Big pharma partnerships continue to get personal
July 30, 2009 – 8:48 am by Gina MonariAccording to a new PricewaterhouseCoopers LLP report, growth in personalized medicine is driving alliances between diagnostics and the pharmaceutical industry. PwC expects the annual number of partnerships between pharmaceutical and diagnostic companies to increase during the next five years. One key factor expected to drive future partnerships is increased pressure on pharmaceutical companies from regulators and payers to provide a diagnostic alongside pharmaceuticals to guide their use.
The leader in the area of diagnostics deals was Roche with 10 partnerships, followed by Pfizer with six, Merck with five, and AstraZeneca with three. Amgen, Biogen Idec, Bristol-Myers Squibb, Ipsen, and Eli Lilly also pursued partnerships between 2004 and 2008. Roche is the largest IVD business with a 20% market share and its pharmaceutical division, including Genentech, stands out as the most active third-party pharmaceutical licensing partner for the diagnostics sector between 2004 and 2008, with 10 announced deals — an average of two deals per year.
Although the effort to better personalize treatments is not new, significant progress is needed because existing patient response rates to medicines can be very low. Pressure from healthcare payers is putting more emphasis on the availability of a companion biomarker test when deciding on a drug’s reimbursement. Companion diagnostics are diagnostic tests designed to guide the prescribing of a specific drug by assessing a patient’s risk of adverse events or likelihood of therapeutic effectiveness when taking this drug.
“Increasingly, pharmaceutical companies will not move a drug candidate to the clinical development stage without a clear biomarker development program,” says Gerald McDougall, principal, health sciences practice, PricewaterhouseCoopers. “These companies understand the contribution of biomarkers and diagnostics in improving the design and probability of success of clinical trials. These factors will combine to accelerate the development of new diagnostics for personalized medicine. Together we anticipate that alliances and collaboration will be inevitable as the market need expands.”
Four biomarkers for which FDA requires testing prior to deciding on the use of the drug include the CCR5 Chemokine C-C motif receptor for Pfizer’s HIV drug Selzentry; epidermal growth factor receptor expression for Bristol-Myers Squibb’s cancer drug Erbitux; Her2/neu overexpression in Genentech’s cancer drug Herceptin; and Philadelphia chromosome-positive responders in Bristol-Myers Squibb’s cancer drug Sprycel.
The EMEA’s communication on the requirement for biomarker testing is less transparent than the FDA’s but its initiatives should not be overlooked. The European agency played a key role in requiring biomarker testing for Amgen’s Vectibix, following the FDA’s accelerated approval without specific testing requirements, and it has a larger number of drugs for which biomarker testing is required.
Representatives from the EMEA reported at least 11 drugs requiring biomarker testing. These drugs include GlaxoSmithKline’s Ziagen in the area of infectous diseases and the cancer drug Tykerb/Tyverb; Novartis’ Epitol/Tegretol in the area of neuropsychiatric diseases and its cancer drug Tasigna; Genentech’s/Roche’s Herceptin and Tarceva; Bristol-Myers Squibb’s Sprycel and Erbitux; Cephalon’s cancer drug Trisenox; and AstraZeneca’s and Teva’s Iressa.
The number of companion diagnostic deals dropped from 14 in 2007 to 7 in 2008. About half the companion diagnostics partnerships announced between 2004 and 2008, 21 of the 45 deals, were for cancer diagnostics. All deals in 2008 focused on cancer and involved a large pharmaceutical partner. Three key factors are driving the strong interest in cancer companion diagnostics are the importance of genetic causes in the pathophysiology of the disease; the extent of research done in this area; and the high price of cancer therapies, which creates a strong demand by payers for a suitable companion tool to direct these costly treatments to those patients most likely to benefit.
According to the report, the position of Roche as the leading pharmaceutical partner for collaborations with diagnostics companies is remarkable considering that none of the other pharmaceutical companies with a major IVD affiliate – Abbott, Bayer and Johnson & Johnson – announced more than one partnership with a third-party diagnostics company from 2004 to 2008.
Outside of cancer, other diagnostics partnerships have been made in metabolism, CNS, infectious diseases, cardiovascular diseases, musculoskeletal, connective tissue, and gastrointestinal.
According to the report, a number of factors are expected to drive the continued development of personalized medicine and why diagnostics will become more important, including:
• Regulatory agencies, including FDA and European Medicines Agency, which are supporting the field of personalized medicine by introducing formal requirements to test for certain biomarkers before certain drugs are prescribed.
• Legislation introduced in May 2008 in the United States and Europe to protect individuals against discrimination resulting from the use of genetic information may now encourage more people to undergo genetic testing or participate in innovative research.
• Genentech’s Citizen Petition of December 2008, which created new momentum around the discussion of the diversity of regulatory paths to market for in vitro diagnostics.
• The formal adoption of new diagnostic technologies in the guidelines of important clinical communities that should accelerate their market adoption. Agendia’s MammaPrint, which is a DNA-based test for evaluating an individual’s risk of breast cancer spreading to other sites, is an example of a new diagnostic tool to help personalize treatment. This was recently validated by a national clinical group in the Netherlands, the Dutch Institute for Healthcare Improvement.
“We expect alliances with the pharmaceutical industry to increase in the next two to five years, but this will be driven by factors including the pricing of diagnostics, the extent of reimbursement coverage, and the burden of any clinical validation work required for market access,” Mr. McDougall says.
