Today's news that Eli Lilly (NYSE: LLY ) won't submit Alzheimer's drug candidate solanezumab for FDA approval without running an additional clinical trial sent shares down 3%. This came after discussions with the FDA, which presumably wanted to see an additional study confirm Eli Lilly's assertion that the drug helps those with mild cases of the disease.
If Eli Lilly gets the study up and running in mid-2013, investors would likely be looking at 2015 before getting results.Considering the terrible track record of this therapeutic class, Johnson & Johnson (NYSE: JNJ ) , Pfizer (NYSE: PFE ) , and Elan (NYSE: ELN ) all had a stake in bapineuzumab, which was discontinued after failing two late-stage trials, investors have to question whether Eli Lilly is doing them a disservice by pouring resources into a drug that also failed both its phase 3 trials because of the market potential for success.
In order to help you answer this question, our senior biotech analyst has composed a brand-new premium research report that explains Eli Lilly's market opportunity, risks, and reasons to both buy and sell today. The following excerpt from the report takes an in-depth look at a key risk for this drugmaker that seems particularly relevant given today's news.
The lure of the mega blockbuster
Swinging for the fences is fine every once in a while, but I wonder if Eli Lilly has had so many blockbusters over the years -- Zyprexa, Gemzar, Humalog, Cymbalta, Cialis, Alimta -- that it's almost as if it doesn't know how to go after the low-hanging fruit.
And that's a little scary. Sometimes four singles is just as good as a home run.
Take Alzheimer's disease drug solanezumab as an example. The market for a successful Alzheimer's disease drug is in the billions -- emphasis on the "s" at the end. Even the current offerings that hardly do anything have been able to reach the blockbuster status.
Solanezumab failed its phase 3 trials. Both of them. And yet, probably because of the huge potential of an Alzheimer's disease drug, Eli Lilly is clinging to a small finding in a subset analysis that the drug might be helping patients earlier in their disease progression. I'm skeptical that it's worth pursuing further.
Striking out occasionally is OK, but investors need to make sure Eli Lilly isn't making a habit of it.
Know your stock
I hope you enjoyed this preview from the Risks section of our brand-new report on Eli Lilly.
Over the next two years, Eli Lilly will see nearly $0.40 of every $1.00 in sales exposed to generic competition. How does the company plan to respond to this huge patent cliff? Better yet, what does this mean for investors? In a bra-new premium report on Eli Lilly, The Motley Fool's top pharmaceuticals analyst delves into everything investors need to know about the stock today. Simply click here now to claim your copy.