-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Ku2av1wY4ymDcT3ECZ6Al31DVeHdDYpXxxZ+cOkDwPvsiGBX/KTZW+uxYbe31buo nlRdvH9rloYUZjuUtsP27Q== 0000950123-08-007939.txt : 20080717 0000950123-08-007939.hdr.sgml : 20080717 20080716212706 ACCESSION NUMBER: 0000950123-08-007939 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080716 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080717 DATE AS OF CHANGE: 20080716 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Biodel Inc CENTRAL INDEX KEY: 0001322505 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33451 FILM NUMBER: 08955882 BUSINESS ADDRESS: STREET 1: 100 SAW MILL ROAD CITY: DANBURY STATE: CT ZIP: 06810 BUSINESS PHONE: 203-796-5000 MAIL ADDRESS: STREET 1: 100 SAW MILL ROAD CITY: DANBURY STATE: CT ZIP: 06810 8-K 1 y63327e8vk.htm FORM 8-K 8-K
 
 
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): July 16, 2008
BIODEL INC.
(Exact name of registrant as specified in its charter)
Commission File Number 001-33451
     
Delaware   90-0136863
(State or other jurisdiction of incorporation or organization)   (IRS Employer Identification Number)
     
100 Saw Mill Road
Danbury, Connecticut
  06810
(Address of principal executive offices)   (Zip code)
(203) 798-3600
(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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 7.01. Regulation FD Disclosure
          On July 16, 2008 Biodel Inc. (the “Company”) issued a press release, a complete copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference.
          This information is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing. By filing this report on Form 8-K and furnishing this information, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.
Item 9.01 Financial Statements and Exhibits.
(d)   Exhibits.
          The following exhibit relating to Item 7.01 shall be deemed to be furnished and not filed:
          99.1 Press Release issued by the Company on July 16, 2008.

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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: July 16, 2008  BIODEL INC.
 
 
  By:       /s/ Gerard Michel    
    Gerard Michel, Chief Financial Officer   
       
 

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EX-99.1 2 y63327exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
EXHIBIT 99.1
Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject™ Program
DANBURY, Conn., July 16, 2008 — Biodel Inc. (Nasdaq: BIOD) today announced that its two pivotal Phase III VIAject™ clinical trials are now complete, with the last study patient visit on July 14, 2008. Results of the full trial will be released either at Biodel’s poster presentation at the European Association for the Study of Diabetes (EASD) on Tuesday, September 9, 2008, or at a later appropriate scientific forum.
Biodel also announced that two abstracts containing interim data from its VIAject™ Phase III clinical trials was posted on the Website for the 44th Annual Meeting of the EASD. The abstracts disclosed results of a January 2008 preliminary interim analysis of the secondary endpoints of dose, weight, and mild and moderate hypoglycemic events for the VIAject™ Phase III clinical trials.
“We continue to meet our timelines and are encouraged by the VIAject™ Phase III interim data, which continues to meet our expectations,” stated Dr. Solomon Steiner, Chief Executive Officer and Chairman of Biodel. “We look forward to performing our final analysis and presenting data from the completed studies after the clinical trial database has been locked.”
The interim analysis, dose and weight changes after six weeks of drug treatment were compared to the baseline for all patients who had completed six weeks or more of treatment. Additionally, total mild and moderate hypoglycemic events as of January 2008 were compared across the two treatment arms. The following additional information was reported in the EASD abstracts:
The interim results demonstrated statistically significant differences in weight changes in patients with Type 1 and Type 2 diabetes using VIAject™ compared to Humulin® R in the first six weeks of the study. Type 1 patients (n=102) receiving VIAject™ showed no change in weight compared to baseline, while a weight gain (1.4 ±2.9 kg) was seen in the patients (n=108) receiving Humulin® R (p<0.001). Type 2 patients (n=173) receiving VIAject™ showed a weight reduction (-0.5 ±4.7 kg) compared to baseline, while a weight gain (0.8 ±6.2 kg) was seen in the patients (n=180) receiving Humulin® R (p<0.05), for a net difference of 1.3 kg.
The interim results demonstrated statistically significant daily meal-time (prandial) dose reductions in patients with Type 1 and Type 2 diabetes using VIAject™ compared to Humulin® R in the first six weeks of the study. With comparable glycemic control targets between treatment groups, Type 1 patients (n=106) receiving VIAject™ showed a 34 percent reduction in daily prandial dose (10 units; p<0.001) compared to baseline, while control patients receiving Humulin® R showed a non-significant 7 percent reduction (2.4 units). Type 2 patients receiving VIAject™ showed a 36 percent reduction (16 units; p<0.001), while control patients receiving Humulin® R showed an increase of 15 percent (6 units; p<0.01), for a net difference of 51 percent.
The interim results demonstrated statistically significant reductions in mild and moderate hypoglycemic events in patients with Type 1 and Type 2 diabetes using VIAject™ compared to Humulin® R. Type 1 patients recorded 8,111 mild and moderate hypoglycemic events, with a significantly lower number of incidents in the VIAject™ group (3,691; p<0.001) than in the Humulin® R group (4,420). Type 2 patients recorded 2,438 mild and moderate hypoglycemic

 


 

events with a significantly lower number of incidents in the VIAject™ group (844 events) than in the Humulin® R group (1,594 events; p<0.001).
Biodel noted that the final data from these trials may differ from those suggested by the preliminary interim analysis. Furthermore, the primary efficacy endpoint for the studies, change in HbA1c, has not been analyzed. Both HbA1c and incidences of severe hypoglycemic events will be analyzed and reported after the clinical trial database for the studies has been locked.
About VIAject™
VIAject™ is an ultra rapid-acting injectable human insulin intended for meal-time use by patients with Type 1 or Type 2 diabetes. In Phase I and Phase II clinical trials, VIAject™ has been shown to have a more rapid onset of activity than those reported for the existing rapid-acting insulin analogs. As a result, VIAject™ may be safer, require a lower dose and promote weight loss when compared to currently marketed meal-time insulins. VIAject™ has been tested in two pivotal Phase III clinical trials, which compared the effects of VIAject™ to Humulin® R, the leading recombinant human insulin.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel’s product candidates are developed by using VIAdel™ technology, which reformulates existing FDA-approved peptide drugs. The Company’s lead product candidate, VIAject™, is an ultra rapid-acting injectable meal-time insulin in development for use by patients with Type 1 or Type 2 diabetes. VIAject™ has been tested in two pivotal Phase III clinical trials. Biodel’s pipeline also includes VIAtab™ a sublingual tablet formulation of insulin in the Phase I stage of clinical testing, and two pre-clinical osteoporosis product candidates. For further information regarding Biodel, please visit the Company’s Website at www.biodel.com.
Safe Harbor
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company’s forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to secure FDA approval for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product

 


 

candidates, particularly VIAject(TM) and VIAtab(TM); our ability to secure additional patents for VIAject(TM) and our other product candidates; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. The Company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
BIOD-G
Contact:
Investors and Media should contact Rebecca Der, rder@burnsmc.com, or Susan Neath, sneath@burnsmc.com, both of Burns McClellan, Inc., +1-212-213-0006, for Biodel Inc.

 

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