biodel inc (BIOD) Key Developments
Biodel Inc. Announces the Results from A Formative Human Factors Study of its Glucagon Emergency Management
Apr 6 15
Biodel Inc. announced results from a formative human factors study of its Glucagon Emergency Management (GEM) device, which is in development for the treatment of diabetes patients experiencing severe hypoglycemia. In the study, the GEM device demonstrated a substantial improvement in ease-of-use and successful delivery of the full dose, as well as a reduction in dosing errors, when compared to commercially available glucagon kits (Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen(R) HypoKit(TM)). The average time to dose delivery was 48% faster with the GEM device compared to the marketed glucagon kits (76.3 seconds vs. 113.4 seconds; p(0.05). The formative human factors study was designed to compare the usability and performance of the GEM device to the current marketed glucagon kits (Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen(R) HypoKit(TM)) under simulated emergency conditions and to determine the impact of previous experience with the glucagon kits and training. The first group consisted of eight caregivers of diabetic patients and first responders, all of whom were familiar with through prior training and/or experience at least one of the marketed glucagon kits. The second group consisted of eight caregivers of diabetic patients and first responders who were naive to the marketed glucagon kits. The third group consisted of eight adults with no relationship to a diabetes patient who were naive to the marketed glucagon kits.
Biodel Mulls Acquisitions
Mar 19 15
Biodel Inc. (NasdaqCM:BIOD) is looking for acquisitions. Biodel Inc. has filed a follow-on equity offering and intends to use the net proceeds from this offering for operating costs, capital expenditures and for general corporate purposes, including working capital. Biodel Inc. may also use a portion of the net proceeds to invest in or acquire businesses or technologies that are complementary to their own.
Biodel Inc. Approves Amendment to the Second Amended and Restated Certificate of Incorporation
Mar 18 15
Biodel Inc. at its annual meeting of stockholders 2015 held on March 17, 2015, approved the amendment to the company's Second Amended and Restated Certificate of Incorporation, as amended, to effect an increase in the number of shares of authorized common stock, par value $0.01 per share, from 62,500,000 shares to 200,000,000 shares.
Biodel Inc. Announces Positive Preliminary Results from Study 6-101, a Phase 1 Clinical Trial
Mar 16 15
Biodel Inc. announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management (GEM) auto-reconstitution device, to Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen(R) HypoKit(TM), which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously (SC) and intramuscularly (IM) in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic (PK) profiles, the pharmacodynamic (PD, glucose) responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Overall, PK and PD (glucose response) profiles among all three glucagon formulations were statistically indistinguishable. Although this study was designed as an exploratory comparison of PK and PD profiles, standard regulatory criteria for PK and PD bioequivalence were satisfied when comparing BIOD-961 to Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen(R) HypoKit(TM). As expected, nausea was the most common adverse event for all glucagon formulations. The incidence of adverse events was similar among treatments. Biodel formulated BIOD-961 for use in a user-friendly injection device, referred to as the Glucagon Emergency Management (GEM) system. The GEM device is a customized version of an auto-reconstitution syringe developed by Unilife Corporation. The device is specifically designed to address and expand an underserved market currently wrestling with cumbersome glucagon kits that are especially difficult to use and operate during an emergency for the treatment of severe hypoglycemia. This is the first glucagon formulation in development for the treatment of severe hypoglycemia which has demonstrated comparable pharmacokinetic and pharmacodynamic profiles to marketed glucagon formulations. In addition to the pivotal clinical trial, a human factors study is planned for the first half 2015 to compare the usability of the GEM device to the existing manually reconstituted commercial glucagon kits in the hands of representative caregivers, with the final pivotal human factors study expected to be completed by the end of 2015. The company plans to request an end-of-Phase 2 meeting with the FDA in the second calendar quarter of 2015 and submit the NDA in mid-2016.
Biodel Inc. - Special Call
Mar 16 15
To discuss preliminary results from Study 6-101, a phase 1 clinical trial comparing company's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management auto-reconstitution device, to Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit