CAMBRIDGE, Mass. & VANCOUVER, Sep 23, 2009 (BUSINESS WIRE) -- CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals,
Inc., a privately-held biopharmaceutical company, today announced that
the U.S. Food and Drug Administration (FDA) in a joint meeting of its
Anesthetics and Life Support Advisory Committee and its Drug Safety and
Risk Management Advisory Committee heard presentations and public
testimony and discussed the New Drug Application (NDA) submitted by
Neuromed for EXALGOTM (hydromorphone HCl extended release)
tablets, seeking FDA approval 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. After hearing
presentations, public commentary and asking questions, the joint
advisory committee was not asked to vote or make any formal
recommendations at the meeting, however the committee did provide
feedback to the FDA with regard to the proposed Risk Evaluation and
Mitigation Strategy (REMS) program for ExalgoTM. The FDA has
assigned a Prescription Drug User Fee Act date of November 22, 2009 to
complete its review of the Exalgo NDA.
The U.S. rights to Exalgo(TM) were acquired by Mallinckrodt Inc., a
subsidiary of Covidien on June 11, 2009. CombinatoRx and Neuromed
entered into a definitive merger agreement on June 30, 2009 for a merger
transaction which is expected to close during the fourth quarter of 2009.
About CombinatoRx
CombinatoRx, Incorporated (CRXX) is pioneering the new field of
synergistic combination pharmaceuticals. Going beyond traditional
combinations, CombinatoRx creates product candidates with novel
mechanisms of action, striking at the biological complexities of human
disease. The CombinatoRx proprietary drug discovery technology provides
a renewable and previously untapped source of novel drug candidates. The
Company was founded in 2000 and is located in Cambridge, Massachusetts.
To learn more about CombinatoRx, please visit www.combinatorx.com.
About Neuromed
Neuromed is a privately held biopharmaceutical company in business to
develop new and improved pain medicines. Neuromed has multiple programs
aimed at addressing this important unmet medical need. The rights to its
lead product candidate, Exalgo(TM), designed to be a once-daily, oral
hydromorphone treatment, seeking FDA approval for chronic to severe
pain, were recently acquired by Mallinckrodt Inc., a subsidiary of
Covidien plc. Neuromed is also developing oral drug candidates to block
N-type and T-type calcium channels, an important target directly
involved in pain signaling, and includes candidates for potentially
treating pain, epilepsy and hypertension. For more information visit
Neuromed's website at http://www.neuromed.com.
Important Additional Information Will Be Filed with the SEC
This press release does not constitute an offer of any securities for
sale. In connection with the merger between CombinatoRx and Neuromed
discussed in this press release, CombinatoRx has filed with the SEC a
registration statement on Form S-4, which includes a joint proxy
statement/prospectus of CombinatoRx and Neuromed and other relevant
materials in connection with the proposed transactions. Investors and
security holders of CombinatoRx are urged to read the joint proxy
statement/prospectus and the other relevant material when they become
available because they will contain important information about
CombinatoRx, Neuromed and the proposed transaction. The joint proxy
statement/prospectus and other relevant materials (when they become
available), and any and all documents filed with the SEC, may be
obtained free of charge at the SEC's web site at www.sec.gov.
In addition, investors and security holders may obtain free copies of
the documents filed with the SEC by CombinatoRx by directing a written
request to CombinatoRx, Incorporated, 245 First Street, Third Floor,
Cambridge, MA 02142, Attention: Secretary. INVESTORS AND SECURITY
HOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THE
OTHER RELEVANT MATERIALS WHEN THEY BECOME AVAILABLE BEFORE MAKING ANY
VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTIONS.
CombinatoRx and its respective executive officers and directors may be
deemed to be participants in the solicitation of proxies from the
security holders of CombinatoRx in connection with the merger.
Information about the executive officers and directors of CombinatoRx
and their ownership of CombinatoRx common stock is set forth in the
joint proxy statement/prospectus and Amendment No. 1 to the CombinatoRx
Annual Report on Form 10-K, which was filed with the SEC on April 30,
2009. Investors and security holders may obtain additional information
regarding the direct and indirect interests of CombinatoRx, Neuromed and
their respective executive officers and directors in the merger by
reading the joint proxy statement and prospectus.
Forward-Looking Statement:
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning CombinatoRx and Neuromed, Neuromed's product candidate
Exalgo(TM), and its potential for FDA approval, the timing of the closing
of the merger of CombinatoRx and Neuromed, the CombinatoRx drug
discovery technology, and the business plans of both CombinatoRx and the
combined company. These forward-looking statements about future
expectations, plans and prospects of CombinatoRx, Neuromed and the
combined company involve significant risks, uncertainties and
assumptions, including risks related to the ability of Neuromed or
Mallinckrodt to obtain regulatory approval for the sale and marketing of
its Exalgo(TM) product candidate, the unproven nature of the CombinatoRx
drug discovery technology, 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 of the CombinatoRx
Annual Report on Form 10-K 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.
(c) 2009 CombinatoRx, Incorporated. All rights reserved.
SOURCE: CombinatoRx, Incorporated
CombinatoRx, Incorporated
Robert Forrester, 617-301-7100
Interim President and CEO
rforrester@combinatorx.com
or
Gina Nugent, 857-753-6562
gnugent@combinatorx.com
