Albireo Appoints Dr. Paresh N. Soni as Chief Medical Officer

BOSTON, Sept. 08, 2016 -- Albireo Limited, a clinical-stage 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, announced the appointment of Paresh N. Soni, M.D., Ph.D. as Chief Medical Officer.  The expansion of Albireo’s management team with the addition of Dr. Soni follows its announcement earlier this year that it has entered into a definitive share exchange agreement with Biodel Inc. for a transaction designed to create a NASDAQ-listed company focused in orphan pediatric liver diseases.  As CMO, Dr. Soni will be responsible for the design and execution of Albireo’s development programs.

“Paresh brings significant orphan, hepatology and gastrointestinal drug development and regulatory experience to Albireo,” said Ron Cooper, Albireo’s President and Chief Executive Officer.  “He has an impressive track record of leading teams across the development spectrum, from translational medicine to NDA approval.  Paresh’s broad background, both with large pharma and emerging biotechnology companies, make him a valued addition to the Albireo team.”

Dr. Soni has more than 25 years of clinical drug development and academic medical experience.  Most recently, he served as Vice President, Global Medical Sciences at Alexion Pharmaceuticals, a global rare disease biopharma company.  Prior to Alexion, Dr. Soni served as Senior Vice President, Head of Development at Amarin Corporation where he was responsible for the development and regulatory approval of Vascepa® for elevated triglycerides. Dr. Soni began his pharmaceutical career at Pfizer, holding various positions of increasing responsibility.  Dr. Soni is an internist and gastroenterologist, who completed his medical training at the University of Natal in South Africa and a research fellowship at the Division of Hepatology, Royal Free Hospital School of Medicine, London. He has authored or co-authored more than 50 scientific papers in peer-reviewed journals, in addition to numerous abstracts.

“I am very pleased to be joining Albireo at this exciting time as we prepare to advance A4250 into planned pivotal clinical development as a treatment for progressive familial intrahepatic cholestasis, explore additional orphan pediatric indications for A4250 development and exploit the company’s promising clinical pipeline,” said Dr. Soni.

About Albireo 
Albireo Limited is a holding company for Albireo AB, a clinical-stage biopharmaceutical company focused 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 and is backed by top-tier life science investors such as Phase4 Ventures, TPG Biotech, TVM Capital Life Science and Aberdeen Asset Management, as well as AstraZeneca.

Albireo Limited is incorporated and registered in England and Wales, and its wholly owned subsidiaries are located in Gothenburg, Sweden and Boston, Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

Forward-Looking Statements
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 potential future pivotal clinical development of A4250 to treat progressive familial intrahepatic cholestasis (PFIC).  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 Biodel Inc. has filed with the Securities and Exchange Commission with regard to the proposed share exchange transaction with Albireo; whether preliminary data from Albireo’s ongoing Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether the ongoing Phase 2 trial of A4250 in children with chronic cholestasis will be sufficient to support advancement into a pivotal trial in PFIC; the timing and outcome of the planned meeting with the FDA regarding the anticipated pivotal program for A4250 in PFIC; and the designs, endpoints, numbers of patients and treatment periods for trials that will be required to support approval of A4250 to treat PFIC or any other orphan pediatric liver disease.  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.

Contacts:
Hans Vitzthum
Managing Director
LifeSci Advisors, LLC.
212-915-2568

Ron Cooper
President & CEO
Albireo Limited
732-687-4238