Medical Device Link.

NEWS

New drug approvals hit a 25-year low in 2007, and pharma firms are facing a surge in brand exposure to generics. Industry, however, is populating drug pipelines, pushing cost control, and shifting to Web-based strategies that integrate company, caregiver, and patient communications. Thani Jambulingam, PhD, chair and associate professor, department of pharmaceutical marketing, Saint Joseph’s University (Philadelphia), reviewed current industry trends at a Pharmaceutical Printed Literature Association (PPLA) meeting during Interphex in March.

Among the notable trends identified by Jambulingam are:

• “2007 was the worst year since 1983 for drug approvals. This trend needs to change, and that is happening.” With industry on high alert over drug safety, 19 new drugs were approved by FDA in 2007. Since 1996, when the agency approved 60 new drugs, approvals have trended, albeit with intermittent upticks, steadily downwards.
• Drug development costs are increasing, with an average “out-of-pocket” cost of $430 million per successful drug. “Capitalized to the point of market approval, the cost is $802 million.”
• Patent expirations have created $38 billion of unprotected sales from 2007 to 2009. “After 2009, there is a great explosion in brand exposure through 2016. Companies cannot survive if their pipelines are hurting.”
• GlaxoSmithKline, AstraZeneca, and Sanofi-Aventis rank with the most drugs in development. And companies are developing promising, potential blockbusters, targeting disease states such as Alzheimer’s, osteo- and rheumatoid arthritis, cholesterol, cardiovascular, and cancer.
• “Companies have figured out they need two new drug applications approved a year. You need to have 12 compounds entering development (to sustain that rate). Failure at the Phase 3 stage (after high investment) is not acceptable.”
• Pharma is in cost control mode, outsourcing manufacturing, packaging, and clinical trials domestically and abroad. “Product managers are going to be incentivized to control costs.”
• Since 1996, direct-to-consumer advertising in dollars and as a percentage of sales has increased every year, hitting $4.2 billion, or 2.6% of sales, in 2005. “Companies are already taking their money away from direct to consumer. The Web will be the next marketing domain.”
• Web marketing captures and leverages patient data, as patients are driven to secure sites by caregivers, community services, public relations events, direct mail, radio, and TV.
• FDA-proposed guidance on the dis­tribution of information on un­approved, or off-label, uses of drugs is “a huge step forward for the industry.”
• As managed-care trends drive pricing pressures and tighter margins, outcomes-based reimbursement as a cost-containment measure is a trend to watch. “The Medicare Part D program is shaping up very well. But the cost will be way over initial projections.”