Hovione files its first Investigational New Drug Application with the FDA
Cork, Ireland, 27th of November 2014 – Hovione announced today it has filed its first Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA). This event represents a milestone in Hovione’s strategy of developing improved drug delivery options for established drugs.
The IND was submitted for minocycline gel, a novel formulation using a new patented crystalline base form of minocycline, to administer topically one of the most widely prescribed oral antibiotics for acne. Currently, there are no approved topical formulations of minocycline for the treatment of acne. While oral administration of minocycline has a well-established efficacy and safety profile in acne, it is also associated with certain adverse events, due to systemic exposure. Pending FDA’s acceptance of the IND submission, Hovione plans to initiate human clinical Phase 1/2 studies in early 2015.
“This filing represents a turning point in Hovione’s history. It builds on 50 years of manufacturing Active Pharmaceutical Ingredients, Particle Engineering and Formulation” commented Carla Vozone, Hovione’s Senior Director of Product Development and Licensing. “This is a novel route of administration for a drug with proven safety and efficacy over more than 30 years of clinical use. We believe the targeted delivery to the site of action will reduce systemic exposure and thus potentially reduce the adverse events profile”.
Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.