PRA has snagged an exclusive deal to run Amgen's worldwide Phase III biosimilar studies.
The contracting coup comes four months after Amgen ($AMGN) tied up with Watson ($WPI) on an ambitious pact to develop biosimilars of some leading cancer therapies. Watson signed on with a capped investment of $400 million over the next seven years, while Amgen has an open-ended commitment to the deal. And analysts were intrigued by the notion of a leading biologics company jumping into an arena that has already attracted a lineup of Big Pharma players like Merck ($MRK) as well as a group of multinationals.
"This relationship represents a key milestone in PRA's commitment to supporting our clients' biosimilar development programs," boasted PRA Executive Vice President Kent Thoelke in a prepared statement. "Amgen is a blue chip company and a world leader with a global reputation for excellence in bringing biologic therapies to patients with grievous illnesses."
Amgen has been diversifying its business in recent months, looking to add international operations as it acquired a string of biotech companies with promising new treatments. The biosimilars deal is considered part of that broader strategy, though some analysts have wondered whether the mix of companies now angling to get into the business will ultimately force down prices to a point that the weakest players will be forced out of the game. That point, though, won't be reached for a few years.
The biosimilars business has been gaining attention since the FDA ran out its draft guidance on development. Based on its rules, developers will be typically required to provide some detailed data from late-stage studies to back up applications. But they can skip the early-stage development work and move more quickly to late-stage trials.
- here's the press release