VANCOUVER, and CONSHOHOCKEN, PA, April 24 /CNW/ - Neuromed
Pharmaceuticals Ltd., a biopharmaceutical company developing next-generation
chronic pain drugs, announced today that it has licensed from ALZA Corporation
the exclusive U.S. rights to develop and commercialize OROS(R) Hydromorphone,
an extended release formulation of a potent opioid analgesic in Phase 3
Under the terms of the agreement Neuromed will make an upfront payment of
$30 million, additional regulatory milestone payments, and will pay royalties
based on commercial sales of the product. Neuromed will develop and market the
product in the U.S., while ALZA will retain the rights to develop and market
the product in other countries. ALZA will manufacture the product for Neuromed
as well as for other markets in which the product is sold.
OROS(R) Hydromorphone was developed by ALZA and uses the OROS(R)
PUSH-PULL(TM) delivery system to release the opioid at a controlled rate.
OROS(R) Hydromorphone has been approved in Germany and other European
countries and is marketed by Janssen-Cilag under the name JURNISTA(TM). The
product received an Approvable Letter from the U.S. Food and Drug
Administration (FDA) in October, 2000. Neuromed anticipates that one
successful adequate and well-controlled clinical trial will be needed to
support approval of OROS(R) Hydromorphone in the U.S.
"Our licensing of the U.S. rights to OROS(R) Hydromorphone from ALZA is
an excellent fit with Neuromed's strategy to address the significant need for
alternative chronic pain treatments," said Dr. Christopher Gallen, President &
CEO of Neuromed. "Hydromorphone is an effective and well-known pain reliever
and we believe a once-daily version can provide a significant benefit for the
large number of patients with moderate to severe pain that require pain relief
around the clock."
"OROS(R) Hydromorphone is a perfect fit with our existing programs,
including our partnered N-type calcium channel program and our own T-type
calcium channel blocker program," Dr. Gallen added. "Neuromed will develop a
specialized sales force to market OROS(R) Hydromorphone in the U.S. upon FDA
approval. The addition of a commercial presence in the U.S. will allow
Neuromed to market niche products while continuing its dedication to the
research and discovery of novel, breakthrough analgesics."
Hydromorphone is a Schedule II opioid that has been widely used for many
years under the brand name DILAUDID(R) and is also available from various
generic manufacturers. Current formulations of hydromorphone marketed in the
U.S. are immediate release, requiring dosing several times per day.
OROS(R) Hydromorphone employs the OROS(R) osmotic drug delivery
The OROS(R) osmotic drug delivery technology provides controlled drug
release over an extended period and has been employed as a sustained release
formulation for many successful products, including CONCERTA(R), DITROPAN
XL(R), COVERA-HS(R), and PROCARDIA XL(R). Four dosage strengths of OROS(R)
Hydromorphone (8 mg, 16 mg, 32 mg and 64 mg) are currently marketed in Europe,
with an additional lower strength (4 mg) in development.
OROS(R) Hydromorphone is an investigational product and is not approved
by the FDA for use in the U.S. OROS(R) Hydromorphone has been studied in more
then 1000 pain patients. The most common adverse events seen in clinical
trials to date were opioid-related events of constipation, nausea, somnolence,
headache, vomiting and dizziness. Respiratory depression is the most important
hazard of opioid preparations including OROS(R) Hydromorphone.
Neuromed is a privately held biopharmaceutical company in business to
develop safer and more effective pain drugs. We are combining our
pharmaceutical expertise in research, development and commercialization to
improve existing pain treatments as well as develop new pain medicines. For
more information visit www.neuromed.com.
CONCERTA(R), DITROPAN XL(R), OROS(R), and PUSH-PULL(TM) are trademarks of
ALZA Corporation; JURNISTA(TM) is a trademark of Janssen-Cilag; PROCARDIA
XL(R) is a trademark of Pfizer Inc.; COVERA-HS(R) is a trademark of G.D.
Searle & Co.; DILAUDID(R) is a trademark of Abbott Laboratories.
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:
For further information: Julie Jang, Manager, Communications, Neuromed
Pharmaceuticals, Phone: (604) 909-2547, Email: firstname.lastname@example.org