Novartis buys FDA priority review voucher from bankrupt Mallinckrodt for $100M

Novartis is forking over cash to speed up a future FDA drug application.

The Swiss pharma shelled out $100 million to acquire an FDA priority review voucher from opioid crisis-crippled Mallinckrodt, a securities filing shows. With it, Novartis can shorten the FDA’s review of a drug to six months from the standard 10 months.

Mallinckrodt got the voucher from the FDA approval of StrataGraft last year to support the body’s ability to heal after thermal burns. It was the first approval for a donor site-free alternative to autograft for deep partial burns.

Priority review vouchers (PRVs) have been trading at around $100 million lately. Back in September, Albireo Pharma sold a voucher for $105 million. That was a rare pediatric disease PRV granted with the approval of Bylvay for treating pruritus in progressive familial intrahepatic cholestasis, a liver disease.

More recently, BioMarin sold a rare pediatric disease PRV for $110 million in February. The company received the voucher from the go-ahead of growth drug Voxzogo in children with achondroplasia.

BridgeBio Pharma, reeling from an unexpected transthyretin amyloid cardiomyopathy trial flop, in May transferred its own pediatric disease PRV to an undisclosed buyer for $110 million. The California biotech got the voucher when its affiliate, Origin Biosciences, won an approval for Nulibry as the first therapy to reduce the risk of death in patients with molybdenum cofactor deficiency Type A, which manifests as the patient having trouble feeding and seizures.

From the purchaser’s perspective, AbbVie in March used a PRV to win a fast approval for Rinvoq in moderate to severe active ulcerative colitis. The voucher appeared to be the one it bought from Eiger Pharmaceuticals in late 2020. This followed the Illinois pharma leveraging a PRV in 2019 to hasten Rinvoq’s original indication in moderate to severe rheumatoid arthritis.

As for Novartis, the Swiss drugmaker used a PRV back in 2019 for ill-fated eye drug Beovu. It also reportedly used two PRVs in 2020 for multiple sclerosis drug Kesimpta and anti-inflammation therapy Cosentyx’s expansion into axial spondyloarthritis.

It’s not immediately clear what indication Novartis has eyes on for the Mallinckrodt PRV. Some of the important potential upcoming regulatory filings include Kisqali in postsugery adjuvant breast cancer, Pluvicto in pre-chemo metastatic castration-resistant prostate cancer, investigational complement inhibitor iptacopan in paroxysmal nocturnal hemoglobinuria and other indications, among others.

Altogether, Novartis has counted about 20 billion-dollar pipeline programs—including both marketed drugs and clinical-stage molecules—with potential approvals by 2026.