COVID-19 is bad news for new drug launches. Which will suffer most?
The COVID-19 pandemic and the ensuing societal countermeasures are upending operations in many sectors—and biopharma isn't immune.
The current lockdown is not only hurting clinical trial enrollment but also delaying regulatory timelines for drugs nearing a decision. And with tried-and-true, in-person marketing techniques no longer allowed, new launches may also feel the pain—or hold off altogether.
Consider Bristol Myers Squibb and its big new approval for multiple sclerosis drug Zeposia. It's a long-awaited med, but BMS is postponing the launch under the circumstances. Also in the MS arena, a regulatory decision for Novartis’ repurposed ofatumumab might also come late, ODDO BHF analysts noted recently.
Rollouts from small-cap biotechs with little to no marketing experience are likely most vulnerable, however. So are new meds challenging existing drugs—like Zeposia—chronic disease therapies and those that need heavy up-front awareness promotions, industry watchers figure. On the flipside, drugs for life-threatening diseases with few other options would be more protected.
Roche's spinal muscular atrophy drug risdiplam might be thwarted, at least for now. It currently bears an FDA decision date for May. But the ODDO team said, “we would not be surprised if approval was postponed.”
Plus, the FDA will likely feel less urgency to review the drug if its resources are under pressure, given there are already Novartis' gene therapy Zolgensma and Biogen's tried-and-true oral Spinraza on the market.
Potential inspection, approval and launch delays will place Gilead Sciences and Galapagos’ JAK inhibitor filgotinib farther behind AbbVie’s Rinvoq in rheumatoid arthritis, RBC Capital analyst Brian Abrahams noted in a recent report.
As for Biogen, the Big Biotech is grappling with the coronavirus from within as several members of senior management have been infected. Therefore, regulatory filing or review of its key value driver—controversial Alzheimer’s contender aducanumab—is likely going to take more time than expected.
Intercept’s closely watched NASH candidate obeticholid—sold for another indication as Ocaliva—already got the delay message as an FDA advisory committee meeting discussing its approvability has already been rescheduled for months later.
Sarepta’s Duchenne muscular dystrophy portfolio, including recently approved Vyondys 53, could also be affected, “especially if the inherent higher infection risk from their underlying disease causes some to reduce physician visits,” Abrahams said. But the lack of alternatives and potential approval or launch delays for Nippon Shinyaku’s rival med viltolarsen could benefit Sarepta.
Meanwhile, Karyopharm’s Xpovio entered late in the crowded multiple myeloma market in mid-2019 and was pushed in late-line use. Still, Abrahams said he believes the drug’s novel mechanism for a deadly disease makes it “more insulated than most from pandemic-related challenges.” Then again, the company’s efforts to expand the drug into diffuse large B cell lymphoma and earlier MM could be slowed.
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Journal of Developing Drugs