SAN DIEGO—Armed with its "phybrid" technology, Amylin Pharmaceuticals Inc. has struck a deal with Bangalore, India-based Biocon Ltd. to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes.
A phybrid, Amylin reports, is a peptide hybrid molecule that combines the pharmacological effects of two peptide hormones into a single molecular entity. Under the terms of the Sept. 10 agreement, Amylin will bring its expertise in peptide hormone development, particularly in the area of the phybrid technology, and more generally its knowledge of metabolic disease therapeutics. Biocon, for its part, offers expertise in recombinant microbial expression for manufacturing the compound, and it also will leverage its experience in preclinical and clinical development of diabetes products.
"This agreement fully leverages the synergistic capabilities of the two companies," says Kiran Mazumdar-Shaw, chairman and managing director of Biocon. "Amylin's knowledge of peptide therapeutics and their leadership in the diabetes market, paired with Biocon's capabilities in process development, manufacturing and clinical development, provides this global program with the potential to effectively bring a novel therapy to patients living with diabetes."
Amylin and Biocon will share development costs, notes Anne Erickson, senior director of corporate affairs for Amylin. Amylin will own the intellectual property rights to the molecule and the phybrid technology, while Biocon will own the IP rights to the manufacturing.
Additionally, Amylin would own commercialization rights for the phybrid in North America, and Biocon would own commercialization rights for the phybrid in South Asia, most of East Asia and the Middle East. The parties would jointly own commercialization rights in the rest of the world. Further details of the terms of the agreement were not disclosed.
Amylin's peptide engineering concept relies on the coupling of the pharmacological effects of two bio-active peptides with unique therapeutic attributes—in the case of diabetes, this might be something like weight loss and glucose lowering—or bringing to bear additive/synergistic qualities of the coupled peptides in a single molecule.
"This program could unleash the potential of cutting-edge peptide science to transform the lives of patients with diabetes," says Daniel M. Bradbury, president and CEO of Amylin, who notes that his company had already developed and gained approval for two first-in-class medicines for diabetes, the pramlintide acetate injection known as Symlin and the exenatide injection known as Byetta. Amylin officially debuted its phybrid technology in 2006.
Biocon is no slouch in the diabetes market either, having launched the world's first recombinant human insulin, Insugen, using a Pichia-based expression system in 2004 and the recombinant glargine, Basalog, in 2009.
"They are a biologics innovator and a world-class manufacturing expert," Erickson notes of Biocon. "As such, they are the best partner for Amylin on this highly innovative and specialized development program."