TOKYO, Japan, February 25, 2011 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President & CEO: Fuminori Yoshida, "SymBio") announced today that the company has completed a JPY2.0 billion (USD24 million) private placement of Series E common stock led by two existing shareholders, Cephalon, Inc. and JAFCO Co., Ltd., a leading private equity firm in Japan.
In the pursuit of creating value for patients and shareholders, SymBio will use proceeds from this financing round to accelerate the development of other hematological indications for bendamustine, including aggressive non-Hodgkin's lymphoma and multiple myeloma, to advance development of its granisetron transdermal patch for RINV/CINV, and to in-license other new drug candidates as the company continues its geographical expansion in key Asian countries.
"I am extremely pleased that our two major shareholders continue to support our business at this juncture where SymBio needs capital to more aggressively expand into other Asia Pacific markets," said Mr. Fuminori Yoshida, President and CEO. "In 2011, SymBio is being transformed into a biopharmaceutical company with top-line revenue, multiple drug candidates in all stages of development, and growing licensing opportunities. We will use proceeds from this round to maximize the value for patients as well as shareholders."
Currently, SymBio has four drug candidates under development in its pipeline. The company's lead drug candidate, SyB L-0501 (bendamustine HCl), is an antineoplastic agent which received Japan market approval in October, 2010 for the treatment of refractory/relapsed low-grade non-Hodgkin's lymphoma and mantle cell lymphoma. The approval of bendamustine HCl for these indications was achieved within 4 years following enrollment of the first patient in its phase 1 study.
[Please read the following for further information on bendamustine hydrochloride, TREAKISYM, Cephalon, and SymBio]
Exchange rate used: Y83.28 = U.S. $1 as of February 14th, 2011.
1. About Bendamustine Hydrochloride
Bendamustine hydrochloride was first synthesized in the early 1960s in the former "East Germany Democratic Republic" (GDR) by Jenapharm, and is currently marketed in Germany under the brand name "Ribomustin" as a treatment for non-Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukemia.
Mundipharma received marketing authorizations for bendamustine in several EU countries last year under the brand name "Levact" In the United States, the drug has been approved by the U.S. Food and Drug Administration (FDA) and is marketed by Cephalon as TREANDAR for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma.
SymBio Pharmaceuticals Limited originally acquired the exclusive right from Astellas Deutschland GmbH (Headquarters: Munich, Germany, formerly Astellas Pharma GmbH) to develop and commercialize bendamustine in Japan (December, 2005), followed by signature of a second license agreement for the exclusive right to China/Hong Kong, South Korea, Taiwan and Singapore (March, 2007).
2. About TREAKISYM
Product Name: TREAKISYM for Injection, for intravenous infusion 100 mg
Generic Name: Bendamustine Hydrochloride
Indications and Usage:
For the treatment of relapsed or refractory forms of:
. Low-grade B-cell non-Hodgkin's lymphoma
. Mantle cell lymphoma
Dosage and Administration:
The recommended dose in Japan is 120 mg/m2 administered intravenously over 60 minutes on Days 1 and 2 of a repeated 21-day cycle. The dosage may be adjusted accordingly depending on the patient's condition.
3. About Cephalon Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company with US headquarters in Frazer, PA, and European headquarters located in Maisons-Alfort, France. Since its inception in1987, Cephalon has delivered first-in-class and best-in-class medicines to patients around the world in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and member of the S&P 500 Index, and employing approximately 4,000 people worldwide.
Cephalon has the development and commercialization right to bendamustine hydrochloride in United States, Canada, China and Hong Kong, receiving market approval from the FDA for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma in March and October of 2008, respectively.
Note to Editors
For more information on Cephalon and their marketed products, please visit their website at http://www.cephalon.com
4. About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Ltd. was established in March, 2005 by Fuminori Yoshida, who previously served concurrently as Corporate VP of Amgen Ltd. and President of Amgen Japan (currently Takeda Bio Development Center Limited). The company's underlying corporate mission is "delivering hope to patients in need" as it aspires to be a leading specialty pharmaceutical company in Asia Pacific dedicated to addressing underserved medical needs in the areas of oncology, hematology and autoimmune disease.