News Feed Item
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.
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams.
In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums.
John Paul is the CEO and Founder of VenueNext. Prior ...
Jul. 24, 2016 10:45 PM EDT Reads: 1,960
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these.
In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effi...
Jul. 24, 2016 10:00 PM EDT Reads: 1,941
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, discussed how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved efficienc...
Jul. 24, 2016 09:45 PM EDT Reads: 1,902
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
Jul. 24, 2016 09:45 PM EDT Reads: 1,624
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems.
In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm ...
Jul. 24, 2016 09:45 PM EDT Reads: 2,116
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 24, 2016 09:00 PM EDT Reads: 1,463
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jul. 24, 2016 09:00 PM EDT Reads: 2,457
Big Data engines are powering a lot of service businesses right now. Data is collected from users from wearable technologies, web behaviors, purchase behavior as well as several arbitrary data points we’d never think of. The demand for faster and bigger engines to crunch and serve up the data to services is growing exponentially. You see a LOT of correlation between “Cloud” and “Big Data” but on Big Data and “Hybrid,” where hybrid hosting is the sanest approach to the Big Data Infrastructure pro...
Jul. 24, 2016 07:45 PM EDT Reads: 1,846
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Jul. 24, 2016 07:30 PM EDT Reads: 1,687
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 24, 2016 07:30 PM EDT Reads: 2,049
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., and Logan Best, Infrastructure & Network Engineer at Webair, focused on real world deployments of DDoS mitigation strategies in every layer of the network. He gave an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He also outlined what we have found in our experience managing and running thousands of Linux and Unix ...
Jul. 24, 2016 07:30 PM EDT Reads: 1,706
Continuous testing helps bridge the gap between developing quickly and maintaining high quality products.
But to implement continuous testing, CTOs must take a strategic approach to building a testing infrastructure and toolset that empowers their team to move fast.
Download our guide to laying the groundwork for a scalable continuous testing strategy.
Jul. 24, 2016 07:15 PM EDT Reads: 1,854
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure.
In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
Jul. 24, 2016 07:00 PM EDT Reads: 1,927
In his session at @DevOpsSummit at 19th Cloud Expo, Yoseph Reuveni, Director of Software Engineering at Jet.com, will discuss Jet.com's journey into containerizing Microsoft-based technologies like C# and F# into Docker. He will talk about lessons learned and challenges faced, the Mono framework tryout and how they deployed everything into Azure cloud.
Yoseph Reuveni is a technology leader with unique experience developing and running high throughput (over 1M tps) distributed systems with extre...
Jul. 24, 2016 06:45 PM EDT Reads: 2,034
"We are a well-established player in the application life cycle management market and we also have a very strong version control product," stated Flint Brenton, CEO of CollabNet,, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 24, 2016 06:45 PM EDT Reads: 1,756