Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease
company developing novel bile acid modulators, today announced that
Bylvay (odevixibat), the first drug approved in Europe for the
treatment of all types of progressive familial intrahepatic
cholestasis (PFIC), is now available by prescription to patients in
Germany. Bylvay is also approved in the U.S. for the treatment of
pruritus in all types of PFIC. A potent, non-systemic ileal bile
acid transport inhibitor (IBATi), Bylvay is administered as a
once-daily capsule or opened and sprinkled onto soft foods and does
not require refrigeration.
“With the availability of Bylvay in Germany, we are now able to
offer the first non-surgical treatment option to the PFIC patients
who are experiencing difficult developmental and physical
symptoms,” said Ekkehard Sturm, M.D., Ph.D., Pediatric Hepatologist
and Head of Pediatric Gastroenterology-Hepatology, Liver and
Intestinal Transplantation at Children's Hospital, University of
Tüebingen in Germany. “We are hopeful that Bylvay will help
patients avoid complications associated with surgery and provide
them with much needed relief from their symptoms.”
Bylvay is now available through retail pharmacies. Sales
promotion has already begun, with Albireo commercial staff covering
the key centers to inform them of the availability of Bylvay for
the treatment of PFIC and the patient support services available.
Once Bylvay is prescribed, healthcare providers and families will
have the option to use Albireo Assist®, which is a
customized patient support program built with input from medical
experts and patient advocates that aims to support patients and
caregivers throughout their treatment journey.
“We are excited to bring the first drug treatment option to PFIC
patients in Germany, which has the largest market potential in
Europe,” said Pamela Stephenson, Chief Commercial Officer of
Albireo. “We have an experienced German team, including,
commercial, medical and operations who are on the ground running.
Based on our initial conversations with healthcare providers, we
know that there is great interest in Bylvay and we are confident in
the uptake.”
To support payor decision-making, Albireo has submitted a value
dossier to the Joint Federal Committee (G-BA) in Germany with the
PEDFIC 1 and PEDFIC 2 Phase 3 data, including long-term data with
patients on drug for over two years; natural history information;
and a caregiver study to reflect the burden of PFIC. This
submission commences the drug benefit assessment process. General
national reimbursement will be granted throughout the entire
process as well as thereafter.
“The PFIC patients around the world who are experiencing extreme
challenges and diminished quality of life underscore our urgency to
continue on our path towards global availability,” said Ron Cooper,
President and CEO of Albireo.
Albireo has launched Bylvay in the U.S. and is working to
commercialize Bylvay in other European countries. Bylvay is
currently being evaluated by a number of reimbursement agencies in
Europe. Albireo is working closely with all relevant agencies to
ensure access for patients in Europe as quickly as possible.
Outside the U.S., access to Bylvay is available through our Managed
Access Program. For more information on this program, please visit
https://www.albireopharma.com/patients-families/patient-access.
Bylvay is currently being evaluated in the ongoing PEDFIC 2
open-label trial in patients with PFIC, ASSERT Phase 3 study for
Alagille syndrome and in the BOLD Phase 3 study for patients with
biliary atresia. The ASSERT and BOLD studies remain on track to
report topline data in 2022 and 2024 respectively.
About Bylvay
(odevixibat)Bylvay is the first drug treatment
approved in the U.S. for the treatment of pruritus in all types of
progressive familial intrahepatic cholestasis (PFIC). The European
Commission (EC) and UK Medicines and Healthcare Products Regulatory
Agency (MHRA) have also granted marketing authorization of Bylvay
in PFIC and will be available for sale in Europe following pricing
and reimbursement approval. A potent, once-daily, non-systemic
ileal bile acid transport inhibitor, Bylvay acts locally in the
small intestine. Bylvay does not require refrigeration and can be
taken as a capsule for older children, or opened and sprinkled onto
food, which are factors of key importance for adherence in a
pediatric patient population. The medicine can only be obtained
with a prescription and treatment should be started and supervised
by a doctor who has experience in the management of PFIC. For more
information about using Bylvay, see the package leaflet or contact
your doctor or pharmacist. For full prescribing information, visit
www.bylvay.com.
