Novartis is now paying $100 million for an opportunity to shorten regulatory review of a rare disease drug candidate in an uncertain future, a move that could save time and bring a potentially blockbuster product to market faster if it passes Called by the FDA.
The Swiss pharma giant has reached an agreement to buy priority review vouchers from Mallinckrodt Pharmaceuticals. Such coupons stem from an FDA program designed to incentivize the development of drugs to treat rare or neglected diseases. Voucher holders can reduce the standard 10-month review period to 6 months.
Companies can get coupons by getting approval for rare disease drugs. In this case, the coupons awarded may be applied to future product candidates. Another way to get vouchers is to buy vouchers from companies that already have them.Dublin, Ireland-based Mallinckrodt gets priority review credential by logging in FDA approved StrataGraft, a treatment for burns, last year. This product forms a scaffold by growing human skin cells, and burn patients’ own skin cells can grow on the scaffold.
Mallinckrodt is currently undergoing restructuring under bankruptcy protection.As a monetizable asset, StrataGraft Priority Review Credentials become part of the company restructuring plan. Under the scheme, Mallinckrodt’s debtors have sole discretion and control over the marketing and sale of vouchers. The document also stipulates that the debtor will receive 35% of the proceeds from the sale of the vouchers. That means the $100 million deal is $65 million for Mallinckrodt and $35 million for corporate debtors.According to Mallinckroth Regulatory filingpayments to the debtor will be directed to a trust established under the Chapter 11 plan for general unsecured claims.
Novartis has extensive experience in priority review vouchers. The company applied for a coupon to autoimmune drug Ilaris, seeking to expand the drug’s approval to gouty arthritis. The FDA rejected the drug application in 2011 and asked the company for more clinical data.Novartis receives priority review voucher 2017 Received approval for CAR T cancer treatment Kymriah and in 2019 Egaton’s approval For the treatment of fascioliasis, a neglected tropical disease. The FDA approved Zolgensma, the first gene therapy for spinal muscular atrophy, in 2019, along with a rare pediatric disease priority review voucher.Novartis success exchanged for a voucher and Beovu approved in 2019an antibody drug for wet age-related macular degeneration.
Recent deals include vouchers sold by Albireo Pharma last year $105 millionand BioMarin Pharmaceuticals’ February Promotional Coupon Promotion $110 million. Albireo gets its voucher Bylvay, a treatment for itching in patients with rare liver diseases; BioMarin for approved dwarfism drug Voxzogo. May Coupon BridgeBio Pharma’s Metabolic Disorder Drug Nubrilvy Approved sell $110 million. In each case, the voucher purchaser was not disclosed.
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