Teva Says Doctors Contacted on Trial of Generic Copaxone Drug
Doctors are being contacted to organize a clinical trial for a copy of Teva Pharmaceutical Industries Ltd. (TEVA)’s multiple sclerosis medicine Copaxone, a Teva executive said.
The prospect of patient studies may mean a generic version of Teva’s biggest-selling product is delayed by two years, said Natali Gotlieb, a Tel Aviv-based analyst for Israel Brokerage & Investments. The Israeli drugmaker has sued to block copies from Swiss drugmaker Novartis AG (NOVN) and partner Momenta Pharmaceuticals Inc. (MNTA) and from U.S. generic-drug maker Mylan Inc.
Teva has heard “noise” about the trial and hasn’t seen actual patient recruitment begin, Jon Congleton, general manager of the Petah Tikva, Israel-based company’s U.S. neuroscience unit, said during a teleconference yesterday with investors organized by the investment bank Cowen & Co., according to a transcript.
“That’s correct,” Congleton said in response to a question about whether Teva was aware doctors were being contacted about a study of generic Copaxone, according to the transcript. Teva doesn’t know which drugmaker may be organizing the trial, he said.
Copaxone had sales of $3.3 billion last year. Teva has said the 14-year-old injected treatment is too complicated to copy without patient trials to prove a generic version is as effective as the original.
‘Best News’[WRONG for Teva!!]
“It would be great news for Teva, the best news,” if a clinical trial were needed, said Gotlieb. “It will take them longer to achieve approval and would be expensive because it costs a lot to run clinical trials.”
A trial may delay U.S. approval of a Copaxone generic for two years, including six months to a year to conduct the trial and a year to review the results and submit data to the Food and Drug Administration, Gotlieb said. She recommends buying Teva’s shares.
Yossi Koren, a spokesman for Teva, declined to comment further today. Eric Althoff of Novartis in Basel, Switzerland, didn’t immediately return a phone call and e-mail requesting comment.
Mylan’s press office in Canonsburg, Pennsylvania, didn’t immediately return a voicemail requesting comment before business hours. Spokespeople for Momenta in Cambridge, Massachusetts, didn’t immediately return an e-mail requesting comment before business hours.
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