Biodel Inc. has partnered with Aegis Therapeutics, LLC (Aegis) and has obtained exclusive worldwide license to Aegis’ proprietary ProTek and Intravail technologies for the development and commercialization of pharmaceutical formulations of glucagon.
ProTek protein stabilization technology comprises the use of proprietary GRAS excipients that prevent aggregation of proteins and peptides thereby improving the stability of drug product formulated with these excipients. Intravail comprises a broad class of transmucosal absorption enhancement agents that allow non-invasive systemic delivery of potent peptide, protein, nucleotide-related, and other small and large molecule drugs.
The agreement will enable the development and commercialization of a wide variety of glucagon presentations, including Biodel’s lead glucagon product candidate, a liquid formulation in an auto injector intended for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia. Other presentations and indications contemplated by the agreement include the use of glucagon in the treatment of hyperinsulinemia with continuous subcutaneous infusion and the treatment of hypoglycemia via intranasal administration and administration via a bi-hormonal pump.
Glucagon is a peptide hormone that stimulates the breakdown of the liver’s glycogen stores into glucose, thereby raising blood glucose levels. Glucagon is prescribed to patients with diabetes for use by a caregiver in case of incapacitating severe hypoglycemia. The need for a convenient, ready-to-use formulation is heightened by the increasing usage of intensive insulin therapy, which can increase the incidence of severe hypoglycemia.
Due to the inherent instability of glucagon, currently available rescue products are lyophilized, two-part presentations that require a caregiver to perform multiple manipulations to reconstitute the drug into a solution prior to injection. This process is difficult for many caregivers to perform during an emergency situation when the patient is semi-conscious, unconscious, or having a seizure from hypoglycemia. The complexity of the reconstitution and injection process results in a requirement for the potential caregivers to schedule and undergo training in a physician’s office. The combination of this training requirement and the difficulty many caregivers have with the process limits the number of patients who choose to keep a glucagon rescue product on hand at home, office or school.
Utilizing Aegis’ technology, Biodel is developing formulations of glucagon designed to be more stable in solution at both refrigerated and room temperatures than existing commercial formulations. Accelerated stability data indicates that ProTek-based glucagon formulations have greater physical and chemical stability than existing commercial formulations following reconstitution. Biodel’s liquid formulation of glucagon administered with an auto injector pen device may eliminate the training requirement and also increase the ability of a caregiver to successfully treat a patient during a severe hypoglycemic event. This improved presentation could increase adoption of this important, life saving therapy and significantly expand the market.