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MEMPHIS, Tenn., and WHITEHOUSE STATION, N.J., Nov. 6, 2007 - GTx,
Inc. (NASDAQ: GTXI) and Merck & Co., Inc. (NYSE: MRK) today announced an
agreement providing for a research and development and global strategic
collaboration for selective androgen receptor modulators (SARMs), a new class of
drugs with the potential to treat age-related muscle loss (sarcopenia) as well
as other musculoskeletal conditions. This collaboration includes GTx's lead SARM
candidate, OstarineTM, which is currently being evaluated in a Phase II clinical
trial for the treatment of muscle loss in patients with cancer, and establishes
a broad SARM collaboration under which GTx and Merck will pool their programs
and partner to discover, develop, and commercialize current as well as future
SARM molecules. As part of this global agreement, Merck will be responsible for
all future costs associated with ongoing development and, if approved,
commercialization of Ostarine and other investigational SARMs resulting from the
collaboration.
Under the terms of the collaboration agreement and related stock purchase
agreement, GTx and Merck will combine their respective SARM research programs.
GTx will receive an upfront payment of $40 million plus $15 million in research
reimbursements to be paid over the initial three years of the collaboration. In
addition, Merck will make an equity investment of $30 million in GTx common
stock at a 40 percent premium to the 30 day average closing price. GTx will also
be eligible to receive up to $422 million in future milestone payments
associated with the development and approval of a drug candidate if multiple
indications receive regulatory approval. Additional milestones may be received
for the development and approval of other collaboration drug candidates. GTx
will receive royalties on any resulting worldwide product revenue.
"By combining our drug candidates, resources and talents, this Merck-GTx
collaboration positions both companies for success in the development and
commercialization of SARMs," said Mitchell S. Steiner, M.D., chief executive
officer of GTx. "We believe that Ostarine and our other SARMs offer the
potential to address a number of unmet medical needs focused on musculoskeletal
disorders. GTx believes that Merck has the world class scientific, clinical
development, and commercial expertise to capture the potential of the SARM
class."
"By selectively targeting the androgen receptor, SARMs offer a promising
alternative to androgen therapy with the potential advantages of oral dosing,
tissue selectivity and improved safety and tolerability," said Alan B.
Ezekowitz, MBChB, D.Phil., senior vice president and franchise head, Bone,
Respiratory, Immunology, and Endocrine, Merck Research Laboratories. "GTx has
established a strong scientific reputation in the research and development of
novel SARMs and we look forward to working with Dr. Steiner and his team."
The effectiveness of the collaboration agreement and the investment in GTx
common stock by Merck are subject to the expiration or earlier termination of
the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, if
applicable, as well as other customary closing conditions.
Conference Call
GTx will host a conference call at 9 a.m.
Eastern Time today to discuss the GTx-Merck collaboration as well as GTx's third
quarter 2007 financial results. To listen to the conference call, please dial:
800-901-5248 from the United States and Canada or 617-786-4512 (International).
The passcode for the call is #62291111.
A playback of the call will be available beginning today at 11:00 a.m.
Eastern Time through November 20, and may be accessed by dialing: 888-286-8010
from the United States and Canada or 617-801-6888 (International). The
reservation number for the replay is #89187183.
About SARMs
Selective androgen receptor modulators (SARM)
are a new class of drugs with the potential to treat sarcopenia (age-related
muscle loss) and other musculoskeletal conditions. Ostarine, a first in class
SARM, has demonstrated the ability to build lean body mass (muscle) in a proof
of concept clinical trial and may have the potential to improve physical
performance. Ostarine is currently being evaluated in a Phase II clinical trial
for the treatment of muscle loss in patients with cancer.
