Pharmaceutical Executive Digest Europe - February 11, 2009 - (Page 11) Diagnostics respond to a class of drugs, not a specific drug. That means class leaders have the potential to gain the greatest value from linkage to a diagnostic test. But other drugs that offer differentiated benefits can also generate returns. How does this work? The linkage to a diagnostic changes the discussion inside the physician’s office. Instead of just pitching a drug, reps can speak with doctors about particular patient populations; early disease detection, diagnosis, and differentiation of patient sub-segments; selecting pharmaceuticals and avoiding therapeutic side effects; and therapy monitoring. Reports from companies pioneering this effort indicate easier physician access and longer sales calls than traditional therapeutic-only pitches — and an incredible increase in sales. The examples from specialty pharma companies below illuminate best practices and viability of this new approach in the US and Europe. Better disease diagnosis Disease areas in which physicians struggle to make a differential diagnosis are ideal for the introduction of diagnostics. Irritable bowel syndrome (IBD) is a good example. Into this market came Entocort EC (budesonide), developed by AstraZeneca and launched in the US in 2001 for the treatment of mild to moderate Crohn’s disease. Entocort EC is an enteric-coated formulation of the well-known steroid, designed to release the drug in the colon and generate lower systemic absorption with fewer side effects. But by 2003, sales of the drug were only $25 million — leading AstraZeneca to outlicense it to Prometheus Labs, a San Diego-based specialty pharma. Given the difficulty in making diagnosis and treatment decisions, the benefits of a diagnostic test were obvious. Prometheus developed a test to help physicians distinguish subtypes of IBD based on serology markers found in the blood, as well as determine the severity of the disease. As a result, the company was able to immediately raise the average wholesale price for Entocort EC by 66% upon acquiring the rights in 2005, and 10% every year thereafter. The current pricing for Entocort EC is 120% of the price when Prometheus started marketing it. The value of this approach becomes even more apparent when compared with the European market, where AstraZeneca retained ownership but attempted to boost sales through traditional models. In Germany, AZ negotiated an exclusive promotion agreement with Eisai GmbH to market Entocort EC. But without a diagnostic, Entocort EC sales grew only 10% annually from 2005 to 2007, and just 7% in constant dollars. Earlier treatment migration Prescription by trial-and-error, particularly when it comes to more serious conditions, is an unacceptable approach to treatment. However, in multiple sclerosis (MS), that was the standard of patient care for far too long. An Austrian company, Sanochemia AG, saw a market opportunity to improve MS diagnosis and improve uptake of Viveo (tolperisone), an immediate-release muscle relaxant used to treat painful muscle cramps and spasticity associated with neurological conditions. In March 2008, Sanochemia launched MR-Lux, an MRI contrast agent (gadopentate dimeglumine) used to diagnose MS and other central nervous system conditions. With this diagnostic on the market, neurologists were able to make a definitive diagnosis of MS, which in turn meant that patients migrated to Viveo more quickly. Since launch, Viveo has doubled initial expected sales and is projected to grow at 40% compared to 7% projected increase in sales of generic tolperisone. Other diseases that follow this pattern present an opportunity for linking diagnostics with therapeutics. First, the marketed drugs are not targeted therapies that work against a specific biomarker or unique disease pathway. Rather, they are small-molecule drugs whose mechanism of action is not unique. In each case, the drugs are reformulations of compounds with generic competitors available. Second, the diagnostic was brought to market after the drug was launched, often by a third party with no special knowledge of clinical results from drug development. Because the biomarkers used for the bundled diagnostic are not exclusive to the drug developer, there is an opportunity for late-to-market participants to effectively compete using this approach. In fact, the basic science that underpins the biomarkers has been either developed by academic research institutions and licensed by diagnostic developers or on the market for some time. Given that the diagnostic test only identifies the class of drugs that are effective for a group of patients, sales presence does matter. The sales force must be able to answer questions about 13 BUSINESS ETHICS Could you blow the whistle? 16 ON THE MOVE This weeks appointments and promotions 2 FROM THE EDITOR A week in pharma is a long time 3 NEWS Best new antidepressants named
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Digest Europe - February 11, 2009 Pharmaceutical Executive Digest Europe - February 11, 2009 Contents From the Editor News Calendar Actavis Exclusive Diagnostics Business Ethics On the Move Pharmaceutical Executive Digest Europe - February 11, 2009 Pharmaceutical Executive Digest Europe - February 11, 2009 - Contents (Page 1) Pharmaceutical Executive Digest Europe - February 11, 2009 - From the Editor (Page 2) Pharmaceutical Executive Digest Europe - February 11, 2009 - News (Page 3) Pharmaceutical Executive Digest Europe - February 11, 2009 - News (Page 4) Pharmaceutical Executive Digest Europe - February 11, 2009 - Calendar (Page 5) Pharmaceutical Executive Digest Europe - February 11, 2009 - Calendar (Page 6) Pharmaceutical Executive Digest Europe - February 11, 2009 - Actavis Exclusive (Page 7) Pharmaceutical Executive Digest Europe - February 11, 2009 - Actavis Exclusive (Page 8) Pharmaceutical Executive Digest Europe - February 11, 2009 - Actavis Exclusive (Page 9) Pharmaceutical Executive Digest Europe - February 11, 2009 - Diagnostics (Page 10) Pharmaceutical Executive Digest Europe - February 11, 2009 - Diagnostics (Page 11) Pharmaceutical Executive Digest Europe - February 11, 2009 - Diagnostics (Page 12) Pharmaceutical Executive Digest Europe - February 11, 2009 - Business Ethics (Page 13) Pharmaceutical Executive Digest Europe - February 11, 2009 - Business Ethics (Page 14) Pharmaceutical Executive Digest Europe - February 11, 2009 - Business Ethics (Page 15) Pharmaceutical Executive Digest Europe - February 11, 2009 - On the Move (Page 16)
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