(Reuters) - Biogen Inc said on Thursday it was preparing for the launch of its experimental treatment for Alzheimer’s as the drugmaker races to become the first to bring a treatment for the memory-robbing disease to market.
The company said it would submit its application for U.S. approval of aducanumab “as soon as possible”, but did not specify a time.
In a stunning reversal, Biogen in October revived plans to seek approval for the treatment based on a detailed analysis of data, months after scrapping the development of the drug.
“We are actively preparing for the potential launch of aducanumab with an initial focus on the United States,” Chief Executive Officer Michel Vounatsos said on a conference call.
Any company with a successful treatment for Alzheimer’s, which affects about 5.7 million Americans over the age of 65, is likely to rake in billions of dollars in sales, given the numerous failures to develop a drug.
In the past months, Biogen has had a “high level of constructive engagement” with the Food and Drug Administration, Alfred Sandrock, executive vice president of research and development said. “It’s basically a matter of putting together documentation.”
To partly account for costs related to the potential launch, Biogen expects to spend about 19.5% to 20.5% of total revenue in 2020, higher than the 18% it spent in 2019. The company said it was ramping up its sales force to market the drug.
Jefferies analyst Michael Yee said while the company remains optimistic, investors will closely watch for the opinion of a panel of independent experts to assess the drug that the FDA usually convenes.
Aducanumab belongs to a class of drugs that have seen multiple trial failures and its approval remains doubtful as some experts have called for an additional trial to demonstrate its clinical benefits.
Biogen’s growth has been driven by its multiple sclerosis drugs, which grew in the fourth quarter, helping it beat profit expectations.
Tecfidera brought sales of $1.16 billion, beating estimates of $1.12 billion, despite the threat of patent challenges and increasing competition.
Biogen expects 2020 full-year adjusted earnings per share of between $31.50 and $33.50 and sales of about $14 billion to $14.3 billion.
Analysts expect 2020 profit to be $33.03 per share and sales of $14.06 billion, according to Refinitiv data.
Excluding items, Biogen earned $8.34 per share, above estimates of $8.02 per share, in the quarter. Revenue rose 4% to $3.67 billion, beating estimates of $3.54 billion.
(This story corrects Alzheimer’s age detail in fifth paragraph)
Reporting by Trisha Roy and Tamara Mathias in Bengaluru; Editing by Arun Koyyur