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Sanofi's CER Deal with Medco's UBC Could Help ID Potential PGx Drugs in Pipeline

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Originally published June 27.

Sanofi-Aventis announced last week that it will conduct comparative effectiveness research with Medco subsidiary United Biosource, which will help the drug developer strategically decide which drugs to advance in its pipeline.

Specifically, the deal could potentially help Sanofi opportunistically apply pharmacogenomic strategies in drug development and commercialize personalized medicines.

The global agreement with UBC will help Sanofi "better leverage the real-world evidence generated during product development and throughout the product lifecycle," the partners said in a statement. As a reason for the partnership, Sanofi and Medco highlighted UBC's capabilities in personalized medicine and pharmacogenomics, in addition to CER.

Neither Medco nor Sanofi could provide additional details about this arrangement. However, according to a statement from the companies, Sanofi plans to use the data generated through this partnership to "define the relative value of products" early in the development process and identify best-responder populations to drugs.

Earlier this year, Sanofi announced that a Phase III trial for an investigational PARP inhibitor, iniparib, failed to meet its survival endpoints in triple-negative breast cancer patients. Unlike other drug developers studying investigational PARP inhibitors with a companion genetic test, Sanofi had not pursued a PGx strategy with iniparib.

However, the drug developer announced at the American Society of Clinical Oncology's annual meeting earlier this month that it was conducting molecular analysis to identify best responders to the drug (PGx Reporter 06/15/2011). Sanofi's current deal with UBC could potentially help the company identify such PGx opportunities earlier in the drug development process.

Importantly, with CER data it seems Sanofi is looking to prioritize the development of drugs that payors will deem reimburseable because they meet clinical and cost-effectiveness standards. The partnership with UBC will "enable Sanofi to maximize the full value potential of R&D innovation through early alignment of patient population assessments, payer and medical needs," the companies said in statement. "The objective is to develop integrated solutions for patients by implementing novel care models and to improve adherence and patient outcomes."

Earlier this year, AstraZeneca inked similar CER arrangement with national payor WellPoint. Under that agreement, AstraZeneca gained access to Wellpoint subsidiary HealthCore's enrollee database, which may allow the drug developer to advance more pharmacogenomically guided treatments (PGx Reporter 02/16/2011).

As with Sanofi's collaboration with UBC, research conducted under AstraZeneca's partnership with HealthCore may focus on how genomically defined subpopulations of patients respond to various treatments. "The breadth of data that will be available through the collaboration will also support studies of sub-populations, some of which may be genetically defined," AstraZeneca spokesperson Katie Lubenow told PGx Reporter at the time.

Comparative effectiveness research is a key provision under the US healthcare reform law, which created the Patient Centered Outcomes Research Institute, a private, non-profit entity charged with developing and funding CER. The institute's aim is to help patients, clinicians, purchasers, and policy-makers make "informed health decisions" by conducting research on the quality and effectiveness of medical treatments (PGx Reporter 09/29/2010).

Drug developers are contracting with payor groups to use CER to inform their drug development pipelines because the healthcare reform law has placed a strong emphasis on lowering unnecessary spending on healthcare treatments and interventions that don’t provide a public health benefit. As such, by using CER to inform drug development, biopharmaceutical firms are ensuring that the drugs they choose to advance in the pipeline have the best shot at regulatory approval and reimbursement.

Even the US Food and Drug Administration is planning to integrate CER in its review processes, in an effort to advance personalized medicine and gain more insight into whether certain drugs work best in specific patient subpopulations (PGx Reporter 04/27/2011).

"Some products, that seemed to hold promise in early research, might not deliver the intended results when used in real-world practice," Rob Epstein, president of advanced clinical research at Medco, said in a statement. "In the framework of this agreement real-world data will be used to develop products that demonstrate value in real-world settings, enabling Sanofi to support high-quality, cost-effective care."

Ultimately, this deal with UBC could help Sanofi get a stronger foothold in the growing personalized medicine market. A recent report by Diaceutics ranked Sanofi among the least prepared pharmas in terms of its ability to advance personalized medicine products in its pipeline. Diaceutics deemed Sanofi, GSK, Amgen, and Merck as "followers" who are "more likely to strive to maintain their existing operating models, rather than adapt them for personalized medicine" (PGx Reporter 06/15/2011).

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