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

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
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SOURCE Besins Healthcare
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