Dive Brief:
- After a year without a permanent head of research and development, Biogen said Thursday it is splitting the role between two executives, promoting interim R&D chief Priya Singhal to run development and undertaking a search for a new research leader.
- Singhal will formally take on the title of executive vice president, head of development, while maintaining the interim job in research for now. The new head of research will also be an executive vice president, and both executives will report directly to new CEO Christopher Viehbacher.
- A medical doctor with a master’s degree in international health, Singhal is in her second stint at Biogen, where she most recently served as head of global safety and regulatory sciences. She is also a veteran of Vertex Pharmaceuticals, Millennium Pharmaceuticals and the clinical-stage biotechnology company Zafgen.
Dive Insight:
Biogen is trying to steady the ship after a year of staff shakeups and controversy stemming from the failed launch of its once-hailed Alzheimer’s disease drug Aduhelm.
In June 2021, the Food and Drug Administration approved Aduhelm as the first drug meant to slow the progression of Alzheimer’s. But the action drew a firestorm of criticism; the agency’s own advisers had overwhelmingly voted against the drug, citing conflicting evidence of its effectiveness. A congressional report recently concluded the review process was “rife with irregularities.”
Meanwhile, doctors were hesitant to prescribe the pricey medication. Insurers decided not to cover it. Amid the struggles, one of the drug’s biggest defenders — Biogen’s R&D chief Alfred Sandrock — surprised investors by saying he would leave the company at the end of 2021.
In April 2022, Medicare finalized a policy that limited Aduhelm coverage only to patients in a clinical trial. The next month, Biogen essentially scrapped marketing for the drug in the U.S. and began searching for a new CEO to replace Michel Vounatsos. The company tapped former Sanofi CEO Viehbacher to take the helm in November.
Singhal, who took over as interim R&D chief after Sandrock’s departure, found herself defending both the company’s handling of Aduhelm and a drug pipeline that analysts view as high risk. Now, she and other executives are trying to point investors toward the future, with an essential decision due Friday from the FDA on another Alzheimer’s drug called lecanemab.
Biogen developed lecanemab with Eisai, which leads decision-making in the companies’ collaboration. Clinical testing has shown treatment slowed patients’ mental and physical decline, although the magnitude of that benefit has been debated by physicians.
Hopes for the drug helped propel a surge in Biogen’s stock price after top-line results were released in September. The shares, which had dipped below $188 apiece, traded around $269 early Thursday. After Aduhelm’s approval, the stock had surged above $400.