CHMP recommendation adds to Teva's financial turmoil

Teva Pharmaceutical Industries ($TEVA), which is facing serious financial head winds as generic competition will soon eat away sales of its workhorse multiple sclerosis drug Copaxone, was blown further off course today. Regulators in Europe refused to give a favorable review to laquinimod, a potential successor treatment to Copaxone, which faces generic competition in May.

The EMA today said it was concerned about elevated risk of cancers as well as a possible risk to unborn babies from the use of laquinimod, Bloomberg reported. The drug has had trouble before. In 2011, Teva decided not to seek U.S. approval for the candidate, given disappointing trial results at the time. In a statement today, the drugmaker said it remained committed to the drug and would ask the EMA to reexamine its position.

But it is another setback for the drugmaker, which is in the midst of trying to cut $2.5 billion in costs--and 5,000 jobs--from its expense sheet. The turmoil caused by that effort last year cost CEO Jeremy Levin his job. On Jan. 9, the company named board member Erez Vigodman to the CEO spot. Teva has acknowledged that it can expect at least a $550 million hit from Copaxone generics this year. U.S.-based generics maker Mylan ($MYL) has said its copy of Copaxone can be available for sale when Copaxone's patent rolls off.

Earlier this week the Israel-based drugmaker appealed to the U.S. Supreme Court, asking it to review the lower court decision to invalidate key patents on Copaxone, which shaved an unexpected 18 months off the drug's exclusivity. The court last fall refused to stay a Federal Circuit Court ruling that would allow generic rivals onto the market May 18. The latest legal maneuver is unlikely to offer much help, even if successful, since a decision could not come until months after generics of Copaxone come to market, giving buyers plenty of time to stock up.

Meanwhile, the predominantly generic drugmaker is looking for new products to fill in its pipeline. It just agreed to buy NuPathe and its migraine treatment patch Zecuity for up to $220 million. Earlier this month, Teva executives also tried to raise hopes by saying they expected a quick approval for the next-generation form of Copaxone, a long-acting dosage. They have said they expect 45% of Copaxone patients to convert to the new formula.

- here's the CHMP statement (PDF)
- and Teva's statement
- get more from Bloomberg

Special Reports: Top 10 Drug Patent Losses of 2014 - Copaxone | Top 10 Generics Makers by 2012 Revenue - Teva - Mylan

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