TOKYO--(BUSINESS WIRE)--Solasia Pharma K.K. announced today a change in its executive leadership team. Yoshihiro Arai, currently General Manager and Head of Development of Solasia Pharma K.K., has been promoted to President and Representative Director of the company. Current Chief Executive Officer Steve Engen has announced his departure to pursue a new career opportunity.
Mr. Arai joined Solasia Pharma K.K. in September 2007 with responsibility for all product development including clinical development and regulatory affairs. Prior to joining Solasia, he spent 14 years at Amgen K.K., from initial stage of the company where he led development of Amgen’s novel hematology/oncology products, built the Clinical Development Division and held numerous senior level positions. Prior to joining Amgen, He spent nine years at Searle Yakuhin K.K. where he developed gastro intestinal, psychiatric and oncology product. He earned a B.S. degree and a master’s degree in Biochemistry & Microbiology from Tokyo University of Pharmacy and a M.B.A. from the University of Wales.
Mr. Arai commented, “Over the past 5 years, Solasia has hired an experienced core team, licensed two compounds, and has advanced clinical development in Japan, Korea and China. I look forward to taking on this important role and responsibility in order to continue to build Solasia. We will accelerate our clinical programs in Asia, and will establish a new sales & marketing organization for commercialization of our 1st product in China. In addition, we will seek new compounds to strengthen our pipeline. Solasia will continue strive to support patients in Asian countries including Japan and China.”
Solasia also announced receipt of the Clinical Trial Permit (CTP) from the China SFDA for SP-01 (brand name: Sancuso®), the company’s product for the treatment of chemotherapy-induced nausea and vomiting. Sancuso® is the first and only commercialized extended release granisetron transdermal product. Having received the CTP, the company said it is now preparing to initiate the required pivotal studies, and expects to file a New Drug Application (NDA) in China in the fourth quarter of 2013.
In order to progress clinical development in China, the company has established operations in Beijing and has hired core development and regulatory affairs staff. Furthermore, Ms. Vivian Zhang has joined the company as Solasia China General Manager and will be based in Shanghai. Vivian will build the Solasia China sales and marketing team, and prepare Sancuso® for China commercialization. Vivian joins Solasia after a career in marketing and sales at Shanghai Roche where she was responsible for Avastin® and Tarceva®, two key oncology products for Roche in China.
About SP-01 / Sancuso®
Sancuso® is an extended release transdermal system, delivering the anti-emetic, granisetron, steadily into the patient’s bloodstream over several days without the need for injections or swallowing pills. Granisetron is a 5-HT3 receptor antagonist with well-established efficacy against chemotherapy-induced nausea and vomiting (CINV). In May 2008, Solasia acquired the exclusive right to Sancuso® from ProStrakan Group plc. (www.prostrakan.com) for China and other territories in Asia. Sancuso® was approved by the U.S. Food & Drug Administration (FDA) on September 12, 2008 for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. ProStrakan launched Sancuso® in the U.S. in the fourth quarter of 2008. Patents protecting Sancuso® have been granted in the EU (2007), Japan (2008), and the US (2009). In 2010, Solasia signed a License and Supply Agreement with Kyowa Hakko Kirin that provides Kyowa Hakko Kirin with an exclusive right to market and sell Sancuso® in Taiwan, Hong Kong, Singapore and Malaysia.
About Solasia Pharma, K.K.
Solasia Pharma K.K. (Tokyo, Japan) was formed in November 2006 to address unmet needs for important new Western oncology therapies 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. In May 2008, Solasia acquired Asian rights to Sancuso® (extended release granisetron transdermal patch) from ProStrakan Group plc. In March 2011, Solasia acquired an exclusive license from ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) to develop and commercialize SP-02 / darinaparsin, in both intravenous and oral forms, across Asia including Japan, China, Hong Kong, Macau, Republic of Korea, Taiwan, Singapore, Australia, New Zealand, Malaysia, Indonesia, Philippines and Thailand. In several studies conducted in the US and other countries, darinaparsin injection has demonstrated good tolerability and safety. In addition, a Phase II study of darinaparsin injection in the US, demonstrated clinical responses in lymphoma, in particular peripheral T-cell lymphoma (PTCL). Solasia is currently conducting a Phase I study of darinaparsin in PTCL in Japan and Korea. To date, Solasia has raised approximately $39 million in Series A and B financing. The company originally established by MPM Capital and ITOCHU Corporation and they continue to support Solasia.