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Biodel Announces Collaboration Agreement With HEC Pharm for Development of Ultra-Rapid-Acting Insulin Aspart Formulation

DANBURY, Conn., April 22, 2014 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today announced the signing of a research supply and technology development agreement with the HEC Pharm subsidiary Yichang Chang Jiang Pharmaceutical Co., Ltd for ultra-rapid-acting insulin aspart. Under the agreement, HEC will supply insulin aspart, the active pharmaceutical ingredient (API) in Novolog®, which Biodel will use to formulate aspart based ultra-rapid-acting insulin formulations. Biodel has granted HEC an option to enter into negotiations for an exclusive license to develop and market in China any resulting product candidates. Biodel maintains rights to the product candidates in worldwide markets outside of China.

Biodel has extensive experience utilizing its proprietary excipient combinations to create ultra-rapid-acting insulin formulations based on both recombinant human insulin (RHI) and insulin lispro, the API in Humalog®. In January of 2013, Biodel announced positive top-line results from a Phase 1 clinical trial of two lispro-based ultra-rapid-acting insulin formulations, BIOD-238 and BIOD-250, both of which demonstrated rates of absorption that were significantly more rapid than that of Humalog®. These clinical data, as well as promising animal model and stability studies with aspart-based formulations, led Biodel to seek a supply of insulin aspart to support further formulation development and, possibly, a partner in the clinical development of an aspart-based ultra-rapid-acting insulin formulation. Biodel's patented formulation technology combines insulin and insulin analogs, such as insulin lispro and insulin aspart, with a proprietary combination of excipients, including EDTA, citrate and magnesium sulfate. Biodel has studied its proprietary insulin formulations in more than ten clinical trials, including Phase 1, Phase 2 and Phase 3 studies, which have shown Biodel's formulation technology to be safe and offer a faster absorption and onset of action of insulin than the commercially available comparators.

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "We are pleased to be working with one of the most experienced and trusted API suppliers in China. They have extensive experience in supplying many U.S. and European based multinationals and have made great progress in developing production processes for RHI, insulin aspart and insulin glargine. Now that we have accessed a supply of high quality insulin aspart, we can rapidly develop aspart-based candidate formulations and expand the potential application of our ultra-rapid-acting technology to RHI, lispro and aspart which, collectively, account for over 90% of the multi-billion worldwide prandial insulin market."

Xinfa Tang, President of HEC R&D Center, stated; "By combining Biodel's formulation technology with our biological production expertise, we can build both a strong insulin biosimilar business and also develop new, differentiated drugs. It is our plan to become known as an innovative drug company."

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. Biodel's product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.

About HEC

HEC Pharm is a holding company owned by HEC Group, one of the top 100 private enterprises in China, which in 2012 exceeded $2.5 billion in revenue. HEC Aluminium (SS.600673), another company holding by HEC Group, is a listed company on the Shanghai Stock Exchange (A shares). HEC Pharm, established in 2002, is one of the most innovative and leading pharmaceutical companies in China. Since inception, HEC Pharm has made over $150 million in R&D capital investment and over the past three years the annual R&D budget has exceeded $50 million. HEC R&D Center is developing new molecular entities, generics and biosimilars in five therapeutic areas: hepatitis, oncology, cardiovascular, diabetes, and neurology. HEC was the first Chinese company to have drug products on the market in both the EU and United States. Currently, HEC Pharm has two API and two formulation manufacturing sites with China, US, EU and WHO GMP certificates. More information about HEC Pharm is available at www.hecpharm.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 and our glucagon presentation that is intended to treat patients experiencing severe hypoglycemia; 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 or a stable glucagon presentation; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a stable glucagon presentation; 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 December 31, 2013. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

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CONTACT: John Graziano, +1 (646) 378 2942Source:Biodel Inc.