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

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

PR Newswire

BANGKOK, April 18, 2013

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.

The CDC estimates that TBI's direct medical costs and indirect costs such as
lost productivity total more than $75 billion annually in the United States.

About Besins Healthcare
Besins, a global leader in transdermal progesterone, estrogen and testosterone
hormone therapy, is a fourth-generation, family-owned business headquartered
in Bangkok, Thailand. Its women's and men's healthcare products are available
in 93 countries around the world. Besins founded BHR Pharma, LLC in January
2008 as a wholly owned pharmaceutical research and development company.
Located near Washington, DC, USA, BHR is committed to bringing to market
specialty treatments that employ non-oral delivery systems, with an emphasis
on unmet and underserved medical needs. BHR currently is running a
1180-patient study to test the efficacy and safety of Besins' proprietary
intravenous progesterone formulation in patients suffering from severe
traumatic brain injury. Enrollment is expected to complete in Q3 of 2013.

About Shin Nippon Biomedical Laboratories
For more than 55 years, SNBL has been a leader in providing development
services to biopharmaceutical companies, generating high quality data with the
exceptional precision needed to rapidly advance new medical therapies and
innovations that improve patients' lives. In addition to providing services,
SNBL has a Translational Research business, which utilizes its development
capabilities to develop value-adding technologies and provides them to the
pharmaceutical and medical industry. Under such business, SNBL has developed
Muco™ System, a novel intranasal drug delivery technology platform, to provide
effective delivery solutions to pharmaceutical products.

[1] Stein DG, Wright DW, Kellerman AL (2008). Does progesterone have
neuroprotective properties? Ann Emerg Med; 51(2): 164–72.

[2] Brain Injury Association of America - Retrieved on Aug. 3, 2012 from

[3] Traumatic Brain Injury Center. (n.d.). Centers for Disease Control and
Prevention. Retrieved May 1, 2012, from

[4] "Injury to brain more than doubles Risk of later dementia," USA
Today/Usaedition. Retrieved May 23, 2012 from

SOURCE Besins Healthcare

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