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Biodel Inc. (BIOD) Obtains Exclusive License to Aegis Therapeutics, LLC' Technologies for Development and Commercialization of Glucagon Pharmaceutical Formulations



6/11/2012 10:43:17 AM

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.

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.

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. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. For further information regarding Biodel, please visit the company's website at www.biodel.com.

About Aegis Therapeutics

Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses. Aegis' Intravail® drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs that can currently only be administered by injection, via the oral, buccal, and intranasal administration routes, and with high bioavailability. Aegis' ProTek® excipients stabilize, prevent aggregation, and reduce unwanted immunogenicity of protein and peptide therapeutics while avoiding the oxidative damage caused by polysorbate surfactants currently found in most protein injectable drugs. For more information about Aegis, please visit the company's website at www.aegisthera.com.

Safe-Harbor Statement

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; our ability advance a proprietary insulin formulation into a Phase 2 clinical trial in a timely manner; 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; 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 quarter ended March 31, 2012. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

BIOD-G

Contact: Seth D. Lewis, +1-646-378-2952

SOURCE Biodel Inc.


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