(Reuters) - Biogen Inc BIIB.O on Wednesday delayed the filing for marketing approval of its experimental Alzheimer's disease drug, saying that it needed more time to prepare the data before submission.
Shares of the company fell 11% in morning trading after the company said it would now file the application in the third quarter instead of the early part of the year.
“We don’t want to rush (the filing) and then face challenges,” Chief Executive Officer Michel Vounatsos said.
“Quality is important and we have to keep in mind that there is an unprecedented dataset, plus COVID-19.”
The company had scrapped two clinical trials of the drug last year after studies showed the treatment had a low chance of success.
It later reversed its decision after analysis of the same data showed some patients benefited from taking higher doses over an extended period of time
The company said it had started submitting “modules” of the filing to the U.S. Food and Drug Administration (FDA) and expects to complete the process in the third quarter.
On a call with analysts, executives also said they were preparing for a meeting with the FDA in the summer.
“We note that this change in timelines does not appear good, especially when many investors do not believe in the Alzheimer’s story in the first place,” said Citi analyst Mohit Bansal.
The company also had to deal with the coronavirus outbreak after several of its employees were infected by the virus following a company meeting in Boston in February.
All infected employees had recovered or were recovering, the company said.
“Some members of the team did get COVID. And I can tell you, it’s hard to work when you have COVID,” Biogen’s head of R&D, Alfred Sandrock, said.
Also on Wednesday, Biogen posted a bigger-than-expected first-quarter profit on higher demand for its spinal muscular atrophy drug, Spinraza, as well as its multiple sclerosis treatment, Tecfidera.
The company was seeing some impact to demand for Spinraza outside the United States due to the COVID-19 pandemic, it said.
Biogen’s results show that the COVID-19 pandemic could temporarily pressure sales of drugs, including Spinraza, administered by a healthcare provider, said Michael Levesque, a senior vice president at Moody’s.
Excluding items, Biogen earned $9.14 per share, beating analysts’ estimates of $7.73 per share, according to IBES data from Refinitiv.
Total revenue rose to $3.53 billion from $3.49 billion.
Reporting by Trisha Roy and Manas Mishra in Bengaluru; Editing by Anil D’Silva
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