IVAX Confirms First To File Status On Zyprexa And Vigorous Pursuit Of Litigation
July 18 2003 - 10:07AM
UK Regulatory
BW20030718002034 20030718T130659Z UTC
( BW)(IVAX-CORPORATION)(IVX) IVAX Confirms First To File Status On
Zyprexa And Vigorous Pursuit Of Litigation
Business Editors
UK REGULATORY NEWS
MIAMI--(BUSINESS WIRE)--July 18, 2003--
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) responded today to
questions raised by a report stating that Teva Pharmaceutical
Industries Ltd. (Nasdaq:TEVA) has agreed not to be a participant in
the trial regarding the patent challenge to Eli Lilly and Company's
(NYSE:LLY) antipsychotic drug, Zyprexa(R). Zyprexa, known generically
as olanzapine, is Eli Lilly's largest selling product, with annual
U.S. sales of approximately $2.5 billion in 2002.
Neil Flanzraich, vice chairman and president of IVAX Corporation,
said, "IVAX was first to file on Zyprexa. It is clear that Teva was
not first to file on Zyprexa, and has never said it was. Teva also has
not been an active participant in the related legal proceedings. Its
decision not to participate in the trial has no significance or
bearing on the conduct or outcome of the litigation. We are working
aggressively to prepare for the olanzapine trial, which is scheduled
for January 2004."
IVAX confirms that it has first to file status on the 2.5, 5, 7.5,
10 and 15 mg dosage strengths of olanzapine and that Dr. Reddy's
Laboratories Limited (NYSE:RDY) has reported being first to file on
the 20 mg strength of olanzapine. Both IVAX and Dr. Reddy's have, and
continue to be, active participants in this patent challenge. Teva was
sued by Lilly in September of 2002, well after Eli Lilly initiated
suits against IVAX and Dr. Reddy's. All three cases were consolidated
in November 2002, and since the consolidation Teva has not been an
active participant in the litigation. According to public record, on
July 15, a joint-stipulation was filed by Lilly and Teva saying that
Teva would not participate in the trial and would be bound by the
ultimate court decision.
IVAX currently has 39 ANDAs pending at the FDA. The company
continues 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' first to file status, timing
of litigation, 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 IVAX may not receive
approval for olanzapine or that its launch will be delayed; that IVAX
may not have first to file status; the impact of the FDA's or other
administrative or judicial agency's decisions on exclusivity periods;
that the olanzapine litigation may be delayed or resolved adversely to
IVAX; 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 IVAX' Annual Report on
Form 10-K and its other filings with the Securities and Exchange
Commission. Zyprexa (R)is a registered trademark of Eli Lilly and
Company.
Short Name: IVAX Corporation
Category Code: RSP
Sequence Number: 00007291
Time of Receipt (offset from UTC): 20030718T134031+0100
--30--JD/mi* zw/uk
CONTACT: IVAX Corporation
KEYWORD: UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
SOURCE: IVAX Corporation
Today's News On The Net - Business Wire's full file on the Internet
with Hyperlinks to your home page.
URL: http://www.businesswire.com