DETROIT, July 10 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical
Laboratories, Ltd. (NYSE Amex: CPD) announced that, as part of the settlement
of the legal proceedings related to Lexapro(R) (escitalopram oxalate) tablets,
it entered into an Asset Purchase Agreement with Forest Laboratories, Inc.
("Forest") to acquire several products from Forest's Inwood line of business.
The ANDA patent litigation settlement resolves litigation involving Caraco,
Forest, Forest Holdings, Ltd., and H. Lundbeck A/S and Sun Pharmaceutical
Industries Limited ("Sun"). Caraco is a subsidiary of Sun.
Among other things, with respect to Caraco, the litigation settlement
involves the following provisions:
1. Forest has agreed to provide licenses to Caraco for any patents
related to Lexapro(R) with respect to the marketing of Caraco's generic
version of the product as of the date that any third party generic enters the
market with final approval from the FDA other than an authorized generic or
the first filer with Hatch-Waxman related exclusivity.
2. Forest will reimburse Caraco for a portion of its attorney's fees
related to this litigation.
3. Pursuant to the Asset Purchase Agreement (the "APA"), Caraco will take
over the commercialization and sale of several products from Forest's Inwood
business. Caraco will pay Forest an advance against royalties and royalties
on net sales of these products.
The terms of the settlement will be submitted to the Federal Trade
Commission and the Department of Justice pursuant to the Medicare
Modernization Act. The APA is scheduled to close no sooner than 40 days after
the signing, which the parties hope will provide the FTC and DOJ with
sufficient time to review the transaction. As the transaction must be
submitted to the FTC and DOJ, there is a possibility that the transaction may
need to either be revised, or it may not be consummated, and the litigation
would be re-instituted.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
manufactures, markets and distributes generic and private-label
pharmaceuticals to the nation's largest wholesalers, distributors, drugstore
chains and managed care providers.
Safe Harbor: This news release contains forward-looking statements made
pursuant to the safe-harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such statements are based on management's current
expectations and are subject to risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties are contained in the
Corporation's filings with the Securities and Exchange Commission and include,
but are not limited to: information of a preliminary nature that may be
subject to adjustment, potentially not obtaining or delay in obtaining FDA
approval for new products, governmental restrictions on the sale of certain
products, development by competitors of new or superior products or less
expensive products or new technology for the production of products, the entry
into the market of new competitors, market and customer acceptance and demand
for new pharmaceutical products, availability of raw materials, timing and
success of product development and launches, dependence on a few products
generating a majority of sales, product liability claims for which the Company
may be inadequately insured, and other risks identified in this report and
from time to time in our periodic reports and registration statements. These
forward-looking statements represent our judgment as of the date of this
report. We disclaim, however, any intent or obligation to update our
forward-looking statements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
-0- 07/10/2009
/CONTACT: Daniel Movens, +1-313-871-8400, or Thomas Versosky,
+1-313-556-4150, both of Caraco Pharmaceutical/
/Web Site: http://www.caraco.com /
(CPD)
CO: Caraco Pharmaceutical Laboratories, Ltd.; Forest Laboratories, Inc.; Sun
Pharmaceutical Industries Limited; Forest Holdings, Ltd.; H. Lundbeck A/S
ST: Michigan
IN: PHA MTC HEA
SU: LAW CON PLW
PR
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0960 07/10/2009 09:15 EDT http://www.prnewswire.com