Attn: Business/City Editors
August 8, 2006
For Immediate Release
Apotex Launches First Generic Plavix®
Consumers Have Immediate Access to an Affordable Version of this
Important Product.
Weston,
FL (August 8, 2006) — Apotex Corp. announced that
it has today launched clopidogrel bisulfate 75 mg tablets. Clopidogrel
is the generic equivalent of Sanofi's Plavix®, which is marketed in the
U.S. by Bristol Myers Squibb.
As the
first generic company to file an Abbreviated New Drug Application (ANDA)
with the Food and Drug Administration (FDA) for clopidogrel, Apotex will
have 180 days of market exclusivity for the product. Sales for
clopidogrel 75 mg tablets in the U.S. for the twelve month period ending
June 2006 are approximately $3.77 billion according to IMS Health.
On July
28, the States' Attorneys General reviewing the modified settlement
submitted in June by Apotex, BMS, and Sanofi to the Federal Trade
Commission (FTC) and the states rejected the agreement. The proposed
settlement, which was first announced in March, halted the trial over
the infringement case filed by Sanofi/BMS against Apotex over U.S Patent
No. 4,847,265 (the '265 patent) that had been scheduled for June.
Apotex
Chief Executive Officer Dr. Barry Sherman said: "Apotex believes its
clopidogrel launch to be the largest and most successful launch in the
history of the generic industry. We are confident that the patent will
be held invalid and that the courts will find inequitable conduct before
the Patent Office on the part of Sanofi. Accordingly, Apotex has
launched prior to trial so that patients and public and private health
care payers can begin benefiting from a quality, low-cost alternative to
Plavix® immediately rather than years from now."
"There
should be no mistaking," Sherman added "that our decision to launch a
generic version of this blockbuster product at risk is a testament to
our commitment to patients, consumers, and taxpayers."
The U.S.
Food and Drug Administration approved Apotex's ANDA for clopidogrel in
January following the expiration of the automatic 30 month stay of
approval imposed by federal law when a brand company files an
infringement suit against a generic manufacturer challenging its
patents. At the time of the ANDA's approval, Apotex was in the midst of
patent litigation with Sanofi-Aventis concerning clopidogrel in the U.S.
District Court of the Southern District of New York, over the validity
and enforceability the '265 patent.
In
March, Apotex, Sanofi and BMS announced a proposed settlement of the
litigation.
After
reviewing the proposed settlement, the States' Attorneys General advised
that they would not approve the agreement in its then current form. In
June, Apotex, BMS, and Sanofi announced a modified agreement had been
submitted to the FTC and the states for review. Both agreements would
have resolved the litigation and would have granted Apotex a license to
market the generic product several months in advance of the expiration
of the patent in return for settling the suit. On July 28 the States'
Attorneys General announced their rejection of the modified agreement.
The latter agreement contained provisions assuring a smooth launch by
Apotex in the event approval of the agreement's settlement terms was not
obtained. Under the agreement, Sanofi and BMS have agreed not to seek a
temporary restraining order in the event Apotex launched sales of the
generic product and not to seek a preliminary injunction until at least
five business days after Apotex began shipments. In the event Sanofi and
BMS ultimately seek a preliminary injunction, Apotex believes it has
strong defenses to such an effort.
As a
result, Apotex has decided to immediately launch clopidogrel.
Apotex'
clopidogrel tablets are packaged in bottles of 30s, 90s, 1000s, and 100
count unit dose blisters.
The
Apotex Group manufactures more than 200 different high-quality generic
pharmaceuticals, used by millions of patients worldwide. Its product
line includes oral solids, liquids, injectables, nasal sprays,
opthalmics, and inhalation solutions.
Plavix® is a registered trademark of Sanofi-Aventis.
Apotex
Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned
manufacturer of prescription drugs. Through its sales and marketing
headquarters in Weston, Florida and operations center in Indianapolis,
Apotex Corp. is committed to providing safe and affordable generic
medicines. Products manufactured and marketed by the Apotex Group are sold
in 115 countries around the world. For more information visit
www.apotexcorp.com.
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For further information:
Mr. Elie Betito
Director Public & Government Affairs
Tel: 416-749-9300 Ext. 7366
Cell: 416-558-5491
ebetito@apotex.com
