Consolidation among contract clinical research organisations (CROs) continues apace, as companies try to offer broad bundles of services and meet the emerging trend among pharmaceutical companies to contract with smaller numbers of providers and make the outsourcing process more cost-effective.

But while this has driven a lot of the activity among the larger CROs, their smaller cousins tend to consolidate to enhance their presence in a specific niche, such as a particular segment of the R&D process, therapeutic area or geographical market. And in late September two deals involving US CROs with annual revenues in the region of $100 million a year – AaiPharma and INC Research - provided excellent examples of this approach.

Therapeutic focus

US CRO AaiPharma said it plans to acquire French company Cvitkovic & Associes Consultants, a specialist in oncology drug development and medical consulting, in a move that extends its therapeutic expertise and boosts its presence in Europe and Latin America.

The acquisition is evidence of the major changes at the company, which last year filed for bankruptcy and was forced to abandon its strategy of buying in and selling pharmaceutical products, and went back to its roots as a CRO pure play.

CAC is the first acquisition by AaiPharma since it switched strategies, and brings on board early-stage cancer drug development expertise as well as additional Phase IIb/Phase III clinical trial capacity. The deal is expected to close in the fourth quarter of this year.

In a statement, AaiPharma said CAC has expertise in a wide range of cancer therapies, including cytotoxics, cytostatics, monoclonal antibodies, cell-based therapies, vaccines, anti-angiogenic agents, apoptosis inducers and hormonal therapies.

As cancer is one of the most pursued areas of medical research at the moment, with more than 600 new drugs in development, this focus bolsters AaiPharma’s presence in a fast-growing area of clinical research. Oncology is the fifth fastest-growing therapeutic category in terms of new Investigational New Drug (IND) applications, according to data supplied by Thomson Centerwatch last year, growing around 9% a year.

Companies developing cancer drugs tend to be small and medium-sized biotech and pharma companies – and these are the primary customer profile for AaiPharma.

CAC will operate as AaiOncology, a business unit within AaiPharma, and the acquisition adds 100 workers to AaiPharma’s current headcount of around 900.

Prof Esteban Cvitkovic, CAC’s chairman and founder, said: "Having established our own model of clinical CRO services based on therapeutic specificity combined with medical and scientific know-how, CAC has now reached the limits of its organic growth. With AaiPharma, we can incorporate our oncology expertise and differentiation into a larger professional organisation that shares our vision.”

Large-scale safety studies

Meanwhile, INC Research, another US CRO, has acquired Pharmaceutical Resource Corp in a move that dramatically increases its capacity to carry out large-scale Phase IIIb and IV adult and paediatric trials.

Focus on late-phase clinical trials, particularly Phase IV post-marketing studies with an emphasis on safety, has been heightened in the wake of recent safety scandals such as the withdrawal of Merck & Co’s painkiller Vioxx (rofecoxib) in 2004. But in fact there has already been a phenomenal increase in the number and size of studies carried out in the last few years.

Spending on Phase IV studies by US pharmaceutical companies more than quadrupled between 2000 and 2004, from $1.2 billion to $4.9 billion, according to data published by Thomson Centerwatch.

INC estimates that 73% of recent new drug approvals received FDA requests for post-marketing studies. Based on this increased regulatory scrutiny, the number of Phase IV studies will continue to increase.

PRC has a track record in pharmacovigilance and drug safety that increases INC’s ability to meet this increasing requirement, commented James Ogle, INC's chief executive. "With the addition of PRC, we are able to offer our customers a greater depth of late-phase clinical trial experience," he said.

About 90% of INC’s business is in Phase I-III testing, while 70% of PRC’s workload is in Phase IIIb/IV studies.

The latest acquisition comes on the tail of a number of other expansion programmes at INC in recent months, including the expansion of its facilities in North Carolina and Texas in March 2006, the opening of new offices in France, Russia and Ukraine and the acquisition of cancer drug development specialist NDDO Oncology in the Netherlands.

- Meanwhile, Tandem Labs, a CRO offering bioanalytical and immunoanalytical testing for the pharmaceutical industry, has boosted its portfolio with the acquisition of PharmKD from Linden Technologies. PharmaKD specialises in mass spectrometry-based pharmacokinetics and pharmacodynamic testing for drug metabolite and biomarker profiling.