Sweden's Medivir deal lends support to embattled GVK

A deal by Sweden's Medivir to trim costs by entering into a partnership for drug research has thrown a bit of support to CRO GVK Biosciences, which faces a European Medicines Agency (EMA) recommendation for the suspension of more than 700 products tied to its facility in India.

Medivir said in a release it has turned its focus tighter on oncology and infectious diseases, halting work in neuropathic pain and shedding about 10 researchers in the process.

This deal marks the first pact for GVK since the EMA issue sprouted a few months ago, the NDTV Profit website said.

"Medivir has conducted a review of its discovery research operations. While committed to maintaining the current size of its discovery portfolio to deliver a constant flow of candidate drugs into its development pipeline, it has identified the opportunity to improve quality and efficiency through partnership with GVK Biosciences," the company said in the release.

GVK, in a statement cited by NDTV Profit, said all current outsourced synthetic chemistry will be conducted in a single facility at GVK Bio's Integrated Discovery Research Campus.

The EMA issue began in May when investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad facility. The inspection found GVK employees repeatedly switched outpatient ECG scores with those of healthy volunteers.

GVK CEO Manni Kantipudi

GVK CEO Manni Kantipudi has said in interviews that the charges have cost the company millions in cancellations and lost contracts.

Before the EMA remarks, GVK was noted as making its way into the U.S. through a buyout of California's Aragen Bioscience earlier this year. Among the CRO's partners are Astellas, Bayer, Endo Health Solutions ($ENDP), Onconova ($ONTX) and the U.S. FDA.

GVK has said that the FDA inspection last year in late September and early October raised only a few concerns related to ECG washout reports.

- here's the story from NDTV Profit
- here's the Medivir release
- get FierceCRO's take