In this regard we became aware at the end of 2014 that an active pharmaceutical ingredient and drug product intermediate manufacturer, Hovione, has submitted an IND for Phase I and II clinical trials of a new topical product containing minocycline for the treatment of inflammatory skin disease including acne and rosacea. If ultimately approved and launched in the U.S., such a product would become a direct competitor of FMX101 and 103, if commercialized.
Hovione currently manufactures and supplies Foamix with pharmaceutical-grade minocycline for use in FMX101 and other products. This increases the risk that we will not have sufficient quantities of minocycline for use in FMX101, FMX102 or FMX103 at an acceptable cost or at all, which could delay, prevent or impair our development or commercialization efforts.
Furthermore, such potential competitors may enter the market before us, and their products may be designed to circumvent our granted patents and pending patent applications. They may also challenge, narrow or invalidate our granted patents or our patent applications, and such patents and patent applications may fail to provide adequate protection for our product candidates