Curis, Inc., a therapeutic drug development company, has licensed its Hedgehog proteins and novel small molecule Hedgehog pathway agonists (activators) to Wyeth Pharmaceuticals, a division of Wyeth, for therapeutic applications in the treatment of neurological and other disorders.
Under the terms of the agreement, Wyeth Pharmaceuticals will pay Curis a license fee (in cash and equity), financial support for a minimum of two years of Curis research dedicated to the programme, and additional cash payments to Curis upon the successful achievement of clinical development and drug approval milestones. Wyeth Pharmaceuticals will also pay a royalty on net product sales that escalates with increasing sales volume. Excluding product royalties, the transaction has a potential value to Curis of more than $170 million, assuming at least two products are successfully developed.
As part of the agreement, Curis has retained development and licensing options for certain therapeutic applications of the Hedgehog activator technologies, including those applications that qualify as orphan drug indications, topical applications for hair growth, local delivery applications for treatment of cardiovascular disease, and use of the technology with stem cells. Wyeth has an option to acquire the orphan drug indications and the cardiovascular applications, pending certain success criteria.
Daniel Passeri, Curis' president and CEO, stated, "We are very pleased to have Wyeth Pharmaceuticals as a partner for our Hedgehog activator technologies. Wyeth is one of the world's largest research-driven pharmaceutical companies. Wyeth's broad range of pharmaceutical interests is an excellent match with Curis to fully exploit the wide array of potential indications for the Hedgehog activator technologies. We believe that this agreement will provide the most effective clinical path forward for Curis' neurology drug development candidates."
The Hedgehog signaling pathway has many biological properties, the best known of these being the promotion of healing of nerve tissues. Curis' small molecule Hedgehog agonists are orally available compounds that can cross the blood-brain barrier and have demonstrated therapeutic efficacy in several models of neurological disease, including Parkinson's disease and stroke.
Parkinson's disease and stroke are two areas of significant unmet medical need. The National institutes of Health estimates that there are at least 500,000 people in the United States who suffer from the effects of Parkinson's disease, with approximately 50,000 new cases reported annually. It is also estimated that there are as many as 700,000 strokes each year in the US.