MedPharm has signed a licence agreement with Sinclair Pharma for the worldwide rights to develop a patented new spray presentation of the generic anti-fungal, terbinafine MedSpray, for the treatment of Athlete’s Foot (Tinea pedis).
Medpharm based in Guildford, close to Sinclair’s own corporate office is a specialist contract formulation and development company for topical drugs and new delivery systems.
Terbinafine is marketed by Novartis under the brand Lamisil.
Sinclair said the product has successfully completed European phase II non-inferiority studies with the brand leader for the indication (Lamisil Once) as a comparator.
After completing its review and strategic planning for US and European market entry, as well as preparation of pilot batches for a new US study, Sinclair will proceed with compiling a dossier for market authorisation applications in Europe and follow up the European study with a new study in the USA.
Sinclair now plans to submit its first MAA within the year with first European launch expected in H1 2012.
In the US, where Lamisil Once is not marketed, Sinclair will seek a major industrial partner for an expected 2014 launch.
Sinclair expects this to be a leading product for the company’s country operations in France, Germany, Italy and Spain, and an appealing product for partners worldwide with the potential to become the company’s leading product by revenue.
Sinclair CEO Chris Spooner said they believe a one-shot spray plaster presentation has clear advantages over current offerings and will prove a strong addition to both Sinclair’s portfolio and those of their partners, having the potential to become easily the company’s biggest product.
Medpharm CEO Andrew Muddle said they see this as validation of the MedPharm business approach to develop technologies, in this case MedSpray, with exemplary partners such as Sinclair.