In the U.S. and Europe, Bylvay has orphan exclusivity for its
approved PFIC indications, and orphan designations for the
treatment of Alagille syndrome, biliary atresia and primary biliary
cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2
open-label trial in patients with PFIC, in the BOLD Phase 3 study
for patients with biliary atresia and the ASSERT Phase 3 study for
Alagille syndrome.
About AlbireoAlbireo Pharma is a rare disease
company focused on the development of novel bile acid modulators to
treat rare pediatric and adult liver diseases. Albireo’s product,
Bylvay, was approved by the U.S. FDA as the first drug for the
treatment of pruritus in all types of progressive familial
intrahepatic cholestasis (PFIC), and it is also being developed to
treat other rare pediatric cholestatic liver diseases with Phase 3
trials in Alagille syndrome and biliary atresia, as well as an
Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has
been approved for the treatment of PFIC and has been submitted for
pricing and reimbursement approval. The Company has also initiated
a Phase 1 clinical trial for A3907 to advance development in adult
cholestatic liver disease, with IND-enabling studies moving ahead
with A2342 for viral and cholestatic liver disease. Albireo was
spun out from AstraZeneca in 2008 and is headquartered in Boston,
Massachusetts, with its key operating subsidiary in Gothenburg,
Sweden. The Boston Business Journal named Albireo one of the 2020
Best Places to Work in Massachusetts for the second consecutive
year. For more information on Albireo, please visit
www.albireopharma.com.
Forward-Looking Statements 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: Albireo’s commercialization
plans and expectations for commercializing Bylvay in the U.S. and
Europe; estimates of the number of patients impacted by PFIC;
expectations about Bylvay’s acceptance by healthcare practitioners
to treat PFIC patients;; 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), and the pivotal trial for
Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907;
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, and the BOLD and ASSERT trials;
discussions with the FDA or EMA regarding our programs; the
potential benefits or competitive position of Bylvay or any other
Albireo product candidate or program or the commercial opportunity
in any target indication; the potential effects of Bylvay of the
treatment of PFIC patients and its potential to improve the current
standard of care; the potential benefits of an orphan drug
designation; the length of time for which Albireo’s cash resources
are expected to be sufficient, and the milestones and activities to
be funded with those cash resources; or Albireo’s plans,
expectations or future operations, financial position, revenues,
costs or expenses. 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:
there are no guarantees that Bylvay will be commercially
successful; we may encounter issues, delays or other challenges in
launching or commercializing Bylvay; whether Bylvay receives
adequate reimbursement from third-party payors; the degree to which
Bylvay receives acceptance from patients and physicians for its
approved indication; challenges associated with execution of our
sales activities, which in each case could limit the potential of
our product; results achieved in Bylvay in the treatment of
patients with PFIC once we have launched the product may be
different than observed in clinical trials, and may vary among
patients; other potential negative impacts of the COVID-19
pandemic, including on manufacturing, supply, conduct or initiation
of clinical trials, or other aspects of our business; 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
outcome and interpretation by regulatory authorities of the ongoing
third-party study pooling and analyzing of long-term PFIC patient
data; 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 the United States
or Europe; delays or other challenges in the recruitment of
patients for, or the conduct of, Company’s clinical trials; and
Albireo’s critical accounting policies. These and other risks and
uncertainties that Albireo faces are described in greater detail
under the heading “Risk Factors” in Albireo’s most recent Annual
Report on Form 10-K or in subsequent filings that it makes with the
Securities and Exchange Commission. As a result of risks and
uncertainties that Albireo faces, the results or events indicated
by any forward-looking statement may not occur. Albireo cautions
you not to place undue reliance on any forward-looking statement.
In addition, any forward-looking statement in this press release
represents Albireo’s views only as of the date of this press
release and should not be relied upon as representing its views as
of any subsequent date. Albireo disclaims any obligation to update
any forward-looking statement except as required by applicable
law.
Media Contact:Colleen Alabiso,
857-356-3905, colleen.alabiso@albireopharma.comLauren Sneider,
857-300-1737, lauren.sneider@albireopharma.com
Investor Contact:Hans Vitzthum,
LifeSci Advisors, LLC., 617-430-7578
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