Icon and Bristol-Myers Squibb (BMS) have inked a preferred-provider agreement for early-phase development. This constitutes the CRO’s second sizable agreement with BMS; in June 2010, the two formed a strategic partnership, with Icon focused on providing global support for the drug developer’s clinical development pipeline.
The terms of the new, three-year arrangement, which makes Icon a preferred provider for full-service pharmacology and exploratory clinical studies, were not disclosed.
“The relative dollar value of early-phase studies is small compared to the phase II to III space,” said Mario Rocci, president of Icon Development Solutions. “However, this is a very significant milestone and a true validation of Icon’s full-service clinical platform, where we will be working on BMS compounds in early phase through late phase supported by central labs and other Icon service lines.”
Neal McCarthy, managing director of investment banking firm Fairmount Partners, said the new agreement is a little surprising, as Icon has not been the first name that comes to mind for early-phase work. CROs that have dominated that area of the industry include Cetero, Covance, PharmaNet and PPD.
But in the last three years, Icon has made a concerted effort to add early-phase holdings. In 2008 it acquired Healthcare Discoveries’ phase I clinic in Texas, and added bioanalytical capabilities and an immunochemistry laboratory with the purchase of Prevalere. In 2009, the CRO bought Qualia Clinical in Omaha, and in 2010 Icon moved its large, Manchester, England-based early-phase facility to a purpose-built, hospital-based clinic. The company now has a 290 phase-I bed capacity.
“What Icon has done is in just a short time said, ‘this is an area that we intend to be in,’ and it has made a concerted effort to build some strength in it, and this is the payoff,” said McCarthy.
Under the new agreement, Icon will provide all supporting scientific services such as protocol design and development, project management, clinical monitoring, medical monitoring/pharmacovigilence, data management, biostatistics, pharmacokinetics and medical writing.
While large strategic partnerships between sponsors and CROs are all the rage, are more such marriages in the early-phase area in the works? In March, Eli Lilly inked a strategic partnership agreement with Advion, a CRO with a focused bioanalytical laboratory.
“I haven’t seen enough to call it a trend yet,” said McCarthy. “Rather, I think it’s just a continuation of outsourcing things in large packages.”
It makes sense, he said, as in recent years large pharma began selling off their early-phase holdings, which led to a corresponding trend of CROs beefing up their early-phase infrastructure to take on the work sponsors would need done.
“The same dynamics driving later-phase partnerships—growing pressure to become more efficient, reduce development time lines and decrease overall development costs—are at play in the earlier phases of development,’’ added Rocci, “especially as the industry looks to make go/no-go decisions earlier in the development process.”
Icon has four publicly announced strategic partnerships. Besides its late-phase partnership with BMS, others are in place with Pfizer, (announced this summer), Merck Serono (announced in 2010) and Eli Lilly (announced in 2009). In addition, it is a preferred provider for many sponsors.