Archimedes Pharma Announces Successful Proof-of-Concept Results on Two Intranasal Development Projects
Phase II trials on both projects to be initiated during 2009
Archimedes Pharma Limited announced positive headline data from its recently completed proof-of-concept trials for two of its intranasal (IN) development projects. 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.
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 organisation in therapeutic areas in which we already have an established presence. The strength of this strategy is exemplified by our lead development project, NasalFent®, an intranasal fentanyl spray that has recently shown a best-in class profile for breakthrough cancer pain in our Phase III programme and the regulatory filings for which will begin in the first half of 2009."
Archimedes' IN Apomorphine and IN Diazepam have been developed by applying the drug delivery expertise of its subsidiary Archimedes Development limited which also developed PecSysT, 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.
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