Mylan is one of a group of drugmakers that have joined the global effort to supply doses of generic hydroxychloroquine, an antimalarial touted as a possible COVID-19 therapy, to ongoing clinical trials. Now, after ramping up production, Mylan is ready to dole out its stockpile faster than expected.
After announcing last month it would restart production of hydroxychloroquine to meet global demand, Mylan plans to donate millions of doses of the drug “ahead of schedule,” the drugmaker said Wednesday.
Mylan will give away 10 million hydroxychloroquine tablets to the U.S. Department of Health and Human Services (HHS) to supplement investigational trials for COVID-19 and bolster the FDA’s emergency use program.
In addition, Mylan’s stockpile will help support the World Health Organization’s (WHO) multi-arm Solidarity trial investigating a range of possible therapeutics for COVID-19, including hydroxychloroquine, Gilead Sciences’ remdesivir and multiple combinations of HIV drugs lopinavir and ritonavir.
Mylan is the only drugmaker supplying 200-milligram doses of hydroxychloroquine for WHO testing and one of three donating supplies of lopinavir/ritonavir.
Mylan is also working with health officials to determine hydroxychloroquine’s use as a prophylactic and identifying possible donation needs, the company said.
With the explicit backing of President Donald J. Trump, aging antimalarials chloroquine and hydroxychloroquine have received booming support as potential therapies for COVID-19 on the heels of positive anecdotal evidence in small-scale French and Chinese clinical studies.
Mylan was one of a suite of drugmakers in March to pledge donations of the cheap generic drug to the cause. On March 30, the FDA designated hydroxychloroquine for emergency use, and the HHS immediately accepted 30 million donated doses from Novartis’ Sandoz unit. And with a similar nod for another form of the med—chloroquine phosphate—officials accepted 1 million tablets from Bayer.
Mylan’s amped-up effort to supply hydroxychloroquine comes as the drugmaker’s operations feel the effects from the novel coronavirus pandemic.
On Wednesday, Mylan said it is taking “extra precautions at manufacturing facilities to aid in the protection of site personnel and operations, including the implementation of social distancing guidelines, daily health assessments and split shifts where feasible.” The drugmaker has also instituted work-from-home procedures at its administrative offices.
Mylan’s operations aren’t the only thing taking a hit from the coronavirus––the drugmaker has also been forced to postpone its planned generics megamerger with Pfizer’s Upjohn unit.
Late last month, the pair announced they would postpone the deal, citing “unprecedented circumstances surrounding the COVID-19 pandemic, including associated delays in the regulatory review process.”
The companies now expect the merger to close in the second half of 2020, Mylan said, with no expected changes to the terms of the deal.
Apr 9, 2020