A number of clinical trials hit primary endpoints in May, despite the COVID-19 pandemic, which still accounted for about 30% of the phase I through phase III news flow during the month.
Money raised through biopharma financings so far in 2020 is double the amount raised within the same timeframe of 2019, partly due to two large financings completed in May by Sanofi SA, which is working on candidates to treat or prevent COVID-19, the disease caused by the SARS-CoV-2 virus.
Swept up into a coronavirus whirlwind, the biopharma industry has ramped up development of therapeutics and vaccines and altered business plans to fight the SARS-CoV-2 virus in a way that nobody could have imagined only months ago.
Few would dispute that the best way to find innovative solutions to the COVID-19 pandemic is through industry, academia and government working together. BioWorld data indicate that more than 45% of the biopharma deals with nonprofit entities (bio/nonprofit) in 2020 are indeed focused on fighting the globally-disruptive SARS-CoV-2 virus.
Of the 160 biopharma deals tracked by BioWorld during the month of April, 36% are for collaborations focusing on the development of therapeutics and vaccines for COVID-19.
Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease.
Representing the highest amount ever raised by a public biopharma company on a U.S. exchange, Moderna Inc. priced a $1.34 billion follow-on offering to help fund worldwide manufacturing and distribution of its mRNA-1273 vaccine for COVID-19.
While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations.
Three biopharma drugs are up for FDA approval this week, including one new chemical entity, dasotraline, from Sunovion Pharmaceuticals Inc. to treat binge eating disorder, and two other candidates that are part of supplemental filings for expanded indications.
While COVID-19 dominated the clinical data news during the month of April, with 45% due to trial delays, suspensions and terminations, and another 12% focused on therapeutic and vaccine development targeting the deadly infection, a number of companies still posted positive phase III data for other indications and are preparing for regulatory filings and commercialization.
