Exclusive license for use of gabapentin in the above indications in EU, Canada, Australia, New Zealand. US Phase 3 trials of MR-gabapentin for menopause by PharmaNova’s US licensee (Depomed, Inc) will complete in 3Q 2009; Co-promotion in US is possible.

Treatment of Menopausal Hot Flushes/Flashes with Modified-Release Gabapentin.

Menopausal hot flushes/flashes (or vasomotor symptoms of the menopause) is a condition of significant unmet medical need and a huge market opportunity worldwide.  The use and sales of hormone replacement therapy (HRT) peaked in 2002 (>$3B in the US) and has now declined to less than 50% (Rx and $) of 2002 levels in both US & EU as a result of major safety concerns asociated with HRT. Recent estimates project that over 68 million women in the seven major markets will seek treatment for menopausal symptoms. The US market is now projected to be $3.5-5.0Bn while EU markets are currently ~ 50-60% of US in dollar value. All are growing rapidly. 

The fall in HRT use has created a huge market gap and the opportunity to access an unusually large market share with rapid uptake into the market in all major territories. Clearly, there is an urgent need for a safe, non‐hormonal alternative to HRT to treat such symptoms. There is currently no non‐hormonal drug approved for use in this indication. For millions of patients around the world, HRT has become unacceptable or is contraindicated. Modified-release gabapentin will address this major need and provide the first real choice in treatment options.

Gabapentin is a known drug approved worldwide and with an extensive safety profile used  in the adjunctive treatment of partial seizures and for neuropathic pain (post‐herpetic neuralgia, PHN). Gabapentin is not a hormone or hormone analogue, nor does it modify endogenous hormones. In numerous well-conducted clinical studies it has been proven to be a highly effective treatment for menopausal hot flushes/flashes, and also in alleviating the hot flushes/flashes associated with tamoxifen treatment of breast cancer and androgen deprivation therapy, (e.g. goserelin, leuprolide) of prostate cancer.

Both of the primary cancer-related indications proposed for gabapentin therapy represent areas of significant unmet medical need and commercial opportunity.  Numerous peer-reviewed clinical studies have been published describing the efficacy of gabapentin in the primary vasomotor indication and also in the related vasomotor-cancer indications. 

A detailed "Clinical Summary" can be provided on request.

PharmaNova has sub-licensed some of its exclusive rights to this therapeutic approach to Depomed Inc., for the development of their proprietary modified-release product "Gabapentin-GR" (GR, gastric retention) for menopausal hot flushes/flashes, in the US only. US Phase 3 trials of gabapentin-GR for menopausal hot flushes/flashes are expected to complete in 3Q 2009. 

Phase III

PharmaNova is seeking exclusive licensees and strategic partners in Europe and other territories to collaborate on clinical development and commercialization of modified-release gabapentin for hot flushes/flashes associated with the menopause and/or those associated with drug-therapy for certain cancers. The opportunity also has the potential for co-promotion and marketing in the USA

US 6,310,098 and EU 1 202 725