TOKYO--(BUSINESS WIRE)--Solasia Pharma K.K. (Headquarters: Tokyo, Japan, President: Yoshihiro Arai, hereinafter “Solasia”) announced today that Solasia and Meiji Seika Pharma Co. Ltd., (Headquarters: Tokyo, Japan, President: Daikichiro Kobayashi, hereinafter “Meiji”) have entered into a license agreement for the development and commercialization of darinaparsin (intravenous formulation) in Japan. Solasia is currently completing a Phase I study of darinaparsin in Japan and South Korea to treat patients with relapsed and refractory peripheral T-cell lymphoma (hereinafter “PTCL”).
Solasia obtained an exclusive worldwide license to develop and commercialize darinaparsin from ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), and the company is currently conducting clinical trials in Japan and other parts of Asia.
Under the terms of the agreement, Solasia will continue to develop darinaparsin for patients with relapsed and refractory PTCL, conduct Phase II Pan-Asian study and upon completion, seek regulatory approval in Japan. Meiji will then commercialize, distribute and promote darinaparsin for PTCL in Japan. In addition, Meiji also obtained the right to develop and commercialize darinaparsin for indications other than relapsed and refractory PTCL in Japan, the option to manufacture intravenous formulation of darinaparsin and a right of first negotiation relating to the formulations other than the intravenous formulation of darinaparsin. In consideration of the license granted to Meiji, Solasia will receive an initial development payment and, upon successful development, regulatory and sales milestone payments, as well as tiered royalties. Meiji will also participate in Solasia’s upcoming private placement.
Darinaparsin is a novel mitochondrial-targeted agent (organoarsenic) being developed for the treatment of various hematologic and solid cancers. In a US Phase II study, darinaparsin demonstrated evidence of clinical activity in lymphoma, in particular PTCL. In a Phase I clinical study, in Japan and South Korea, positive efficacy and safety have also been demonstrated.
About Meiji Seika Pharma Co., Ltd.: - Ethical Pharmaceuticals Business:
As a “Specialty and Generic Pharmaceuticals Company,” Meiji runs its pharmaceutical business in the two main fields, infectious disease and central nervous system disorders, and generic drugs. Meiji strives to respond to diversified medical needs and contributes to the well-being of people worldwide. For details, please visit its corporate website:
Solasia was formed in November 2006 by MPM Capital and ITOCHU Corporation to address unmet needs for important new Western oncology therapies and supportive care products throughout Asia. The company’s mission is to expedite patient access to unique oncology therapies through aggressive development and specialized commercialization throughout Japan, China and other Asian countries. To date, Solasia has raised approximately $50 million in venture financing.
The current pipeline of products are as follows:
- Indication: CINV
- NDA Filed in 2014 (China)
- Indication: relapsed and refractory PTCL
- Phase II completed in 2009 (US)
- Phase I completion expected in 2015 (JP, KR)