Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, and Fujisawa Pharmaceutical Co., Ltd., one of Japan's top pharmaceutical companies, announced that Gloucester has acquired from Fujisawa an exclusive worldwide license to develop and commercialize Fujisawa's novel histone deacetylase inhibitor (HDAC), known as FK228, as an anti-cancer agent.

FK228 (depsipeptide) is currently in Phase 2 clinical trials for the treatment of renal cell carcinoma and hormone refractory prostate cancer. FK228 is also being studied in separate Phase 2 clinical trials for the treatment of cutaneous T-cell lymphoma, as well as other indications by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Fujisawa.

Under the terms of the license agreement, Fujisawa will receive an upfront licensing fee, in addition to R&D and commercialization milestone payments and royalties on net sales.

"The licensing of FK228 is an important first step in validating our business model to build a franchise of new cancer therapeutics," said Jay Mohr, President and CEO of Gloucester. "Our licensing strategy is to obtain novel compounds that, either as monotherapy or in combination with other therapies, can have a profound effect in the treatment of many hematologic and solid tumours. We believe that FK228 has such potential and we are very pleased to have an opportunity to develop a first-in-class HDAC inhibitor."

"We have been very impressed by Gloucester's experienced management team and their capabilities to develop FK228 as an anti-cancer agent," stated Hirofumi Onosaka, Corporate Vice President, Global Corporate Strategic Planning of Fujisawa. "We believe that Gloucester is well positioned to realize the full commercial potential of FK228 as an anti-cancer compound - one that fits perfectly into their business strategy."