A Differentiated Business Model
We intend to enter the market no later than the first generic drug with an enhanced formulation of the branded reference drug. During this period, the number of competitors is lowest and branded drugs are generally at peak or near-peak value, creating an advantageous situation for capturing incremental market share.
This strategy also allows us to influence usage patterns and market our products as enhanced versions, thereby achieving preferred pricing and appealing to savvy pharmacy directors.
Even if Eagle enters the market simultaneously with, or after, the first generic drug, as a 505(b)(2) applicant, we could launch without regard to any generic drug’s 180-day exclusivity period.
Take, for example, our novel formulation of ready-to-use argatroban. It received 505(b)(2) NDA approval in June 2011 and entered the market ahead of the first generic version. It eventually captured 43% of the total market. By comparison, our competitors were unable to prove non-infringement of the applicable patents and had to wait until the patents expired in June 2014 before receiving final approval for commercialization.
Protecting Intellectual Property and Maintaining a Competitive Edge
Our patent estate consists primarily of formulation and method-of-use patents. Included are 13 owned or exclusively licensed US issued patents and several additional applications that have been filed in various worldwide territories. These patents will protect, as applicable, the market value of our approved and pipeline products.
Our goal is to continue to build our patent portfolio by filing for patent protection on new developments with respect to our product candidates without infringing upon patents that cover the branded reference drugs. We expect that these will, if issued, allow us to list our own patents in the FDA Orange Book. Once our patents are listed, potential competitors will be required to reference our products when submitting their patent applications. Patents expire 20 years from the date of filing.
Additionally, we seek Orphan Drug status for our products when applicable. This gives us the potential for 7 years of exclusivity upon approval of the product to treat the rare disease or condition for which Orphan Drug designation was granted.
Furthermore, our strategy of optimizing branded reference drugs may also give us the potential to have 3 years of regulatory exclusivity for our future product candidates if they are approved under the FDA’s New Use/New Clinical Studies Exclusivity clause. To achieve this exclusivity, our NDA application must include reports of new clinical investigations that we conducted. If granted, during the three-year exclusivity period commencing on the NDA approval, this exclusivity bars the FDA from approving any ANDA or 505(b)(2) application by another party that relies on the same studies.
Building a Robust Product Portfolio
We are committed to strengthening and expanding our product portfolio in the areas of oncology, critical care, and orphan diseases. By leveraging our expertise, we will identify additional products with suboptimal characteristics that present us with significant opportunity for revenue generation. In addition to our internal efforts, we will consider in-licensing or acquiring product candidates that fit our therapeutic areas of focus and meet our rigorous evaluation process.
We believe that we can cost-effectively commercialize our products with our own specialty sales and marketing organization in the United States, thereby retaining more of the commercial value of our products. Our small, focused, specialty sales force will target hospitals and acute care settings.
Outside of the United States, we intend to explore selective partnerships with third parties to develop and commercialize our products.