SWITZERLAND – Novartis has shelled out US$100 million to acquire an FDA priority review voucher from opioid crisis-crippled Mallinckrodt, a securities filing shows.
Such vouchers stem from an FDA program intended to incentivize the development of drugs for rare or neglected diseases. With it, Novartis can shorten the FDA’s review of a drug to six months from the standard 10 months.
Companies can obtain a voucher by winning approval for a rare disease drug. In such cases, the voucher that’s awarded may be applied to a future product candidate.
The other way to get a voucher is to buy one from a company that already has one. That’s what Novartis is doing.
Dublin, Ireland-based Mallinckrodt earned its priority review voucher by landing FDA approval last year for StrataGraft, a regenerative medicine treatment for burn injuries.
This product is made by growing human skin cells to form a scaffold upon which a burn patient’s own skin cells can grow.
Mallinckrodt got the voucher from the FDA approval of StrataGraft last year to support the body’s ability to heal after thermal burns.
Priority review vouchers (PRVs) have been trading at around US$100 million lately. Back in September, Albireo Pharma sold a voucher for US$105 million.
That was a rare pediatric disease Priority Review Voucher 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 US$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 US$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.
Such vouchers stem from an FDA program intended to incentivize the development of drugs for rare or neglected diseases. With it, Novartis can shorten the FDA’s review of a drug to six months from the standard 10 months.
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.
Others in the pipeline include 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.
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