Biodels glucagon formulation for use in a proprietary autoreconstitution device for the treatment of severe hypoglycemia meets primary efficacy endpoint in phase 1 clinical trial marketwired. A phase 3 trial is expected to start in late 2015 or early 2016. The medication that is currently on the market is unstable and therefore problematic. Glucagon is a 20amino acid peptide secreted by the alpha islet cells. All content is posted anonymously by employees working at biodel.
Biodel to present data on concentrated ultrarapidacting. Biodel, latitude, and xeris had notable announcements on their glucagon programs. According to the deal, emergent will fill and complete commercial quantities of biodel inc nasdaq. The company completed a phase 1 clinical trial to assess the pharmacokinetic and pharmacodynamic profiles of biod961, the reconstituted glucagon formulation intended for use in the gem device. A novel readytouse liquid stable glucagon rescue pen grp. The device has been customized for convenient portability and ease of use to enable rapid treatment during emergency situations with little to no training. Glucagon is a naturally occurring hormone in the body released by the. Financial terms of the agreement have not been disclosed. As background, current forms of glucagon require mixing a powder with water before injection reconstitution. First, biodel demonstrated a prototype of its new glucagon rescue delivery device. Biodel s glucagon formulation for use in a proprietary autoreconstitution device for the treatment of severe hypoglycemia meets primary efficacy endpoint in phase 1 clinical trial marketwired. The form of glucagon that biodel is developing is a breakthrough for the hi population because it is a more stable form of the drug. Glucagon you and your hormones from the society for. Glucagon has a major role in maintaining normal concentrations of glucose in blood, and is often described as having the opposite effect of insulin.
Ive written about them before, and they were even an entrant in last years diabetesmine. Technically, neither of these products is considered a generic medication. Biod announced today that management will present new preclinical pharmacokinetic and pharmacodynamic data on its glucagon formulation intended for use in a novel autoreconstitution device. Biodel initiates clinical proof of concept study in. Biod will present data from human and animal studies with its ultrarapidactingbasal insulin and glucagon product candidates during the 75th scientific sessions of the american. Pdt the company recently received feedback from the fda regarding. The gem device, to which biodel holds exclusive rights for use with glucagon, is a customized version of unilifes dualchamber autoreconstitution. Biodel reported a loss of 15 cents per share, narrower than the yearago loss of 66 cents per share and the zacks consensus estimate of a loss of 26 cents. Development of stable liquid glucagon formulations for use. Biodel is also working on a simpler glucagon device that would autoreconstitute the glucagon powder and water in three steps. Stabilized glucagon formulation for bihormonal pump use. Albireo completes transaction with biodel to create publicly.
Biodels gem product candidate is a lyophilized glucagon formulation provided in a proprietary autoreconstitution device intended for the. Biodel obtains technologies for development of glucagon. Biodel plans to submit nda for glucagon rescue device to. Glucagon increases blood glucose concentration and is used in the treatment of severe hypoglycemia. Traditional glucagon kits require users to inject liquid from a syringe into a vial of glucagon powder, shake the vial until the liquid turns clear, and withdraw the liquid into the syringe before injecting. Familiarize patients and yourself with pen devices or delivery kit. Like insulin, glucagon is dysregulated in type 2 diabetes t2d and contributes to its pathology.
Apr 30, 2020 glucagon plural glucagons biochemistry a peptide hormone, produced by the pancreas, that opposes the action of insulin by stimulating the production of sugar derived terms edit. Biodel announces commercial supply agreement with bd for. Dec 17, 20 low unit costs allow biodel to develop liquid glucagon filled multipacks that enable users to remove a single device from refrigerated storage every four months to be carried as a goanywhere. Hans vitzthum managing director lifesci advisors, llc. Better formulations and devices for glucagon treatment of hypoglycemia are. Recent small pharma offerings create tempting current entries. Glucagon production is under the control of both hormones and neurotransmitters. Biodel to produce glucagon rescue product asweetlife. A device system which automatically maintain blood glucose concentrations in the normal range by dosing. Biodel signs manufacturing agreement with emergent for. Find patient medical information for glucagon emergency kit human recomb injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The purpose of this study is to evaluate how much biod961 absorbs into the bloodstream, how much it raises glucose concentrations the intended. Building a bionic pancreas innovation smithsonian magazine. And the american diabetes association instructs users to inject glucagon into a large muscle.
