
Under the terms of the Joint Venture Agreement between the two drug delivery companies Labtec GmbH of Germany (Labtec) and APR Applied Pharma Research s.a. of Switzerland (APR) Donepezil RapidFilm and Ondansetron RapidFilm are currently under final development. Labtec and APR are currently completing full development of new oral formulations:
Donepezil RapidFilm is generic to ARICEPT® ODT marketed in Europe as well as in the US by Eisai and Pfizer.
Ondansetron RapidFilm is generic to ZOFRAN® Zydis Lingual ODT (Oral Dispersible Tablet) marketed in Europe as well as in the US by Glaxo Smith Kline. Both use 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.The products are packed in a specially designed proprietary packaging system named RapidCard.
Donepezil RapidFilm: A pilot bioequivalence study was successful. The pivotal bioequivalence study is planned for Q3/2009. Submission for approval is expected in Q1/2010. The product will be registered as generic of Aricept.
Ondansetron RapidFilm: A pilot bioequivalence as well as the pivotal bioequivalence study were successful. Dossier is submitted in EU. 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.
Patents pending on both technology and packaging.
Donepezil RapidFilm is available for licensing wherever Donepezil is off-patents. We are looking to license the product at European or Worldwide level.
Ondansetron RapidFilm is available for licensing outside Europe and US.
Dr Ingo Lehrke
Managing Director; Business Development
Labtec GmbH provides innovative Product Development and Manufacturing Services all over the world.
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