India Offers Insider Look at CRO-Sponsor Relationships for Global Trials

By Zachary Brennan contact

- Last updated on GMT

Too subtle a metaphor for CDSCO's publication of pending trial requests?
Too subtle a metaphor for CDSCO's publication of pending trial requests?

Related tags: Glaxosmithkline

India’s top drug regulator on Wednesday unveiled a list of all the pending clinical trials before its apex committee, which includes information on what the top CROs are working on in the subcontinent. 

Of the 94 clinical trials listed​, 23 global CROs are awaiting approval for trials from the apex committee, which was established earlier this year to increase oversight of trials in a country plagued with uncertainty​.

Trial Breakdown

Parexel leads all CROs with five pending trials in India and the CRO seems to be ramping up its work with GlaxoSmithKline. The Parexel list include three trials for GSK with fluticasone/salmetrol, fluticasone/salmetrol MDI, and belimumab, as well as Amylin’s exenatide, and Eli Lilly’s oncology drug, known as LY2127399. Parexel declined to comment on the release of the trial info.

Quintiles, meanwhile, is running four clinical trials for sponsors Otsuka, Roche and AstraZeneca.

David Windley, equity analyst at Jefferies, told that the announcement about Otsuka is a surprise because “years ago Covance struck a deal with Otsuka that was supposed to be sole-sourced and Otsuka was not able to push all of its work through Covance. So this Quintiles notification could be confirmation that Otsuka is using other CROs​.”

Quintiles spokesman Phil Bridges told us, “Due to customer confidentiality, Quintiles cannot confirm our participation in specific projects​.”

The apex committee also is evaluating four trials from PPD in India, including for AstraZeneca’s antibiotic combo ceftazidime/avibactam, Novartis’ everolimus, and Astellas’ solifenacin succinate and conivaptan.

Novartis hasn’t really gone down the path of a narrow deal yet, so it’s a little informative but not too surprising​,” Windley said regarding information about its deal with PPD. PPD declined to comment.

Covance has two trials pending with Merck’s mometasone furoate/formoterol fumarate MDI and Lilly’s evacetrapib. Windley noted that Covance’s work with Lilly “might be notable​” since Lilly is doing a lot of clinical work with other CROs. Among the largest CROs listed, Lilly is also the only sponsor shared among them.

For the mid-sized and smaller CROs, Indian CRO Max Neeman leads the pack with two trials for Octapharma’s Octafibrin and its Human Cell Line Recombinant Factor.

Icon, Clintec International, Asiatic Clinical Research and Jubilant are all listed as looking to gain approval for a single trial.

Rare Disclosures

Despite the release of this information, which is rare for pharma companies that live and die by the timelines of drugs in their pipeline, Windley said he does not think this will encourage more companies to reveal more information on deals between CROs and sponsors.

In the cases where clients allow it and CROs or sponsors announce the deals, they tend to be sorry they did because then there’s more acute attention on a single client and more questions during earnings calls​,” Windley said, noting there will probably be less disclosures on deals in the future.

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