Andrx Announces Commercialization Agreement with InvaGen
January 23 2006 - 12:20PM
Business Wire
Andrx Corporation (Nasdaq:ADRX) ("Andrx" or the "Company")
announced today that it has entered into an agreement with InvaGen
Pharmaceuticals Inc. ("InvaGen") to commercialize 11 abbreviated
new drug applications (ANDA), which, according to IMS data, had
total brand sales exceeding $13 billion for the trailing 12 months
ended September 2005. ANDAs for two of the products have been filed
with the U.S. Food and Drug Administration ("FDA") and it is
anticipated the ANDAs for the remaining products will be submitted
during 2006 and through early 2007. Pursuant to the agreement,
InvaGen will be responsible for all formulation work, regulatory
submissions and manufacture of each of the products. Andrx will be
responsible for sales and marketing efforts and coordination of
legal activities, if any. In addition, the agreement also provides
that Andrx, at its option, may site transfer manufacturing of
certain products to InvaGen's facility. InvaGen is a U.S. generic
pharmaceutical company based in Long Island, New York. To date,
InvaGen has filed 10 ANDAs with the FDA, two of which have been
approved and are being marketed by other parties. About Andrx
Corporation We are a pharmaceutical company that: -- develops,
manufactures and commercializes generic versions of
controlled-release, niche and immediate-release pharmaceutical
products, including oral contraceptives; -- distributes
pharmaceutical products, primarily generics, which have been
commercialized by others, as well as our own, primarily to
independent pharmacies, pharmacy chains and physicians' offices;
and -- develops and manufactures pharmaceutical products for other
pharmaceutical companies, including combination products and
controlled-release formulations utilizing our patented technologies
and formulation capabilities. Forward-looking statements
(statements which are not historical facts) in this release are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. For this purpose, any
statements contained herein or which are otherwise made by or on
behalf of Andrx that are not statements of historical fact may be
deemed to be forward-looking statements. Without limiting the
generality of the foregoing, words such as "may," "will," "to,"
"plan," "expect," "believe," "anticipate," "intend," "could,"
"should," "would," "estimate," or "continue" or the negative or
other variations thereof or comparable terminology are intended to
identify forward-looking statements. Investors are cautioned that
all forward-looking statements involve risk and uncertainties,
including but not limited to, the timing and outcome of patent,
class action and other litigation; the submission of Citizen
Petitions, if any; the timing and outcome of future product
launches by us or by InvaGen pursuant to this agreement; the timing
and scope of patents issued to our competitors; the FDA's pending
inspection; what sanctions, if any, FDA may seek following its
decision to place us in OAI status, including without limitation
sanctions relating to any failure to comply with cGMP requirements
and if and when the "hold" on our ANDA approvals will be lifted;
business interruption due to hurricanes or other events outside of
our control; our dependence on a relatively small number of
products; licensing revenues; government regulation generally;
competition; manufacturing capacities, safety issues, output and
quality processes; our ability to develop and successfully
commercialize new products; the loss of revenues from existing
products; the success of our joint ventures; the impact of sales
allowances; product liability claims; recent management changes and
the potential loss of senior management and other key personnel;
the absence of certainty regarding the receipt of required
regulatory approvals or the timing or terms of such approvals; and
our ability to commercialize all of our pre-launch inventory.
Actual results may differ materially from those projected in a
forward-looking statement. We are also subject to other risks
detailed herein or detailed from time to time in our 2004 10-K or
in our other SEC filings. Subsequent written and oral
forward-looking statements attributable to us or to persons acting
on our behalf are expressly qualified in their entirety by the
cautionary statements set forth in our 2004 10-K and in our other
SEC filings. This release and additional information about Andrx
Corporation are also available on the Internet at:
http://www.andrx.com.
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