Biopharma companies face regulatory, deal delays due to Covid-19

Covid-19 is already taking a toll on biopharma, with companies putting off clinical development and canceling meetings and other plans in order to slow the spread of the SARS-CoV-2 virus and free up space at hospitals that are quickly becoming overburdened. On Thursday, two companies announced that they had hit regulatory snags at the Food and Drug Administration, while two others have had to put off completion of a planned deal.

New York-based Intercept Pharmaceuticals said the FDA had notified it that an advisory committee meeting to discuss the drug obeticholic acid as a treatment for liver fibrosis due to nonalcoholic steatohepatitis, originally scheduled for April 22, had been rescheduled for June 9. However, the company said the FDA remained on track to decide whether or not to approve the drug by June 26. If approved, obeticholic acid, also known as OCA, would be the first ever drug approved for NASH. The company noted that its NASH trials are fully enrolled, while it is pausing screening and randomization of patients in some of its primary biliary cholangitis trials of OCA.

Meanwhile, Cambridge, Massachusetts-based bluebird bio said did not anticipate completing its rolling application submission for the gene therapy LentiGlobin as a treatment for the blood disorder beta-thalassemia until the middle of next year, around the second or third quarter. It had previously expected to complete the submission in the first half of this year. Bluebird said the pandemic is also likely to affect the assays that it plans to use for LentiGlobin, which are the subject of discussions and disagreements with the FDA.

However, if completing the submission is delayed until then, the company said it may have the opportunity to seek approval for a broader patient population, including patients with beta-zero/beta-zero genotypes as well as pediatric patients. Moreover, its plans – with Bristol-Myers Squibb – to file for approval of the CAR-T cell therapy idecabtagene vicleucel in multiple myeloma in the first half of this year remain on track.

Shares of Intercept were up more than 12% on the Nasdaq in midday trading Thursday. Bluebird’s shares were down slightly.

“The Covid-19 pandemic has created new challenges for bluebird, the broader biotech community and society as a whole,” bluebird CEO Nick Leschly said in a statement.

In a note to investors, Baird analyst Brian Skorney wrote that while Covid-19 has caused several delays in clinical development, Intercept’s NASH trials being fully enrolled may help it avoid any such issues. Furthermore, he wrote, the company has significant financial resources to weather the pandemic, with $650 million in cash and equivalents at the end of fiscal year 2019.

On Wednesday, Reuters reported that Pfizer was pausing most of its clinical trials, except for those among patients with life-threatening conditions who have no other therapeutic options.

The pandemic has caused additional speed bumps for Pfizer as well.

On Thursday, Pfizer and Mylan said that the creation of a new company that would combine operations of the latter with Pfizer’s Upjohn division would be delayed until the second half of this year. The companies announced the deal last July, anticipating that it would close in the middle of this year, with Pfizer shareholders owning 57% and Mylan shareholders owning 43%.

Pfizer’s shares were up 5.4% on the New York Stock Exchange, while Mylan’s shares were up 4.5% on the Nasdaq.

Photo: Ekkaluck, Getty Images

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