A study investigating a nasally-delivered, needle-free form of epinephrine demonstrated that it was readily absorbed and is comparable to EpiPen(R).
The new product is expected to enter clinical trials in 2014.
http://globenewswire.com/news-...asibility-Study.html
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 SNBL a world class CRO, it also possesses a superior nasal technology platform and expertise in the development of nasally delivered pharmaceuticals. 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 caregivers alike."
Anaphylaxis is a systemic and life-threatening allergic reaction to food allergies, insect stings, and other triggers. It is characterized by anaphylactic shock associated with a decrease in blood pressure and deterioration in consciousness. The prevalence of food allergies is estimated at 3-4% in the US and 1-2 % in Japan, with recent studies documenting a rapid increase in the prevalence of food allergies among children in both the U.S. and Europe. Epinephrine is considered the gold standard treatment for anaphylaxis.
EpiPen® is a registered trademark of Mylan Inc. Fit-lizerTM and µcoTM are trademarks of SNBL, Ltd.
SNBL
For more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies to generate 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's patented nasal delivery technology platform has been shown to significantly 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: http://www.snbl-nds.co.jp/en/).
G2B Pharma
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).
Shin Nippon Biomedical Laboratories, Ltd. Tokyo Stock Exchange, First Section: Code # 2395 NDS Division, Mic Iwashima () G2B Pharma Inc. Executive Chairman, Michael Doodson (Tel: (415) 320-4391) or Chairman and CEO, Nigel Ten Fleming PhD
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