CORK, Ireland, November 27, 2014 /PRNewswire/ --
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."
About Hovione
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. Hovione is a member
of Rx-360, EFCG and participates actively in
industry quality improvement initiatives to lead new global
industry standards. http://www.hovione.com
Contact
Isabel Pina
Director of Corporate Communications
Tel.: +35121-982-9362
ipina@hovione.com
SOURCE Hovione