Are there different rules for orphan drugs?
Orphan drugs, if biologics, are all subject to the same patents. Because there is no pathway to allow these drugs to be genericized, they do have the same monopoly potential. They also have market exclusivity for seven years post-approval that is awarded by the FDA. Again, that’s an incentive to bring companies to the table to develop these types of products, recognizing that they are going into very small patient populations and may not have the ability to bring the financial returns to pay for that development. The Orphan Drug Act was specifically passed to incentivize companies to develop drugs for these types of diseases. Are there other drugs that you are focusing your research on—other new drugs? No, IPLEX is our flagship product for orphan diseases. In this follow-on biologic space, we are focused on the development of five different drugs that represent about $10 billion in sales at today’s prices. And when these drugs come off patent, we will be positioned to get these drugs a
