As if Biogen didn’t have enough to worry about, what with its February management meeting linked to a COVID-19 outbreak and outrage over an infected employee who traveled to China, the company is now facing a new coronavirus-related issue.
Biogen said some patients being treated with its spinal muscular atrophy (SMA) drug Spinraza have seen doses postponed by hospitals needing to prioritize COVID-19 patients. The therapy is used to treat adults and children with SMA, an inherited disease that's almost always fatal without treatment.
“We are working with health systems and institutions to help navigate these unprecedented times while also providing access to a critical therapy for people with SMA,” said Biogen in a statement emailed to FiercePharma.
Patient group Cure SMA isn’t concerned—at least not yet. It said in a COVID-19 web posting that delaying Spinraza treatment for a few weeks “should not have a huge impact” but that patients and caregivers should make sure they’re working with their providers to reschedule their doses. “We do not recommend viewing Spinraza doses as elective or non-urgent and dosing should not be delayed for a significant period of time,” Cure SMA said.
The news came shortly after Biogen posted a COVID-19 update on its website that listed several initiatives it's taking to address the outbreak. They include committing $10 million from the Biogen Foundation to support the global response and keeping its own manufacturing facilities up and running to lessen the risk that there will be supply shortfalls of its branded and biosimilar drugs, it said.
Biogen’s COVID-19 update included a business forecast, though it was notably short on details. “Given the fluidity of the current environment … we cannot rule out future impact to our business as a result of the ongoing COVID-19 pandemic, including impact on sales, manufacturing and clinical trials,” the company said in the statement.
The company warned that its ongoing clinical trials could see their timelines changed because of COVID-19. That’s no surprise. Last week, RBC Capital Markets analysts warned investors that a range of clinical trials at all phases could be hit by the virus. Enrollment, particularly in phase 1 trials that rely on healthy volunteers, could slow down, they said, as people steer clear of medical facilities during the outbreak.
“Clinical conduct for ongoing studies is also likely to be negatively impacted, as mobility precautions (particularly for studies in sites in highly-affected countries like China or Italy) or illness itself could reduce patient compliance and follow-up,” RBC added.
In addition to working to keep Spinraza and its other products on track, Biogen is taking an active role in addressing COVID-19 directly. Last week, it partnered with Vir Biotechnology to help develop and manufacture antibodies that may treat or prevent the virus. Biogen’s former CEO, George Scangos, is CEO of Vir and leader of the Biotechnology Innovation Organization's COVID-19 response.
As for the delayed Spinraza treatments, investors will surely be watching closely to make sure COVID-19 doesn’t hamper the product’s momentum. The drug's sales rose 22% last year to $2.1 billion, despite the entry of new competitors including Novartis’ gene therapy Zolgensma. And Biogen could be facing another SMA rival in a few months: Roche and PTC Therapeutics’ risdiplam, which scored priority review status from the FDA last year.