Besins Healthcare, Shin Nippon Biomedical Laboratories, Ltd Announce Delivery Technology Licensing Agreement for …

Investigational Treatment for Mild Traumatic Brain Injury to be Studied in Phase I Trial Later This Year

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 2013.

Progesterone (P4) belongs to a class of hormones called progestogens and is the major naturally occurring human progestogen. A potent, naturally occurring neurosteroid hormone, P4 is produced in both male and female brains normally and in response to brain injury. Research suggests that progesterone has a number of mechanisms of action through which it asserts neuroprotective effects by protecting or rebuilding the blood-brain barrier, decreasing development of cerebral edema (brain swelling), down-regulating the inflammatory cascade and limiting cellular necrosis and apoptosis (programmed cell death).[1]

"As we have seen in the preclinical phase, we expect that our Muco System will safely deliver therapeutic levels of progesterone, enabling the drug to be used in a broad population of brain injured patients," said Ryoichi Nagata, MD, PhD, SNBL President and CEO. "We are pleased to partner with a company so dedicated to finding a viable treatment for this unmet medical condition. Establishment of this relationship is another important milestone in using Muco System to provide intranasal solutions to biopharmaceutical products. With its versatility to deliver different types of compounds, we expect that there will be many more partnerships to follow."

Despite significant efforts and more than 75 clinical trials over the past 20 years, there is still no approved treatment for TBI.

About TBI TBI is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force.[2] According to the World Health Organization, the condition is the leading cause of death and disability in children and young adults worldwide and is involved in nearly half of all trauma deaths. The U.S. Centers for Disease Control (CDC) calls TBI a "serious public health problem"[3] and estimates that 3.5 million Americans suffer some form of TBI annually. Of that number, approximately 75 percent of all TBIs are "concussions or other forms of mild TBI," according to the CDC.

TBI is roundly regarded as the "signature wound" of the Iraq and Afghanistan wars, accounting for 22 percent of all injuries and 59 percent of blast-related injuries.[4] According to the Defense Centers of Excellence For Psychological Health and Traumatic Brain Injury, more than 230,000 American soldiers were diagnosed with TBI in the past decade. Understanding about the devastating impact of the condition on athletes at all levels of competition is growing. The University of Pittsburgh Department of Neurological Surgery estimates that in the United States, over 300,000 sports-related concussions occur annually, and the likelihood of suffering a concussion while playing a contact sport is estimated to be as high as 19 percent per year of play.

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Besins Healthcare, Shin Nippon Biomedical Laboratories, Ltd Announce Delivery Technology Licensing Agreement for ...