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G2B Pharma Receives Project Financing From Sosei and Right to In-license Nasal Delivery Technologies From SNBL

Financing for Development of Needle-Free Epinephrine for Proposed Treatment of Allergy-Induced Anaphylaxis

SAN FRANCISCO, Aug 13, 2014

G2B Pharma Inc. (‘G2B’ Chairman and CEO, Nigel Ten Fleming PhD, San Francisco, USA) announces the signing of an agreement with Sosei Group Corporation (‘Sosei’ CEO, Shinichi Tamura; Tokyo, Japan) for financing of G2B011, a needle-free nasal epinephrine formulation, and the signing of an option-for-license agreement with Shin Nippon Biomedical Laboratories, Ltd. (‘SNBL’ Chairman and CEO, Ryoichi Nagata MD PhD FFPM, Tokyo, Japan) for the use of SNBL’s µco™ System nasal delivery platform with the Fit-lizerTM nasal device for the product.

G2B and SNBL are jointly developing G2B011 for treating anaphylaxis. Sosei has recognized the potential of G2B011 to fulfill unmet clinical needs and has committed to finance the initial product expenses. In conjunction with this agreement, SNBL has granted G2B a licensing option for its nasal platform technologies. In return for providing initial project financing, Sosei will receive a portion of future G2B revenue, as well as the first negotiation right for financing the full development of the product and the right to negotiate for the licensing of worldwide development and commercialization rights for this project.

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 swelling of the lips, constriction of the throat, decrease in blood pressure and potential loss of 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. The only marketed products of epinephrine are injections and are mostly auto-injectors; however, 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. Nevertheless, sales of auto-injectors have been increasing steadily over the last few years with EpiPen®, the leading auto-injector product, is on track to become a billion dollar product in 2014 according to its distributor Mylan Inc.

In 2013, G2B and SNBL conducted a successful proof of concept study which showed that nasally administered G2B011 demonstrates rapid and high absorption comparable to EpiPen®, and has the potential to become a novel anaphylaxis treatment.

EpiPen® is a registered trademark of Mylan Inc. Fit-lizerTM and µcoTM are trademarks of SNBL, Ltd.

About G2B Pharma

G2B Pharma Inc. is a US based biopharmaceutical company focused on the development of nasally delivered drugs, including nasally delivered epinephrine for the treatment of anaphylaxis. http://www.g2bpharma.com

About Sosei

Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets. http://www.sosei.com

About SNBL

For more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies 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. http://www.snbl-nds.co.jp/en/

Novel Nasal Epinephrine Shows Comparable Absorption to EpiPen® in a Feasibility Study

Needle-free Epinephrine for Proposed Treatment of Allergy-Induced Anaphylaxis

September 10, 2013. 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.

About SNBL

For more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies 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. http://www.snbl-nds.co.jp/en/

About 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.

http://www.g2bpharma.com

For further information contact:

Shin Nippon Biomedical Laboratories, Ltd.
Tokyo Stock Exchange, First Section: Code # 2395
CFO and Executive Vice President, Toshihiko Seki (TEL: +81 (0)3 5565 5001)

G2B Pharma Inc.
Executive Chairman, Michael Doodson (TEL: (415) 320-4391)
CEO, Nigel Fleming (Email: nfleming@g2bpharma.com)