Eli Lilly & Co. : Lilly to Discontinue Late-Stage Tabalumab Program on Lack of Efficacy
02/07/2013| 08:48am US/Eastern
By Saabira Chaudhuri
Eli Lilly & Co. (LLY) said it will discontinue the Phase 3 program for its rheumatoid arthritis drug, tabalumab, citing a lack of efficacy.
The announcement comes less than two months after the drug company said it would stop one of three late-stage registration studies of tabalumab due to insufficient efficacy. At the time, Lilly said it was continuing to evaluate tabalumab in two other Phase 3 rheumatoid-arthritis registration studies as well as an open-label extension study and several smaller studies.
Lilly on Thursday said it has decided to discontinue the development of tabalumab in its current rheumatoid-arthritis program based on the outcomes of two separate interim-futility analyses. All ongoing Phase 2 and Phase 3 rheumatoid-arthritis studies will be stopped.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Dr. Eiry Roberts, vice president of autoimmune product development at Lilly.
The decision is expected to result in a first-quarter charge to research-and-development expenses of about $50 million.
The Indianapolis company is experiencing one of the steepest "patent cliffs" in the drug industry, grappling with recent and looming generic competition for top-selling drugs as a result of patent expirations. The company lost exclusivity for its former No. 1 product, Zyprexa, in October 2011, and it will lose U.S. patent protection for the blockbuster antidepressant Cymbalta this December.
Lilly is trying to replenish revenue lost to generic competition for the older drugs by bringing new products to market and by increasing sales of drugs that remain patent-protected.
Last month, Lilly said its fourth-quarter earnings slipped 3.6% as the drug maker recorded weaker revenue as sales of Zyprexa slid.
Shares of Lilly, which backed its view for the year, edged down 18 cents to $53.75 in recent premarket trading. The stock has risen 37% in the past 12 months.
Write to Saabira Chaudhuri at firstname.lastname@example.org
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