Albireo Presents Odevixibat Commercialization Road to $1 Billion
February 11, 2021 at 08:30 AM EST
– 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
“Children and families are urgently waiting for odevixibat, which, if approved, will be potentially the first non-surgical treatment for PFIC,” said Pamela Stephenson, Chief Commercial Officer of Albireo. “We are building a commercial team that is dedicated to delivering seamless access to patients and HCPs and delivering good value for payors and HCPs.”
Until odevixibat is approved for commercial sale, the Company provides an Expanded Access Program (EAP) for eligible patients with PFIC in the U.S., Europe, Canada and Australia. Physicians and patients can learn more about Albireo’s odevixibat EAP at albireopharma.com/patients-families/expanded-access-policy.
As part of the ex-U.S. commercial strategy, Albireo entered into its first of multiple ex-U.S. commercial distributorships with Medison Pharma, Ltd. ("Medison") for odevixibat in Israel. Medison is a leading international commercial partner for highly innovative therapies. Under the agreement, Medison will be responsible for approval and commercialization in Israel in close alignment and with oversight from Albireo.
Expansion Beyond PFIC
The Company is exploring multiple methods for modulating bile acids to significantly change the bile acid transporter approach in adult liver. In developing therapies for adult liver conditions, the Company will initially focus on primary sclerosing cholangitis (PSC) and primary bilateral cholangitis (PBC) with two promising new candidates with two different mechanisms of action.
“Albireo maintains a global, wholly owned, unencumbered pipeline of products addressing multiple indications and commercial opportunities in multiple rare liver indications,” added Cooper. “The enterprise infrastructure we are building for the PFIC launch will be sufficient to effectively serve multiple rare liver diseases in the coming years.”
The Company has sufficient capital resources to fund the planned launch and development programs. Cash runway into 2023 and plans to monetize a Priority Review Voucher, if received upon approval. 2020 unaudited cash burn was $101 million, cash at the end of 2020 $251 million, and planned operating cash burn in 2021 $120-$130 million. 2021 revenue from odevixibat is anticipated to be in the low single digit US $ millions.
When: Today, February 11, 2021, from 11:30am-1:00pm EST
Dial-in: To access the live conference call by phone, dial 1-877-407-0792 (domestic) or 1-201-689-8263 (international). Provide access code: 13714756
Live webcast link: http://public.viavid.com/index.php?id=142919
Link is also accessible from the Media & Investors page of Albireo’s website http://ir.albireopharma.com/
In Europe, the Company has submitted odevixibat for a Marketing Authorization Application (MAA) to the EMA seeking approval in PFIC. Odevixibat is the only IBATi granted accelerated assessment by the EMA. It has also been granted Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of ALGS, biliary atresia and PBC. With U.S. and EU regulatory filings in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021.
The MAA and NDA filings are supported by results from PEDFIC 1 and PEDFIC 2 Phase 3 studies. PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of odevixibat in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial. In the PEDFIC 1 study, odevixibat met both primary endpoints and was well tolerated with very low incidence of diarrhea/frequent bowel movements (9.5% of odevixibat treated patients vs. 5.0% of placebo patients). PEDFIC 2 is a long-term, open-label Phase 3 extension study. Odevixibat is also currently being evaluated in the BOLD Phase 3 trial in patients with biliary atresia, and the global Phase 3 ASSERT trial for ALGS.
About Biliary Atresia