IDD meeting – Overview of the respiratory generic market

Last week in London I gave a presentation on the Spiroscout GPS inhaler device at the Inhaled Drug Delivery conference. It was a great meeting and I thought well worth writing up a few words on some of the presentations over the course of the next couple of weeks.

One of my favorites was a talk by Peter Wittner, of consulting group Interpharm, who gave a very interesting talk on the evolution of the respiratory (inhaled) generic market and the dissolving boundary between the traditional innovators and the generic manufacturers.

A recent article in the Economist – “Generically Challenged,” from the World in 2010 issue – lays out the growing interest of the major innovators in the generics drug companies, prompted in part by the “looming patent cliff.” According to EvaluatePharma, the total sales of prescription drugs at risk from patent expiry is set to more than double from 2010 to 2011. Vijay Vaitheeswaran argues that government attempts to control prices are propelling generics in high income countries, while in low income countries it is the growing middle classes. In fact, emerging economies already make up more than half of total global pharmaceutical sales.

Back in London, Wittner drew attention to the appeal of the branded generics approach. These are products made of off-patent formulations but sold for premium price. By his account, one company (Norton) was able to recognize that a lengthy generic name (sodium cromoglycate, rather than Intal) was hindering physicians from writing a prescription. In response, they adopted a branded generic approach, raised the price of their product, and labeled it Cromolyn. The Economist predicts that the major drugs firms are set to aggressively enter the branded generics market next year. It highlights a number of recent acquisitions and alliances between the big drugs firms and Asian generics firms like Ranbaxy.

Wittner also outlined the barriers facing the generics companies (such as proving bioequivalence) and some of the complicated struggles around patents in the respiratory drug market. There are several examples that illustrate how skilled generics companies have become at attacking weak patents; he discussed the recent European challenges to the Seretide and Symbicort patents in particular.

Finally, Wittner offered great bit on the lateral thinking and agility of generics companies, who are developing and protecting innovative new respiratory delivery devices and active pharmaceutical ingredients (API). He closed with some observations on the uncertainty around the potential competitors set to emerge from the Asian market and outlined some of the competitive advantages that Asian companies have, including a favorable regulatory environment.