Dopo aver "sventato" i problemi con il farmaco Byetta:
Amylin shares recover slightly after Byetta deaths
Wall Street has been concerned about how the reported deaths might affect prescription growth, along with any impact from stricter warnings on Byetta's label.
"While good execution will be required, we believe that the (Wall) Street concerns are addressable," said Goldman Sachs analyst Meg Malloy in a note to investors.
In the coming months, she said, key milestones will include an actual label change, the potential for label expansion and updates on the FDA filing for a new, longer-lasting version of the drug.
San Diego-based Amylin and Indianapolis-based Eli Lilly have said the deaths cannot be directly connected to Byetta. They pointed out in a conference call late Tuesday that diabetes patients were already three times more likely to have pancreatitis, compared with the general population.
The companies also said that pancreatitis likely was not the primary cause of death in the newly reported cases.
Eli Lilly ha portato importanti progressi sul Prasugrel, nuovo prodotto che aspetta l'approval della FDA il 26 settembre:
Prasugrel better for diabetes patients than Plavix:
United States - - Eli Lilly (nyse: LLY - news - people ) and Daiichi Sankyo's new blood-thinning drug prasugrel appears better for diabetes patients than Plavix, researchers said on Sunday.
Prasugrel -- a rival to Plavix from Sanofi-Aventis (nyse: SNY - news - people ) and Bristol-Myers Squibb (nyse: BMY - news - people ) -- is a key product for Lilly and Daiichi. But its path to market has been delayed and the drug has been associated with serious bleeding.
That has left doctors debating how it might best be used, assuming it is approved by regulators.
Stephen Wiviott of the Brigham and Women's Hospital in Boston said a new analysis of results from the previously reported TRITON-TIMI 38 clinical trial showed the benefit of prasugrel tended to be greater in patients with diabetes than those without the condition.
Patients were 40 percent less likely to suffer a subsequent heart attack if they got prasugrel, with this occurring in 8.2 percent of people against 13.2 percent of those on Plavix, he told the annual meeting of the European Society of Cardiology.
In non-diabetics, there was a much smaller difference.
The findings suggest that a more powerful drug may be more effective in the growing group of diabetic patients who are at high risk of suffering a second heart attack.
The U.S. Food and Drug Administration is due to give its verdict on prasugrel by Sept. 26.
Industry analysts believe the agency's decision to delay a decision on whether to approve the product could be due in part to uncertainty over how to define precisely which patients should use it.
Plavix is one of the world's biggest ever drugs, with worldwide sales in 2007 of more than $8 billion and prasugrel is also seen as a potential blockbuster, as long as concerns about bleeding do not derail the medicine.
Potenzialmente il Prasugel è molto più importante di Byetta perchè va ad attaccare uno dei farmaci più venduti al mondo, il Plavix della Sanofi-Aventis.
Occhi aperti quindi, non penso proprio che il possibile approval della FDA per il nuovo prodotto sia prezzato nel titolo...