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Albireo Announces Two New U.S. Patents Allowed for A4250 with Term into 2031

May 16, 2017

— USPTO allowances provide method of use coverage for PFIC, NASH and other diseases —

BOSTON — May 16, 2017 — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 15/276,446, “IBAT inhibitors for the treatment of liver diseases” (‘446 patent). The ‘446 patent claims a method of treatment for Albireo’s lead product candidate A4250 in progressive familial intrahepatic cholestasis (PFIC) and other specified liver diseases. Upon issuance, the regular term of the ‘446 patent will expire in November 2031.

A4250 is an ileal bile acid transporter (IBAT) inhibitor initially in development for the treatment of patients with PFIC, a rare and life-threatening genetic liver disorder for which there are currently no approved therapies. In addition to the ‘446 patent, Albireo has issued composition of matter coverage for A4250 in more than 50 countries, as well as a method of use patent in Europe and Japan corresponding to the ‘446 patent. A4250 has also been granted orphan designation in the U.S. and the European Union.

“The allowance of this patent further fortifies our intellectual property protection for our lead product candidate, providing expected exclusivity into 2031 for A4250 in the treatment of PFIC among other indications,” said Ron Cooper, President and Chief Executive Officer of Albireo. “This patent allowance is another step forward in our efforts to bring a pharmacological treatment option for children with PFIC who greatly need it. We plan to initiate a Phase 3 clinical program for A4250 in PFIC patients in the second half of this year.”

Additionally, the USPTO allowed U.S. Patent Application No. 15/069,355, “IBAT inhibitors for the treatment of liver diseases,” which claims a method of treatment for A4250 in nonalcoholic steatohepatitis (NASH). Albireo previously generated promising preclinical data with A4250 in an animal model of NASH and is currently conducting a preclinical program directed towards novel bile acid modulators to treat NASH.

About A4250 

A4250 is a first-in-class product candidate in development for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), has minimal systemic exposure and acts locally in the gut.

A4250 has been granted orphan drug designation for PFIC in the United States and the European Union and has been granted access to the PRIority MEdicines (PRIME) program of the European Medicines Agency (EMA) for the treatment of PFIC.

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” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the progress or scope of development of A4250, including regarding the planned Phase 3 clinical program for A4250 in patients with PFIC; the timing for initiation of the planned Phase 3 PFIC program for A4250; the exclusivity provided by the allowed method of use patent for A4250 in the treatment of PFIC among other indications or the duration of the exclusivity; the competitive position of A4250 or the commercial opportunity in any target indication; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. 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 and uncertainties, including, but not limited to, risks and uncertainties relating to: Albireo’s ability to protect and maintain its allowed method of use patents for A4250, when issued, and to expand its intellectual property estate for A4250; whether or for how long Albireo’s allowed method of use patents for A4250, when issued, will provide market exclusivity for A4250, if approved by applicable regulatory authorities, in the treatment of PFIC or any other indication; whether preliminary data from the Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; whether either or both of the FDA and EMA will determine that the primary endpoint and duration of a clinical trial included in the planned Phase 3 PFIC program is sufficient, even if such 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 or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study sponsored by Albireo pooling and analyzing long-term PFIC patient data; whether Albireo’s cash resources will be sufficient to advance A4250 through completion of the planned Phase 3 PFIC program; the timing for initiation or completion of, or for availability of data from, ongoing or future trials of A4250, including the trials comprising the planned Phase 3 PFIC program, and the outcomes of such trials; and delays or other challenges in the recruitment of patients for the planned Phase 3 PFIC program. 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 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.

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 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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