Biodel (BIOD) Says Albireo Announces Positive Top-Line Phase 3 Results for Elobixibat in Japan

October 3, 2016 5:14 PM EDT

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As previously announced, Biodel Inc. (Nasdaq: BIOD) has entered into an amended and restated share exchange agreement (the “Exchange Agreement”) with Albireo Limited, a company registered in England and Wales (“Albireo”), and the holders of Albireo shares or notes convertible into Albireo shares, pursuant to which, subject to the satisfaction or waiver of the conditions set forth in the Exchange Agreement, the Company will acquire the entire issued share capital of Albireo in exchange for newly issued shares of the Company’s common stock.

On October 3, 2016, Albireo issued the press release attached hereto as Exhibit 99.1 announcing positive top-line results from a pivotal Phase 3 clinical trial of its product candidate, elobixibat, in chronic constipation conducted in Japan. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.

Press Release:

Albireo Limited announced today positive top-line results from a pivotal Phase 3 clinical trial of its product candidate elobixibat in chronic constipation conducted in Japan. In the 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. The SBM endpoint is the endpoint required to support regulatory approval to treat chronic constipation in Japan.

EA Pharma Co., Ltd., exclusive licensee of elobixibat to treat gastrointestinal (GI) disorders in Japan and other select countries in Asia, conducted the trial. Based on discussions with EA Pharma, Albireo expects that EA Pharma will file a new drug application for elobixibat in Japan in the first quarter of 2017 and make a milestone payment to Elobix AB, Albireo’s indirect wholly owned subsidiary, later in 2016 under the terms of the parties’ license agreement.

“We are grateful to and congratulate our strategic partner for elobixibat in Japan, EA Pharma, for executing a successful pivotal study,” said Ron Cooper, President and Chief Executive Officer of Albireo. “We believe this positive Phase 3 outcome validates the therapeutic promise of the IBAT inhibitor mechanism and Albireo’s scientific focus on bile acid modulation.”

The results of the trial also favored elobixibat with high statistical significance on all secondary efficacy endpoints assessed statistically, including assessments of change in frequency of complete SBMs, time to first SBM, severity of constipation and stool consistency. A complete SBM is an SBM without a self-reported sensation of incomplete evacuation. There were no serious adverse events reported in the trial. Consistent with prior clinical trials of elobixibat, the most common adverse events were abdominal pain (18.8%) and diarrhea (13.0%), all of which were characterized as mild or, in one case, moderate in severity.

Mr. Hajime Shimizu, Representative Director, President & CEO of EA Pharma, said, “I am really pleased to receive positive data in this pivotal Phase 3 trial. EA Pharma will strive to increase treatment choices and improvement of quality of life for patients with chronic constipation in Japan by bringing elobixibat’s novel mechanism of action to market.”

As previously announced, Albireo has entered into a definitive share exchange agreement with NASDAQ-traded Biodel Inc. The share exchange is expected to be completed in the fourth quarter of 2016, subject to the approval of the Biodel stockholders and other customary conditions. Upon completion of the share exchange, Biodel will be renamed Albireo Pharma, Inc. and trade on The NASDAQ Capital Market under the symbol “ALBO” and Albireo’s business will continue as the business of the combined organization.

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