Alpharma Announces Acceptance of the EMBEDA(TM) Capsule NDA Filing
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U.S. Food and Drug Administration Grants Priority Review Status
BRIDGEWATER, N.J.--(Business Wire)--
Alpharma Inc. (NYSE:ALO), a global specialty pharmaceutical
company, today announced that the United States Food and Drug
Administration ("FDA") has advised the Company that its New Drug
Application ("NDA") for EMBEDA(TM) (morphine sulfate extended-release
with sequestered naltrexone hydrochloride) Capsules has been accepted
and designated for priority review. The priority review status
provides for a review period of six months from the date of
submission. The EMBEDA(TM) Capsule NDA was submitted on June 30, 2008.
"We are pleased with the FDA's decision to grant the EMBEDA(TM)
Capsule application a priority review and now anticipate the potential
for an advisory panel meeting, where we can share the positive results
from our Phase III clinical trials in the appropriate public forum,"
commented Dean Mitchell, President and Chief Executive Officer. "We
remain committed to further development of novel alternatives for the
treatment of chronic pain utilizing Alpharma's proprietary abuse
deterrent technology, and look forward to collaborating with the FDA
on safe and effective solutions."
EMBEDA(TM) Capsules were developed using Alpharma's proprietary
technology, which combines an extended-release opioid with sequestered
naltrexone, an opioid antagonist. In clinical trials, when EMBEDA(TM)
Capsules were taken as directed, pain relief was provided and the
sequestered naltrexone passed through the body without observed
clinical effect. If an EMBEDA(TM) Capsule is crushed or dissolved in
alcohol, which are common approaches abusers use to tamper with an
opioid product in order to gain euphoria, both the morphine and the
naltrexone are released. When both are released, the study results
showed that the euphoric effect of morphine was significantly reduced.
The EMBEDA(TM) Capsule is an investigational pharmacological extended
release opioid in development for the relief of moderate to severe
chronic pain.
Statements made in this press release include forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements, including those relating to
future financial expectations, involve certain risks and uncertainties
that could cause actual results to differ materially from those in the
forward-looking statements. Information on other important potential
risks and uncertainties not discussed herein may be found in the
Company's filings with the Securities and Exchange Commission
including its Annual Report on Form 10-K for the year ended December
31, 2007.
About Alpharma
Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical
company with leadership positions in products for humans and animals.
Alpharma is presently active in more than 80 countries. Alpharma has a
growing branded pharmaceutical franchise in the U.S. pain market with
its KADIAN(R) (morphine sulfate extended-release) Capsules, and the
FLECTOR(R) Patch (diclofenac epolamine topical patch) 1.3%. Alpharma
is also internationally recognized as a leading provider of
pharmaceutical products for poultry and livestock.
If you would like to receive Alpharma press releases via email
please contact: investorrelations@alpharma.com. Alpharma press
releases are also available at our website: http://www.alpharma.com.
Alpharma Inc.
Jack Howarth, 908-566-4153
Vice President, Investor Relations
Jack.howarth@alpharma.com
or
Kekst and Company
Kimberly Kriger/Thomas Davies, 212-521-4800 (Media)
Copyright Business Wire 2008
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