CONSHOHOCKEN, PA and VANCOUVER, BC, June 17 /CNW/ - Neuromed
Pharmaceuticals Ltd. announced today that its subsidiary Neuromed Development
Inc., has sold the U.S. rights to its lead investigational drug candidate,
Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII), to Covidien's
subsidiary Mallinckrodt Inc.
On March 23, 2009, Neuromed announced that Exalgo met the primary
endpoint in a pivotal phase III clinical trial. On May 22, 2009, Neuromed
submitted a response to an Approvable Letter to the U.S. Food and Drug
Administration seeking approval for Exalgo 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. On June 12, 2009, the FDA
informed Neuromed that the Exalgo submission would be classified as a
Complete, Class 2 Response with a corresponding PDUFA date of November 22,
"We believe that Exalgo, designed to be a once-daily hydromorphone
formulation, if approved, will offer an additional option in the management of
moderate to severe pain in opioid tolerant patients requiring continuous,
around-the-clock opioid analgesia for an extended period of time," said Dr.
Christopher Gallen, President and Chief Executive Office of Neuromed. "The
sale of the Exalgo U.S. rights to Mallinckrodt ensures that Exalgo will be
optimally supported going forward."
Neuromed has received a one-time upfront payment. In addition, Neuromed
could receive additional development and, if Exalgo is approved, regulatory
approval milestone payments, as well as a royalty based on commercial sales of
"The proceeds of the sale of the U.S. rights to Exalgo provides the
resources to focus on our corporate strategy of advancing our other key assets
and realizing our goal of creating innovative medicines," said Dr. Christopher
Gallen, President and Chief Executive Officer of Neuromed. "This strategic
move raises significant capital in a manner that supports moving our science
forward during a challenging period for our entire industry."
Neuromed acquired from ALZA Corporation the U.S. rights to Exalgo, an
extended release formulation of hydromorphone. Hydromorphone is a Schedule II
opioid that has been used for many years. Exalgo is an investigational drug
and has not been approved by the FDA. Oral hydromorphone products currently
available in the U.S. are immediate release formulations, requiring dosing
several times per day. Exalgo employs the OROS(R) PUSH-PULL(TM) osmotic
delivery system designed to release hydromorphone at a controlled rate over an
extended period of time. An identical formulation, under the trade name
JURNISTA(R), has been launched in several countries by Janssen-Cilag.
JURNISTA(R) was first launched in Germany in August 2006.
To date, Exalgo has been studied in more than 2,000 patients in clinical
trials. The most common adverse events seen in those clinical trials to date
are opioid-related events such as constipation, nausea, somnolence, headache,
vomiting and dizziness. Respiratory depression is the most important hazard of
opioid preparations including Exalgo.
Neuromed is a privately held biopharmaceutical company in business to
develop new and improved pain medicines. Neuromed has three programs aimed at
addressing this important unmet medical need. Its lead investigational drug
candidate, Exalgo is an extended release formulation of hydromorphone.
Neuromed is also developing oral drug candidates to block N-type calcium
channels, a new and important target directly involved in pain signaling. Its
third program is focused on producing promising T-type calcium channel
blockers aimed at treating pain, epilepsy and hypertension. For more
information visit our website at www.neuromed.com.
OROS(R) and Push-Pull(TM) are trademarks of ALZA Corporation.
Neuromed cautions you that statements included in this press release that
are not a description of historical facts may be forward-looking statements.
Forward-looking statements are only predictions based upon current
expectations and involve known and unknown risks and uncertainties. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of release of the relevant information, unless
explicitly stated otherwise. Actual results, performance or achievement could
differ materially from those expressed in, or implied by, Neuromed's
forward-looking statements due to the risks and uncertainties inherent in
Neuromed's business including, without limitation, statements about: the
progress and timing of its clinical trials; difficulties or delays in
development, testing, obtaining regulatory approval, producing and marketing
its products; unexpected adverse side effects or inadequate therapeutic
efficacy of its products that could delay or prevent product development or
commercialization, or that could result in recalls or product liability
claims; the scope and validity of patent protection for its products;
competition from other pharmaceutical or biotechnology companies; and its
ability to obtain additional financing to support its operations. Neuromed
does not assume any obligation to update any forward-looking statements.
For further information:
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