• Opportunities Abound For Those Prepared
  • October 27, 2003
  • Law Firm: Troutman Sanders LLP - Atlanta Office
  • Stay alert to the confluence of factors that will affect the industry. These critical developments include the appointment of a new FDA commissioner; new regulations that change the implementation of the Hatch-Waxman Act and protections for patented pharmaceuticals; and movements in both the House and Senate, with backing from the White House, to facilitate use of generic products by consumers. The FDA commissioner, who appears to be a proponent of new approaches and initiatives, will help jump-start the moribund biotechnology sector. Generic competition for biological products will provide a new venue for takeover by the biotechnology entrepreneurs. New opportunities created by viable products mean investment dollars will follow -- as already seen with the $1 billion in financing that took place in just nine days last spring -- and deals will flow.

    Of course, these developments are occurring at a time when the life cycle of quite a few blockbuster drugs is ending. For example, biologically based products with $10 billion in sales (Year 2000) are reaching the end of their patent terms in the next few years, which creates a market ripe for entry by generic biologics, a new focus for the healthcare/pharmaceutical industry. Some of these new generic biologics may enter the market as early as 2004.

    Companies that are in the pharmaceutical, biotechnology and healthcare sectors, or are affected by these areas, need to prepare for this new surge of investment and to consider the long-term effects that a new biologics industry sector will have on their own products or services, and plan their competitive strategies accordingly.