Andrx Announces Filing of NDA by Takeda for ACTOS and Extended-Release Metformin Combination Product
April 04 2006 - 7:58AM
Business Wire
Andrx Corporation (Nasdaq:ADRX) announced today that Takeda Global
Research & Development Center Inc. filed a New Drug Application
(NDA) for a combination product consisting of Takeda's ACTOS(R)
(pioglitazone HCl) and Andrx's extended-release metformin to the
U.S. Food and Drug Administration (FDA) for the treatment of type 2
diabetes. Thomas P. Rice, Andrx Corporation Chief Executive
Officer, said: "We are extremely satisfied to see several years of
development work come to fruition with the filing of an NDA for a
product jointly developed by Andrx and Takeda. This once-a-day
combination product is designed to provide a more convenient
treatment option for those affected by type 2 diabetes. Through our
Andrx Therapeutics contract services segment, we hope to forge more
relationships like the one we have with Takeda in which we can
utilize our strengths in formulation and process development and
extend the life cycle of brand products," Rice said. In January
2004, Andrx and Takeda Pharmaceutical Company Limited announced
they entered into an agreement to manufacture and develop a
combination product consisting of Takeda's ACTOS and Andrx's
extended-release metformin. Under the agreement, Andrx will
manufacture this combination product, if and when it is approved,
and Takeda will hold exclusive, worldwide marketing rights. This
NDA filing triggers the payment to Andrx of the third $10 million
development milestone. Andrx may receive an additional development
milestone from Takeda upon the occurrence of a future specified
event. Andrx may also receive a transfer price for tablets
manufactured, together with royalties and certain additional
milestones related to the level of sales of the combination
product. About Andrx Andrx Corporation is a pharmaceutical company
that: -- develops and commercializes generic versions of primarily
controlled-release pharmaceutical products, as well as oral
contraceptives and selective immediate-release products; --
distributes pharmaceutical products, primarily generics, which have
been commercialized by others, as well as our own, primarily to
independent and chain pharmacies and physicians' offices; and --
develops and manufactures pharmaceutical products for other
pharmaceutical companies, including combination products and
controlled-release formulations. Forward-Looking Statements
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, risks and
uncertainties related specifically to our collaborative agreement
with Takeda, including whether the NDA for the Andrx/Takeda
combination product of ACTOS and extended-release metformin will be
approved and, if approved, whether it will be successfully
commercialized; our ability to meet the supply and manufacturing
requirements relating to the Andrx/Teva combination product; as
well as other risks and uncertainties, including which sanctions,
if any, the Food and Drug Administration (FDA) may seek in
connection with its decision to place us in Official Action
Indicated (OAI) status or after any current or future inspections,
including without limitation sanctions relating to any failure to
comply with current Good Manufacturing Practices (cGMP)
requirements and if and when the "hold" on our Abbreviated New Drug
Application (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; the timing and
scope of patents issued to our competitors; whether we will be
awarded any marketing exclusivity period for any of our products
and, if so, the precise dates thereof; whether additional charges
related to pre-launch inventory will be required; government
regulation generally; competition; manufacturing capacities; our
ability to develop and successfully commercialize new products;
active pharmaceutical ingredients (API) issues; the loss of
revenues and profits from existing products; our inability to
obtain, or the high cost of obtaining, licenses for third party
technologies; the consolidation or loss of customers; our
relationship with our suppliers; our inability to obtain sufficient
finished goods for distribution, supplies and/or API from key
suppliers; product liability claims; rising costs and limited
availability of product liability and other insurance; management
changes and the potential loss of key personnel; the absence of
certainty regarding the receipt of required regulatory approvals or
the timing or terms of such approvals; our ability to commercialize
all of our pre-launch inventory; and the completion of our merger
with Watson Pharmaceuticals, Inc. Actual results may differ
materially from those projected in a forward-looking statement. We
are also subject to other risks detailed in our Annual Report on
Form 10-K for the year ended December 31, 2005, or from time to
time 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 Annual Report on Form 10-K
for the year ended December 31, 2005, and in our other SEC filings.
Readers are cautioned not to place reliance on these
forward-looking statements, which are valid only as of the date
they were made. We undertake no obligation to update or revise any
forward-looking statements to reflect new information or the
occurrence of unanticipated events or otherwise, except as
expressly required by law. This release and additional information
about Andrx Corporation is also available on the Internet at:
http://www.andrx.com.
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