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Besins Healthcare, Shin Nippon Biomedical Laboratories, Ltd Announce Delivery Technology Licensing Agreement for Intranasal Progesterone
Date:4/18/2013

BANGKOK, April 18, 2013 /PRNewswire-USNewswire/ -- Besins Healthcare (Besins) and Shin Nippon Biomedical Laboratories (SNBL), a global leader in hormonal products, announced today that they have completed a licensing agreement to use SNBL's proprietary intranasal drug delivery system, Muco™ System, to further develop its BHR-310 investigational agent containing progesterone for treating mild traumatic brain injury (TBI).

Under the terms of the licensing agreement, Besins gains access to SNBL's delivery technology, along with associated patents and know-how for delivery of progesterone.  Besins will be responsible for completing the development of the product, seeking regulatory approval and commercializing the product.  SNBL will be entitled to certain undisclosed milestone payments and royalties on sales.

"The overwhelming need for a treatment for concussions or mild TBI cannot be overstated," said Thomas W. MacAllister , JD, PhD, Besins Chief Development Officer.  "The condition is a huge unmet medical need, especially in theaters of war and on sports fields.  Partnering with SNBL will allow us to quickly accelerate our intranasal progesterone research program.  They have a tremendous amount of expertise in nasal delivery and the platform we are licensing gives far superior performance than the numerous other approaches we have tried."

An intranasal progesterone powder, BHR-310 is designed as a ready-for-use nasal spray treatment for wounded warriors or athletes with TBI at the site of injury.  Outcomes from preclinical studies of BHR-310 in rats and monkeys conducted by Besins' research and development affiliate, BHR Pharma, LLC, (BHR), support the feasibility of a high-dose, rapidly absorbed intranasal progesterone product able to deliver clinically meaningful doses of progesterone to the brain.  BHR anticipates entering the clinic in Q3
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