Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease
company developing novel bile acid modulators, joins the PFIC
Advocacy and Resource Network (PFIC Network) in recognition of PFIC
Awareness Day 2021, a global effort to support patients and
families affected by progressive familial intrahepatic cholestasis
(PFIC). Established in 2019, PFIC Awareness Day aims to highlight
the impact of this disease on patients and families, and to call
for new levels of support, including research, advocacy, education
and opportunities to connect and share information.
PFIC is a rare disorder that causes progressive,
life-threatening liver disease. Patients have impaired bile flow,
or cholestasis, caused by genetic mutations. The resulting bile
build-up in liver cells causes liver disease and symptoms. The most
prominent and problematic ongoing manifestation of the disease is
pruritus, or intense itching, which often results in a severely
diminished quality of life. Other symptoms include jaundice, poor
weight gain and slowed growth. In many cases, PFIC leads to
cirrhosis and liver failure within the first 10 years of life, and
nearly all people with PFIC require treatment before age 30.
Every year the PFIC Network recognizes, shares, and supports the
PFIC community in hopes for a better future for those impacted by
PFIC (events.pfic.org/awareness-day-2021/). This year, PFIC Network
is working with the global community to recognize PFIC Awareness
Day around the world through a variety of initiatives,
including:
- Raising Awareness: Share your story and photos
with the #ItchingForACure hashtag and your journey will help spread
awareness around the world. To learn more about how you can
participate, visit events.pfic.org/raise-awareness/.
- Fundraising: Join a team, pick a cause and
help raise money for resources that have direct impact on the PFIC
community. For information on how to support, visit
events.pfic.org/fundraising/.
- Advocacy: Get involved and help connect the
PFIC community with available information and resources. To learn
more about how to get involved, visit
events.pfic.org/advocacy/.
Albireo is committed to advancing research in PFIC and other
rare pediatric and adult liver diseases. The Company recently
launched a new treatment option for PFIC and is working with the
community and patient advocacy groups like the PFIC Network and
Children’s Liver Disease Foundation to raise awareness of PFIC and
support families managing the burden of this devastating
disease.
“Guided by our mission of providing hope to families, we stand
with the PFIC community in recognizing PFIC Awareness Day,” said
Ron Cooper, President and Chief Executive Officer of Albireo.
“While we are thrilled that we are now able to provide a drug
treatment option to patients with PFIC, there is still more work to
be done to ensure access and to elevate the important perspectives
of the patients and families that have been impacted by this
devastating disease.”
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 first
product, Bylvay™ (odevixibat) 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. Bylvay is available for sale in Germany and will be
available for sale in other European countries following pricing
and reimbursement approval. A potent, once-daily, non-systemic
ileal bile acid transport inhibitor, Bylvay acts locally in the
small intestine. Bylvay 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.
Bylvay is being evaluated in the ongoing PEDFIC 2 open-label
trial in patients with PFIC. It is also being developed to treat
other rare pediatric cholestatic liver diseases with the BOLD Phase
3 study for patients with biliary atresia and the ASSERT Phase 3
study for Alagille syndrome. 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. 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; 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; or the potential benefits of an orphan drug
designation. 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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