The new strategy is to take proven drugs that are off patent and use Antares injection technology to improve the performance of the drug and to provide the intellectual property protection needed to block generic competition. These drugs will be marketed by Antares, not a partner. Its products can be approved by the 505 (B) (2) pathways in which Antares only has to demonstrate bioequivalence to the generic drug.
This strategy makes for a quick turnaround time on product development time. For example, it took three years between the IND filing and NDA approval of Otrexup. For a new chemical entity, this time could very well be 7 to 10 years. The FDA review time for Otrexup was 10 months. Antares believes that its next major product, QS T for testosterone replacement can be launched in 2016. Thereafter, it believes that it can launch one major new product per year for the next five years. If so, this should provide explosive sales and earnings growth over the balance of this decade.