The contract development and manufacturing organization (CDMO) has four FDA inspected sites in the US, China, Ireland, and Portugal and development laboratories in Lisbon, Portugal, and the US.
The first-in-human study of HY02, a proprietary minocycline sterile ointment to treat a subset of ocular surface inflammation, is a double-blinded, randomized trial and will enroll approximately 36 subjects over the next few months. The company expects topline results by the end of the year.
“Product Development and Licensing is a new business area for Hovione with the mission of developing Hovione’s medicines,” Carla Vozone, VP, product development and licensing, told Outsourcing-Pharma.com.
“The difference from our core and established business is that in this new area we identify certain target diseases in the areas of ophthalmology, dermatology and inhalation in which Hovione’s know-how and technology platforms can contribute to develop an innovative medicine to the patient,” she said.
The company uses known molecules and repurpose them in new routes of administration or new indications, Vozone explained.
The CDMO plans to develop its products up to proof-of-concept and then out-license to pharmaceutical companies interested in further development, registration, and commercialization.
Vozone said the company is planning to launch another clinical trial during 2017.
“Over the next 5 years we hope to establish licensing partnerships with pharmaceutical companies and progress further the clinical development and NDA filing,” she added.