Praecis Pharmaceuticals Inc. signed an agreement with Schering AG for overseas commercialization of Plenaxis, a prostate cancer treatment.
Financially, Praecis could earn $90 million in performance-based milestones, as well as a share of every sales dollar through a transfer price mechanism. Kevin McLaughlin, executive vice president and chief financial officer of Waltham, Mass.-based Praecis, told BioWorld Today the terms are intended, depending on performance levels, to approximate an equal sharing of the value of the product.
Plenaxis, the first gonadotropin-releasing hormone antagonist available as a depot formulation, was cleared in November by the FDA as a treatment for pain relief in advanced symptomatic prostate cancer patients who meet a variety of conditions. For instance, Plenaxis patients would not be viable candidates for treatment with luteinizing hormone-releasing hormone agonists, and they would not seek surgical castration. Also, patients must exhibit one or more other conditions, including a risk of neurological compromise due to metastases, ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or severe bone pain from skeletal metastases persisting on narcotic analgesia. (See BioWorld Today, Dec. 1, 2003.)
Recent U.S. sales figures will be made public Friday when the firm releases its first-quarter earnings. Praecis is commercializing Plenaxis on its own in the U.S. Meanwhile, Schering, of Berlin, will be in charge of Plenaxis in Europe, Russia, the Middle East, South Africa, Australia and New Zealand.
"As a company, we are just extraordinarily pleased with Schering as a partner," McLaughlin said. "They are a large substantial company that has worldwide operations and expertise in urology, and we believe they are the right partner for this drug."
Praecis last June submitted a marketing authorization application in Germany for the candidate. Action is expected mid- to late 2004. Assuming a favorable ruling in Germany, Praecis and Schering will pursue additional European Union member state approvals under the mutual recognition procedure. Schering will handle regulatory approvals and surrounding activities in remaining countries included in its contract.
Plenaxis is Praecis' first product to market. The company believes Plenaxis likely will demonstrate activity in other diseases, but has not released information on future trials.
Praecis also has clinical programs in Alzheimer's disease and non-Hodgkin's lymphoma, as well as discovery programs in oncology, autoimmune diseases and antiviral therapies. Praecis' stock (NASDAQ:PRCS) fell 8 cents Wednesday to close at $5.71.