WILMINGTON, N.C., March 1 /PRNewswire-FirstCall/ -- aaiPharma Inc.
(Nasdaq: AAII) said today that it has entered into a definitive agreement to
sell its M.V.I.(R) (Multi-Vitamin Infusion) and Aquasol(R) product business to
Mayne Pharma (USA) Inc., Paramus, N.J., a subsidiary of Australia's Mayne
Group Limited (ASX: MAY).
Under terms of the agreement, aaiPharma will receive $100 million in cash
from Mayne upon closing of the transaction, as well as an additional $5
million contingent cash payment upon U.S. Food and Drug Administration (FDA)
approval of a Supplemental New Drug Application (sNDA) for a new M.V.I. (R)
product, subject to certain adjustments. Royalties on certain sales levels of
this new product will be paid to aaiPharma as part of this agreement.
"The sale of this business is consistent with aaiPharma's long-term
corporate strategy to focus on pain management while leveraging the non-pain
components of our business for the greatest value for both shareholders and
physicians," stated Dr. Philip S. Tabbiner, President and CEO of aaiPharma.
"With its robust portfolio of injectable pharmaceuticals, we believe Mayne
Pharma is in an excellent position to fully leverage the enhancements we have
made to the product line over the last two years. The proceeds from this sale
will be used to further pay down our debt."
Since purchasing the M.V.I.(R) and Aquasol(R) line from AstraZeneca in
August 2001 for less than $100 million including the forthcoming final payment
of $31.5 million, aaiPharma has brought innovative science to bear on
reformulating and extending the product family, consistent with its strategy
to improve well-known medicines through science. The company received
approval of a New Drug Application (NDA) for M.V.I Adult(TM), a reformulation
of M.V.I.-12(R) in single-dose and unit vial presentations in January 2004, as
well as approval of an NDA for M.V.I. Adult(TM) Pharmacy Bulk Package earlier
this month. Details of the aforementioned sNDA are not disclosed for
competitive reasons.
M.V.I.-12(R) and M.V.I.-Pediatric(R) are multivitamin market leaders for
patients who require intravenous feeding as a result of surgery, extensive
burns, fractures and other trauma, severe infectious disease, or comatose
states in which the replenishment of nutrients is critical. M.V.I. Adult(TM),
the newest addition to the M.V.I. (R) family, is a reformulation of M.V.I.-
12(R) in which concentrations of four vitamins are increased and vitamin K is
added.
The Aquasol(R) brands of nutritional products include Aquasol A(R)
parenteral (water-miscible vitamin A Palmitate), for the treatment of vitamin
A deficiency and Aquasol E(R) Drops (aqueous vitamin supplement), which are
administered for the treatment of infants, children and adults with a vitamin
E deficiency.
aaiPharma's sale of its M.V.I.(R) and Aquasol(R) business to Mayne is
subject to early termination or expiration of the waiting period mandated by
the Hart-Scott-Rodino Antitrust Improvement Act of 1976 and other contractual
conditions.
About aaiPharma
aaiPharma Inc. is a leading, science-based pharmaceutical company focused
on pain management, with corporate headquarters in Wilmington, North Carolina.
With more than 24 years of drug development expertise, the Company is focused
on developing, acquiring, and marketing well-known, branded medicines in its
targeted therapeutic areas. aaiPharma 's development efforts are focused on
developing improved medicines from established molecules through its
significant research and development capabilities. For more information on
the Company, including its product development organization AAI Development
Services, please visit aaiPharma's website at http://www.aaipharma.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 future payments and royalties to be received by the
Company, the Company's plans for use of the proceeds of the sale, and the
closing of the sale after satisfaction of the relevant approvals and
conditions. The "forward-looking statements" herein involve risks and
uncertainties that could cause actual results to differ materially, including,
without limitation, risks and uncertainties pertaining the satisfaction of the
relevant approvals and conditions; the level of sales of products on which
royalties would be paid; the commercial and medical attractiveness of the
Company's present and planned products in light of sales of competitive or
generic products; regulatory decisions by the FDA and other agencies
regulating the Company; and the Company's ability to successfully acquire,
finance, conduct successful research on, develop, improve, obtain timely
regulatory approval for, launch, extend product life cycles of, and sell, on a
commercially profitable basis, pharmaceutical products; to obtain, use,
enforce, defend and license valid and commercially valuable patents,
including, without limitation, in the Company's patent litigation; to obtain
and enforce existing and future contracts; 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 exhibits;
its Forms 10-Q filed on May 15, 2003, August 14, 2003 (including its Exhibit
99.1) and November 14, 2003, 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 James B. Sloan,
Jr., Senior Vice President, Corporate Finance, +1-910-254-7690,
both of aaiPharma Inc.
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