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news.Biohaven Pharmaceutical (Biohaven) has entered into an exclusive world-wide agreement with Catalent Pharma Solutions for its Zydis Orally Disintegrating Tablet (ODT) technology to be used in the development of Biohaven's lead drug development candidate, BHV-0223.
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Canada-based Portage Biotech holds 54% equity of Biohaven, a privately-held biopharmaceutical firm engaged in the identification and development of clinical stage neuroscience compounds targeting the glutamatergic system.
Catalent’s Zydis technology is a freeze-dried, oral solid dosage form that disperses instantly in the mouth with the need of water.
Zydis has a dispersion speed of three seconds or less and more than 20 products were launched in 50 countries.
Biohaven executive chairman and Portage CEO Declan Doogan said: "This exclusive agreement with Catalent now adds the world’s leading formulation development experts to our efforts and represents an important strategic relationship."
Over the last six months, Catalent has been working with Biohaven to optimize its formulation of BHV-0223 using Zydis ODT.
Currently, prototype development has been completed and manufacturing of clinical drug supplies is being started to support the formal Investigational New Drug (IND) application for BHV-0223 as well as begin of a pharmacokinetic trial.
Biohaven chief medical officer Dr Robert Berman said: "The license and formulation R&D collaboration with Catalent represents a key company milestone – the optimization of a commercially viable formulation of BHV-0223 ready to advance into our clinical studies."
By the third quarter of 2015, Biohaven intends to begin a pharmacokinetic and biomarker study to confirm optimized drug exposure levels of its new formulation.