It develops its product candidates by applying its formulation technologies to existing drugs. Glucagon glucagon rdna origin dose, indications, adverse. This project is student created and the result of the design team recognizing a serious problem and. Theres no question that current glucagon injection kits are very difficult to use correctly, but these data show even the trained caregivers of people with diabetes find them hard to use. Mixing pens and the future of diabetes drugs europe pmc. Biod today will provide an update on its stabilized glucagon program at the roth 24th annual oc growth stock conference in laguna niguel, california. Since the glucagon receptor has several moving parts, it has been a challenging target for structural study. The current method of injecting glucagon during a hypoglycemic seizure is lengthy and complicated when time equates to minimizing the effects of an emergency situation. Glucagon is available from two different manufacturers in the united states. This has led to dramatic underutilization of glucagon.
The process is rather clunky and involves several steps, a significant roadblock for untrained. Glucagon, a pancreatic hormone produced by cells in the islets of langerhans. The formulation consists of lysolecithin, reducing sugar, alcohol, and phosphate buffer to maintain the ph at 7. Biodel, latitude, and xeris seek to improve glucagon diatribe. Calculations from a 1 mg dose showed a small volume of distribution mean, 0. The fda has approved baqsimi, a nasally administered glucagon, for the. The concept is to immobilize the glucagon in a micelle. Biodel completes enrollment in phase 2 clinical trial of. The new gem delivery system would provide clear, stepbystep instructions written on the device, rather than on a.
The secretion from the p beta cells and a alpha cells of the pancreatic islets is regulated largely by the blood glucose concentration. Practical use of glucagonlike peptide1 receptor agonist therapy. Biodel intends to submit an investigational new drug application for the device to the u. According to many studies on glucagon immunoassay, it has been established that the antibody against the c terminal fragment 19 29 of glucagon has specific binding with pancreatic glucagon, whereas the antibody against the n terminal fragment 9 19 of glucagon has specific binding with both of pancreatic and intestinal glucagon total glucagon. Biodels glucagon device speeds the preparation process for lifesaving glucagon and minimizes confusion. Biod today announced the completion of patient enrollment in a phase 2 clinical study of ultrarapidacting prandial insulin candidate biod123 for the treatment of diabetes.
Recently, biodel and emergent biosolutions signed a longterm manufacturing agreement for a dualchamber glucagon rescue device under the glucagon emergency management development program. Proxy advisory firms, iss, glass lewis recommend biodel stockholders vote in favor of the proposals necessary to complete the companys planned combination with. Eli lilly is the first pharmaceutical company to commercialize native glucagon for the treatment of hypoglycaemia. These include biodels since acquired by albireo pharma, boston, ma. Human factors usability and validation studies of a. Biod961 is a dry powder formulation of glucagon intended for use in a device that mixes reconstitutes the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. For an overview of glucagon action, see the section on the glucagon receptor. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0. Glucagon administered through a parenteral route relaxes smooth muscle of the stomach, duodenum, small bowel, and colon. Now, bus drivers, teachers, and coaches will feel more confident that they.
