There is bad news out of ASCO for Eli Lilly's ($LLY) Alimta, its blockbuster lung cancer drug that is already under a patent assault by Teva Pharmaceutical Industries ($TEVA).
Lilly today announced that the drug did not hit its primary endpoints of showing improved progression-free survival without grade four adverse events in a comparison study. The trial compared Alimta (pemetrexed), carboplatin doublet regimen to a paclitaxel, carboplatin and bevacizumab triplet regimen. Dr. Richard Gaynor, vice president of product development and medical affairs for Lilly Oncology, said the results add to Lilly's knowledge, and the drug's history "encourages us to explore new avenues to determine if we can improve patient outcomes."
Alimta produces about $3.5 billion a year in badly needed revenue for Lilly. The Indianapolis-based company is fighting Teva over the patent, which expires in 2016. Lilly additionally is trying to throw up a hurdle with its method-of-use patent, which covers the use of folic acid and vitamin B-12 for patients taking Alimta. Its approved label tells doctors to give patients the nutrients ahead of and during treatment with the drug. If that separate patent stands up to legal challenges and generics makers cannot include the prescription of those on their own labels, then Lilly may get 5 more years of protection on the drug. The case is slated to go to trial this summer. Teva is expected to argue that giving folic acid and vitamin B-12 as part of the treatment is so obvious that there is no reason that it should be patent-protected.
Many patent lawyers think the chances are small for Lilly winning the method-of-use argument. But if Lilly were to prevail, it would get much-needed breathing room as it works to recover from other patent losses. Lilly lost exclusivity in 2011 on the antipsychotic Zyprexa, at one time a $4.5-billion-a-year seller. It will lose protection late this year on the blockbuster antidepressant Cymbalta, which generates $5 billion a year. Next year, Evista, its drug for treating osteoporosis in postmenopausal women, also a blockbuster, loses to generics.
- here's Lilly's release
Special Report: Cymbalta - Top 15 drug patent losses for 2013