Andrx (NASDAQ:ADRX)
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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.