Wednesday, December 6 2000 12:40
By Sharon Berger
JERUSALEM (December 6) - Teva Pharmaceutical Industries Ltd. said yesterday it had finally launched its sale of multiple sclerosis (MS) drug Copaxone (R) in Britain. In addition the generic pharmaceutical company said that it received approval from the US Food and Drug Administration (FDA) for the exclusive sale for 180 days of hypertension drug Nifedipine CC 60mg.
In August, Teva received official approval to sell the drug in the UK, but the company delayed its introduction till yesterday. Teva is planning to use its UK launch as a stepping-stone into the European Union market.
In Britain there are an estimated 30,000 people suitable for treatment with Copaxone. Dan Seusskind, chief financial officer of Teva, declined to give an estimate of future sales, but said, "The UK is a relatively small market, because the number of treated patients is the lowest in Europe, as the drug is often not prescribed because it is not reimbursed." Seusskind added that in Britain 10% of relevant patients were treated, while in Europe it was closer to 40%, compared to 70% of patients who are treated in the US. He said that the company hopes to start selling in the rest of Europe by the second half of 2001.
"The association welcomes the launch of Copaxone and sees it as a step forward in effectively treating the disease, by improving the quality of life of the patients," said the head of the UK association for relapsing-remitting MS, Peter Cardy. Copaxone, which was developed at the Weizmann Institute of Science, helps reduce relapses in those suffering from that form of the condition.
Copaxone, which will be sold in the UK by Teva in cooperation with Aventis, has been authorized for sale in 19 countries, including the US, Israel, Canada, Australia, and Switzerland and is currently used by 30,000 people. In the US, Teva has been selling Copaxone since the second quarter of 1997 and the American market accounts for close to 85% of total sales.
Teva has also been testing an oral version of the injected Copaxone, which if successful should be launched by 2002.
The FDA's final approval for hypertension drug Nifedipine was given to the Biovail Corporation. Teva has a cooperation agreement giving it the exclusive sales right to all of Biovail's generic slow release products.
Nifedipine is the generic version of Adalat CC, produced by Bayer, and used in treating high blood pressure. Last year sales of the 60 mg dosage reached $200 million, while overall sales of all three available dosages were $419m.
Seusskind said that Teva was considering further cooperation agreements similar to its Biovail arrangement as it gave Teva access to products that it could not develop in-house. However, Teva was also examining acquisition opportunities, although there was nothing definite in the pipeline to date. He said that in light of Teva's acquisitions in the US, Europe was a more likely prospect for further purchases.
Teva is traded on the Tel Aviv Stock Exchange (TASE) and on Nasdaq. Over 80% of its sales are outside Israel, mainly in North America and Europe.