Under the agreement, HEC will supply insulin aspart, the active pharmaceutical ingredient (API) in Novolog(R), 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(R).
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(R).
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 I, Phase II and Phase III 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.
Biodel’s president and CEO Dr Errol De Souza noted that the company is 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," Souza added.