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Lilly plans 10 drugs in final-stage trials by year's end

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Eli Lilly and Co., the drugmaker slated to lose U.S. patent protection on its biggest-selling medicine Zyprexa in October, said it would have at least 10 new therapies in final-stage studies by year’s end.

Lilly has 33 drugs in the second and third stages of clinical trials, including medicines for cancer, diabetes and Alzheimer’s disease, up from seven in 2005, the Indianapolis-based company said Thursday in a statement. The company confirmed its forecast of at least $20 billion in annual revenue and $3 billion in annual net income from 2011 to 2014. Lilly’s 2010 net income was $5.07 billion with revenue of $23.1 billion.

Patent expirations on Zyprexa and other drugs are estimated to reduce annual sales “roughly $7 billion” from 2010 to 2014, Lilly said in a statement released before its investor meeting in New York. New products will help growth return after 2014, the company said. Zyprexa had $5.03 billion in sales last year.

“Lilly has moved quickly to transform and re-energize our innovation engine, deliver a wave of potential new medicines, bridge our patent expiration period and ignite a new period of growth,” CEO John C. Lechleiter said in the statement.

Growth in the emerging markets, Japan, and in the company’s Elanco animal-health unit may generate more than $4 billion of additional revenue by 2015, the company said. Earnings per share are expected to decline from 2011 to 2012, grow in 2013, and decline again in 2014.

“Expectations are pretty low,” Les Funtleyder, a portfolio manager with Miller Tabak & Co., said in a telephone interview. “The street is about as negative as you are going to get for a pharma company.”

Growth-oriented investors “have a hard time reconciling” Lilly’s strategy of shrinking first and growing later, he said. “I am looking for an articulation of their strategy.”

Lilly faces generic competition in 2013 for the antidepressant Cymbalta, the company’s second-biggest seller at $3.46 billion in 2010, and in 2014 to its $1 billion osteoporosis drug, Evista.

U.S. drugmakers face patent losses this year to products with $34 billion in yearly sales. Sales at risk from generic rivals will increase to $147 billion by 2015, according to Bloomberg data.

In the statement, Lilly said it had fully enrolled patients in two final-stage trials of solanezumab, the company’s experimental Alzheimer’s drug. The company expects to complete the studies in the first half of 2012.

Three phases of clinical trials are generally required for U.S. regulatory approval of new drugs.

 

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