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Novartis and Astex Therapeutics form global licensing and drug discovery alliance to focus on developing novel cell cycle cancer drugs


Novartis receives worldwide license to investigational cell cycle inhibitor AT9311 and option to license second investigational cell cycle inhibitor AT7519

Basel, December 6, 2005 - Novartis announced today a strategic alliance with Astex Therapeutics Limited focused on the research, development, and commercialization of 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 currently completing preclinical studies. Novartis also has an option for a global license to a parenteral cell cycle inhibitor, AT7519, currently in Phase I clinical trials.

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 US, 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, Novartis Oncology.

About AT7519 and AT9311
Astex’s lead drug candidate, AT7519, is a potent cell cycle inhibitor that targets key cyclin-dependent kinases (CDKs). AT7519 entered clinical development during late 2005 in a Phase I dose escalation study designed to evaluate its safety and tolerability when delivered intravenously in patients with advanced solid tumors. AT7519 went from first synthesis to first dosing in patients in just 18 months. AT9311 is an orally active cell cycle inhibitor that inhibits selected CDKs with a differentiated biological profile in comparison to AT7519. AT9311 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 cyclin-dependent kinases (CDKs). These key enzymes are involved in the mechanisms that control cell division, making them important targets for preventing cancer cell proliferation.

Details of the agreement
Astex will maintain responsibility for completing the preclinical development and IND/CTA filing for AT9311 to US and UK regulatory authorities as well as for conducting an initial Phase I 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. Astex also is responsible for the ongoing clinical development of AT7519 until the completion of Phase II studies when Novartis can assume responsibility by exercising its licensing option.

Novartis 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.

The foregoing release contains forward-looking statements that can be identified by terminology such as “to focus,” “novel,” “option” “will maintain,” “anticipates,” or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or future sales of AT9311 or AT7519. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with AT9311 or AT7519 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that AT9311 or AT7519 will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. In particular, management’s expectations regarding commercialization of AT9311 or AT7519 could be affected by, among other things, additional analysis of AT9311 or AT7519 clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in the Company’s current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group’s businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world.

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