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GSK forms two new drug partnerships

GSK has entered partnerships with both biotech Amplimmune to develop cancer therapies, and Five Prime Therapeutics for skeletal muscle disorders

GlaxoSmithKline (GSK) has entered into a partnership deal with the immunology-focused biotechnology company Amplimmune to develop therapies for cancer and other indications, as well as an agreement with Five Prime Therapeutics covering potential therapies for skeletal muscle disorders.

The experimental products at the centre of the Amplimmune deal target PD-1, a protein that may negatively regulate immune responses.

The deal gives GSK exclusive worldwide rights to Amplimmune's investigational therapy AMP-224, as well as to other potential next-generation fusion proteins targeting PD-1. In return, the company will pay $23m upfront to Amplimmune, with the potential for another $485m in regulatory, development and sales milestone payments throughout the life of the deal, as well as royalties on product sales. 

Early milestone payments are tied to an Investigational New Drug (IND) filing for the product and to the initiation of a phase I clinical trial. The agreement gives Amplimmune responsibility for conducting a phase I study in cancer patients, which the company plans to begin next year. Amplimmune is also responsible for good manufacturing practice (GMP) manufacturing and good laboratory practice (GLP) toxicology research to support that study.

Amplimmune and GSK will collaborate on researching AMP-224's mechanism and therapeutic potential in oncology, infectious diseases and vaccine applications, and GSK will be responsible for all other development and manufacturing activities.

In vivo studies of AMP224 have suggested that the therapy induces immune responses to tumours and pathogens. Targeting PD-1 on cells with high levels of PD-1 can restore immune function, resulting in tumour eradication and enhanced protection against infection, according to Amplimmune.

GSK's deal with San Francisco-based Five Prime Therapeutics, which is worth around $139m before royalties, gives the pharma giant the option to develop drugs discovered by Five Prime as treatments for skeletal muscle disorders including the age-related muscle-loss conduction sarcopaenia and cachexia, a muscle-wasting condition related to diseases like cancer and AIDS.

The deal calls for a $15m payment from GSK, including upfront payments, research payments, and stock purchases.

5th August 2010

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