Exelixis Submits Diligence Report for Cdc7 Inhibitor to Bristol-Myers Squibb

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 15, 2008 - Exelixis, Inc. (Nasdaq:EXEL) today announced that it has submitted a comprehensive data report for investigational new drug (IND) candidate XL413, a selective inhibitor of Cdc7, to Bristol-Myers Squibb Company (NYSE:BMY). Bristol-Myers Squibb now has 30 days to review the data package and determine if it will select the compound for clinical development and commercialization. If Bristol-Myers Squibb selects XL413, Exelixis will be entitled to a $20 million milestone payment under the 2007 collaboration agreement with Bristol-Myers Squibb to discover, develop, and commercialize novel targeted therapies for the treatment of cancer.

"XL413 is the second compound that we have submitted under our current oncology discovery collaboration with Bristol-Myers Squibb," said Michael Morrissey, PhD, President of Research and Development at Exelixis. "One of our key R&D goals is to continue to expand our pipeline with new compounds focused on key pathways and targets that play important roles in cancer. XL413 selectively targets Cdc7, which is a very exciting cancer-related target. To our knowledge, no other selective inhibitors of Cdc7 have advanced to this stage of preclinical development, giving XL413 potential to become a first-in-class therapy."

About XL413

XL413 is a small molecule inhibitor of the serine-threonine kinase Cdc7. The function of Cdc7 is required for DNA replication to proceed, and its activity is often upregulated in cancer cells. Studies suggest that Cdc7 plays a role in regulation of cell cycle checkpoint control and protects tumor cells from apoptotic cell death during replication stress. Therefore, inhibition of Cdc7 may have utility in the treatment of a wide variety of cancers, either as a single agent or in combination with DNA damaging agents.

Background on the Collaboration Agreement

Under the terms of the agreement, Exelixis is fully responsible for the identification and preclinical development of small molecule drug candidates directed against mutually selected targets. In addition to an upfront payment of $60 million in January 2007, the agreement provides for Exelixis to receive $20 million for each of up to three different IND-stage drug candidates selected by Bristol-Myers Squibb. For each candidate selected by Bristol-Myers Squibb, Exelixis has the right to opt in to the co-development or co-promotion in the United States. If Exelixis does not opt in to co-promote the selected IND candidates, Exelixis would be entitled to receive milestones and royalties in lieu of profits from sales in the United States. Outside of the United States, Bristol-Myers Squibb will have primary responsibility for development activities and Exelixis will be entitled to receive royalties on product sales.

In January 2008, Bristol-Myers Squibb selected XL139, a small molecule inhibitor of the hedgehog signaling pathway, for further development and commercialization. In connection with this selection, Exelixis received a $20 million milestone payment and also exercised its option under the collaboration agreement to co-develop and co-commercialize XL139 in the United States. Following the transfer of the XL139 development program in mid-2008, Bristol-Myers Squibb is leading all global activities.

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis' broad product pipeline includes investigational compounds in phase 3, phase 2, and phase 1 clinical development. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Bristol-Myers Squibb, Genentech, Wyeth Pharmaceuticals, and Daiichi-Sankyo. For more information, please visit the company's website at http://www.exelixis.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the timing of a potential compound selection and milestone payment by Bristol-Myers Squibb; Exelixis' key R&D goals for the expansion of and direction for the Exelixis pipeline; and the future development and potential efficacy of XL413. Words such as "will," "continue," "may," "suggests," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis' current plans, assumptions, beliefs, and expectations. Forward-looking statements involve risks and uncertainties. Exelixis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the potential failure of XL413 and other Exelixis compounds to demonstrate safety and efficacy in clinical testing; the therapeutic and commercial value of XL413 and other Exelixis compounds; and Exelixis' ability to advance preclinical compounds into clinical development. These and other risk factors are discussed under "Risk Factors" and elsewhere in Exelixis' quarterly report on Form 10-Q for the quarter ended June 27, 2008, and Exelixis' other filings with the Securities and Exchange Commission. Exelixis expressly disclaims any duty, obligation, or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.

Exelixis and the Exelixis logo are registered U.S. trademarks.

Contact

Exelixis, Inc.
Charles Butler, 650-837-7277
Senior Director
Corporate Communications
& Investor Relations
cbutler@exelixis.com
Soleil Harrison, 650-837-7012
Senior Manager
Corporate Communications
sharrison@exelixis.com

Posted: October 2008

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