Click here to close now.




















Welcome!

News Feed Item

Biodel to Present Data on Ultra-Rapid-Acting Insulin and Glucagon Product Candidates at 2014 American Diabetes Association Scientific Sessions

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.

About BIOD-123

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.

About BIOD-531

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.

Safe-Harbor Statement

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.

BIOD-G

CONTACT:
John Graziano
+1 (646) 378 2942

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Malicious agents are moving faster than the speed of business. Even more worrisome, most companies are relying on legacy approaches to security that are no longer capable of meeting current threats. In the modern cloud, threat diversity is rapidly expanding, necessitating more sophisticated security protocols than those used in the past or in desktop environments. Yet companies are falling for cloud security myths that were truths at one time but have evolved out of existence.
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
Public Cloud IaaS started its life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in adop...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with ...
The Cloud industry has moved from being more than just being able to provide infrastructure and management services on the Cloud. Enter a new era of Cloud computing where monetization’s services through the Cloud are an essential piece of strategy to feed your organizations bottom-line, your revenue and Profitability. In their session at 16th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed how to easily o...
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. The DevOps approach is a way to increase business agility through collaboration, communication, and integration across different teams in the IT organization. In his session at DevOps Summit, Chris Van Tuin, Chief Technologist for the Western US at Red Hat, will discuss: The acceleration of application delivery for the business with DevOps
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, S...