Navigation Links
Biodel Inc. Expands Ongoing Phase III VIAject(TM) Clinical Trials Into Europe
Date:9/21/2007

DANBURY, Conn., Sept. 21 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) today announced that the Company has expanded its two ongoing pivotal Phase III clinical trials of VIAject(TM) into Europe. Clinical sites have been initiated in Germany and patient treatment has begun.

"We are expanding VIAject(TM)'s pivotal Phase III trials into Europe to support our planned European registration of VIAject(TM)," stated Dr. Solomon S. Steiner, Chairman and CEO of Biodel. "Given the worldwide prevalence of diabetes, we are determined to establish VIAject(TM) as a global solution. Evaluating VIAject(TM)'s therapeutic profile in European patients with Type 1 and Type 2 diabetes gives us the opportunity to demonstrate VIAject(TM)'s clinical outcomes across a more diverse patient population."

VIAject(TM) is currently undergoing two pivotal Phase III clinical studies. The two studies, one enrolling 400 Type 1 diabetic patients and the other enrolling 400 Type 2 diabetic patients, are comparing the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin. Both studies are open label and involve a treatment regimen that is six months in duration. Clinical endpoints of both trials include non-inferiority in terms of HbA1c levels and safety.

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(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 trials and two osteoporosis product candidates 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 then 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 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 June 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©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Biodel Inc. to Present VIAject Clinical Progress at the 2007 American Diabetes Association Meeting
2. PromegaExpress Expands Easy Access to Products with New Cabinet
3. Pharmacyclics Announces Interim Results From Two Ongoing Phase 2 Trials Supporting Potential of Xcytrin Plus Chemotherapy to Treat Recurrent Non-Small Cell Lung Cancer
4. Advanced Viral Research Corp. Announces Positive Preliminary Findings from Ongoing Phase II Dermatological Study
5. Novelos Therapeutics Announces Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dana-Farber/Partners Cancer Care
6. Columbia Laboratories Reports Preliminary Findings from the Ongoing Data Analysis of the Phase III Clinical Study of PROCHIEVE 8% (progesterone gel) to Prevent Preterm Birth
7. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
8. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
9. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
10. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
11. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... , Oct. 12, 2017 AVACEN Medical , ... company with their  2017 New Product Innovation Award for ... extensive primary and secondary medical device market research by Frost ... its first-to-market OTC, drug-free pain relief product, the AVACEN 100, ... to treating fibromyalgia widespread pain. ...
(Date:10/11/2017)... -- Caris Life Sciences ® , a leading innovator in ... medicine, today announced that St. Jude Medical Center,s Crosson ... as its 17 th member. Through participation with ... Institute will help develop standards of care and best ... cancer treatment more precise and effective. ...
(Date:10/10/2017)... --  West Pharmaceutical Services, Inc. (NYSE: WST), a ... today shared the results of a study highlighting the ... administration of polio vaccines. The study results were presented ... by Dr. Ondrej Mach , Clinical Trials and ... and recently published in the journal Vaccine. i ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Ellevate Network, the leading network for professional women, brought together some of ... their inaugural Summit in New York City in June. The event was livestreamed with ... 3 million. To watch the Mobilize Women video, click here . , ...
(Date:10/13/2017)... ... , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has ... least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a ... centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: ... “America On The Brink” is the creation of published author, William Nowers. ... As a WWII veteran, he spent thirty years in the Navy. Following ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... now treating sleep apnea using cutting-edge Oventus O2Vent technology. As many ... sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer significant ...
Breaking Medicine News(10 mins):