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Study Protocols Will be Amended in Two Small Early-Phase Prasugrel Studies

These amendments are strictly protocol-related and do not provide a basis for inferring overall outcomes of other prasugrel trials.–J Anthony Ware

Usually, a company studying an important new drug in a competitive market tries to keep progress of the program sort of, well, secret. Certainly, Lilly (NYSE:LLY) and Daiichi/Sankyo are doing what they can to keep the top-line efficacy and safety results from the Phase 3 prasugel study of nearly 14,000 patients a well-kept secret until unveiled at the AHA meeting in a couple of weeks. So, why this press release.–for two, small Phase 2 studies that Lilly says shouldn’t be interpreted as inferring anything about the “overall outcomes” of the prasugrel program?

This disclosure has but a single interpretation; Lilly and Daiichi/Sankyo are essentially saying that this dosage adjustment news is material to investors. There is no other reason for it that would make any sense.

In order for the news to be material to investors it must mean that there are implications for the larger program; suspension of two Phase 2 studies for a dosage adjustment amendment, considered in isolation, would never rise to the level of being material news that must be released to investors, especially not right before Phase 3 results are expected.

Granted, these implications apparently do not reflect the ”overall outcomes” of the program, but that doesn’t mean they aren’t very important to the program and to the eventual approval and sales of this highly anticipated drug. By making this announcement Lilly and Daiichi/Sankyo are admitting as much.

In analyzing the data and looking over the numerous studies and then considering all the patient populations, we decided it would be prudent to start considering the potential dosages, said Joedy Isert, a spokesman for Lilly. You want to make sure you provide the right dose to the right patient at the right time.
[from Bloomberg]

What a mess. I don’t know what Mr. Isert was trying to say, but what he said was not only a cliche without substance, it was also harmful to the company, making Lilly appear derelict in its dose-finding responsibilities. Not good; get better spokespeople.

Bottom line–If you’re a Lilly or Daiichi/Sankyo investor on the long side, you have good reason to be concerned.

Source: Eli Lilly: It’s That We Were Told That’s Telling