Novartis buys licensing for Astex investigational agents in cancer research alliance

By E. Janene Geiss

Philadelphia, Dec. 6 - Novartis announced Tuesday a strategic alliance with Astex Therapeutics Ltd. to research, develop and commercialize novel cell cycle control drugs for the treatment of cancer and other diseases.

Under the agreement, Novartis has obtained worldwide licensing rights to investigational agent AT9311, an Astex cell cycle inhibitor that is completing preclinical studies, officials said in a news release.

Novartis also has an option for a global license to a parenteral cell cycle inhibitor, AT7519, currently in phase 1 clinical trials, officials said.

Novartis said it will make an initial payment and deferred equity commitment to Astex totaling $25 million and will provide research funding, development reimbursements, funding for milestones during clinical development and registration, royalties on sales and fees related to exercising the option on AT7519.

Astex will maintain responsibility for completing the preclinical development and IND/CTA filing for AT9311 to U.S. and U.K. regulatory authorities and for conducting an initial phase 1 clinical study with the agent.

Astex anticipates filing an IND/CTA for AT9311 during the first half of 2006. After that time, Novartis will be responsible for additional clinical development and commercialization of AT9311, officials said.

Astex also is responsible for the ongoing clinical development of AT7519 until the completion of phase 2 studies when Novartis can assume responsibility by exercising its licensing option, officials said.

In addition, the two companies have agreed to establish a new drug discovery alliance focused on the identification of novel inhibitors of other cell-cycle control enzymes. In the United States, Astex will have the option to co-market oncology products developed through the alliance.

"As a well-established leader in the development of novel cancer treatments, Novartis has made tremendous scientific contributions toward improving the lives of cancer patients. We believe AT9311 represents a potential best-in-class compound that will compliment our already broad and deep oncology pipeline," said David Epstein, president of Novartis Oncology, in the release.

Astex's lead drug candidate, AT7519, is a potent cell cycle inhibitor that targets key cyclin-dependent kinases (CDKs). It entered clinical development during late 2005 in a phase 1 dose-escalation study designed to evaluate its safety and tolerability when delivered intravenously in patients with advanced solid tumors. It went from first synthesis to first dosing in patients in just 18 months, officials said.

AT9311 is an orally active cell cycle inhibitor that inhibits selected CDKs with a differentiated biological profile in comparison to AT7519. It was selected for formal preclinical development during early 2005 with an IND/CTA filing planned for early 2006.

Cancers are characterized, in part, by a loss of control of cell division. Cell cycle inhibitors are a class of compounds that target mechanisms of cell division to prevent or interfere with cancer growth. One novel approach to cell cycle inhibition is targeting the CDKs. These key enzymes are involved in the mechanisms that control cell division, making them important targets for preventing cancer, officials said.

Astex, based in Cambridge, England, develops molecularly targeted drugs in areas of unmet medical need with a focus on oncology.

Novartis is a Basel, Switzerland, pharmaceutical and health care products company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.