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Biodel Obtains Exclusive License To Aegis Therapeutics' Technologies For Development And Commercialization Of Glucagon Pharmaceutical Formulations

DANBURY, Conn., June 8, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) and Aegis Therapeutics, LLC (Aegis) today announced a partnership providing Biodel an 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. 

Biodel's chief executive officer Dr. Errol De Souza stated: "This license is complementary to our internal efforts to develop stabilized liquid formulations of glucagon for use in a variety of presentations, routes of delivery and indications.  We remain on track for filing an NDA for our first glucagon presentation in late 2013 or early 2014.  The glucagon program addresses an important unmet medical need – the lack of a convenient, user friendly treatment for severe hypoglycemia, while significantly strengthening our pipeline."

Aegis Therapeutics' chief executive officer Dr. Edward T. Maggio stated: "We are pleased to be working with Biodel on this exciting application of our technology and look forward to a fruitful relationship as Biodel works toward commercializing a number of different glucagon products utilizing our patented or propriety ProTek® and Intravail® technologies."

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. 

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