WILMINGTON, N.C., April 16 /PRNewswire-FirstCall/ --
aaiPharma (Nasdaq: AAII) announced today that it has acquired exclusive
rights to a parenterally administered methadone product, formerly branded as
Dolophine(R) Hydrochloride Injection, from Roxane Laboratories, Inc.
aaiPharma plans to re-brand the product under a new trade name and launch the
product in the third quarter of this year. This acquisition expands
aaiPharma's pain management product offerings into the severe pain, Schedule
II class of pain products while also complementing its existing portfolio of
hospital-based injectable products. Financial terms of the agreement were not
disclosed.
"We are pleased to expand our current pain franchise to include this
valued treatment for relief of severe pain," commented Mr. David Hurley,
President of aaiPharma's Pharmaceuticals Division. "Methadone hydrochloride
injection is an important product for patients in severe pain who require
treatment via injection. Upon launch, this pain product will provide us with
an additional product for our sales professionals to detail in the hospital
setting and is an excellent strategic fit with both our growing pain portfolio
and our hospital-based parenteral critical care products."
Roxane Laboratories will continue to allocate the product until all
supplies have been exhausted, or until aaiPharma's launch, whichever occurs
first. Roxane will continue to market Dolophine(R) Tablets for oral
administration.
aaiPharma is poised to offer physicians and patients one of the most
comprehensive portfolios of pain products. Currently, the Company markets the
Darvon(R) and Darvocet-N(R) family of pain management products for the
treatment of mild-to-moderate pain, and is developing a pipeline of line
extensions to this brand franchise as well as novel products for the treatment
of pain. These products, coupled with methadone hydrochloride injection, will
provide physicians with treatment options across a broad spectrum of
prescription pain relief. The Company plans to manufacture methadone
hydrochloride injection at its own facility and re-brand the product prior to
launching commercially in the third quarter.
About Methadone Hydrochloride Injection
This product is an injectable methadone product indicated for the relief
of severe pain, for detoxification treatment of narcotic addiction and for the
temporary maintenance treatment of narcotic addiction.
Methadone hydrochloride injection is contraindicated in patients with a
hypersensitivity to methadone. Methadone hydrochloride, a narcotic, is a
Schedule II controlled substance under the Federal Controlled Substances Act.
About aaiPharma
aaiPharma Inc. is a science-based pharmaceutical company with more than 23
years of drug development experience. Focusing on targeted therapeutic areas,
the Company markets a growing portfolio of established branded products and
applies innovative technologies to increase the commercial potential of these
products. At the same time, aaiPharma's research and development organization
is developing an impressive pipeline of products to position the Company for
near-term and long-term growth in its targeted therapeutic areas. In addition
to developing and marketing its own line of proprietary pharmaceutical
products, aaiPharma continues to be a world leader in providing contract
pharmaceutical development services through its AAI International division.
For more information on the Company, please visit the website at
http://www.aaipharma.com .
About Roxane Laboratories, Inc.
Roxane Laboratories, Inc. is a subsidiary of Boehringer Ingelheim
Corporation, based in Ridgefield, Connecticut, and a member of the Boehringer
Ingelheim group of companies.
The Boehringer Ingelheim group of companies ranks among the 20 leading
pharmaceutical corporations in the world and has 156 affiliated companies in
44 countries worldwide. Focusing on human pharmaceuticals and animal health,
it posted revenues of US $7.2 billion (7.6 billion Euro) in 2002.
Since 1885, Boehringer Ingelheim has been a privately held company,
headquartered in Ingelheim, Germany, with a long history of successfully
marketed pharmaceutical innovations.
Research and development, production and distribution facilities are
located around the globe. In 2002, Boehringer Ingelheim's R&D spending was
more than US $1.2 billion (1.3 billion Euro), which is about a fifth of net
sales in Prescription Medicines.
For more information on Roxane Laboratories, please visit the website
http://www.roxane.com .
Forward Looking Statements
Information in this press release contains certain "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities and Exchange Act of 1934, including the
statements pertaining to the Company's plans and expectations as to re-
branding, manufacturing and launching methadone hydrochloride injection, its
potential medical and commercial opportunities and interest, the Company's
research and development activities, and commercialization and growth of
products in the Company's pipeline and of its product portfolio. The "forward-
looking statements" herein involve risks and uncertainties that could cause
actual results to differ materially, including, without limitation, risks and
uncertainties pertaining to the Company's ability to timely and successfully
meet such re-branding, manufacturing and launch plans, and to successfully
find, acquire, finance, develop, improve, enhance, obtain timely regulatory
approval for, maximize the value of, extend product life cycles of, conduct
successful research on, renew marketing of, and sell, on a commercially
profitable basis, pharmaceutical products (including methadone hydrochloride
injection) without adversely affecting its client relationships or business
opportunities and without future litigation or resulting damages or injunctive
relief; to obtain, use, enforce, defend and license valid and commercially
valuable patents; to obtain and enforce existing and future contracts with
major pharmaceutical companies for significant royalties and other
consideration; and on the commercial success of the contemplated products.
Additional factors that may cause the actual results to differ materially are
discussed in aaiPharma's recent filings with the Securities and Exchange
Commission, including, but not limited to, its Annual Report on Form 10-K
filed on March 28, 2003, including its Exhibit 99.1 and other exhibits; its
Form 8-Ks; and its other periodic filings.
SOURCE aaiPharma Inc.
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Related links:
http://www.aaipharma.com
CONTACT:
media, Andrea L. Johnston, Vice President,
Corporate Communications, +1-910-254-7340, or investors, James B.
Sloan, Jr., Senior Vice President, Corporate Finance,
+1-910-254-7690, both of aaiPharma Inc.
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