IVAX Corporation Announces Settlement; IVAX Allowed To Begin Marketing Pergolide In Early September
May 14 2003 - 8:56AM
UK Regulatory
BW20030514002068 20030514T125602Z UTC
( BW)(IVAX-CORPORATION)(IVX) IVAX Corporation Announces Settlement; IVAX
Allowed To Begin Marketing Pergolide In Early September
Business Editors
UK REGULATORY NEWS
LONDON--(BUSINESS WIRE)--May 14, 2003--
MIAMI--(BUSINESS WIRE)--May 14, 2003--IVAX Corporation (AMEX:IVX)
(LSE:IVX.L) today announced that it has entered into a settlement of
patent litigation with Amarin Corporation plc which will allow IVAX to
begin marketing pergolide mesylate, the generic equivalent of
Permax(R), in early September. The litigation related to two U.S.
patents licensed to Amarin by Eli Lilly and Company when Amarin
acquired the exclusive U.S. license rights to Permax tablets from Elan
Corporation.
Under the terms of the settlement, IVAX receives a nonexclusive
U.S. sublicense from Amarin and Lilly to the two patents beginning
September 2, 2003, in return for payments to Amarin during the first
six months of sales of the product following final approval by the
FDA. IVAX previously announced that its ANDA for pergolide mesylate
tablets in .05mg, .25mg and 1mg strengths received tentative approval
from the FDA. This product will be sold through the company's wholly
owned subsidiary, IVAX Pharmaceuticals, Inc. Pergolide mesylate is
used as adjunctive treatment in connection with Parkinson's disease.
Pergolide's active pharmaceutical ingredient is produced at IVAX'
facility in the Czech Republic.
IVAX currently has 38 ANDAs pending at the FDA. The company is
continuing its aggressive filing schedule for new ANDA submissions.
IVAX Corporation, headquartered in Miami, Florida, discovers,
develops, manufactures, and markets branded and brand equivalent
(generic) pharmaceuticals and veterinary products in the U.S. and
internationally.
Copies of this and other news releases may be obtained free of
charge from IVAX' website at http://www.ivax.com.
Except for the historical matters contained herein, statements in
this press release are forward-looking and are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. Investors are cautioned that forward-looking statements,
including the statements regarding IVAX' pending ANDAs and filing
schedule for ANDA submissions, involve risks and uncertainties which
may affect the company's business and prospects, including the risks
that final approval of IVAX' ANDA for pergolide mesylate tablets in
.05mg, .25mg and 1mg strengths may be delayed or not received at all;
that launch of the tablets may be delayed; changing market conditions;
the availability and cost of raw materials and other third party
products; the impact of competitive products and pricing; that IVAX
may not receive approval of its pending ANDAs, or that if approved,
the products will not be successfully commercialized; that IVAX may
not file any additional ANDAs; and other risks and uncertainties based
on economic, competitive, governmental, technological and other
factors discussed in the Company's Annual Report on Form 10-K and its
other filings with the Securities and Exchange Commission. Permax(R)
is a registered trademark of Eli Lilly and Company.
Short Name: IVAX Corporation
Category Code: MSC
Sequence Number: 00004778
Time of Receipt (offset from UTC): 20030514T133319+0100
--30--ac/uk*
CONTACT: IVAX Corporation
KEYWORD: UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
SOURCE: IVAX Corporation
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