Novel Nasal Epinephrine Shows Comparable Absorption to EpiPen(R) in a
Needle-Free Epinephrine for Proposed Treatment of Allergy-Induced Anaphylaxis
SAN FRANCISCO, Sept. 10, 2013 (GLOBE NEWSWIRE) -- Shin Nippon Biomedical
Laboratories, Ltd. ('SNBL' Chairman and CEO, Ryoichi Nagata MD PhD FFPM,
Tokyo, Japan) and G2B Pharma Inc. ('G2B' Chairman and CEO, Nigel Ten Fleming
PhD, San Francisco, USA) announce the completion of a preclinical feasibility
study investigating a nasally-delivered epinephrine (adrenaline) formulation
for treating anaphylaxis. The study demonstrated that this needle-free nasal
epinephrine formulation succeeded in achieving rapid absorption in peripheral
blood comparable to EpiPen^®, the leading injectable product.
G2B and SNBL have agreed to use SNBL's µco™ System nasal delivery platform
with the Fit-lizer® nasal device, together with G2B's proprietary drug
strategy, to develop a nasally-delivered epinephrine product. The proposed
product, which is covered by multiple issued or pending patents worldwide, is
expected to enter clinical trials in 2014.
"We are very excited to report the results of this study and to announce our
relationship with SNBL," said Nigel Ten Fleming PhD. "SNBL brings a unique
combination of assets. Not only is SNBLa world class CRO, it also possessesa
superior nasal technology platform and expertise inthedevelopment of nasally
deliveredpharmaceuticals. Only a small fraction of diagnosed at-risk
anaphylaxis patients carry an auto-injector, which is in part due to needle
phobia and lack of training in their use. Our joint product promises to
provide patients [and their families] with a needle-free alternative."
"SNBL is pleased to support the efforts of the team at G2B," stated Ryoichi
Nagata MD PhD FFPM."Anaphylaxis commanded recent headlines in Japan when a
child tragically died of the condition. We believe that a simple and effective
emergency treatment, without needles, will be a benefit to patients and
Anaphylaxis is a systemicandlife-threatening allergic reactionto food
allergies, insect stings, and other triggers. It is characterized
byanaphylactic shockassociated with a decrease in blood pressure
anddeterioration in consciousness.The prevalence of food
allergiesisestimatedat 3-4% in the US and1-2 % in Japan, with recent
studiesdocumentinga rapid increase in the prevalence of food allergies among
childreninboththe U.S. and Europe. Epinephrine is considered the gold
standard treatment for anaphylaxis.
EpiPen^® is a registered trademark of MylanInc. Fit-lizer^TM and µco^TM are
trademarks of SNBL, Ltd.
For more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has
been a leader in helping biopharmaceutical companiestogenerate high quality
data with the exceptional precision needed to rapidly advance new medical
therapies and innovations that improve patients' lives.SNBL has facilities in
Japan, the United States, China, and Cambodia.SNBL'spatented nasal delivery
technology platformhas been shown tosignificantly enhance the absorption of
powder nasal drugs from the nasal mucosa. The technology has been shown in
several clinical trials to be safe and effective. (Web site:
G2B Pharma Inc.is a specialty pharmaceutical company, focused on the
reformulation of off-patent drugs. G2B's mission is to take drugs that have
recently come off patent and reformulate them into a different dosage form
that may achieve clinically significant benefits "making good drugs better".
(Web site: http://www.g2bpharma.com).
CONTACT: Shin Nippon Biomedical Laboratories, Ltd.
Tokyo Stock Exchange, First Section: Code # 2395
NDS Division, Mic Iwashima (firstname.lastname@example.org)
G2B Pharma Inc.
Executive Chairman, Michael Doodson
(Tel: (415) 320-4391)
Chairman and CEO, Nigel Ten Fleming PhD
G2B Pharma Inc. logo
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