Glucagon, which folds into a short alpha helix, is taken from a crystal structure of the isolated hormone, from pdb entry 1gcn. Biodel has obtained exclusive worldwide license to aegis proprietary protek and intravail technologies for the development of glucagon formulations. Gem is an intuitive, easytouse device designed to address and expand a market underserved by the currently. Glucagon is a 29aminoacid peptide that is produced specifically by the alpha cells of the islets. Biodel inc biodel announces commercial supply agreement. In fact, lilly recently introduced an iphone and android app called glucagon, a welldesigned free tutorial that explains how to use its rescue kit. The financial terms for the deal have not been disclosed. Fda grants orphan drug status to biodel s glucagon. Biods gem device, to which it holds exclusive rights for use with glucagon. Biodel q3 loss narrower than expected, gives pipeline update. Glucagon inhibits insulin secretion, and vice versa. Oral delivery of therapeutic levels of glp1 has also been achieved in human subjects.
A simpler approach to treating hypos insulin nation. The precise locus for glp1 action in these studies is not clear, as levels of insulin, glucagon or rate of gastric emptying was not reported. Whether measured by time or accuracy, the locemia device performed dramatically better in this human factors study. Emergency glucagon injection device by john corbett. It works to raise the concentration of glucose and fatty acids in the bloodstream, and is considered to be the main.
Biodel glucagon was formulated with pure crystalline glucagon from celtek nashville, tn. The device is more complicated than the xeris, locemia, and zosano approaches, but simpler than the current kits. Because glucagon is of little help in states of starvation, adrenal insufficiency or chronic hypoglycemia, intravenous glucose should be used for treatment of hypoglycemia in those conditions. Glucagon is a drug administered to people with diabetes that are experiencing a seizure due to low blood glucose levels. Fda approves nasal glucagon baqsimi a radical improvement. Glucagon has been studied following intramuscular, subcutaneous, and intravenous administration in adult volunteers. Biodel s glucagon device speeds the preparation process for lifesaving glucagon and minimizes confusion. Biodel inc biodel announces commercial manufacturing. Biodel s glucagon emergency management gem system is a lyophilized glucagon formulation provided in a proprietary autoreconstitution device intended for the rescue treatment of patients with. Glucagon is a 29 amino acid peptide hormone liberated in the.
As clampart, our novel automated clamp device, offers the option to modify the. Biodel announces commercial supply agreement with bd for liquid glucagon rescue device danbury, conn. Regulation of insulin and glucagon secretion human physiology. Apr 08, 2015 damiano is striving to have a fully integrated deviceone single unit the size of an iphone 5 with an insulin pump, glucagon pump, sensor and receiver in a batterypowered infusion setready. Biodel biod announces study 6101 met primary endpoint. Glucagon content of biodel glucagon and lilly glucagon at ph 2 and ph 4, as measured by highperformance liquid chromatography at 25 c, was 100% at 7 days compared to 87% and glucagon at ph 4 formed an opaque gel, while biodel glucagon formulation remained a clear solution. Both companies expect to submit their products to the fda in late 2015 or 2016. Glucagon stimulates hepatic gluconeogenesis and glycogenolysis, thereby increasing blood glucose. Jan, 2012 in all of these pathological scenarios, hypoglycemia is not a primary driver for glucagon secretion, and instead, other provoking factors must be sought. A stable liquid formulation of glucagon would also be of use for the cur. Thus, a family member or friend must mix glucagon powder with diluent it in a syringe, as required by current glucagon kits. As a medication it is used to treat low blood sugar, beta blocker overdose, calcium channel blocker overdose, and those with anaphylaxis who do not improve with epinephrine. The release of glucagon is prevented by raised blood glucose and carbohydrate in meals, detected by cells in the pancreas. Glucagon should be given only if the patient is unconscious or unresponsive and unable to ingest oral glucose.
The design integrates the glucagon powder and diluent into a dual chamber cartridge within the pen. Albireo pharma previously biodel is developing stable, neutral ph 7 liquid formulations of glucagon, utilising its proprietary viadel technology, which can. That is, glucagon has the effect of increasing blood glucose levels. Biodel, latitude, and xeris seek to improve glucagon. The release of glucagon is stimulated by low blood glucose, proteinrich meals and adrenaline another important hormone for combating low glucose. In the longerterm, glucagon is crucial to the bodys response to lack.
