Clavis will receive $15 million up front and retain an option to co-promote and share profits in Europe.

Newly formed oncology company Clovis Oncology negotiated a deal potentially worth $380 million with Clavis Pharma for development and commercialization of the latter’s Phase II-stage lipid-conjugated gemcitabine anticancer drug, CP-4126, in the U.S., Canada, Europe, and Central and South America.

The companies also aim to collaborate on the development of a companion diagnostic to identify patients likely to benefit most from CP-4126.

Under terms of the deal, Norway-based Clavis will receive an up-front payment of $15 million, plus development, regulatory, and sales milestones of up to $365 million, and double-digit sales royalties. The company also retains an option to co-promote the drug in Europe and share European profits.

CP-4126 was developed using Clavis’ Lipid Vector Technology and is designed to improve the therapeutic profile of gemcitabine so that it can enter cancer cells without requiring uptake by the hENT1 nucleoside transporter molecule. Gemcitabine is the current standard therapy for advanced pancreatic cancer, with estimated worldwide sales of some $1.7 billion 2008, Clavis reports.

Intravenous CP-4126 is currently undergoing a Phase II pancreatic cancer trial that is comparing overall survival in patients receiving either CP-4126 or gemcitabine. Clovis and Clavis are now amending the design of the international trial to increase the number of patients enrolled from 120 to 250. The trial will also categorize patients as to whether they express high or low levels of hENT1, to determine whether CP-4126 has particular survival benefits in the low-hENT1 group. An oral formulation of CP-4126 is currently undergoing a Phase I dose-escalating trial for various solid tumors.

“This strategic partnership for CP-4216, our second product under development, will enable us to focus resources on developing our portfolio further and provides great momentum toward building a successful oncology business,” explains Geir Christian Melen, Clavis’ CEO.

At the end of October, the EC granted intravenous CP-4126 orphan drug designation for the treatment of pancreatic cancer. Orphan status for the drug has also been applied for in the U.S. The company maintains CP-4126 has potential utility in other cancers currently treated with gemcitabine, including lung, breast, ovarian, and bladder tumors. 

Headquartered in Boulder, CO, Clovis was founded earlier this year by former executives of Pharmion, which was acquired by Celgene in 2008 for $2.9 billion. The new company has already raised $146 million in start-up financing from international investors. Clovis’ business strategy is to license or acquire rights to oncology compounds in all stages of clinical development.

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