Teva Pharmaceutical Industries ($TEVA) hasn't had much good news to share lately. It has lost its CEO. Its foundational drug product has a patent loss looming, and it is whacking plants and people as it tries to reduce costs by $2 billion. Today, it had a little something to crow about: The FDA has granted orphan status to its cancer-fighting drug, Treanda.
The Israel-based company said today the orphan drug designation gives Treanda exclusivity through October 2015. Pair that with the 6 months of pediatric exclusivity, and the protection will run to April 2016. The orphan tag applies to use of Treanda for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within 6 months of treatment with rituximab or a regimen containing rituximab. Orphan status is granted to therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the U.S.
Teva picked up the drug in 2011 in its $6.8 billion acquisition of Cephalon. The FDA approved it in 2008, first for for treating patients with chronic lymphocytic leukemia and 7 months later as secondary therapy for patients with the slow-growing form of non-Hodgkin lymphoma. Sales of the drug have grown from $131 million in 2011 to $531 million through the first 9 months of this year, the drugmaker said today.
It is good news, but extra sales of the orphan drug will not go very far toward offsetting the revenue hit it will take when its multiple sclerosis drug Copaxone goes off patent next year. It generated $3.9 billion worldwide last year, $2.9 billion of that in the U.S. But with a court ruling this year, Teva will lose exclusivity on the drug next year, about 18 months sooner than it expected. And according to numbers leaked this week, the company is anticipating a 42% hit to the drug's profits. The company has said the estimates are out of date but did not deny them.
Treanda is one of the products Teva picked up in the Cephalon deal in an effort to prepare for the patent loss of Copaxone. It also got narcolepsy treatments Nuvigil and Provigil. But Copaxone last year accounted for two-thirds of the company's specialty pharma sales and almost one-fifth of sales overall, making it a very hard act to follow.
And of course, the company has other issues to deal with, like finding a new CEO after Jeremy Levin's quick exit in October after a reported falling-out with the board of directors over his cost-cutting plans for the generics giant. The company has said it will continue with the proposed cuts, which affect about 5,800 employees.
- here's the release
Special Report: Top 10 Drug Patent Losses of 2014 - Copaxone | Top 10 Generics Makers by 2012 Revenue - Teva