Friday June 2, 1:56 pm Eastern Time
Company Press Release
JERUSALEM--(BUSINESS WIRE)--June 2, 2000--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - news) today announced that Copaxone® (glatiramer acetate for injection) has been recommended for approval for the treatment of relapsing-remitting multiple sclerosis (RR MS) by the Licensing Authority in the U.K. It is anticipated that a marketing authorization will be issued shortly.
"We are extremely pleased with the news", said Mr. Eli Hurvitz, Teva's President and CEO, "Teva has been confident all along that the growing body of scientific and clinical evidence regarding Copaxone® will satisfy the stringent requirements of the U.K. Teva has worked closely together with the U.K. authorities to achieve this goal".
Following the approval in the U.K., Teva will initiate the European mutual recognition procedure to make Copaxone® available in the remainder of the European Union and will ask the U.K. to act as the reference member state. The successful completion of this procedure will enable the launch of Copaxone® in the E.U. during the first half of 2001.
"This recommendation for approval means that neurologists will shortly have a much-needed option to offer people with relapsing-remitting multiple sclerosis", said Prof. Lance Blumhardt of Queen's Medical Centre, U.K., "Glatiramer acetate, with its proven clinical benefits and excellent patient tolerability, represents a significant addition to treatment options for people with RRMS. Glatiramer acetate is also the drug of choice for people who fail with beta interferons or who cannot tolerate their side-effects".
Copaxone® represents a new class of therapy for MS, an MS specific immunomodulator. Copaxone® is the first and only non-interferon agent proven to reduce the frequency of relapses in patients with relapsing-remitting MS.
Similar to the U.S., there are 150,000 relapsing-remitting patients in the E.U. Importantly, the untreated MS population in Europe is at least twice as large as that of the U.S. As a widely accepted first-line therapy and the drug of choice for patients who do not benefit or cannot tolerate beta-interferon, Copaxone® is poised to gain its share rapidly.
Copaxone® has been approved in the U.S. since December 1996 and is the fastest growing MS therapy and the second most prescribed MS drug in the U.S. This growth is fueled by continued evidence emerging from on-going basic research and clinical work done with Copaxone®.
Copaxone® is currently approved in 18 countries including the U.S, Canada, Israel, Switzerland and Australia. Since the beginning of this year, Copaxone® has been approved in Turkey, the Czech Republic, Slovakia and Poland.
"The recommendation of approval by the U.K. Licensing Authority represents a major milestone for Teva and for Israeli research" said Mr. Eli Hurvitz. "It means that Copaxone® will become Teva's first globally marketed innovative pharmaceutical product. Copaxone® will be the first such product to emerge from Teva's close relationship with the world renowned academic research institutes in Israel". Copaxone® was discovered at the Weizmann Institute of Science in Israel.
Teva continues to invest heavily in further developing Copaxone® for the treatment of MS. The company is actively developing both an Oral formulation of Copaxone® and conducting a major clinical trial investigating the safety and efficacy of Copaxone® for the primary progressive stage of the disease.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 50 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of its sales are outside Israel, mainly in the United States and Europe. The Company develops, manufactures and markets generic and branded pharmaceuticals and active pharmaceutical ingredients.
Safe Harbor Statement: This report contains forward-looking statements,
which express the beliefs and expectations of management. Such statements
are based on current expectations and involve a number of known and unknown
risks and uncertainties that could cause the Company'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
the impact of pharmaceutical industry regulation, the difficulty of predicting
FDA and other regulatory authority approvals, the regulatory environment
and changes in the health policies and structure of various countries,
acceptance and demand for new pharmaceutical products and new therapies,
the impact of competitive products and pricing, the availability and pricing
of ingredients used in the manufacture of pharmaceutical products, uncertainties
regarding market acceptance of innovative products newly launched, currently
being sold or in development, the impact of restructuring of clients, reliance
on strategic alliances, fluctuations in currency, exchange and interest
rates, operating results, the impact of the year 2000 issue and other factors
that are discussed in the Company's Annual Report on Form 20-F and the
Company's other filings with the U.S. Securities and Exchange Commission.
Teva Pharmaceutical Industries Ltd.
Chief Financial Officer
Dr. Aaron Schwartz
Vice President, Global Products Divison
Director, MS Products
Global Products Division
(011) 972-3-926-7249/(011) 972-50-512778