The deal allows the Japanese company to develop and commercialise the DPP4 inhibitors further, after acquiring rights previously shared by PPD and Takeda San Diego under the collaboration agreement of November 2003.
The agreement further provides that PPD will serve as the sole provider to Takeda of Phase II and Phase III clinical development services in the US and the EU for the DPP4 inhibitors. This will enable the DPP4 development program to continue without interruption.
DPP4 inhibitors have the potential to treat type 2 diabetes. DPP4 degrades GLP-1 (glucagon-like peptide-1), an important hormone that is released in response to the intake of food and that stimulates pancreatic beta cells to increase the secretion of insulin and that has potential to improve beta cell function itself. DPP4 inhibitors, taken orally, work by blocking GLP-1 degradation to keep its concentration for a longer period of time.
In exchange for terminating the collaboration agreement and transferring its rights to Takeda, PPD will receive an upfront payment of $15 million plus development and sales milestones, and royalties on sales of DPP4 inhibitors if approved for marketing.
"We believe that these DPP4 inhibitors will enhance Takeda's diabetes franchise in the future," said Yasuchika Hasegawa, president and chief operating officer of Takeda.
DPP4 inhibitors help to activate the appropriate physiological responses to food intake by increasing the level of incretins that stimulate insulin secretion, suppress glucose production, slow digestion, and decrease appetite. In animal models, long term treatment with DPP4 inhibitors has lead to improved physiological response to glucose and delayed onset of disease.
"This becomes the second program under which we have advanced the clinical development of a compound and then transferred it to a third party for continued development and commercialisation, further validating our compound partnering strategy," said Fred Eshelman, chief executive officer of PPD.
DPP4 inhibitors have become a research area of intense focus with a number of pharmaceutical companies involved in the development of what is hoped is a new diabetes therapy that approximately 8-10 per cent of the adult western population. Currently, worldwide sales of drugs for Type 2 diabetes exceed $12 billion (€9.9 billion) per year.
Drug company Phenomix is currently in preclinical development with compounds that based on in vivo data. Phenomix' lead program treats type 2 diabetes through inhibiting the DPP4 enzyme.
Phenomix is developing PHX1149, an orally administered, once-daily drug that prevents increase in glucose levels and mitigates the progression of insulin resistance that occurs over time in diabetic patients. PHX1149 compares favourably with existing marketed and investigational drugs, and Phenomix expects the compound to enter human trials in the fall of 2005.
Swiss pharmaceutical firm, Novartis, demonstrated in clinical studies that its investigational drug vildagliptin improves the function of pancreatic islets in both animals and humans.
Vildagliptin, a novel investigational Incretin Enhancer, previously known as LAF237, inhibits DPP-4, resulting in an increase of circulating levels of GLP-1, a crucial incretin hormone.