Press release

Aug 13, 2014

Sosei Announces Letter of Intent with Shin Nippon Biomedical Laboratories, and Project Finance

Sosei and SNBL have executed a Letter of Intent to negotiate the terms for co-development of pharmaceutical products 
Sosei has decided to finance the initial period expenses for the SNBL and G2B Pharma co-development project of a nasally-delivered adrenaline (epinephrine) formulation for treating anaphylaxis
Sosei will receive a portion of future G2B revenues, as well as the first negotiation rights for the future investments and the right to negotiate the licensing of worldwide development and commercialization rights for this project

Tokyo, Japan – 13 August 2014: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) is pleased to announced that it has executed a non-binding letter of intent (“LOI”) with Shin Nippon Biomedical Laboratories, Ltd. (“SNBL”, Chairman and CEO Ryoichi Nagata, Tokyo, Japan) to negotiate the terms for co-development of pharmaceutical products based on SNBL’s nasal delivery technology platform¹.

As a part of its translational research business², SNBL conducts research and development of nasal formulations, based on its novel nasal delivery technology, and out-licenses its platform technology to multiple pharmaceutical companies. Part of Sosei’s pipeline strategy has been drug reprofiling³, an approach that enables identifying new uses for existing drugs (either halted or marketed), and as a part of its reprofiling strategy Sosei utilizes APNT⁴ (a core technology platform for nanonizing insoluable solutions) for research and development.

Sosei and SNBL will enter the negotiations for co-development that would make the maximum use of Sosei’s expertise in reprofiling and formulation development, with SNBL’s expertise in nasal delivery technology and development know-how.

In addition, prior to executing the LOI, a joint project for development and commercialization of nasally-delivered adrenaline (epinephrine) formulation for treating anaphylaxis has been initiated.

SNBL and G2B Pharma Inc. (“G2B”, Chairman and CEO, Nigel Ten Fleming, San Francisco, USA) have decided to jointly develop nasally-delivered adrenaline (epinephrine) formulation for treating anaphylaxis. Sosei has recognized that the project has the potential to fulfill clinically unmet medical needs, and has decided to finance the initial period expenses for this project. At the same time, SNBL has provided a licensing option for its nasal platform technology to G2B. In return for financing the project, Sosei will receive a part of future G2B revenue, as well as the first negotiation right for the future investments and the right to negotiate the licensing of worldwide development and commercialization rights for this project.

Sosei and SNBL tie-up will not be limited to this project only. Both parties will enter the negotiations for future wide spectrum collaboration that would make a maximum use of both sides’ know-how and technologies.

Notes

1 Nasal Delivery Technology - SNBL has discovered and developed an innovative nasal delivery technology, consisting of a muco-adhesive powder drug carrier designed for enhanced drug absorption and nasal delivery devices. The technology, now protected by international patent, is a versatile platform technology that can be applied to a broad range of drugs. Safety and efficacy of the technology have been proven in a number of clinical studies. For more information please visit www.snbl-nds.co.jp

2 Translational research - translates the findings of basic research into clinical applications quickly and efficiently, in order to bring new drugs to those in need as early as possible. SNBL utilizes its pre-clinical and clinical development facilities to develop value-adding technologies and provides them to the pharmaceutical and medical industry.

3 Drug reprofiling – one of Sosei’s development strategies that is based upon identifying new uses for existing drugs (either halted or marketed), or drug templates for which clinical development has been undertaken and the safety profile in humans confirmed.

4 APNT – (Activus Pure Nanoparticle Technology) unlike other nano-particle processing technologies, keeps compounds virtually free from contamination. At the same time, it can yield pharmaceutical ingredients with particle sizes ranging from 50 to 300nm levels. Thus, APNT enables the development of injections, ophthalmic solutions and inhalations with poorly soluble compounds where high purity is required.

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