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news.Archimedes Pharma, a pan-European specialty pharmaceutical company, has announced positive headline data from its recently completed proof-of-concept trials for two of its intranasal development projects.
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According to the company, both the IN Apomorphine and IN Diazepam Phase I studies showed high bioavailability, positive pharmacokinetics and good tolerability and confirmed that each candidate has the potential to replace existing formulations in high value markets. The agents are being developed for the treatment of motor fluctuations or ‘off episodes’ in Parkinson’s disease and acute repetitive seizures (ARS) in refractory epilepsy patients, respectively.
Archimedes’s IN Apomorphine and IN Diazepam have been developed by applying the drug delivery expertise of its subsidiary Archimedes Development which also developed PecSys, the proprietary technology which underpins NasalFent.
Archimedes will now begin preparations to take both IN Apomorphine and IN Diazepam into further clinical trials and management anticipates the initiation of Phase II studies later in 2009. If development proceeds to plan, both IN Apomorphine and IN Diazepam could be approved in 2012.
Richard de Souza, CEO of Archimedes, said: “Both these trials have generated exciting results, highlighting the quality of our development capabilities and providing further validation of our business model.
“We look forward to driving our in-house development projects through to commercialization to provide an ongoing stream of novel products to our rapidly growing pan-European commercial organization in therapeutic areas in which we already have an established presence.”