Lilly’s losses put pressure on key Alzheimer’s program

Posted under Blog, Companies, Diabetes, Diagnostics, Eli Lilly, Funding, John Lechleiter, Medical Devices, Medical Supply, Pharmaceuticals, solanezumab, Startups, Universities, Videos, Zyprexa by Ryan McBride

Eli Lilly ($LLY) saw its fourth-quarter profit slide 27% after the loss of its patent on Zyprexa last year hit sales of the schizophrenia drug harder than expected, Bloomberg reported. And the fresh setback could raise the stakes on CEO John Lechleiter's big bet on Lilly's internal R&D programs.

Swearing off megamergers like the Pfizer/Wyeth and Merck/Schering-Plough deals, Lechleiter needs some major successes in the drugmaker's late-stage pipeline to stay out of hot water with investors. Analysts have panned Lechleiter's gamble on the company's internal pipeline as too risky, and we'll see whether the criticisms are justified as Lilly reveals data on its most highly prized programs in cancer, diabetes and Alzheimer's disease.

Solanezumab, for instance, is perhaps the crown jewel of Lilly's pipeline. Phase III data for the Alzheimer's drug are expected in the third quarter, providing some indication of whether the antibody can slow the progression of the memory-stealing disease and live up to its blockbuster potential. Analysts at Cowen have estimated that sales of the drug could hit $1.5 billion in four years if the program succeeds.

Lilly had a modest victory this week with the FDA approval of its linagliptin-metformin combo pill for diabetes, a program partnered with Boehringer Ingelheim.

Lechleiter has been upbeat on the use of external collaborators to complement the work of his internal R&D group. Yet any major meltdown in the company's internal pipeline--such as if solanezumab bombs--could force Lilly to cave in and do a merger deal that is larger than Lechleiter would like.

- here's the Bloomberg report

Special Report: Solanezumab - 15 top blockbuster contenders

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Bleak forecast puts Eli Lilly’s ambitious R&D game plan to the test

Posted under Big Pharma, Blog, Companies, Diagnostics, Eli Lilly, Funding, John Lechleiter, Medical Devices, Medical Supply, Pharmaceuticals, solanezumab, Startups, Universities, Videos, Zyprexa by John Carroll

Eli Lilly ($LLY) stepped right up to the edge of the patent cliff this morning, looked down and predicted a $3 billion drop in Zyprexa sales as cheaper generics muscle into the market. The bleak news--which you can read more about in FiercePharma--immediately  took a painful bite out of the Big Pharma's share price as Lilly CEO John Lechleiter failed to gain much excitement by touting 12 late-stage therapeutics in the pipeline, besting its goal of 10 for the end of 2011. But there's little doubt that with billions of dollars of revenue to replace, Lechleiter's unbending reliance on internal R&D efforts will be put to the test throughout this year.

As Big Pharma rivals went after some of the biggest trophies on the life sciences preserve in recent years, Lechleiter has consistently ignored pressure to jump into the M&A game, vowing that the company's big R&D budget is being well spent in pursuit of ambitious new drug programs. And the R&D team was positioned front and center this morning as Lechleiter pressed his case for better days ahead.

"First and foremost, we are replenishing and advancing our pipeline," the CEO said in a statement. "We've successfully rebuilt our mid- to late-stage pipeline to position Lilly for growth post-2014, with 12 assets now in Phase III, exceeding our goal of 10 by the end of 2011. We continue to revamp our discovery efforts to ensure a more sustainable flow of innovation for the long-term."

Certainly one of the biggest tests for R&D will come when Lilly announces Phase III results for solanezumab, its experimental therapy for Alzheimer's, in the third quarter of this year. Lilly has already experienced severe setbacks in the Alzheimer's field and any more slips in late-stage testing can only add to the considerable market pressure Lilly is under.

- here's the press release on Eli Lilly's forecast

Special Reports: Solanezumab - 15 top blockbuster contenders |  Eli Lilly - 10 Largest U.S. Patent Losses

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Posted under Alzheimer's, Blog, Companies, Cymbalta, Diagnostics, Eli Lilly, Funding, John Lechleiter, Medical Devices, Medical Supply, Pharmaceuticals, solanezumab, Startups, Type 2 Diabetes, Universities, Videos, Zyprexa by Ryan McBride

John Lechleiter hasn't followed his peers into the mega-merger fray, believing that Eli Lilly ($LLY) can survive the loss of patents on key drugs with its internal R&D programs and via partnerships with other companies. Many industry watchers disagree with the gambit, but those critics have failed to alter the course of Lilly's CEO, who took the hot seat in an interview with Xconomy's Luke Timmerman and explained why he thinks better days are ahead for the Indianapolis-based drugmaker.

Lilly has a lot riding on its pipeline, and Lechleiter made note of some of the late-stage compounds in development such as solanezumab for Alzheimer's disease and dulaglutide for type 2 diabetes. The company has 10 compounds in late-stage trials, but it still faces some tough years ahead with the loss of patents on blockbuster drugs such as Zyprexa and Cymbalta. Xconomy reported that 5 of Lilly's drugs that will lose patent protection accounted for more than half of the company's 2010 revenue.

Lechleiter seemed optimistic about the company's R&D future. While avoiding the big buyouts like Pfizer's acquisition of Wyeth and Roche's purchase of Genentech, the CEO noted during the interview that partnerships with external groups are key to boosting productivity in R&D. He also expects the increase in knowledge of biology and improved research tools such as computational systems and imaging technologies to pave the way to new treatments.

"My own personal belief is that we are in a new era of higher research productivity," Lechleiter told Xconomy. "And that will be reflected in medicines that come out of our pipeline and other people's pipelines."

When Xconomy relayed one biotech commentator's desire for Lechleiter to call it quits, the CEO said: "I have no plans to resign. You can quote me on that."

- read parts one and two of the Xconomy interview

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