COMPLEX ACTIVE PHARMACEUTICAL INGREDIENTS (API) & FORMULATIONS

We are currently developing finished dosage formulations, or FDFs, and a portfolio of 13 complex APIs for the development, manufacture and sale of generic pharmaceuticals. We specifically intend to develop six FDFs for generic versions of branded drugs that are scheduled to come off patent between 2015 and 2030, including generic versions of the daily 20 mg dosage and thrice-weekly 40 mg dosage of Copaxone® and the every two week formulation of Risperdal® Consta®, which we expect to develop under abbreviated new drug applications, or ANDAs. Five of the six FDFs we intend to develop will utilize complex APIs owned and developed by us.

Developing viable APIs can be complex due to the intricate, multiple production stages required and existing patent limitations of branded pharmaceuticals. Our proprietary know-how, which was developed in-house by our experienced personnel, allows us to develop products that avoid solid form and production process patent limitations. Three of our APIs and two of our FDFs are scheduled to launch starting in 2017. We believe the APIs and FDFs we are developing are particularly complex to manufacture and thus tend to have a high barrier to entry into the market, which we believe will limit the number of generic drug competitors. Therefore, we expect the price erosion of the APIs and FDFs we are developing in the off-patent stage to be less significant than the price erosion of non-complex APIs and FDFs. We are currently developing our own manufacturing plant in Israel, where we expect to manufacture our APIs upon completion. We also plan to develop other FDFs using our APIs or third-party APIs.

Mapi API and FDF Pipeline