Teva talks healthcare reform, Copaxone

Teva Pharmaceutical Industries (NASDAQ: TEVA) President and CEO Shlomo Yanai told attendees at the Bank of America Merrill Lynch Health Care Conference Thursday that he sees U.S. healthcare reform as a positive thing for his company.

"At the end of the day, we're going to see 31 million more potential customers" who will use the company's products, Yanai told the conference. Although there will be price pressure, Teva is in a constant effort to reduce costs. And he sees volume as outpacing the price consequences.

Yanai also discussed Europe, telling the audience that the region's aging, wealthy population has a desire for high-level care, despite recent economic troubles. He sees the region as a great place to do business.

Teva USA head Bill Marth also was in attendance and addressed the FDA's rejection of the company's second citizen petition for its multiple sclerosis drug Copaxone. He said the agency's action wasn't unexpected, and that the issue isn't ripe at this time since the FDA isn't close to approving an ANDA for the product. Marth said the company plans to have an ongoing dialogue with the FDA on the issue.

Last November, the company asked the FDA not to approve any ANDA for Copaxone until the product is fully characterized. It further maintained it isn't possible for a generic applicant to show that its product has the "same active ingredient" as the drug "because neither Copaxone nor any significant subset of its polypeptides has been fully characterized, and because it is unknown which of Copaxone's potentially millions of protein-like polypeptides are clinically active and responsible for its therapeutic effects in reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis," according to the FDA's response, available at regulations.gov.

Momenta Pharmaceuticals and Mylan both have filed to make generic verison of the blockbuster drug, and Teva has sued both companies. That triggered an automatic 30-month stay on FDA approval, meaning no generic version of Copaxone can enter the U.S. market until early 2011, as the Wall Street Journal notes.

- see the report from the Wall Street Journal (sub. req.)

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