Solasia Announces New Executive Leadership, Clinical Activities, and China
TOKYO -- February 6, 2013
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 1^st 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
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.
Takashi Ono, Vice President, +81-(0)3-6721-8332
Toshio Miyashita, Acting CFO, +81-(0)3-6721-8329
Shari Annes, 650-888-0902
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