Albireo
Feb 1, 2017

Albireo Announces Submission of New Drug Application for Elobixibat in Japan

BOSTON, Feb. 01, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that EA Pharma Co., Ltd. has submitted a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for elobixibat for the treatment of chronic constipation in Japan. EA Pharma is the exclusive licensee of elobixibat to treat gastrointestinal disorders in Japan and other select countries in Asia.  Subject to receipt of approval from the PMDA, EA Pharma plans to co-market elobixibat in Japan with Mochida Pharmaceutical Co., Ltd.

Elobixibat is a once-daily, orally available ileal bile acid transporter (IBAT) inhibitor that improves secretion and motility in the large bowel. In a Phase 3 clinical trial, elobixibat met the primary endpoint, change in the number of weekly spontaneous bowel movements (SBMs) from baseline to the first treatment week compared with placebo, with high statistical significance.  

"We are pleased that the first regulatory application for elobixibat has been submitted and look forward to the decision of the Japanese regulatory authority," said Ron Cooper, President and Chief Executive Officer of Albireo. "Positive data from the Phase 3 trial of elobixibat in Japan and the achievement of this important corporate milestone validate our scientific focus on IBAT inhibition and mark significant progress toward providing an important new treatment option for Japanese patients suffering from chronic constipation."

About Elobixibat
Elobixibat is a first-in-class product candidate in development for chronic idiopathic constipation (or, in Japan, chronic constipation). Elobixibat inhibits ileal bile acid transporters (IBAT and also sometimes referred to as the apical sodium-dependent bile acid transporter) in the terminal ileum to increase secretion and motility in the large bowel without negatively affecting important functions in the small intestine. Elobixibat has been evaluated to date in more than 1,000 healthy volunteers and chronic constipation patients worldwide.

About Albireo 
Albireo 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, Albireo AB, 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."  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 regulatory approval or marketing of elobixibat in Japan. 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: the outcome of the ongoing long-term safety clinical trial of elobixibat in Japan; the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan; and the timing and success of acceptance and approval of the new drug application filed with the Japanese Pharmaceuticals and Medical Devices Agency for elobixibat for the treatment of chronic constipation in Japan. These and other risks and uncertainties are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K and in other 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.

Source: Albireo Pharma, Inc.

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Source: Albireo, Inc.

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