Staff Writer

Curis Inc. licensed its bone morphogenetic protein-7 (BMP-7) program to Stryker Corp., ending a seven-month search to replace former partner Ortho Biotech Products L.P.

Michael Gray, chief financial officer of Cambridge, Mass.-based Curis, said Stryker is "the ideal partner" to develop and manufacture BMP-7, which he called a "complicated protein."

Stryker certainly has the experience to get the job done. The company already markets a BMP-7 product used to stimulate bone healing in certain spinal fusion and long-bone procedures. That product, called OP-1, combines recombinant human BMP-7 with a purified Type I collagen carrier.

Stryker gained access to the BMP-7 patents through a 1985 deal with Creative BioMolecules Inc., which later became a part of Curis. But Stryker's license previously covered the use of BMP-7 only in the repair or regeneration of local musculoskeletal tissue defects and dental defects. Curis initially licensed all other BMP-7 rights to Johnson & Johnson's Ortho unit.

Under the Ortho deal, Curis received $3.5 million up front and might have gotten up to $30 million in milestone payments if a BMP-7 product had gained FDA approval for the treatment of kidney disease. But the program never made it past preclinical development, and Ortho handed back all rights earlier this year. (See BioWorld Today, Dec. 2, 2002, and May 22, 2007.)

Now Stryker is picking up those rights in exchange for $1 million up front and undisclosed clinical, regulatory and sales milestones. Curis said global commercialization of a BMP-7 product could result in $41 million in payments, $14 million of which would go to a former collaborator of Creative BioMolecules if the product is associated with chronic kidney disease.

Preclinical data thus far indicate that BMP-7 might indeed be applicable in treating conditions associated with chronic kidney disease, such as fibrosis and blood vessel calcification. The signaling protein also has been linked to upkeep of the skeleton and vascular system, and Gray mentioned stroke as another possible indication.

Out-licensing the BMP-7 program leaves Curis free to concentrate on its small molecules, most of which, Gray said, target cancer.

Farthest along is a systemic Hedgehog antagonist program, which partner South San Francisco-based Genentech Inc. said is slated to begin Phase II solid tumor trials in the first half of next year. Genentech also is working with Curis on an early-stage Wnt pathway program. (See BioWorld Today, Dec. 13, 2007.)

Meanwhile, partner Wyeth Pharmaceuticals, of Madison, N.J., is conducting preclinical studies with a small-molecule systemic Hedgehog agonist to treat stroke and neurological disorders and with a protein systemic Hedgehog agonist for cardiovascular indications.

Internally, Curis plans to begin cancer clinical trials in the second quarter of 2008 with CUDC-101, a small-molecule triple inhibitor of histone deacetylase and EGFR and HER2 kinases. The company also plans to select and file an investigational new drug application for another multi-targeted cancer molecule next year.

Shares of Curis (NASDAQ:CRIS) fell 4 cents to close at 98 cents Friday.