Albireo Increases 2021 Bylvay™ (odevixibat) Sales Guidance
– Bylvay net sales guidance revised to
– Unaudited cash of at least
– BOLD Phase 3 study in biliary atresia is over 50% enrolled
– ASSERT Phase 3 study in Alagille syndrome on track for topline data by end of year
“Bylvay launch uptake has been faster than anticipated and has significantly exceeded our internal expectations,” said
The Company has unaudited cash and cash equivalents of at least
Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi) which was recently approved in the
The early development pipeline continues to advance. A3907, the first oral systemic ASBT inhibitor, is expected to enter Phase 2 for adult liver diseases and A2342, the first oral NTCP inhibitor being developed for hepatitis B and D, will begin first in human studies this year.
The Company’s management will participate in the H.C. Wainwright Virtual BioConnect 2022 Conference to be held January 10-13, 2022. The presentation will be available beginning January 10, 2022 on the Investors page of the company website at https://ir.albireopharma.com/ and archived for replay two weeks following the event. The Company starts the year with a strong financial and commercial position based on the following milestones achieved in 2021:
- First patient dosed in ASSERT global Phase 3 study of Bylvay for Alagille syndrome
- European Marketing Authorization of Bylvay, the First Drug Treatment for Progressive Familial Intrahepatic Cholestasis (PFIC)
- FDA Approval of Bylvay, the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
- Albireo Sells Priority Review Voucher (PRV) for
- Albireo Receives
UKMHRA Approval of Bylvay® (odevixibat)
- Bylvay Available in
- Expanded Phase 3 Data on Bylvay and A3907 at
Upcoming EASL International Liver Congress
- New Phase 3 Data at WCPGHAN Show Long-Term Safety, Tolerability, and Treatment Benefits of Bylvay in PFIC
- New Phase 3 Data for Bylvay in PFIC and First Reveal of New Next Generation Bile Acid Modulator Data at AASLD The Liver Meeting 2021
- Albireo Presenting New Bylvay Data at NASPGHAN 2021
- Exclusive Licensing Agreement with Jadeite Medicines for Bylvay in
Japanwith upfront payment of $15Mand up to $120Min milestones and double-digit royalties
- Positive Topline Data from Phase 1 Study of A3907
The Company also congratulates Dr.
“Over the last five years, Roger has been a dedicated member of our Board and his contributions have been invaluable as we achieved major milestones, including global commercialization of our first product and exceeding our product revenue forecast in the first quarter of sales. We thank Roger for his contributions over his tenure and wish him luck in his new role,” added Cooper.
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the pivotal trial for Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; the IND-enabling studies for A2342; the target indication(s) for development or approval; the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for Bylvay in PFIC, the BOLD and ASSERT trials, Phase 2 trial for A3907 and the IND-enabling studies for A2342; or the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” or the negative of these terms or other similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: whether favorable findings from clinical trials of Bylvay to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of Bylvay; the timing for initiation or completion of, or for availability of data from, clinical trials of Bylvay, including BOLD and ASSERT, and the Phase 1 clinical trial of A3907, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in
Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578
Source: Albireo Pharma, Inc.