Sunesis Cancer Product In-License
SOUTH SAN FRANCISCO, CA (October 15, 2003) - Sunesis Pharmaceuticals, Inc. announced today that the Company has entered into an agreement with Dainippon Pharmaceutical Co., Ltd. to acquire exclusive worldwide development and marketing rights for Dainippon's anti-cancer compound, referred to as SPC-595. This product candidate is a patented novel compound that acts as a cell-cycle modulator and is a member of a class of compounds known as naphthyridines, which has not previously been used in anti-cancer therapy. SPC-595 has shown broad anti-tumor activity in multiple preclinical in vitro and in vivo models, including multi-drug-resistant tumor models. Under the terms of this agreement, Sunesis will make an up-front payment and a series of milestone payments based on successful development and approval of SPC-595. Sunesis will also make royalty payments based on net sales. In return, Sunesis will receive an exclusive, worldwide license. No additional terms were disclosed. "The acquisition of this product is a transforming event for Sunesis and significantly enhances our oncology pipeline. We anticipate filing the IND and initiating phase I clinical studies in 2004," commented James Young, PhD, CEO of Sunesis. "We have been actively looking for a high-quality product in-licensing opportunity that would complement our advancing pipeline of oncology and inflammation therapeutics," Dr. Young continued. "SPC-595 is a very promising program that passed our rigorous six-month diligence with flying colors." Dainippon's President Kenjiro Miyatake stated, "Dainippon has a well-deserved reputation as an innovative, research-based pharmaceutical company. Consistent with our shift in marketing focus on alimentary & metabolic, respiratory & allergic, vascular, psychiatric and neurological diseases, we have made the strategic decision to license this oncology program to Sunesis. We believe that Sunesis has the experienced team and commitment to advance this program forward and ultimately to benefit cancer patients with an important new treatment option."
Preclinical Overview of SPC-595
Dainippon has tested SPC-595 (formerly called AG-7352) in vivo in various murine syngeneic and human xenograft tumor models, comparing the efficacy of SPC-595 with the activity of leading, marketed cytotocic therapies, as reported at the NCI-EORTC-AACR Symposium on New Drugs in Cancer Therapy (November 2000). In these studies, SPC-595 demonstrated inhibition rates up to 99% with some complete tumor regressions while irinotecan and paclitaxel showed significantly less activity in three different murine syngeneic solid tumor models. Further, in xenograft models, SPC-595 had broad efficacy in all models and inhibited tumor growth by more than 80% in eight of the ten cancer lines evaluated. In addition, in three drug-resistant human cancer models, SPC-595 demonstrated strong tumor inhibition rates ranging from 73% to 87%, while the comparator drugs, irinotecan and paclitaxel, showed considerably less efficacy, ranging from 19% to 58% tumor inhibition.
Dainippon Pharmaceutical Co., Ltd, founded in 1897 as one of the pioneers of the modern Japanese pharmaceutical industry, strives to contribute to the modern world economy through its research and business in pharmaceuticals, animal health, food additives, industrial chemicals and research instrumentation. Dainippon’s group consolidated revenues for the year ended March 31, 2003 were 172 billion Japanese Yen (USD 1,440 million). Headquartered in Osaka, Japan, Dainippon Pharmaceutical’s current pharmaceutical R&D is focused on its fields of expertise in vascular diseases, psychiatric & neurological diseases, immuno-inflammatory diseases and infectious diseases. For further information please consult www.ds-pharma.co.jp/english/index.html.
Sunesis Pharmaceuticals Inc. is an emerging, research-and-development-based pharmaceutical company that applies fragment-based drug discovery to create superior therapeutics for challenging and important disease targets. Sunesis is building a pipeline of innovative therapeutics addressing major diseases through internal development and selective partnering. For further information, visit www.sunesis.com.
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