Sanofi is looking to enhance efforts to consult payers and their real-world evidence to inform drug development and marketing efforts with a multi-year global agreement with pharmacy benefit manager Medco Health Solutions and its United BioSource health economics and outcomes research unit, announced June 22.

Under terms of the arrangement, Medco and UBC will contribute their perspective and comparative data to the product development strategy, allowing Sanofi "to define the relative value for products early in development, by more precisely identifying patient populations in which drugs are most effective," the company explains in a release.

The deal also will enable Sanofi to meet payer evidence requirements as well as develop novel care models that will improve treatment adherence and patient outcomes. Financial terms were not disclosed.

There are no limitations on the product areas covered by the agreement, a Sanofi spokesperson said. Work will primarily focus on drugs in Phase II and III. One example might be to use real-world data to identify the right patients with unmet needs for lipid-lowering treatment, the spokesman added.

Sanofi has two drug candidates for lipid reduction in Phase II or III. The firm is studying mipomerson (gained through its acquisition of Genzyme) in Phase III trials in patients with heterozygous familial hypercholesterolemia and in patients already on maximally tolerated doses of existing lipid lowering therapy. In addition, the company is evaluating a treatment in partnership with Regeneron that targets the PCSK9 gene for hypercholesterolemia in patients who are unresponsive to statins and other anti-hyperlipidemia therapies.

Among the French drugmaker's other late-stage clinical candidates are teriflunomide, an oral therapy for relapsing-remitting multiple sclerosis and lixisenatide, a GLP1 agonist for type 2 diabetes. With the Genzyme, Sanofi also obtained the Phase III multiple sclerosis drug Lemtrada (alemtuzumab).

The partnership with Medco is Sanofi's latest effort to bolster its research and development program, which is especially important as it faces the loss of patent protection for its key products - Lovenox (enoxaparin sodium injection), Taxotere (docetaxel) and Plavix (clopidogrel). It follows a comprehensive initiative in 2010 to streamline and reorganize the company's R&D programs (Also see "Reenergizing R&D: Sanofi Stirs The Pot, But Does It Have The Recipe?" - Pink Sheet, 25 October, 2010.).

Medco has been garnering attention for taking its research in new directions. In a separate and unrelated project, Medco is engaged in a large observational study - part of its "Genetics For Generics" research initiative - using claims data that aims to generate cost-effectiveness data for clopidogrel (Bristol-Myers Squibb/Sanofi's Plavix) relative to Effient (prasugrel), marketed by Lilly and Daichii Sankyo (Also see "Medco "Genetics For Generics" Research Anticipates Plavix Patent Loss" - Pink Sheet, 26 October, 2009.). Sanofi is not collaborating on that study, Medco said.

A Global Perspective

Medco brings the pharmacy claims data it administers for 65 million Americans to the agreement as well as a global payer perspective through its joint ventures and partnerships in the UK, Germany, Amsterdam and Sweden. In addition, UBC has offices in South America, Europe and Asia and approximately one-third of its business comes from abroad, according to Rob Epstein, president of Medco's Advanced Clinical Science and Research activities.

UBC specializes in applying health economics and outcomes research to characterize product effectiveness, address safety risk and demonstrate value, including drug cost-benefit and cost-effectiveness analyses. It is also the market leader in designing risk mitigation and evaluation strategies for new drugs, though safety evaluations are not part of the Sanofi deal. Medco acquired the company in 2010.

The arrangement between Sanofi and Medco/UBC is reminiscent of the U.S.-focused partnership announced in early 2011 between AstraZeneca and WellPoint's clinical outcomes research unit, HealthCore (Also see "AstraZeneca, HealthCore Launch Outcomes Data Project, Seek Multi-Stakeholder Consortium" - Pink Sheet, 3 February, 2011.).

The AstraZeneca/HealthCore collaboration aims to generate "real world" data on the most effective and economic ways to treat disease, with a focus on chronic ailments such as diabetes, cardiovascular disease and dyslipidemia, but also addressing areas such as oncology.

[Editor's note: Elsevier Business Intelligence's upcoming Pharmaceutical Strategic Alliances conference includes a panel addressing "The Importance of Outcomes Data: A Case Study Of The AstraZeneca/ HealthCore Collaboration." See the online conference brochure for information on the conference, convening Sept. 21-23.]

-Cathy Kelly (c.kelly@elsevier.com)

Sanofi's Deal With Medco/UBC Seeks Payer Perspective To Inform Drug R&D, Marketing

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