It causes liver glycogen, a polysaccharide, to break down to glucose, thereby increasing the amount of sugar in the bloodstream. The biggest problem with todays glucagon kitsmade by novo nordisk and eli lilly and companyis that they involve several steps before administering, and those steps are easy to forgot or screwup when someone is watching a person they love lying unconscious on the floor or having a seizure due to severe hypoglycemia. Gem is being developed for use as a rescue treatment for severe hypoglycemia. Biodels autoreconstitution devices are designed to offer twoyear stability for emergency glucagon administration with little to no training. Recently, biodel and emergent biosolutions ebs signed a longterm manufacturing agreement for a dualchamber glucagon rescue device under the glucagon emergency management gem development. It also develops ultrarapidacting proprietary insulin formulations, such as biod531, a concentrated ultrarapidacting insulin formulation. The product is a portable, singleuse dispenser containing readytouse nasal spray of 3 mg native glucagon with improved stability. Biodel held a series of lunch briefings to introduce their glucagon emergency management gem system, currently still in development. Biodel s glucagon injection system is designed to improve on existing treatments for. The process is rather clunky and involves several steps, a significant roadblock.
Jul 09, 2010 enter enject, the smart folks who are developing a simpletouse glucagon pen, aptly named the glucapen. The company recently received united states food and drug administration usfda approval for firstever nasal glucagon, baqsimi. Gem is a customized version of unilifes dual chamber auto reconstitution syringe. To be fair, both lilly and novo know how to design appealing solutions that are user friendly. Administration of the intravenous glucagon showed dose proportionality of the pharmacokinetics between 0. Biodel is also working on a simpler glucagon device. Biodel is working with physicians to develop a more stable form of glucagon for use in bihormonal pumps, which could replace current insulin pumps and continuous glucosemonitoring devices. Pharmacokinetics and pharmacodynamics of biod961 vs.
Glucagon definition of glucagon by medical dictionary. Glucagon, insulin infusion systems and carbohydrates researchgate, the. The gem device, to which biodel holds exclusive rights for use with glucagon, is a customized version of unilifes dualchamber autoreconstitution syringe. Biodels glucagon emergency management autoreconstitution. The company is a biopharmaceutical company focused on the development and commercialization of treatments for diabetes.
Development of novel and stable glucagon formulations for closed loop systems. It has a high degree of similarity with several glucagon like peptides that are secreted by cells scattered throughout the gastrointestinal tract. Glucapen glucagon without prior mixing glucapen is an autoinjector pen containing glucagon which is substantially different from the currently marketed hypokits. Abstract presented at diabetes technology meeting, october 2224, 2015. Glucagon acts only on liver glycogen, converting it to glucose. Biod announced positive preliminary results from study 6101, a phase 1 clinical trial comparing biodel s lyophilized glucagon. Biodels glucagon formulation for use in a proprietary. It can also mobilize fatty acids for energy purposes. The device automatically reconstitutes lyophilized glucagon when prepared for injection and features automatic, usercontrolled retraction of the needle upon full dose delivery, virtually eliminating dosing errors. The image shown here is a model of the whole complex built from several different pdb entries. Having previously signed a longterm commercial supply agreement for bulk glucagon, biodel expects to select a final formulation of its novel glucagon therapy and appoint a contract manufacturing.
Biodels glucagon emergency management gem system is a lyophilized glucagon formulation provided in a proprietary autoreconstitution device intended for the rescue treatment of patients with. Diabetes in school children pa department of health pa. A composite model of glucagonglucose dynamics for in silico. Ching k, andre a, crick m, et al biodel s glucagon emergency management auto reconstitution device demonstrates superior usability compared to marketed glucagon kits in human factors study. Under the agreement, emergent will fill and finish commercial quantities of the gem device. Biodel has announced plans to submit a new drug application nda to the fda in 2015 for a novel glucagon rescue device to treat severe hypoglycemia. Biodel s current prototype device would require just two steps to prepare for use.