Benzinga | Sep 7, 2021 08:37AM EDT

Albireo Sells Priority Review Voucher For $105M

-- PRV was granted to Albireo with the FDA approval of BylvayTM (odevixibat) in July --

-- Non-dilutive capital further strengthens the Company's financial position --

BOSTON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare pediatric liver disease company developing novel bile acid modulators, today announced that it has entered into a definitive agreement to sell its Priority Review Voucher (PRV) for $105 million. The PRV was granted to Albireo under a U.S. Food and Drug Administration (FDA) provision that encourages the development of treatments for rare pediatric diseases. The Company received the voucher with the approval of Bylvay for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC).

"The sale of the PRV provides Albireo with an important source of non-dilutive capital and further strengthens our balance sheet. The proceeds allow us to continue our mission to ensure that all diagnosed children with PFIC in the U.S. and Europe will have access to Bylvay, progress two additional Bylvay Phase 3 studies and advance two new product candidates," said Ron Cooper, President and Chief Executive Officer of Albireo. "We are proud that Bylvay is our first approved product and the first approved therapy for patients with PFIC."

Albireo will receive a payment of $105 million upon the closing of the transaction, which is subject to customary closing conditions and is expected to occur following expiration of the applicable U.S. antitrust clearance requirements.

Jefferies LLC acted as financial advisor to Albireo on this transaction and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. acted as legal advisor.

The net sales proceeds expected from this transaction are in addition to the $186.3 million in cash, cash equivalents and short-term investments Albireo reported as of June 30, 2021.