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2012 Licensing and Partnering Opportunities

Gabapentin and Women’s Health: Post-Menopausal Hot Flashes

2012 EU/International:  Non-Hormonal Treatment for Hot Flushes/Vasomotor Symptoms of Menopause and Cancer Therapies

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Gabapentin and Women’s Health: Post-Menopausal Hot Flashes
Many millions of women, worldwide, are seeking a safe and effective alternative to hormone replacement therapy (HRT) to treat vasomotor symptoms (VMS), such as hot flashes, sweating, and sleep disturbances associated with the menopause. HRT, the conventional treatment, has been linked to serious risks of cancer, stroke, and heart disease, and the World Health Organization has designated HRT as “carcinogenic”.

Gabapentin, 
a non-hormonal drug, was recently compared with estrogen in the treatment of moderate to severe hot flashes (Reddy S. et al, 2006, Obstetrics and Gynecology, 108 (1) 41-48). Results suggest that immediate release gabapentin may be as effective as estrogen in reducing the frequency and severity of hot flashes.

PharmaNova owns the exclusive worldwide rights to 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.

“Gabapentin-GR” (SeradaTM;DM-5689)  is a proprietary formulation being developed by Depomed Inc. (NASDAQ: DEPO; www.depomedinc.com) under sub-license from PharmaNova, for treatment of menopause hot flashes only and for commercialization solely in the U.S.  This formulation is currently undergoing Phase 3 clinical trials in the U.S.

European (EU), Canadian, Australian, and New Zealand rights to the use of gabapentin for hot flash vasomotor indications are retained exclusively by PharmaNova and are available for Licensing/Partnering/Commercialization.  We encourage companies interested to contact us.

 

Gabapentin: A Non-Hormonal Treatment for Menopause Hot Flushes and other Vasomotor Symptoms (VMS)

For License:  PharmaNova is  seeking partners and licensees for European and other territory rights to develop and market gabapentin for conditions associated with hormonal variation such as hot flushes of the menopause.  PharmaNova, Inc. holds exclusive rights for use of any and all formulations of gabapentin in these and other VMS indications.  Patent life through 2020.

 

Therapeutic Area(s):

 

Women’s Health; Neuroscience; Endocrinology; Menopause; Cancer.

 

Indications:

Symptoms of Hormonal Variation e.g. i) hot flushes & related vasomotor symptoms (VMS) associated with the menopause ii) adjunctive treatment of prostate cancer and breast cancer to alleviate VMS side effects of drug therapy or surgery.

 

Mode of Action:

 

CNS: Non- hormonal control and normalization of vasomotor function.

 

Active Pharmaceutical Ingredient:

 

Gabapentin [1-(aminomethyl)cyclohexaneacetic acid]

Regulatory & Clinical Status:

q  Prescription products approved since 1993 for adjunctive anticonvulsant therapy in epilepsy in EU and US.

q  Indications for gabapentin associated with hormonal variation VMS are new and not yet FDA-approved.

q  ER-gabapentin (Serada™[1]) in late stage Phase 3 clinical trials for “Menopause Hot Flashes”.

q  Serada™ being developed in USA by Depomed, Inc. under license from PharmaNova.

 

Clinical Evidence:

q  Proof of Concept originally established in multiple studies for IR-gabapentin.

q  Phase 2 studies: dose-effect established for Serada.

q  Two Phase 3 studies (“Breeze 1”, “Breeze 2”) completed.

q  One additional study (Breeze 3) expected to complete 3Q 2011.

Proposed Prescription Products:

q  Controlled/extended release solid oral dosage forms for 1-2X daily dosing.

 

Sales Potential for EU:

 

q  >$500M

Business Development Contacts:

Kieran Rooney PhD (UK): kieran.rooney@pharmanovaco.com

Tom Parker (USA):           tom.parker@pharmanovaco.com

 

 [1] Registered trademark of Depomed, Inc.

 

 

 

 NovaSperse-based Products
PharmaNova has developed numerous candidate products based on its proprietary NovaSperseSM nanoparticle platform.  We are active in the fields of topical antivirals and eye disease.  These projects are currently pre-clinical and poised for partnering for further development and/or out-licensing. 

Our client-sponsored and partnered projects include formulations in the fields of oncologic chemotherapeutics and glaucoma.