially sometime in 2013, millions of American women may stand to benefit from the introduction of a non-hormonal treatment for menopausal hot flashes, if it is approved for marketing.”
About Menopausal Hot Flashes
According to the North American Menopause Society, hot flashes are the most common menopause-related discomfort for over 32 million women in the U.S. and represents a significant unmet need in women’s health.
PharmaNova holds a worldwide license to a patent for the use and commercialization of gabapentin for the treatment of hot flashes and to certain other vasomotor conditions including the alleviation of hot flash VMS associated with e.g. breast cancer and prostate cancer. Depomed’s has a sub-license from PharmaNova under the patent to develop and commercialize a gabapentin product for menopausal hot flashes in the U.S. Depomed exclusively owns the Serada drug formulation, including several patents covering it, as well as all clinical data and Depomed’s regulatory filings.
European (EU), Canadian, Australian, and New Zealand rights to the patent for the use of gabapentin for hot flash vasomotor indications are retained exclusively by PharmaNova and are available for Licensing/Partnering/Commercialization.
PharmaNova Inc. is a privately held pharmaceutical company. Our in-house product candidates are derived from the re‐positioning and enhancement of known drugs using our proprietary NovaSperse℠ nanoparticle technology platform. We address low risk, fast to market products in areas of clear medical need and generate revenue from partnering and licensing strategies with commercialization partners and clients worldwide. PharmaNova also conducts contractual formulation development work applying NovaSperse℠ technology to client‐owned products and compounds to support new product development or the extended life cycle management of existing products. Independently of Serada™, which does not utilize NovaSperseSM technology, PharmaNova has other new product candidates in various stages in its development pipeline. Our focus is on the development of novel, improved nanoparticle formulations of ophthalmic and anti-infective products.
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