Navigation Links
Biodel Inc. Completes Enrollment of Two Pivotal Phase III Clinical Trials of VIAject(TM) and Plans Manufacturing Facility for VIAject(TM)
Date:1/3/2008

DANBURY, Conn., Jan. 3 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) today announced that the Company has completed enrollment of its two pivotal Phase III clinical trials of VIAject(TM), a rapid-acting injectable meal-time insulin for use by patients with Type 1 and Type 2 diabetes. The Company also announced its intention to build and operate a fill and finish manufacturing facility for VIAject(TM), on the campus of its current headquarters in Danbury, Connecticut.

"We are pleased to have completed enrollment of the VIAject(TM) clinical trials on schedule," commented Solomon S. Steiner, Ph.D., Chairman and Chief Executive Officer of Biodel. "We believe that VIAject(TM)'s superior pharmacokinetic and pharmacodynamic profile should improve the treatment of millions of patients with diabetes."

Biodel has now enrolled over 400 patients with Type 1 diabetes at approximately 60 clinical sites in the United States, Europe, and Asia, and over 400 patients with Type 2 diabetes at approximately 50 clinical sites in the United States, Europe, and Asia. Both studies are multi-center, open label and six months in duration, comparing the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin. Biodel expects to complete these trials and, if the trials are successful, the Company intends to submit a New Drug Application for VIAject(TM) to the Food and Drug Administration by the end of 2008.

To prepare for commercialization of VIAject(TM), the Company plans to build a fill and finish manufacturing facility which will be dedicated to manufacturing a full line of VIAject(TM) liquid formulations and presentations. The dedicated manufacturing facility will improve margins, provide superior quality control, and better inventory control. Biodel anticipates that the facility will cost under $15 million and will be available for commercial production in 2009.

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 lead product candidates are all insulin formulations developed by using the VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. The Company's lead product candidate, VIAject(TM), is a rapid-acting injectable meal-time insulin in development for use by patients with Type 1 or Type 2 diabetes. VIAject(TM) is currently being tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM), a sublingual tablet formulation of insulin in Phase I clinical development, and two osteoporosis product candidates, both of which are in pre-clinical studies. For further information regarding Biodel, please visit the Company's website at http://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 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-K for the fiscal year ended September 30, 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


'/>"/>
SOURCE Biodel Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Biodel Inc. Expands Ongoing Phase III VIAject(TM) Clinical Trials Into Europe
2. Alexza Completes Target Enrollment in AZ-104 Phase 2a Clinical Trial in Migraine Patients
3. NicOx Completes Enrollment in Second Pivotal Phase 3 Study for Naproxcinod and Provides Development Update
4. YMed, Inc. Successfully Completes First Clinical Cases With Innovative VascuTraK(TM) II PTA Dilatation Catheter
5. Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
6. Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
7. AstraZeneca Completes Enrollment in First Phase III Study of the Investigational Drug Vandetanib (ZACTIMA)(R) in Non-Small Cell Lung Cancer
8. U.S. Department of Health and Human Services Completes Funding of 2006 Contract Award to CSCs DVC and Baxter
9. Genta Completes Initial Clinical Dosing of G4544, a New Oral Drug for Bone Diseases
10. Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge(R) For Advanced Prostate Cancer
11. VioQuest Pharmaceuticals Completes Enrollment of Phase I Trial of Lenocta(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  Redwood Scientific Technologies, Inc. ... product designed to help women balance their hormones. This ... technology. Jason Cardiff , President and ... able to help the millions of women across the ... effects of imbalanced hormones. Our research and development team ...
(Date:2/5/2016)... Ontario , Feb. 5, 2016  Aralez Pharmaceuticals ... combination of POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada Inc. ... POZEN and shareholders of Tribute. The combined company will ... pharmaceutical company with operations in Canada ... the United States . Under the terms of ...
(Date:2/5/2016)... -- Dehaier Medical Systems Ltd. (Nasdaq: DHRM ... markets and sells medical devices and wearable sleep ... and international markets, today announced its corporate and ... Company,s resources to develop its mobile health business, ... more on its major businesses. As of this ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... ... the company's lighter, sleeker next generation LYNX VR Indoor Trainer with multi-rider capability ... in design and manufacturing not only reduce the weight of the unit, they ...
(Date:2/5/2016)... ... February 05, 2016 , ... The event is being ... Block Event Center in Minneapolis, Minn. Triumph Over Parkinson’s will fund nearly $100,000 for ... of Schneiderman’s Furniture, lives with Parkinson’s disease and is the architect of this informative ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Looking for a ... be at the tips of your toes. Foot massage, whether administered by a professional ... comfort and relaxation. The American Board of Multiple Specialties in Podiatry (ABMSP) ...
(Date:2/5/2016)... ... 05, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... Tasting Event at the La Gorce Country Club in Miami Beach on March ...
(Date:2/5/2016)... ... 2016 , ... The American public tends to feel uncomfortable about drinking recycled ... municipal or well water. The recent experience with lead contaminated water in Flint, Michigan, ... way toward increasing public acceptance of recycled waste water as drinking water. , ...
Breaking Medicine News(10 mins):