Clavis seals $380M deal for pancreatic cancer drug

Collaboration

Clavis Pharma ASA has signed a deal with Clovis Oncology, Inc 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 version of the cancer drug gemcitabine that has the potential to improve treatment in pancreatic cancer and certain other solid tumours.   

Clovis Oncology will take over responsibility for development and manufacturing of CP-4126, and for filing of marketing approvals in the US, Europe, Canada, and Central and South America, and will be responsible for commercialisation in those territories.  Clavis retains the option to co-develop and co-promote CP-4126 in Europe.

In return, Clavis will receive an upfront cash payment of $15 million and be eligible for further payments totalling up to $365 million

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 tumour cells, whereas CP-4126 enters and kills tumour cells in an 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.

While gemcitabine is the standard of care in pancreatic cancer, accumulating data suggest a significant percentage of patients may derive little benefit because they have a low level of expression of the hENT1 transporter that allows the drug to enter tumour cells.

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.  

The agreement is seen as an important validation of Clavis’ potential to apply its lipid delivery technology to generate multiple novel cancer drugs with enhanced performance over existing therapeutics.”