Medivir had no concerns about selecting GVK for discovery services; Assessing cathepsin S options
The deal will expand Medivir’s research programmes according to discovery research VP Richard Bethell, who said GVK will do “some work currently conducted in house, some work we wanted to do but didn’t have the capacity, and a consolidation of work that had previously been out-sourced.”
He added that: “By increasing chemistry capacity, and integrating chemistry and primary assays in the same facility we expect to be able to make more compounds and generate more data on them more quickly in order to advance our projects more rapidly.”
Bethell said there would be 10 redundancies at Medivir, but stressed the infectious diseases and oncology-focused drugmaker will not be closing any laboratories.
GVK is expected to hire an additional 20 staff to service the Medivir contract.
Discovery, not clinical
GVK has been in the headlines a lot of late as a result of French and German concerns data from trials conducted at the contract research organisation’s (CRO) research site in Hyderabad, India had been ‘manipulated.’
In January the European Medicines Agency (EMA) recommended the Commission withdraw marketing authorization for generic drugs whose approval relied on data generated at the site. The Agency reiterated this position after a reevaluation in March.
The criticism – which GVK is working to address and Indian trade group Pharmexcil has called ‘unjustified’ – has not gone unnoticed by Medivir. However, the Swedish drug firm stressed the scandal did not impact its decision to contract the CRO.
Bethell stressed that: “This is a discovery services contract, not a clinical research contract. Nevertheless we had extensive discussions with GVK Bio about the issues at their clinical research facility during our negotiations.”
Medivir refocus
In addition to awarding GVK the discovery services contract, Medivir announced that it will exit its neuropathic pain research programmes and halt development of its candidate, cathepsin S.
Bethell confirmed this, telling us “we’re looking at a number of options for our cathepsin S inhibitor assets."
