Albireo Presents Odevixibat Commercialization Road to $1 Billion

– Company outlining large global rare cholestatic liver disease opportunity –

– Advancing plans for anticipated odevixibat U.S. and EU launch, with focus on market access –

– Expansion opportunity beyond PFIC and beyond odevixibat –

– Commercial management to host conference call and webcast today at 11:30 a.m. EST–

BOSTON, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, is hosting a commercial deep dive today at 11:30 a.m. EST. The presentation will detail the Company’s corporate potential, market opportunity in rare pediatric and adult liver disease and the global commercialization and launch readiness plans for odevixibat in progressive familial intrahepatic cholestasis (PFIC), an ultra-rare pediatric cholestatic liver disease.

“We are delighted that both the EMA and FDA confirmed acceptance of our odevixibat filings in the U.S. and Europe with priority and accelerated reviews,” said Ron Cooper, President and Chief Executive Officer of Albireo. “Odevixibat’s demonstrated profile in the largest ever clinical program of PFIC, coupled with our strong commercial strategy and ongoing development programs, positions Albireo to seize the large global cholestatic liver disease market.”

Today’s presentation will describe efforts the Company is taking to advance its broad, wholly owned pipeline of rare pediatric and adult liver assets. Management will present commercial plans for lead candidate odevixibat, which has imminent regulatory milestones in the U.S. and EU. Odevixibat holds the promise to expand to multiple rare pediatric cholestatic indications to drive company growth. Albireo is in a strong financial position for commercialization, sufficient to fund odevixibat launches, advance clinical studies and support the Company into revenue generation.

Large Global Opportunity
Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being developed to treat patients with rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome (ALGS). Albireo conducted extensive research to understand the global market opportunity for PFIC, an ultra-rare pediatric liver disease for which there is no approved drug therapy today. Based on these efforts, the Company expects the global market opportunity in pediatric cholestatic liver diseases to be larger than anticipated. The top 25 global markets (excluding China and India) have approximately 100,000 patients living with rare cholestatic liver diseases. Albireo has initiated or completed three gold standard Phase 3 studies in PFIC, biliary atresia and Alagille syndrome and these studies should be sufficient for approval in multiple geographies around the world.