CAMBRIDGE, Mass., Mar 02, 2010 (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(TM) (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
"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.
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.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning CombinatoRx, the product Exalgo(TM), 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(TM), 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.