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Eli Lilly & Co. : Lilly to Discontinue Late-Stage Tabalumab RA Program on Lack of Efficacy

02/07/2013 | 01:59pm US/Eastern

--Lilly to discontinue rheumatoid arthritis Phase 3 program for tabalumab

--Company will take a first-quarter charge of about $50 million

--Tabalumab continues to be in Phase 3 development for systemic lupus, and in Phase 2 development for multiple myeloma.

(Updates with additional details, share movement)

   By Saabira Chaudhuri 

Eli Lilly & Co. (LLY) said it will discontinue the rheumatoid arthritis Phase 3 program for its 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.

A spokesperson for the company noted Tabalumab is still in Phase 3 development for systemic lupus, and in Phase 2 development for multiple myeloma.

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 41 cents to $53.52 in recent trading. The stock has risen 36% in the past 12 months.

Write to Saabira Chaudhuri at saabira.chaudhuri@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

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