One of Eli Lilly's biggest success stories has been Zyprexa, a blockbuster schizophrenia drug it developed and sold for billions of dollars a year. But over the years Lilly has also been forced to pay out huge settlements to cover claims that it hid data on a nasty side effect: massive weight gain. And now that the developer is staring at the loss of patent protection for Zyprexa this year, it's ramped up a major Phase III program for a next-gen schizophrenia drug that promises to treat the ailment without triggering the weight gain.
As the Wall Street Journal explains in an in-depth feature, Lilly is aiming to wrap Phase III studies for LY2140023 in 2013, giving it a shot at a 2014 approval and a chance to plug a huge gap in its earnings with another blockbuster performer. For Lilly, which has been plagued by a string of late-stage setbacks over the past year as CEO John Lechleiter adamantly refuses to consider a mega-M&A deal, it's also a chance to redeem its reputation as a drug developer capable of delivering major new products.
The treatment works differently than currently used therapeutics. Rather than block the effects of dopamine, the new treatment stimulates metabotropic glutamate receptors, or mGlu. Back in 2007 Lilly produced mid-stage data indicating that the treatment worked as hoped for without the weight gain. But Lilly also had to discount 2009 data that failed to demonstrate the drug's superiority over a placebo, faulting the study design. While Lilly is clearly hoping for a blockbuster outcome from Phase III, the company is also out to see if a particular genetic profile would flag patients who are particularly likely to respond positively.
"Intriguing preliminary data suggest it could be possible to identify a subpopulation of patients which responds better," Lilly R&D chief Jan Lundberg tells the Journal.
- here's the article from the Wall Street Journal