Clavis Pharma ASA (OSE: CLAVIS), the clinical stage oncology focused pharmaceutical company, and Clovis Oncology, Inc., the newly formed oncology company led by former Pharmion Corporation executives, announced today an agreement for the further development and commercialisation 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 tumours.
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 commercialisation 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 totalling 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, randomised, 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 analysed based on patient classification in relation to their levels of expression of the hENT1 pancreatic tumour 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 tumour 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.
“We view this agreement as an important validation of Clavis Pharma’s potential to generate multiple novel cancer drugs with enhanced performance over existing therapeutics. This strategic partnership for CP-4126, our second product under development, will enable us to focus resources on developing our portfolio further and provides great momentum towards our building a successful oncology business.”
Patrick Mahaffy, President and CEO of Clovis Oncology added: "We are very enthusiastic about the potential for CP-4126. Gemcitabine is the standard of care in pancreatic cancer, but accumulating data suggest that a significant percentage of patients may derive little benefit from its use because of low expression of the hENT1 transporter that allows gemcitabine to enter tumour cells. In vitro data demonstrate that CP-4126 overcomes this resistance mechanism. We now have the opportunity to show that a cytotoxic, which remains the backbone of cancer therapy, can become an effective, targeted therapy in this large subset of patients. Our development philosophy is to focus on providing meaningful benefit to subset patient populations with unmet medical need and we believe CP-4126 will do exactly that.
Confirmation of the hENT1 hypothesis offers a promising and novel enhancement to current treatments for patients with pancreatic cancer,” said Daniel D. Von Hoff, M.D., Physician in Chief, Translational Genomics Research Institute and Clinical Professor of Medicine at the University of Arizona. “This is an exciting new concept that may enable both superior targeting of an established drug, gemcitabine, as well as providing a new, rational treatment option, CP-4126, to hENT1-low patients.”