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Biodel to Present Data on Ultra-Rapid-Acting Insulin and Glucagon Product Candidates at 2014 American Diabetes Association Scientific Sessions
|By Marketwired .
|June 10, 2014 07:00 AM EDT
DANBURY, CT--(Marketwired - June 10, 2014) - Biodel Inc. (NASDAQ: BIOD)
- Updated safety and efficacy data from Phase II trial of ultra-rapid-acting recombinant human insulin formulation BIOD-123 in patients with Type 1 Diabetes presented in Oral Scientific Session.
- Two late-breaking poster presentations on concentrated, ultra-rapid-acting insulin formulation BIOD-531.
- New data from a study of glucagon formulation BIOD-961 for use in a novel auto-reconstitution device to treat severe hypoglycemia.
Biodel Inc. will present data on its investigational diabetes product candidates in a scientific forum during the 74th Scientific Sessions of the American Diabetes Association, June 13 - 17, in San Francisco, CA. These data, including an oral presentation of an abstract on the ultra-rapid-acting prandial insulin product BIOD-123 and two poster presentations of the ultra-rapid-acting concentrated insulin BIOD-531, demonstrate significant progress in the development of recombinant human insulin and glucagon therapies.
"We are pleased to present data on novel insulin formulations with unique profiles that may offer important advantages for patients with diabetes," said Alan Krasner, M.D., Chief Medical Officer, Biodel Inc. "BIOD-961 is a glucagon formulation designed for use with a user-friendly auto-reconstitution injector device. This may represent an attractive alternative to current therapies which involve cumbersome, labor-intensive reconstitution kits for emergency treatment of severe hypoglycemia."
Biodel presentations and published abstracts include:
Oral Presentation Abstract #130-OR: Safety and Efficacy of Ultra-Rapid-Acting Human Insulin Formulation BIOD-123 in Patients with Type 1 Diabetes will be presented by Alan Krasner, M.D. (Biodel Inc.) on Saturday, June 14, 2014, at 4:45 pm PDT in the Oral Session entitled Prandial Insulin Therapy scheduled for 4:00 - 6:00 pm PDT. In a Phase 2 study, BIOD-123 met the primary efficacy endpoint of non-inferiority in change from baseline HbA1c relative to the rapid-acting insulin analog marketed as Humalog®.
Late Breaking Poster Presentation Abstract #79-LB: Pharmacokinetic and Pharmacodynamic Profiles of BIOD-531 Vs. Insulin Lispro U-100 or U-500R Following Pump Bolus or Subcutaneous Administration in Miniature Diabetic Swine will be presented by Roderike Pohl, Ph.D. (Biodel Inc.) on Sunday, June 15, 2014, 12:00 pm - 2:00 pm PDT, #79-LB in category 01-B Clinical Therapeutics/New Technologies-Insulins.
Late Breaking Poster Presentation Abstract #82-LB: Concentrated Insulin BIOD-531 Is Associated with Accelerated Onset of Action Compared to Humulin® R U-500 and Humalog®
Mix75/25™ and a Basal Duration Profile
will be presented by Linda Morrow, M.D. (Profil Institute of Clinical Research) on Sunday, June 15, 2014, 12:00 pm - 2:00 pm PDT, #82-LB in category 01-B Clinical Therapeutics/New Technologies-Insulins. In a head-to-head Phase I trial, BIOD-531 demonstrated a faster onset of action compared to concentrated human insulin and Humalog® Mix 75/25 and a basal duration of action.
Abstract #2387-PO: Novel Adult and Pediatric Auto-Reconstitution Glucagon Formulations for Treatment of Severe Hypoglycemia: Comparison to Marketed Glucagon in Dogs by lead author Roderike Pohl, Ph.D. (Biodel Inc.). This abstract will be published in the Clinical Therapeutics/New Technology-Non-Insulin Injectables category.
The presentation abstracts can be accessed by registered meeting attendees through the association's website, www.diabetes.org.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. Biodel's product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.
BIOD-123 is an ultra-rapid-acting mealtime insulin in development for the treatment of type I and type II diabetes. BIOD-123 combines recombinant human insulin (RHI) with a proprietary combination of excipients to increase the rate of absorption following injection when compared to other commercially available insulin formulations.
BIOD-531 is an ultra-rapid-acting concentrated insulin (U-400) formulation intended to address insulin-resistant patients requiring large doses of insulin and patients who use premixed insulins. In clinical studies, BIOD-531 demonstrated a more rapid rate of absorption and onset of action than Humulin® R U-500 and Humalog®
Mix75/25™ premixed insulin and an extended duration of action that is expected to be suitable for basal insulin needs.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. 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, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the "rapid-acting" mealtime insulin analogs presently used to treat patients with type 1 and type 2 diabetes and our glucagon presentation that is intended to treat patients experiencing severe hypoglycemia; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize a proprietary formulation of injectable insulin or a stable glucagon presentation; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a stable glucagon presentation; our ability to secure approval from the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, development and clinical programs, including any resulting data analyses; our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than Linjeta™ (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the degree of clinical utility of our product candidates; the ability of our major suppliers to produce our products in our final dosage form; our commercialization, marketing and manufacturing capabilities and strategies; our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent report on Form 10-Q for the first fiscal quarter ended March 31, 2014. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
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