SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 29, 2012
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Item 8.01. Other Events.
FDA Approval of COMETRIQ (cabozantinib) Capsules for Treatment of Progressive Metastatic Medullary Thyroid Cancer
On November 29, 2012, Exelixis, Inc. (the Company) announced that the U.S. Food and Drug Administration (FDA)
has approved COMETRIQ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer in the United States. COMETRIQ is an inhibitor of multiple receptor tyrosine kinases involved in both normal cellular function and
pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. The COMETRIQ label has boxed warnings concerning risk of perforations and fistulas, and hemorrhage. The recommended dose of
COMETRIQ is 140 mg orally, once daily (one 80 mg capsule and three 20 mg capsules). The Company currently expects that COMETRIQ will be commercially available in late January 2013, and the wholesale acquisition cost has been set at $9,900 for a
28-day supply. COMETRIQ has been flat priced, meaning each dosage strength will be priced the same. Exelixis currently estimates that there are between 500 and 700 patients diagnosed annually in the United States with metastatic medullary thyroid
cancer eligible for COMETRIQ.
EMA Acceptance of Marketing Authorization Application for COMETRIQ (cabozantinib)
On November 29, 2012, the Company announced that the European Medicines Agency (EMA) has accepted for
review the Marketing Authorization Application (MAA) for COMETRIQ (cabozantinib) for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. The completion of the
MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union. COMETRIQ previously received orphan drug designation in the European Union from the Committee for
Orphan Medicinal Products for the treatment of medullary thyroid cancer.
report on Form 8-K contains forward-looking statements, including, without limitation, statements related to: Exelixis expectations regarding the commercial availability and pricing of COMETRIQ; the number of patients eligible for COMETRIQ;
and the referenced review for marketing authorization for COMETRIQ in the European Union. Words such as expects, will, estimates, eligible, sufficient, permit,
review, 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
risk that unanticipated developments could delay or prevent the launch, commercialization, manufacturing, distribution and availability of COMETRIQ; the degree of market acceptance of COMETRIQ; the extent to which coverage and reimbursement for
COMETRIQ will be available from third-party payors; risks and uncertainties related to Exelixis compliance with applicable regulatory requirements, including healthcare fraud and abuse laws and post-marketing requirements; the companys
dependence on third-party vendors; market competition; the uncertainty of the regulatory approval process; and changes in economic and business conditions. These and other risk factors are discussed under Risk Factors and elsewhere in
Exelixis quarterly report on Form 10-Q for the quarter ended September 28, 2012, filed with the Securities and Exchange Commission (SEC) on November 7, 2012, and Exelixis other filings with the SEC. 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.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: November 30, 2012
/s/ James B. Bucher
||Vice President, Corporate Legal Affairs and Secretary|