Message #91 From:
NewsBot Date: December 18, 2006 05:00:00 AM
TEVA News Teva Announces Launch of Generic Wellbutrin XL(R) Tablets, 300 mg Under Agreement with Anchen and IMPAX
JERUSALEM, Israel--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that
it has commercially shipped Bupropion Hydrochloride Extended-Release
Tablets, 300 mg, the generic version of Biovail Corporation’s
antidepressant Wellbutrin XL® Tablets,
pursuant to an agreement with IMPAX Laboratories, Inc. (NASDAQ:IPXL) and
Anchen Pharmaceuticals, Inc. Wellbutrin XL®
Tablets, 300 mg, marketed by GlaxoSmithKline, had U.S. sales of
approximately $972 million for the 12 months ended September 2006,
according to IMS data.
Under the agreement, Anchen has taken the regulatory steps necessary to
permit IMPAX to obtain final U.S. Food and Drug Administration approval
of IMPAX's Bupropion Hydrochloride Extended-Release Tablets, 300 mg and
for Teva to sell the product within Anchen's 180-day exclusivity. In
return, Anchen will receive certain payments, both during and after the
exclusivity period. Pursuant to Teva's existing strategic alliance
agreement with IMPAX, Teva has U.S. marketing rights to IMPAX's version
of this product. Teva will record the revenues resulting from sales of
the product and remit payments to Anchen and a negotiated percentage of
its gross profit to IMPAX.
Anchen and IMPAX are currently in patent litigation concerning this
product. Suits were brought against them by Biovail Laboratories
International SRL involving their Paragraph IV certifications to U.S.
Patent No. 6,096,341. Anchen has been granted summary judgment of
noninfringement with regard to its product. IMPAX has filed a motion for
summary judgment of noninfringement.
Anchen was the first generic applicant to file an Abbreviated New Drug
Application (ANDA) containing a paragraph IV patent challenge on the
patents related to the Wellbutrin XL® tablet
product and consequently was granted 180 days exclusivity, which it has
now transferred to IMPAX.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among
the top 20 pharmaceutical companies in the world and is the leading
generic pharmaceutical company. The company develops, manufactures and
markets generic and innovative human pharmaceuticals and active
pharmaceutical ingredients, as well as animal health pharmaceutical
products. Over 80 percent of Teva’s sales are
in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:This release contains
forward-looking statements, which express the current beliefs and
expectations of management. Such statements are based on management’s
current beliefs and expectations and involve a number of known and
unknown risks and uncertainties that could cause Teva’s
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to Teva’s
ability to rapidly integrate IVAX Corporation’s
operations and achieve expected synergies, Teva’s
ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic products,
the impact of competition from brand-name companies that sell or license
their own brand products under generic trade dress and at generic prices
(so called “authorized generics”)
or seek to delay the introduction of genericproduct, the impact
of consolidation of our distributors and customers, regulatory changes
that may prevent Teva from exploiting exclusivity periods, potential
liability for sales of generic products prior to a final resolution of
outstanding litigation, including that relating to the generic versions
of Allegra®,
Neurontin®
and Zithromax®,
the effects of competition on Copaxone®
sales, including as a result of the reintroduction of Tysabri®
into the market, the impact of pharmaceutical industry regulation and
pending legislation that could affect the pharmaceutical industry, the
difficulty of predicting U.S. Food and Drug Administration, European
Medicines Agency and other regulatory authority approvals, the
regulatory environment and changes in the health policies and structures
of various countries, Teva’s ability to
successfully identify, consummate and integrate acquisitions, potential
exposure to product liability claims, dependence on patent and other
protections for innovative products, significant operations worldwide
that may be adversely affected by terrorism or major hostilities,
environmental risks, fluctuations in currency, exchange and interest
rates, operating results and other factors that are discussed in Teva’s
Annual Report on Form20-F and its other filings with the U.S.
Securities and Exchange Commission. Forward-looking statements speak
only as of the date on which they are made and the Company undertakes no
obligation to update publicly or revise any forward-looking statement,
whether as a result of new information, future developments or otherwise.