CRO

GVK inks another R&D deal as it moves on from data scandal

GVK BioSciences, an Indian CRO under fire from European regulators, has signed a deal with Australia's Akaal Pharma to help the company move its in-development psoriasis treatment into mid-stage trials.

Akaal is at work on a topical ointment that blocks the pro-inflammatory cytokines at the root of psoriasis and other autoimmune diseases. The drug, AKP-11, demonstrated promise in early trials, and Akaal has tapped GVK to advance it into Phase II.

Through its Begaluru-headquartered formulation business, GVK is on hand to provide clinical supplies, manufacturing and analytical services as Akaal ramps up for psoriasis trials. The pair is also exploring future trials in eczema and other inflammatory skin conditions, GVK said.

The deal builds on an existing relationship between the two companies, and Akaal believes it has found a CRO partner to take its top asset through the development process.

"We have had a very efficient CRO relationship with GVK for our clinical trials supplies support due to GVK Bio's experience, capabilities and facilities," Akaal CEO Dale Dhanoa said in a statement.

Meanwhile, GVK is working to repair its reputation after a data-falsification scandal tied to one of its facilities led European regulators to recommend the suspension of more than 700 approved products. The ensuing fallout has made life difficult for GVK, costing the company millions of dollars in cancelations and lost contracts, CEO Manni Kantipudi has said.

Last month, GVK signed a wide-ranging deal with Swedish drug developer Medivir ($MVIR), agreeing to handle the bulk of the biotech's chemistry work, and Kantipudi has said the CRO's continued success in landing such partnerships is an affirmation of its reliability.

- read the statement