Saturday 21 April 2018

Pfizer, J&J scrap Alzheimer's drugs plan

New York, August 7, 2012


Pfizer and Johnson & Johnson scrapped further studies of one of the most anticipated experimental drugs for Alzheimer's disease after it failed to help patients with the memory-robbing condition in a second high-profile clinical trial.
The companies said they would discontinue all other studies of the drug bapineuzumab in its intravenous (IV) form, including two more late stage trials and follow-up extension studies, in patients with mild to moderate Alzheimer's.
The result marked the second such late-stage failure announced in recent weeks and was especially disappointing as bapineuzumab had been given a better chance of success in the patients studied in the second trial.
If successful, bapineuzumab would have been the first drug to fight the progression of the debilitating brain disease.
Attention will now turn to solanezumab, a similar drug being developed by Eli Lilly & Co that is also considered a long-shot to succeed, but will still carry fading hopes at least until late-stage test results are released later this year.
Shares in Pfizer, J&J and Lilly all fell in after-hours trading following news of the latest disappointment. Stock in Pfizer and J&J's partner Elan Corp Plc also dropped more than 10 percent in early trade in Dublin on Tuesday.
Any successful Alzheimer's treatment is likely to reap many billions of dollars in sales and industry analysts said many investors were holding shares in the companies as an insurance policy in case the drugs were to succeed.
J&J said it would take a charge of $300 million to $400 million in the third quarter related to discontinuation of the bapineuzumab Phase III clinical trial program, while Elan will take a writedown of $117.3 million.
Bapineuzumab failed to improve cognitive or functional performance compared with placebo in patients who did not carry a variation of a gene called ApoE4, according to initial results of the Phase III study released late on Monday.
Pfizer on July 23 announced the failure in the first of four high-stakes trials, in patients with the ApoE4 gene variation. That trial was considered more of a long-shot based on poor results in earlier trials, but hopes were high that the data would prove more encouraging in ApoE4 non-carriers.
"We are obviously very disappointed in the outcomes of this trial. We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer's disease and their caregivers," Steven Romano, head of Pfizer's Medicines Development Group, said in a statement. - Reuters

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