FDA Approves Exalgo™ Extended-Release Tablets
02 Março 2010 - 9:00AM
Business Wire
CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that
the U.S. Food and Drug Administration (FDA) has approved the New
Drug Application (NDA) for Exalgo™ (hydromorphone HCl)
extended-release tablets, for the management of moderate to severe
pain in opioid tolerant patients requiring continuous,
around-the-clock opioid analgesia for an extended period of
time.
CombinatoRx will receive a $40 million milestone payment from
Covidien based on Exalgo approval and is eligible to receive tiered
royalties on Exalgo net sales. Under the terms of the agreements
relating to the merger with Neuromed Pharmaceuticals, effective
with the FDA approval of Exalgo, approximately 38,609,168
additional shares of CombinatoRx common stock are outstanding,
resulting in CombinatoRx having total shares of common stock
outstanding following FDA approval of Exalgo of approximately
88,610,640.
“Our considerable product development expertise played a key
role in facilitating this successful NDA submission, with the goal
of providing much needed relief to those who suffer from chronic
pain,” commented Mark H.N. Corrigan, MD, President and CEO of
CombinatoRx. “We will continue to apply our strong development
capabilities to the many promising drug candidates in our pipeline
going forward.”
The U.S. rights to Exalgo tablets were acquired from Neuromed by
Mallinckrodt Inc., a Covidien company, in June, 2009. Neuromed
acquired the U.S. marketing rights to Exalgo tablets from ALZA
Corporation in April 2007 and was responsible for clinical
development and regulatory filings. Covidien is responsible for all
commercialization activities for Exalgo in the U.S., including
marketing, sales and all post-approval FDA regulatory filings, and
will now own the intellectual property for the product. ALZA is
responsible for manufacturing, packaging and supply of the product.
CombinatoRx and Neuromed merged on December 21, 2009.
About CombinatoRx
CombinatoRx, Incorporated (CRXX) develops novel drug candidates
with a focus on the treatment of pain and inflammation. The company
applies its combination drug discovery capabilities and its
selective ion-channel modulation platform to generate innovative
therapeutics. To learn more about CombinatoRx, please visit
www.combinatorx.com.
Forward-Looking Statement:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
concerning CombinatoRx, the product Exalgo™, its potential and any
royalties CombinatoRx may receive from Mallinckrodt based on net
sales of Exalgo, the CombinatoRx drug discovery technologies, and
the business plans of CombinatoRx. These forward-looking statements
about future expectations, plans, objectives and prospects of
CombinatoRx may be identified by words like "believe," "expect,"
"may," "will," "should," "seek," or “could” and similar expressions
and involve significant risks, uncertainties and assumptions,
including risks related to the ability of Mallinckrodt to
successfully market Exalgo™, the unproven nature of the CombinatoRx
drug discovery technologies, the Company's ability to obtain
additional financing or funding for its research and development
and those other risks that can be found in the "Risk Factors"
section beginning on page 31 of CombinatoRx's Form S-4 Registration
Statement filed in connection with its merger with Neuromed (File
No. 333-161146), on file with the Securities and Exchange
Commission and the other reports that CombinatoRx periodically
files with the Securities and Exchange Commission. Actual results
may differ materially from those CombinatoRx contemplated by these
forward-looking statements. These forward looking statements
reflect management’s current views and CombinatoRx does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this release except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
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