05 September 2013
WALTHAM, Mass., Sept. 4, 2013 - Syndax Pharmaceuticals Inc., which is developing epigenetic therapies for treatment-resistant cancers and Eddingpharm, a leading specialty pharmaceutical company in China, entered into a licensing, development and commercialization agreement that gives Eddingpharm exclusive rights to develop, market and sell entinostat in China and certain other Asian countries/regions. Financial details are undisclosed but include milestone payments and royalties on future entinostat sales. Details of the agreement include:
• Eddingpharm receives exclusive rights to develop, market and sell entinostat in mainland China, Hong Kong, Thailand, Macau, Taiwan, Malaysia and Singapore
• Eddingpharm receives rights to manufacture entinostat
• Syndax will receive royalties on future entinostat sales
• Eddingpharm may participate in entinostat's first three global Phase 3 registration trials
• A joint development committee will oversee conduct of any trials
• A joint commercialization committee will oversee marketing
• Eddingpharm can explore further indications for entinostat in China
• All data will be shared by both companies for regulatory purposes
"We look forward to working closely with Syndax to develop entinostat in breast and lung cancer as well as other indications," said Xin Ni, chairman and chief executive officer of Eddingpharm. "We are focused on bringing new and effective treatments to patients in our Asian communities and we believe this partnership with Syndax has the potential to help a large number of cancer patients across our Asian markets."
Arlene M. Morris, Syndax's chief executive officer added, "We view this agreement as the start of an important collaborative effort between our two companies. The agreement to a joint development committee, trial participation and sharing of data represents Eddingpharm's important commitment to that effort. The result will be a cooperative effort that has the potential to impact many patients in China suffering with advanced, treatment-resistant cancers."
Entinostat, Syndax's lead product candidate, has been studied in more than 800 cancer patients where objective tumor responses have been observed in both solid and hematologic malignancies. Entinostat's established safety and efficacy profile as both a single agent and in combination with a number of commercially available targeted therapies differentiates it from other histone deacetylase inhibitors(HDACi). Having demonstrated promising clinical results in breast and lung cancer, entinostat is moving toward pivotal clinical testing. It is an oral, novel inhibitor of class I histone deacetylases, key enzymes that alter the structure of chromatin to control gene expression. This aberrant gene expression can result in reversible, epigenetically-based drug tolerance. Designed to selectively target the HDAC isoforms most relevant to the biology of tumors, entinostat can normalize dysregulated gene expression in cancer cells, thereby restoring sensitivity to targeted therapy. Entinostat is the first HDACi with positive results in a randomized Phase 2 study in breast cancer and is the only HDACi in late-stage development for this indication.
Founded in 2001, Eddingpharm is a leading specialty pharmaceutical company in the fast growing China market, committed to actively introducing quality products into China's pharmaceutical market. The Company focuses on the development and promotion of pharmaceutical products in four therapeutic areas: medical nutrition, oncology, anti-infective and respiratory. Eddingpharm has established long-term cooperative relationships with a number of multinational pharmaceutical companies and overseas specialty pharmaceutical companies, and has built up a competitive product portfolio and pipeline in the four major therapeutic areas. Eddingpharm recently established its US affiliate and set up a product development team with R&D capabilities in Los Angeles, CA, USA, to coordinate and communicate with leading global R&D institutions and explore opportunities for introducing innovative pharmaceutical products in China. The Company currently employs over 700 people.
About Syndax Pharmaceuticals
Syndax is focused on employing epigenetic strategies to overcome the problem of resistance in oncology care in solid tumors. The company holds worldwide rights to entinostat, an oral, highly selective histone deacetylase (HDAC) inhibitor in late-stage clinical development for the treatment of advanced breast cancer and lung cancer. A randomized, placebo-controlled Phase 2 study of entinostat in combination with aromatase inhibitors in breast cancer (ENCORE 301) demonstrated an improvement in both progression-free survival and overall survival, providing the basis for the evaluation of entinostat in pivotal Phase 3 testing in metastatic breast cancer. Entinostat also demonstrated promising results in a subset of non-small cell lung cancer patients when given in combination with the EGFR-TKI erlotinib (ENCORE 401). NCI and Syndax are collaborating on the development of entinostat under a Cooperative Research and Development Agreement aimed at improving survival in advanced, hard-to-treat cancers.Print
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