Biodel Inc. and Albireo Limited Agree to Combine

DANBURY, CT and BOSTON, MA--(Marketwired - May 24, 2016) - Biodel Inc. (NASDAQ: BIOD)

• Transaction to result in NASDAQ-listed company focused in orphan pediatric liver diseases
• Albireo brings wholly owned, Phase 2 lead asset A4250 to treat Progressive Familial Intrahepatic Cholestasis (PFIC), an orphan pediatric liver disease with no approved drug treatment
• Combined company expected to be sufficiently capitalized to support advancement of A4250 through planned pivotal trial in PFIC
• Second Albireo clinical asset, elobixibat, currently being studied by Japanese licensee in Phase 3 clinical trials for treatment of chronic constipation
• Conference call on Wednesday, May 25, 2016 at 8:30 a.m. ET

Biodel Inc. (NASDAQ: BIOD) and Albireo Limited, a privately held biopharmaceutical company, today announced that the companies, together with Albireo's stockholders, have entered into a definitive share exchange agreement. The transaction will result in a combined company focused on the development of novel bile acid modulators to treat orphan pediatric liver diseases, as well as other liver and gastrointestinal diseases and disorders. A syndicate of existing Albireo investors, including Phase4 Ventures, TPG Biotech, TVM Capital Life Science and AstraZeneca, has committed to invest an additional $10 million prior to the closing of the transaction.

Albireo is developing its lead product candidate, A4250, initially for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC), which is a life threatening, orphan liver disease that affects young children. A4250 is currently being studied in a Phase 2 clinical trial in children with cholestatic liver disease that is designed to support Albireo's planned future pivotal development in PFIC.

Under the terms of the share exchange agreement, Albireo stockholders have agreed to exchange their shares of Albireo for newly issued shares of Biodel common stock. On a pro forma basis, Biodel stockholders are expected to own approximately 33%, and Albireo stockholders are expected to own approximately 67%, of the combined company, subject to certain adjustments based on net cash of Biodel and Albireo prior to closing. The transaction is subject to the approval of the stockholders of Biodel and other customary closing conditions.