Albireo Expands Team, Appoints Martha J. Carter as Chief Regulatory Officer

BOSTON, Nov. 29, 2016 -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the appointment of Martha J. (Muffy) Carter as Chief Regulatory Officer. In this role, Ms. Carter will oversee all regulatory affairs for Albireo worldwide.

“The wealth of regulatory and operational experience Muffy has accumulated during her four decades in the biopharmaceutical industry, including having successfully secured approval for an orphan drug in 36 countries, will be invaluable to Albireo,” said Ron Cooper, President and Chief Executive Officer of Albireo. “Muffy will be instrumental in guiding A4250, our lead product candidate in development for the treatment of progressive familial intrahepatic cholestasis (PFIC), through the regulatory processes in the United States and Europe. We are delighted to welcome her to our management team.”

Most recently, Ms. Carter was Chief Regulatory Officer and Senior Vice President of Aegerion Pharmaceuticals, a biopharmaceutical company focused in rare diseases, where she established global regulatory and quality functions and played a key role in bringing JUXTAPID®/LOJUXTA® (lomitapide) for the treatment of homozygous familial hypercholesterolemia to market. Prior to Aegerion, Ms. Carter served as Senior Vice President and Chief Regulatory Officer at Proteon Therapeutics and Senior Vice President, Regulatory Affairs at Trine Pharmaceuticals. Earlier in her career, Ms. Carter held various positions of increasing responsibility in regulatory affairs, strategic planning and compliance. She has authored and co-authored numerous publications on regulatory matters and professional ethics. Ms. Carter holds a B.A. in biology from Northeastern University.

“I am thrilled to be joining Albireo as we ready A4250 for a potentially pivotal clinical trial in PFIC,” said Ms. Carter. “I look forward to supporting the development of A4250 and Albireo’s pipeline of bile acid modulators as we work to bring much needed new treatment options to patients suffering from orphan liver diseases and gastrointestinal disorders.”

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 clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. 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 — Albireo
This press release includes “forward-looking statements.”  Forward-looking statements include statements, other than statements of historical fact, regarding Albireo’s intentions, plans, beliefs, expectations or forecasts for the future, including regarding a potentially pivotal clinical trial of A4250 in PFIC or the ability of Albireo to successfully develop A4250 or any of its pipeline product candidates and obtain regulatory approval. Albireo 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 and uncertainties, including, but not limited to: those described in the documents Albireo (f/k/a Biodel Inc.) has filed with the Securities and Exchange Commission, risks and uncertainties relating to: the conduct and results of Albireo’s ongoing clinical trial of A4250 in children with chronic cholestasis; whether such ongoing clinical trial of A4250 will be sufficient to support advancement of A4250 into a pivotal clinical trial in PFIC; and the timing and success of submission, acceptance and approval of regulatory filings. 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.

Source: Albireo Pharma, Inc.

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