Alimta

Company: Eli Lilly ($LLY)
2013 Global Sales: $2.7 billion
Indications: Lung cancer

Alimta was first approved to treat mesothelioma, a malignant disease associated with asbestos exposure but the approval for lung cancer in 2008 lifted the drug's sales substantially. It is now Eli Lilly's second-best-selling drug, behind antidepressant Cymbalta, which is seeing rapidly eroding sales after losing patent protection in December.

But patent protection is exactly what Lilly has been fighting for with Alimta, and in April, the company won a huge ruling in that regard, one worth billions more in revenue for the struggling company. A federal judge agreed that Lilly's patent covering Alimta's use in combination with two B vitamins is valid. Without those supplements, Alimta (pemetrexed) can cause potentially fatal side effects. Teva Pharmaceutical Industries ($TEVA) challenged the patent on the grounds that it was just common sense to add B vitamins to the Alimta regime. The judge swatted that argument down, saying the company's method of combining folic acid and B-12, and getting the doses just right, was not at all obvious and so left the patent in place until 2022. The drugmaker is fighting similar attacks on its method patents in the U.K. and Germany.

Lilly has also tried to get wider approvals for the drug, but its track record in that regard has not been very good. It failed in a late-stage trial for an anticipated use in head and neck cancer in 2010. Last year, it didn't meet the primary endpoints showing improved progression-free survival without grade four adverse events in a comparison study as a treatment for nonsquamous non-small cell lung cancer. -- Eric Palmer (email | Twitter)

For more:
Special Report: Top 20 orphan drugs by 2018 - Alimta
It's a big win for Eli Lilly in multibillion-dollar Alimta patent fight
Lilly blockbuster Alimta burned by more disappointing news
Lilly betting B12 can protect blockbuster Alimta from generics

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