Biogen Relies on Old Drugs and Risky Alzheimer’s Treatment, Former Employees Say

As Biogen turns 40 years old, some biotech insiders and analysts seem to be concerned that the Boston-based pharmaceutical company has too many eggs in one developmental basket.

As Biogen turns 40 years old, some biotech insiders and analysts seem to be concerned that the Boston-based pharmaceutical company has too many eggs in one developmental basket. The company’s future fortune, they opine, may hinge just a bit too much on its experimental Alzheimer’s drug, aducanumab.

In a Stat New report, former Biogen employees and other industry officials expressed some concern with the company’s business strategy. There is a concern the company is “pressing forward with a cupboard of aging drugs” and no real strategic plan in place to ensure the company coffers remain filled. The company built its fortunes on the back of the multiple sclerosis drug Tecfidera. In its most recent quarterly report Tecfidera, which now has generic challengers, was the primary revenue driver. The MS drug generated $987 million but failed to match the previous quarter’s sales of $1 billion. Analysts had expected Tecfidera to at least match the most recent quarter.

Some of the analysts and former Biogen employees Stat spoke with claim the company is too reliant on its MS franchise, which also includes the drugs Avonex and Plegridy. The MS business has become stagnant, those employees said, and is being propped up by “politically risky price increases,” Stat reported.

Investors are looking for new drivers, such as Spinraza, a treatment for spinal muscular atrophy (SMA), was a key revenue source during the most recent quarter. The SMA treatment, which is the first of its kind approved in the United States, generated $364 in global revenues. Stat News noted that Spinraza, which was co-developed by Ionis Pharmaceuticals, treats about half of the SMA patients in the United States. Despite its potential, the concerned analysts do not see the unique treatment as a replacement for Tecifedra.

Biogen and Ionis hope to strike gold again as the two companies recently expanded their collaborative partnership. The companies tied up a $1 billion 10-year developmental partnership to develop novel antisense drug candidates for a broad range of neurological diseases. The two companies are hoping to build on the success of their co-development of Spinraza. Biogen and Ionis have a goal of diving seven drug candidates into the clinic within the next two years.

But until such collaborations and programs yield fruit, the concern for a new key revenue source falls on aducanumab. This year the company anticipates enrollment of a Phase III study for its most-watched drug candidate, aducanumab – a potential treatment for Alzheimer’s disease. During a call with investors and analysts last month, Biogen’s head of R&D Michael Ehlers said the company was well-aware of the risks in Alzheimer’s treatment, particularly the recent failure of Merck’s Phase III BACE inhibitor verubecestat. That trial was halted in February following an interim data analysis. So far Biogen has seemed confident in the success of aducanumab, even shoring up its potential profit potential in a royalty-rate reduction payment made last year, as well as another $50 million made on May 1 to Neurimmune Holding AG, the company from which Biogen licensed the drug.

While Biogen appears confident in the future of aducanumab, others are far more nervous. That’s because most potential Alzheimer’s disease therapies never successfully make it through Phase III testing. Stat noted that Wall Street analysts give the Alzheimer’s treatment a 50-50 chance of working.

While the analysts are fretting though, Biogen is continuing its business strategy, which includes an expansion in North Carolina. The company is expanding its presence in Research Triangle Park and will hire an additional 150 employees, The News & Observer reported this morning. The expansion in RTP is part of Biogen’s commitment to the development of novel antisense drug candidates. Over the past year Biogen has invested more than $25 million into an expansion of its RTP site in order to facilitate the advancement of its research, the N&O reported.

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