-- Significant recent rare disease product launch
and access experience -- -- Key addition as Albireo prepares for
commercialization of A4250 --
Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced the appointment of Pamela Stephenson,
MPH, as Chief Commercial Officer, effective March 25, 2019.
In the newly created leadership position, Stephenson will be
responsible for overseeing the company’s commercial strategy and
global commercial operations.
“Albireo has entered the critical pre-commercial phase, as we
prepare for results from our Phase 3 trial of A4250 in progressive
familial intrahepatic cholestasis (PFIC),” said Ron Cooper,
President and Chief Executive Officer of Albireo. “Pamela brings a
unique set of commercial and leadership skills to Albireo, having
built organizations and successfully launched orphan products. We
are pleased to have Pamela join Albireo at this important stage for
the Company.”
Stephenson has more than 20 years of biopharma commercial
leadership experience across multiple functions and disease areas.
Before joining Albireo, Stephenson served as Vice President, Global
Market Access and Value, at Vertex Pharmaceuticals, where she led
the global market access and pricing strategy for current and
future products. Earlier in her tenure at Vertex, she led marketing
and sales activities for the company’s hepatitis C and cystic
fibrosis lines of business, and oversaw the U.S. launches of
Incivek® (telaprevir) and Orkambi®(lumacaftor/ivacaftor). Prior to
Vertex, Stephenson spent 10 years at Pfizer in marketing roles of
increasing responsibility for brands such as Viagra® (sildenafil
citrate), Lyrica® (pregabalin), and Aromasin® (exemestane).
Stephenson holds a bachelor’s degree from Brown University and
received her master’s degree in public health from Boston
University School of Public Health.
“I am pleased to join Albireo at this pivotal time in the
company’s growth,” Stephenson said. “A4250 is poised to make a
profound impact on the lives of patients with PFIC and their
families, and the development pipeline holds enormous potential. I
look forward to contributing to the company’s continued
success.”
About Albireo Albireo Pharma is a
clinical-stage biopharmaceutical company focused through its
operating subsidiary on the development of novel bile acid
modulators to treat orphan pediatric liver diseases, and other
liver and gastrointestinal diseases and disorders. Albireo’s lead
product candidate, A4250, is being developed to treat rare
pediatric cholestatic liver diseases and is in Phase 3 development
in its initial target indication, progressive familial intrahepatic
cholestasis. Albireo’s clinical pipeline also includes two Phase 2
product candidates. Albireo’s elobixibat, approved
in Japan for the treatment of chronic constipation, is
the first ileal bile acid transporter (IBAT) inhibitor
approved anywhere in the world. Albireo was spun out
from AstraZeneca in 2008.
Albireo Pharma is located
in Boston, Massachusetts, and its key operating
subsidiary is located in Gothenburg, Sweden. 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:
the plans for, or progress, scope, cost, duration or results or
timing for availability of results of, development of A4250,
including regarding the Phase 3 clinical program for A4250 in
patients with PFIC; the target indication(s) for development, the
size, design, population, location, conduct, objective, duration or
endpoints of any clinical trial, or the timing for initiation or
completion of or reporting of results from any clinical trial,
including the double-blind Phase 3 PFIC trial for A4250; the size
of the PFIC population; the potential benefits or competitive
position of A4250; Albireo often uses words such as “anticipates,”
“believes,” “plans,” “expects,” “projects,” “future,” “intends,”
“may,” “will,” “should,” “could,” “estimates,” “predicts,”
“potential,” “planned,” “continue,” “guidance,” and 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
A4250 to date, including findings in indications other than PFIC,
will be predictive of results from the trials comprising the Phase
3 PFIC program or any other clinical trials of A4250; whether
either or both of the FDA and EMA will determine that the
primary endpoint for their respective evaluations and treatment
duration of the double-blind Phase 3 trial in patients with PFIC
are sufficient, even if the primary endpoint is met with
statistical significance, to support approval of A4250 in the
United States or the European Union, to treat PFIC, a
symptom of PFIC, a specific PFIC subtype(s) or otherwise; 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 A4250, including the
trials comprising the Phase 3 PFIC program, and the outcomes of
such trials; Albireo’s ability to obtain coverage, pricing or
reimbursement for approved products in the United
States or European Union; delays or other challenges in
the recruitment of patients for, or the conduct of, the
double-blind Phase 3 trial; 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.
Investor Contact: Hans Vitzthum, LifeSci
Advisors, LLC.,
212-915-2568
Media Contact: Heather Anderson, 6 Degrees,
980-938-0260, handerson@6degreespr.com Source: Albireo Pharma,
Inc.
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