Pharmaceutical Commerce - January/February 2010 - (Page Cover1)

Business Strategies for Pharma/Bio Success www.PharmaceuticalCommerce.com JANUARY/FEBRUARY 2010 Legal | Regulatory Brand Marketing | Communications Patient Outcomes Research Moves Drug Safety Issues Dominate Pain Market Development Beyond Clinical Results In the ever-escalating battle for medicinal value and competitive positioning, drug developers and marketers are relying on outcomes research By Suzanne Shelley What makes a drug worth commercializing, worth prescribing, and worth paying for? Years ago, the answer was simple: a drug cured a disease or corrected a medical condition. But today, as drug research ventures farther into specialized areas like better mental or emotional health, diffuse conditions like obesity or chronic conditions where there’s a fine line between using and not using a drug, the answer is more Looking at real-world cohort studies complicated. As this complexity increases, and as everyone in healthcare focuses on costs, the analysis of “patient outcomes” Limitations becomes more critical. “Economists, pharmacists, physi- Benefits - Lack of detailed clinical cians and payors are all looking for ratioinformation + Evaluate active comparators nal ways to justify drug expenditures, so - Does not establish + Assess clinical outcomes increasingly, they’re embracing all types efficacy/superiority + Real-world prescribed doses of patient outcomes studies to gain greater - Clinical vs statistical insight and strengthen their approach,” significance says Mick Kolassa, PhD, chairman of Medical Marketing Economics LLC (MME; Oxford, MS). continued on page 28 > Fig. 1. “Cohort” studies of like patients with real-world drug utilization are one way of getting at patient outcomes. Credit: Xcenda. While researchers study new pain-killing pathways, the pharma industry tries drug combinations and alternativedelivery mechanisms By Angelo DePalma, PhD Pain relief has in some ways become, both linguistically and as an endeavor, a metaphor for the larger pharmaceutical industry. Today’s pain market is vibrant and growing, but more focused on risk avoidance or mitigation than on innovation As a consequence, resources that might have been devoted to developing new classes of pain drugs become diverted to making centuries-old painkillers safer and less attractive to abusers. IMS Health calculated the 2008 US market for prescription pain products at $8.2 billion, up 7.6% over the year before, but up only 8.4% since 2004 (Fig. 1, p. 18). Kalorama Information (New York) estimated the global market for prescription pain products at $26.1 billion in 2006, with drugs comprising 90% of the market’s revenues. According to their report, “The World Market For Pain Management Drugs And Devices,” sales will grow approximately 6% per year through 2010, to $33.2 billion. The paucity of new pain drugs has not been for lack of effort. Pfizer’s experience with its Celebrex COX-2 inhibitor illustrates the types of issues facing developers. Approved in 1998, Celebrex became the numcontinued on page 18 > Business & Finance Unpacking Risk Sharing and Alternative Pricing Schemes Shared-risk or ‘pay for performance’ agreements between drugmakers and payers can represent uncertain rewards for both parties. Use strategic planning before entering into them By Ed Schoonveld and Stefan Kloss, ZS Associates With increasing frequency in Europe, and now starting to show up in the US, biopharma companies and payers are entering into agreements to provide some form of risk sharing or price protection as new drugs are adopted into formularies. The best known among these include Pfizer’s Sutent (sunitinib malate) and Onyx/Bayer’s Nexavar (sorafenib) anti-cancer drugs; Novartis’ Aclasta (zoledronic acid), and Sanofi-Aventis/Procter & Gamble’s Actonel (risedronate sodium), both osteoporosis drugs. Manufacturers have agreed to various plans in Italy, Germany and the US to provide drug for free if no improvement is seen after initial treatment, or to reimburse health plans if bone fractures occur despite the osteoporosis therapy. There are numerous others, and more under consideration. There is a lot of misunderstanding and controversy about risk sharing in the pharmaceutical industry. Some love it, others hate it, but most of us are just confused about the topic. What continued on page 14 > is the risk and who is sharing? What’s Inside Roundtable in Print: Public Accounting 12 Air Cargo’s Future Biopharma Capacity 21 Revenue Leakage in Distribution Channels MENDOTA, IL PERMIT 200 PRSRT STD US POSTAGE PAID http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - January/February 2010

Pharmaceutical Commerce - January/February 2010
Contents
Editorial
Op-Ed
Top News
Business & Finance
Brand Marketing | Communications
Supply Chain | Logistics
Information Technology
Packaging & Drug Delivery
Legal | Regulatory
Executive Training & Development
Editorial Index | Meetings

Pharmaceutical Commerce - January/February 2010

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