Pharma execs with blockbuster drugs on the market should be up staying at night strategizing in case someone comes up with a “companion diagnostic” that the FDA requires before the blockbuster  can be prescribed.

So write Scientia Advisors authors Amit Agarwal and Jonathan Pan in “Theranostics and Already Approved Drugs: What You Don’t Know Can Hurt You,” published in the 2010-2011 Parexel Yearbook.

Disclosure: Scientia is my client.

In the article, Agarwal, partner, and Pan, senior associate, describe the situation that led the US Food and Drug Administration (FDA) to require warning labels and recommend diagnostic testing for the blockbuster drug Plavix more than 10 years after the anti-thrombotic hit the market.  Plavix is marketed by Bristol-Myers Squibb and Sanofi-Aventis to prevent myocardiofaction (MI) or strokes.

As early as 2001, when Plavix had been on the market for four years, studies began to show that Plavix helped certain patients more than others, the authors write. By 2008, genetic testing by a competing pharmaceutical company showed that nearly one-third of Plavix users did not fully benefit from the drug.  Based on these and other trial results, in 2010 the FDA required that the manufacturers include a “black box” warning label and a diagnostic testing recommendation for the product.

In 2009, Plavix had worldwide sales of $9.5B including $5.6 B in the US. As a result of the FDA diagnostic testing recommendation, the authors project that by 2012, BMS and Sanofi Aventis will lose $450M to $575M in sales in the US alone– and more if regulators in other nations add requirements. “Given the need to maximize revenue in the face of generic competition across their portfolios, it is a significant amount to offset.” Other drugs, prescribed in conjunction with Plavix, will also most likely be impacted.

Agarwal and Pan recommend a number of actions that pharmaceutical executives can take to mitigate such potential post-launch losses.

  • Expand competitive landscape and threat assessment coverage to monitor the diagnostic environment for new research and clinical trials which could potentially impact the sales of marketed drugs
  • Upgrade skills, capabilities, reporting relationships and the organizational clout of the theranostic function
  • Develop organizational structures that allow knowledge of new biomarkers and clinical trials to reach commercial decision makers

Scientia Advisors’ article is available in the PAREXEL’s Bio/Pharma R&D Statistical Sourcebook 2010/2011 at Barnett Educational Services.

—Anita M. Harris, President, Harris Communications Group

Scientia Advisors, located in Boston and San Francisco, is a management consulting firm specializing in growth strategies for major and emerging companies in health care, life sciences, biotechnology and nutrition.

HarrisComBlog is a publication of the Harris Communications Group, an award-winning public relations and marketing communications firm in Cambridge, MA.

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