Out-licensing

4 and 8 mg Ondansetron ready for submission in EU (exp. Q4/08) using the proprietary RapidFilm drug delivery Technology securing fast dissolution in the oral cavity without the need of water

Ondansetron RapidFilm is a novel proprietary formulation consisting of a polimeric film strip dissolving quickly wihtout any need of water and releasing the drug in the oral cavity.

Under the terms of the Joint Venture Agreement between the two drug delivery companies APR Applied Pharma Research s.a. of Switzerland (APR) and Labtec GmbH of Germany (Labtec) an Ondansetron RapidFilm is now ready for submission for Markting Authorization in EU.

APR and Labtec have successfully completed the development of a new oral formulation, generic to ZOFRAN® Zydis Lingual ODT (Oral Dispersible Tablet) marketed in Europe as well as in the US by Glaxo Smith Kline. It uses the proprietary RapidFilm® technology which is a novel, non-mucoadhesive, fast dissolving oral dosage form based on a water soluble polymer. The film disintegrates rapidly within seconds in contact with saliva, releases the drug in the oral cavity and promotes gastrointestinal absorption which is comparable to immediate release oral solid dosage forms. The RapidFilm® dosage form was especially designed for higher patient compliance. The application is easy. The patient does not face any swallowing difficulty. The fact that no water intake after administration is needed is very well accepted by patients with nausea.

Dossier is completed and submission is expected in November 2008; approval is expected between Q2 and Q3 2009 The product will be registered as generic of Zofran ODT.

Internal evaluations suggests that RapidFilm can offer multiple competitive advantages over Zydis technology such as manufacturing costs, innovation, etc. so enabling RapidFilm to even successfully compete in a generic environment.

Preregistration

Patent Pending on either technology and packaging.

Ondansetron RapidFilm is already licensed in US, Europe and other countries. It is still available for Licensing in Russia and former CIS countries, Japan, China, Turkey, Canada, Central and South America,  Australia and New Zealand and some other African and Asian countries where Ondansetron is off-patent. We are looking for licensing Ondasetron RapidFilm at regional or local level.