WILMINGTON, N.C., April 1 /PRNewswire-FirstCall/ --
aaiPharma Inc., (Nasdaq: AAII) and SICOR Inc. (Nasdaq: SCRI) today
announced that they have entered into a manufacturing and co-promotion
agreement for Calcitriol Injection vial, a drug used primarily to treat
chronic kidney dialysis patients with abnormally low levels of calcium in
their circulating blood. Financial terms have not been disclosed.
aaiPharma received final marketing approval for Calcitriol from the U.S.
Food and Drug Administration (FDA) on February 20, 2003. In conjunction with
this approval, aaiPharma received shared 180-day marketing exclusivity from
the FDA. According to the terms of the shared exclusivity, the 180-day clock
starts upon the launch of Calcitriol by either of the companies sharing
exclusivity. aaiPharma announced its first commercial sale of Calcitriol last
week.
Under the terms of the co-promotion agreement, aaiPharma has selectively
waived its shared exclusivity to SICOR to allow SICOR to supply Calcitriol to
aaiPharma for sale in the marketplace. The FDA had tentatively approved
SICOR's Calcitriol Injection vial on January 2, 2003, with final approval
pending conclusion of the 180-day shared exclusivity time period. The FDA
approved this transfer of shared exclusivity on March 31, 2003, and SICOR has
since assumed responsibility for additional manufacturing of the product in
finished dosage form for aaiPharma. aaiPharma and SICOR will now co-promote
Calcitriol to dialysis centers and hospitals in the U.S. According to 2002
IMS data, annual sales for similar injectable vitamin D nutritional products
were in excess of $300 million.
"We are very pleased to enter into this alliance with SICOR, which will
add significantly to the manufacturing capacity for this product," according
to Dr. Philip S. Tabbiner, President and CEO of aaiPharma. "Calcitriol is an
important extension of our line of critical care products. We expect that our
unique vial form and competitive pricing will be a welcome option for health
care professionals administering injectable vitamin D therapy."
"This strategic alliance with aaiPharma will allow us to offer a
differentiated, cost effective alternative product to our customers," stated
Marvin Samson, president and chief executive officer of SICOR Inc. "By
aligning our efforts with aaiPharma, we are able to maximize the benefits for
our customers and their patients, who will welcome the return of a high
quality product at an affordable price."
About aaiPharma
aaiPharma Inc. is a leading, science-based specialty pharmaceutical
company with corporate headquarters in Wilmington, North Carolina. With more
than 23 years of drug development expertise and a proven sales and marketing
track record, aaiPharma is focused on acquiring, improving and marketing well-
known, branded medicines in pain management, gastroenterology and critical
care. In addition to its branded product portfolio and robust pipeline,
aaiPharma continues to offer comprehensive drug development services to the
pharmaceutical, biotechnology, generic and device industries through its
services division, AAI International. For more information, please visit
aaiPharma's website at http://www.aaipharma.com.
About SICOR Inc.
SICOR Inc. is a vertically integrated, multinational pharmaceutical
company that focuses on finished dosage injectable pharmaceuticals, active
pharmaceutical ingredients, or APIs, and biopharmaceuticals. Using internal
research and development capabilities, together with operational flexibility
and manufacturing and regulatory expertise, SICOR is able to take a wide
variety of products from the laboratory to the worldwide market. Leveraging
these capabilities, SICOR concentrates on products and technologies that
present significant barriers to entry or offer first-to-market opportunities.
SICOR operates several manufacturing facilities in the U.S., Western and
Eastern Europe and Mexico, while maintaining its corporate headquarters in
Irvine, California. For more information on SICOR, please visit
http://www.sicorinc.com.
Forward Looking Statements - aaiPharma
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 market and medical reaction to calcitriol in vials
instead of ampoules and to the expected pricing of the product, and future
development (including through the use of aaiPharma's research and drug
development capabilities), commercialization and growth of products in the
aaiPharma'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 actual market and medical reactions to our product
format and pricing, and aaiPharma's ability 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 calcitriol, without adversely affecting its
client relationships or business opportunities and without future litigation
or resulting damages or injunctive relief. 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.
Forward Looking Statements - SICOR
This press release contains forward looking statements that are subject to
risks and uncertainties that could cause actual results to differ materially
from those set forth in the forward looking statements, including whether the
commercial launch of calcitriol injection will be successful, whether
aaiPharma and SICOR will be able to gain market share for calcitriol over
currently marketed vitamin D nutritional products, whether SICOR will
successfully manufacture calcitriol, and those matters set forth in the risk
factors section of SICOR's filings on Forms 10-K and 10-Q with the Securities
and Exchange Commission. These forward-looking statements represent the
Company's judgment as of the date of this press release. The Company
disclaims any intent or obligation to update these forward-looking statements.
SOURCE aaiPharma Inc.
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Related links:
http://www.aaipharma.com
CONTACT:
investors, James B. Sloan, Jr., Senior Vice
President, Corporate Finance, +1-910-254-7690, or media, Andrea
L. Johnston, Vice President, Corporate Communications,
+1-910-254-7340, both of aaiPharma Inc., or Laurie Little,
Director, Investor Relations of SICOR Inc., +1-949-455-4879
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