Clavis Pharma signs multi-million dollar cancer drug deal
Norwegian pharmaceutical company Clavis Pharma has signed a cancer drug development deal worth around US$380m with US-based Clovis Oncology.
Norwegian pharmaceutical company Clavis Pharma has signed a cancer drug development deal worth around US$380m with US-based Clovis Oncology.
The agreement is for the development and commercialisation of Clavis Pharma's pancreatic drug CP-4126, currently in Phase II development. CP-4126 is a novel, patented, lipid-conjugated form of the anti-cancer drug gemcitabine.
Clavis Pharma will receive an upfront cash payment of US$15m from Clovis and will be eligible to receive further payments totalling up to US$365m. Clavis Pharma will also receive tiered double-digit royalties on sales.
Under the terms of the agreement, the companies are amending the design of the ongoing Phase II study 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 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.
"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," said Geir Christian Melen, ceo of Clavis Pharma.
