April 21, 2014

Clinipace becomes a ‘preferred provider,’ starts acting like a big CRO

By reaching a preferred provider deal with a mid-market drug developer, Clinipace is starting to act like a much bigger contract research organization.

On April 9, Morrisville’s Clinipace Worldwide announced a partnership with Massachusetts pharmaceutical company Karyopharm Therapeutics (Nasdaq: KPTI), a development-stage company working primarily on cancer treatments. In this arrangement, Karyopharm chose Clinipace as a “preferred provider” in which Clinipace will manage several clinical programs, including oncology and wound healing.

As drug developers test their new therapies in patients, they often turn to CROs to manage trials. Large CROs, like Durham’s Quintiles (NYSE: Q) or the nonprofit RTI International, have begun hashing out contracts with Big Pharma, like GlaxoSmithKline (NYSE: GSK) or Merck & Co. (NYSE: MRK), for a long-term relationship.

These broad agreements exist less in small- to mid-sized pharmaceutical markets, partly because smaller drug developers don’t require a broad agreement. Companies in Big Pharma have drugs under development in many therapeutic areas and in all stages of development, so they benefit by reaching an agreement with one CRO to bring more consistency across trials. GSK, for example, currently has more than 50 new molecular entities under clinical development in more than a dozen therapeutic areas. Small developers typically work on only one or two drugs at a time, so don’t need broad agreements to span various trials.

Except Karyopharm. It’s not actually developing one specific drug, but a platform that it hopes can apply to many therapeutic areas. As such, it will run multiple concurrent trials. Clinipace’s bread and butter is in that middle market, and Karyopharm, which spent $28 million on research and development last year, fits right in there.

“You don’t generally see that a whole lot in the mid market,” said Clinipace CEO Jeff Williams of these preferred provider agreements.

Of course, that doesn’t mean the mid-market CROs don’t want agreements like this. “I would take these all day long,” Williams says with a laugh, but notes that they simply aren’t as widespread.

Although Karyopharm identified Clinipace as a preferred provider, there is no requirement to spend a certain threshold. Each trial will still run individually, and the agreement does not have a set term. That said, Williams expects to manage several of Karyopharm’s clinical programs.

“You develop a familiarity with the protocols and investigators,” he said.

The Karyopharm deal isn’t the only piece of news Clinipace has had in recent weeks. On April 1, it announced it would manage the U.S.-based clinical trial for Navigated Brain Therapy (NBT) System for Finnish drug developer Nexstim, and in March it announced an acquisition of Choice Pharma, a Pan-Asian CRO that gives Clinipace a stronger presence in the eastern world and expands the Clinipace staff to 640 employees globally.

Clinipace is currently running 334 active clinical projects, though that includes for regulatory clients, typically a much smaller contract than for customers with clinical trial needs.