Around the same time Eli Lilly ($LLY) and Boehringer Ingelheim were boasting of a slate of Phase III successes for their critical diabetes therapy empagliflozin, the two pharma giants put out the word that they were parting ways on another key partnership for a diabetes drug that also figured prominently in their big R&D pact. From now on, says Eli Lilly, they'll go it alone on LY2605541 after Boehringer decided to bow out.
The basal insulin analog has been touted as a potential long-acting rival to Sanofi's ($SNY) Lantus, a $5 billion mega-blockbuster that's been earning the kind of money that Lilly badly needs to replace a trio of its own blockbusters being lost to the patent cliff. And Lilly's release makes clear that even though its big partner has bowed out, it's barreling ahead with an ambitious late-stage program on its own. Success in Phase III would put it on track for a possible regulatory submission in 2014.
"We're encouraged by the pre-clinical, Phase I and II data we've seen for our novel basal insulin analog," said Gwen Krivi, Ph.D, vice president, diabetes product development, Lilly Diabetes. "We look forward to sharing the Phase III data results of our novel basal insulin therapy with the medical community as early as 2014."
Eli Lilly has a lot on the line this year. With two more big drugs losing patent protection, Cymbalta and Humalog, its late-stage diabetes effort represents one of its best shots on goal for achieving badly needed approvals. After a series of late-stage failures, including the Phase III flop for solanezumab, as well as the obliteration of its Zyprexa franchise, any misstep this year could scuttle its game plan to advance big new treatments to approval. And company executives will be expected to start performing on its longstanding promise to deliver two new drug approvals a year--beginning in 2013.
Lilly and Boehringer are at work on another basal insulin analog dubbed LY2963016. And Lilly is also hopeful about its once-weekly GLP-1 analog called dulaglutide, which is particularly important in the wake of its big split with Amylin. With 13 drugs in late-stage development, including a few with a troubled past, the stars will have to align nicely for Lilly this year if it wants to maintain credibility with investors.
- here's the press release
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