Eli Lilly and Co. and Pfizer Inc., which are both suffering through some of the largest patent cliffs in the industry, will split any future costs and profits of an osteoarthritis drug that has stalled in clinical testing.
If approved, the drug would be a potent boost to Lilly’s product portfolio. It would also mean a critical new therapy for a cancer that’s proven difficult to treat.
Lilly has set up not one, not two, but five head-to-head trials of its experimental drug dulaglutide against other leading diabetes therapies. So far, dulaglutide’s record is four wins, no losses.
The trial of 2,100 patients, called Expedition III, will use new measures of cognitive function, such as the ability to do tasks like cooking or driving, or remembering words after a delay.
Lilly officials said they will push ahead with the first-of-a-kind imaging chemical, despite the mostly negative ruling by Medicare officials.
Lilly’s drug, if approved, may be a significant competitor to Novo Nordisk A/S’s Victoza, which generated $1.64 billion in 2012.
Eli Lilly and Co. is seeking to revoke a patent held by a Johnson & Johnson unit, arguing at a London court it might delay availability of a potential treatment for Alzheimer’s disease.
Endocyte Inc. saw its shares fall nearly 7 percent Tuesday morning after the drug development firm announced that its application for U.S. approval of a cancer drug could be delayed another 10 months.
With Eli Lilly and Co. set to see patents expire on its best-selling drug at year’s end, it is in the company’s interest to say its pipeline is about to produce new drugs. But the Indianapolis drugmaker may be in a position to submit five new drugs for regulatory approval this year.
Eli Lilly and Co. said it discontinued a last-stage trial of experimental rheumatoid arthritis drug tabalumab for lack of efficacy. Lilly is still evaluating the drug in the two other late-stage studies.
China takes eight years longer on average to approve drugs than other major countries, and U.S. drugmakers are looking at ways to help speed things up, Eli Lilly and Co. CEO John Lechleiter said.
Eli Lilly and Co. said dulaglutide lowered blood sugar better than three existing diabetes drugs in three Phase 3 clinical trials. Analysts expect the drug to hit the market in 2014 or 2015 and become a blockbuster.
Researchers are set to test drugs by Eli Lilly and other companies that may prevent Alzheimer’s disease after efforts to find a cure have been unsuccessful.