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
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
SYS-CON Events announced today that Bsquare has been named “Silver Sponsor” of SYS-CON's @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. For more than two decades, Bsquare has helped its customers extract business value from a broad array of physical assets by making them intelligent, connecting them, and using the data they generate to optimize business processes.
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
SYS-CON Events announced today that Secure Channels will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The bedrock of Secure Channels Technology is a uniquely modified and enhanced process based on superencipherment. Superencipherment is the process of encrypting an already encrypted message one or more times, either using the same or a different algorithm.
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?