Exelixis to receive $12M upfront payment and be eligible for
potential development, regulatory and commercial milestones, plus
royalties
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 21, 2011--
Exelixis, Inc. (NASDAQ:EXEL) today announced that it has granted to
Merck, known as MSD outside of the United States and Canada, an
exclusive worldwide license to its PI3K-delta research and development
program, including XL499, the company’s most advanced preclinical
PI3K-delta inhibitor and other related compounds. Under the agreement,
Merck will have a worldwide exclusive license and have sole
responsibility to research, develop, and commercialize compounds
originating from the program.
Merck will make an upfront payment of $12 million to Exelixis and
Exelixis will be eligible for potential development and regulatory
milestone payments for multiple indications of up to $239 million.
Exelixis will also be eligible for potential combined sales performance
milestones and royalties on net-sales of products emerging from the
agreement. Milestones and royalties are payable on compounds emerging
from Exelixis’ PI3K-delta program or from certain compounds that arise
from Merck’s internal discovery efforts targeting PI3K-delta during a
certain period.
“PI3K-delta is an interesting target with potential utility in a number
of therapeutic areas, including inflammation and oncology,” said Michael
M. Morrissey, Ph.D., president and chief executive officer of Exelixis.
“Our PI3K-delta program builds on our prior interest in the PI3K family,
which led to the advancement of pan-PI3K inhibitors into clinical
development for cancer. Merck’s global presence and significant
resources make it the ideal organization to carry the PI3K-delta program
forward. At the same time, this agreement provides Exelixis with
resources for the continued development and potential commercialization
of our lead compound, cabozantinib, which is in late-stage development
for medullary thyroid and prostate cancers.”
“Exelixis has established a strong reputation for innovation in the
development of targeted kinase inhibitors,” said Don Nicholson, Ph.D.,
Vice President and Head of Worldwide Discovery, Respiratory and
Immunology Franchise, Merck Research Laboratories. “Collaborations like
this are an important part of our strategy as we seek new ways to
address unmet needs in inflammatory disease and oncology.”
PI3K-delta is a member of the Class 1 family of phosphoinositide-3
kinases and is predominantly expressed in cells of the immune system.
Activation of PI3K-delta occurs in response to a variety of immune cell
stimuli, and inappropriate PI3K-delta activation is thought to
contribute to multiple inflammatory and allergic disorders, including
rheumatoid arthritis and allergic asthma. Selectively targeting
PI3K-delta has also shown potential in the treatment of certain
lymphomas.
About Exelixis
Exelixis, Inc. is a biotechnology company committed to developing small
molecule therapeutics for the treatment of cancer. Exelixis is focusing
its proprietary resources and development efforts exclusively on
cabozantinib, its most advanced solely-owned product candidate, in order
to maximize the therapeutic and commercial potential of this compound.
Exelixis believes cabozantinib has the potential to be a high-quality,
differentiated pharmaceutical product that can make a meaningful
difference in the lives of patients. Exelixis has also established a
portfolio of other novel compounds that it believes have the potential
to address serious unmet medical needs. For more information, please
visit the company's web site at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: the payment to Exelixis of an
upfront payment; Exelixis' potential receipt of development, regulatory
and sales milestones, as well as royalties on sales of products; the
clinical, therapeutic and commercial potential of the PI3K-delta
program; the belief that Merck is the ideal organization to carry the
PI3K-delta program forward; the belief that the agreement will provide
resources for the continued development and potential commercialization
of cabozantinib; and the clinical, therapeutic and commercial potential
of cabozantinib. Words such as "will," “eligible,” “potential,”
“emerging,” “arise,” “provides,” “continued,” 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: risks related to Exelixis' dependence
on the activities of Merck under the described agreement, the potential
failure of the PI3K-delta program or cabozantinib to demonstrate safety
and efficacy in clinical testing; the therapeutic and commercial value
of the PI3K-delta program and cabozantinib; Exelixis' ability to conduct
clinical trials of cabozantinib sufficient to achieve a positive
completion; the sufficiency of Exelixis' capital and other resources;
uncertain timing and level of expenses associated with the development
of cabozantinib; the uncertainty of the FDA approval process; market
competition; 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
30, 2011 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.
Source: Exelixis, Inc.
Exelixis, Inc.
Charles Butler, 650-837-7277
Vice
President, Investor Relations and Corporate Communications
cbutler@exelixis.com
