Assistant Managing Editor

SymBio Pharmaceuticals Ltd., a firm founded three years ago with the aim of bridging the gap between drug developers and patients in the Japan and Asia-Pacific regions, signed neighbor Tokyo-based Eisai Co. Ltd. to a Japanese co-development and commercialization deal for SyB-L-5010 (bendamustine hydrochloride), an antineoplastic agent in late-stage development in non-Hodgkin's lymphoma (NHL).

Under the terms, Eisai gains rights to the product - known in the U.S. as Treanda and marketed by Cephalon Inc. in chronic lymphocytic leukemia, with a pending application in refractory NHL - in exchange for up to 4 billion yen (US$36.3 million) in up-front and milestone payments. SyB-L-0501 is in pivotal development in low-grade NHL in Japan, and pending successful results, SymBio anticipates filing for regulatory approval as early as the fourth quarter in 2009.

The licensing agreement also calls for the two companies to work together on SyB-L-0501 in other indications. The drug, first approved in Germany, has been used to treat multiple myeloma and CLL, in addition to NHL.

A cancer of the lymphatic system, NHL is believed to affect about 15,000 people in Japan.

SymBio, which acquired Asian rights to the drug from Munich, Germany-based Astellas Deutschland GmbH in March 2007, retains sole rights in China, Korea and Singapore.

Earlier this year, it licensed the drug to InnoPharmax Inc., a specialty pharma firm based in Taipei, Taiwan, and InnoPharmax is responsible for developing and launching the drug there.

SymBio could not be reached for comment but said in its press release that, like the InnoPharmax licensing agreement, the Eisai deal will help "maximize the market potential" of bendamustine hydrochloride by putting the drug in the hands of a firm with an established marketing infrastructure in Japan.

So named because its goal is to build symbiotic relationships among scientists, investors, government, physicians and patients, Tokyo-based SymBio was established in early 2005 by Fuminori Yoshida, former Amgen Japan president, with the express purpose of in-licensing late-stage programs and pushing them through to market in Asia.

The firm has no plans to conduct basic research. Instead it employs a global search engine to find "orphan or orphan-like drugs" in development, mainly in the areas of oncology, hematology and autoimmune diseases.

Bendamustine hydrochloride was the first product brought on board, though SymBio has added others since. In March 2007, the company picked up a transdermal patch product for chemotherapy-induced nausea and vomiting from Abeille Pharmaceuticals Inc., of Princeton, N.J. in a $21 million deal.

That product - known as AB-1001 at Abeille and as SyB-D-0701 at SymBio - is designed to deliver the 5-hydroxytryptamine3 antagonist granisetron in a more convenient formulation than the existing oral and intravenous forms sold by Nutley, N.J.-based Hoffmann-La Roche Inc. (See BioWorld Today, March 16, 2007.)

The Abeille deal gave SymBio rights to SyB-D-0701 in Japan, China, Korea, Taiwan and Singapore, but the firm already has signed regional licensing agreements with Yuhan Yang Haeng, of Seoul, South Korea, and InnoPharmax to develop the anti-emetic in Korea and Taiwan, respectively.

The company licensed exclusive global rights to a third product, SyB-0702, a PEG-conjugated zinc protoporphyrin product from Sojo University in Japan.

That product has demonstrated activity against Gleevec-resistant leukemia cells. SymBio is conducting the necessary nonclinical studies and plans to seek a partner for U.S. development.

The company's main stockholders include drug development companies Frazer, Pa.-based Cephalon and Tokyo-based Daiichi Sankyo Co. Ltd., as well as Japanese service company Summit Pharmaceuticals International Corp., of Tokyo, and venture firms such as Tokyo-based VCs Jafco V2 Venture Capital Investment Ltd. Partnership and Japan Asia Investment Co. Ltd.