CombinatoRx Announces Extension of Exalgo™ Extended-Release Tablets PDUFA Date to March 1, 2010
16 Fevereiro 2010 - 7:01PM
Business Wire
CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that
the U.S. Food and Drug Administration (FDA) has extended the
Prescription Drug User Fee Act (PDUFA) goal date for review of the
Exalgo™ (hydromorphone HCl) extended-release tablets New Drug
Application (NDA) from Monday, February 22, 2010 to Monday, March
1, 2010 due to federal government closings.
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 candidate Exalgo™, the timing
of FDA action regarding the NDA for Exalgo, the CombinatoRx drug
discovery technologies, and the business plans of CombinatoRx.
These forward-looking statements about future expectations, plans
and prospects of CombinatoRx involve significant risks,
uncertainties and assumptions, including risks related to the
ability of CombinatoRx or Mallinckrodt to obtain regulatory
approval for the sale and marketing of the Exalgo™ product
candidate, the ability of Mallinckrodt to successfully market
Exalgo™ if approved by the FDA, 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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