Clavis Pharma and Clovis Oncology Sign $380 Million Partnership
News Nov 25, 2009
Clavis Pharma ASA and Clovis Oncology, Inc., the newly formed oncology company led by former Pharmion Corporation executives, announced an agreement for the further development and commercialization of the Clavis Pharma drug candidate, CP-4126, currently in Phase II development in pancreatic cancer.
CP-4126 is a novel, patented, lipid conjugated form of the anti-cancer drug gemcitabine that has the potential to improve treatment outcomes in a large subset of patients with pancreatic cancer and certain other solid tumors.
Under the terms of the agreement, Clovis Oncology will take over responsibility for product development and manufacturing of CP-4126, and for filing of marketing approvals in the United States, Europe, Canada, Central and South America and will be responsible for commercialization in those territories. Clavis Pharma retains the option to co-develop and co-promote CP-4126 in Europe.
Clavis Pharma will receive an upfront cash payment of $15 million from Clovis Oncology and will be eligible to receive further payments totaling up to $365 million on Clovis Oncology’s successful attainment of development, regulatory and sales milestones. Clavis Pharma will receive tiered double-digit royalties on all product sales in the licensed territories.
Under the terms of the agreement, the Companies are amending the design of the ongoing Phase II study in pancreatic cancer to enroll approximately 250 patients in an international, randomized, comparative trial of CP-4126 versus gemcitabine with overall survival as a primary endpoint. In addition to evaluating survival in all patients, study results will be analyzed based on patient classification in relation to their levels of expression of the hENT1 pancreatic tumor protein.
The hENT1 (human equilibrative nucleoside transporter 1) cell membrane transporter is believed to be critical for gemcitabine entry into tumor cells, whereas CP-4126 enters and kills tumor cells in a hENT1-independent manner. Patients will be classified as being hENT1-high or hENT1-low and particular emphasis will be given to comparative overall survival in the hENT1-low population. Data from this trial are expected in the first half of 2012.
Commenting on the deal, Geir Christian Melen, CEO of Clavis Pharma, said: “We are delighted to be working closely with the team at Clovis Oncology, who will now be responsible for bringing our new and improved anti-cancer product to market in the Americas and Europe. They have substantial experience of successful cancer drug development and marketing and will bring significant resources, expertise and commitment to the conduct of the CP-4126 clinical programme and achieving regulatory approvals in these major markets.