JERUSALEM - Teva Pharmaceutical Industries Ltd. plans to introduce Copaxone (glatiramer acetate for injection) into the UK by the end of the year, following the recommendation for approval this week by the British Licensing Authority for the treatment of relapsing-remitting multiple sclerosis. Marketing authorization is anticipated shortly.
Dan Seusskind, Teva's CFO, said Copaxone was approved in the U.S. in December 1996 and is "the fastest growing MS therapy and the second most prescribed MS drug in the U.S."
Copaxone currently is approved in 18 countries including Canada, Israel, Switzerland and Australia and, since the beginning of 2000, in Turkey, the Czech Republic, Slovakia and Poland.
"The UK approval will have immediate impact on Wall Street, on sales in the countries where the drug is already being marketed, and for introduction to the rest of Europe," which "is hoped for during the first half of 2001" as approval by the European mutual recognition procedure for the remainder of the EU is "usually a formality," Seusskind said.
Eli Hurvitz, Teva's president and CEO, said, "Teva had been working closely with the UK authorities and was confident all along that the growing body of scientific and clinical evidence regarding Copaxone would satisfy their stringent requirements.
"Copaxone is the first non-interferon agent proven to reduce the frequency of relapses in patients with relapsing-remitting MS," he said. Similar to the U.S., there are 150,000 relapsing-remitting patients in the EU, but "the untreated MS population in Europe is at least twice as large as that of the U.S." and "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 market share rapidly."
"We continue to invest heavily in further developing Copaxone(r) for the treatment of MS," Hurvitz said. The company is developing an oral formulation and also is conducting a Phase I/II clinical trial of Copaxone for the primary progressive stage of the disease.