About GTx
GTx, headquartered in Memphis, Tenn., is a
biopharmaceutical company dedicated to the discovery, development, and
commercialization of small molecules that selectively target hormone pathways to
treat cancer, osteoporosis and bone loss, muscle wasting and other serious
medical conditions. GTx is developing ACAPODENE® (toremifene citrate), a
selective estrogen receptor modulator, or SERM, in two separate clinical
programs in men: first, a pivotal Phase III clinical trial for the treatment of
serious side effects of androgen deprivation therapy for advanced prostate
cancer, and second, a pivotal Phase III clinical trial for the prevention of
prostate cancer in high risk men with high grade prostatic intraepithelial
neoplasia, or PIN. GTx has licensed to Ipsen Limited exclusive rights in Europe
to develop and commercialize ACAPODENE. GTx has agreed to a collaboration with
Merck & Co., Inc. for the development and global commercialization of
selective androgen receptor modulators, or SARMs, a new class of drugs with the
potential to treat a variety of indications associated with muscle wasting and
bone loss including sarcopenia and osteoporosis, cancer cachexia, and chronic
kidney disease muscle wasting. GTx is also developing GTx-878, an estrogen
receptor beta agonist for the treatment of benign prostatic hyperplasia and
chronic prostatitis. GTx is planning to initiate human clinical studies for
GTx-878 in 2009.
About Merck
Merck & Co., Inc. is
a global research-driven pharmaceutical company dedicated to putting patients
first. Established in 1891, Merck currently discovers, develops, manufactures
and markets vaccines and medicine to address unmet medical needs. The company
devotes extensive efforts to increase access to medicines through far-reaching
programs that not only donate Merck medicines but help deliver them to the
people who need them. Merck also publishes unbiased health information as a
not-for-profit service. For more information, visit http://www.merck.com.
GTx Forward-Looking Statement
This press release contains
forward-looking statements based upon GTx's current expectations, including all
statements (i) that reflect the completion of the proposed collaboration with
Merck (including statements related to GTx's receipt of upfront licensing fees,
guaranteed preclinical development reimbursements, development and approval
milestone payments and royalty payments, as well as proceeds from the sale of
GTx common stock to Merck); and (ii) relating to the prospects for, and the
development and commercialization of, Ostarine and other SARMs. Forward-looking
statements involve risks and uncertainties. GTx's 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 risks that (i) the collaboration agreement may not become
effective and the investment by Merck in GTx common stock may not occur as a
result of the failure to satisfy certain closing conditions under the agreements
with Merck, including relating to the Hart-Scott-Rodino Antitrust Improvements
Act of 1974; (ii) even if the collaboration agreement becomes effective, future
payments to GTx may not be realized due to the inability to achieve certain
milestones under the collaboration agreement or the failure to develop and
commercialize Ostarine and other SARMs included in or arising from the
collaboration; (iii) product candidates developed under the collaboration may
not be commercialized as a result of the failure to obtain required regulatory
approvals, including if clinical trials do not demonstrate safety and efficacy
in humans; (iv) even if required regulatory approvals are obtained, products
developed under the collaboration may not gain market acceptance among
physicians, patients, health care payors and the medical community; and (v) GTx
could utilize its available cash resources sooner than it currently expects and
may be unable to raise capital when needed, which would force GTx to delay,
reduce or eliminate its product development programs or commercialization
efforts. You should not place undue reliance on these forward-looking
statements, which apply only as of the date of this press release. GTx's
quarterly report on form 10-Q filed with the U.S. Securities and Exchange
Commission on August 1, 2007, contains under the heading "Risk Factors," a more
comprehensive description of these and other risks to which GTx is subject. GTx
expressly disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained herein to
reflect any change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements are based.
Merck Forward-Looking Statement
This press release
contains "forward-looking statements" as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and uncertainties, which may
cause results to differ materially from those set forth in the statements. The
forward-looking statements may include statements regarding product development,
product potential or financial performance. No forward-looking statement can be
guaranteed and actual results may differ materially from those projected. Merck
undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events, or otherwise.
Forward-looking statements in this press release should be evaluated together
with the many uncertainties that affect Merck's business, particularly those
mentioned in the risk factors and cautionary statements in Item 1A of Merck's
Form 10-K for the year ended December 31, 2006, and in its periodic reports on
Form 10-Q and Form 8-K, which the Company incorporates by reference.
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