Form DEFA14A Biodel Inc

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE 14A

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

 

 

Filed by the Registrant ☒

Filed by a Party other than the Registrant ☐

Check the appropriate box:

☐	Preliminary Proxy Statement

☐	Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2))

☐	Definitive Proxy Statement

☒	Definitive Additional Materials

☐	Soliciting Material under §240.14a-12

BIODEL INC.

 

(Exact name of Registrant as specified in its charter)

 

 

 

(Name of Person(s) Filing Proxy Statement, if other than Registrant)

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☐	Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11.

 

(1)

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(2)

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(3)

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☐	Fee paid previously with preliminary materials.

 

☐	Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing.

 

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 3, 2016

BIODEL INC.

(Exact name of registrant as specified in its charter)

Commission File Number 001-33451

 

Delaware (State or other jurisdiction of incorporation or organization)		90-0136863 (IRS Employer Identification Number)
100 Saw Mill Road Danbury, Connecticut (Address of principal executive offices)		06810 (Zip code)

(203) 796-5000

(Registrant’s telephone number, including area code)

Not Applicable

 

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

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Item 8.01

Other Events.

As previously announced, Biodel Inc. (“Biodel” or the “Company”) 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.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits

 

99.1	Press release of Albireo Limited dated October 3, 2016

Additional Information and Where You Can Find It

Biodel filed a definitive proxy statement with Securities and Exchange Commission (the “SEC”) on September 19, 2016 in connection with the solicitation of proxies for its 2016 Annual Meeting of Stockholders and has mailed the definitive proxy statement and other relevant materials to Biodel’s stockholders. At the 2016 Annual Meeting of Stockholders, Biodel’s stockholders will be asked to approve, among other things, a proposal for the issuance of Biodel’s common stock in the previously announced proposed transaction with Albireo. BIODEL’S STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN CONNECTION WITH THE SOLICITATION OF PROXIES FOR BIODEL’S 2016 ANNUAL MEETING OF STOCKHOLDERS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT BIODEL, ALBIREO AND THE PROPOSED TRANSACTION. These documents and other documents filed by Biodel can be obtained free of charge from the SEC’s website at www.sec.gov. These documents also can be obtained free of charge by accessing Biodel’s website at www.biodel.com or by contacting Biodel’s Corporate Secretary at 203-796-5000 or by mail at Investor Relations, Biodel Inc., 100 Saw Mill Road, Danbury, Connecticut 06810.

 

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Participants in Solicitation

Biodel, Albireo, their respective directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies from Biodel’s stockholders in connection with Biodel’s 2016 Annual Meeting of Stockholders under the rules of the SEC. Information about these participants, and a description of their direct and indirect interests, by security holdings or otherwise, may be found in the definitive proxy statement that Biodel filed with the SEC on September 19, 2016 relating to its 2016 Annual Meeting of Stockholders. The definitive proxy statement has been mailed to all stockholders of record as of the record date set for the 2016 Annual Meeting of Stockholders and can also be obtained free of charge from the sources indicated above. Other information regarding participants in the proxy solicitation may be contained in other relevant materials filed by Biodel with the SEC.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: October 3, 2016				BIODEL INC.
				By:		/s/ Paul S. Bavier
						Paul S. Bavier Interim President and General Counsel

 

 

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EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press release of Albireo Limited dated October 3, 2016

 

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Exhibit 99.1

Albireo Announces Positive Top-Line Phase 3 Results for Elobixibat in Japan

BOSTON, MA — October 3, 2016 — 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.

About the Phase 3 Clinical Trial

The Phase 3 clinical trial of elobixibat was a double blind, placebo controlled, multicenter study in patients with chronic constipation in Japan. Patients were randomized to receive a fixed dose of elobixibat or placebo for 14 days. The Phase 3 trial, together with an ongoing clinical trial to evaluate the long-term safety of elobixibat in chronic constipation, represents the Phase 3 registration program in Japan for elobixibat as a treatment for chronic constipation.

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About Elobixibat

Elobixibat is a first-in-class product candidate in development for chronic idiopathic constipation (or, in Japan, chronic constipation). Elobixibat inhibits the 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 the small intestine. Elobixibat has been evaluated in over 1,000 healthy volunteers and chronic constipation patients to date worldwide.

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.

About EA Pharma

EA Pharma Co., Ltd. is a gastrointestinal specialty pharma having a full value chain of research and development, production and logistics, sales and marketing, established in April 2016 by integration of the gastrointestinal business unit with more than 60 year-history of the Eisai Group and the Ajinomoto Group’s gastrointestinal business unit with the core in amino acid. Please see http://www.eapharma.co.jp/ for more information about EA Pharma Co., Ltd.

Forward-Looking Statements — Albireo

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 the filing of an application for regulatory approval of elobixibat to treat chronic constipation 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: those described in the documents Biodel Inc. has filed with the Securities and Exchange Commission with regard to the proposed share exchange transaction among Biodel, Albireo and Albireo shareholders and noteholders, including the possibility that Biodel may be unable to obtain the stockholder approval required to complete the proposed transaction; the outcome of the ongoing long-term safety clinical trial of elobixibat in Japan; and the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan. 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 and CEO

Albireo Limited

732-687-4238

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