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Archimedes Pharma Ltd ("Archimedes"), a European specialty pharmaceutical company, today announces the commencement of its global Phase III programme for Nasalfent(r) in breakthrough cancer pain.

Up to 180 patients are being recruited in a placebo controlled, randomised trial across 43 centres in the US and Canada. The endpoints will focus on assessments of pain intensity and pain relief at several time points up to 60 minutes post treatment and will provide data on the acceptability and safety of Nasalfent. The lead investigator is Russell K. Portenoy, MD, chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, New York, and one of the world's leading authorities on breakthrough cancer pain. Patients who successfully complete the trial will be eligible to enrol in a longer term open safety study.

Nasalfent is an innovative fentanyl citrate nasal spray aimed at providing a fast, effective and convenient treatment for breakthrough cancer pain - sudden, unpredictable episodes of intense pain that occur despite background pain medication and which can affect up to 95% of cancer patients. Patients suffering from breakthrough cancer pain may have very limited treatment options. Fentanyl is a highly effective opiate analgesic and is seen as the drug of choice for breakthrough cancer pain because of its rapid onset and short duration of action.

Nasalfent incorporates Archimedes' proprietary PecSys(tm) nasal drug delivery system, an enabling technology which can optimise fentanyl's rapid absorption to give a profile that should provide fast, tolerable pain relief in these patients. Archimedes believes intranasal delivery offers significant potential benefits in the treatment of breakthrough cancer pain and will represent an advance over oral transmucosal presentations through its high acceptability and fast onset of action.

Dr Portenoy said: "Cancer-related breakthrough pain is highly prevalent, presents a huge burden to patients and caregivers and increases the cost of care. There continues to be substantial unmet clinical need in the treatment of this condition, part of which presumably relates to a mismatch between the quick onset of most pains and the time-action relationships of oral therapies. An opioid formulation that has a rapid onset of effect, and is safe and effective, will address this unmet need."

Dr Mark Watling, Medical Director of Archimedes said: "Enrolling our first patient in our global Phase III programme for Nasalfent is an important milestone for Archimedes. We believe Nasalfent could offer real benefits to patients and the fact that this significant programme is being supported by many of the leading figures in breakthrough cancer pain highlights its significance.

Richard de Souza, Archimedes' CEO, said: "Our ability to develop high-value specialty products through our own proprietary drug delivery technologies, to add to those already sold by our established commercial organisation, is an important part of our business model and our rapid progress with Nasalfent over the last 20 months further demonstrates the quality of our Development capabilities."

About Nasalfent(r)

Archimedes' Nasalfent(r) is an innovative fentanyl citrate nasal spray aimed at providing a fast, effective and convenient treatment for breakthrough cancer pain - sudden, unpredictable episodes of intense pain that occur despite background pain medication and which can affect up to 95% of cancer patients. Archimedes is seeking licensees for the further development of Nasalfent(r) in North America and Japan and will market the product through its own commercial organisation in Europe. Nasalfent utilises PecSysTM, a proprietary enabling technology owned by Archimedes which modulates the flow of molecules across mucosal membranes. When used in intranasal drug delivery the technology offers the potential to optimise the profile of molecules and with Nasalfent facilitates fast absorption ad rapid onset of pain relief but controls the amount of fentanyl absorbed to minimise side effects.

About Archimedes Pharma

Archimedes is a European specialty pharmaceutical company with an established commercial organisation in the UK, France and Germany and a portfolio of products marketed to specialist prescribers. Archimedes' products include Gliadel, for high grade glioma, Zomorph, an oral sustained release morphine product for cancer pain, Nozinan, an anti-emetic used in patients with cancer, and Pabrinex a high potency formulation of vitamins B and C for alcoholics experiencing acute withdrawal. Archimedes' strategy is to grow its commercial presence organically and through the acquisition of pharmaceutical companies or marketed brands in Europe and through partnering or licensing of European rights to new specialist prescribed products. In parallel, Archimedes is developing a robust pipeline of innovative near term products to support its commercial organisation. Its lead product, Nasalfent(r), intranasal fentanyl for rapid relief of breakthrough cancer pain, is in phase III clinical development and is targeted for launch in 2009. To provide further impetus and sales growth for the company in the medium term, Archimedes has an established development organisation with proprietary enabling technologies for nasal drug delivery and a number of products in development.

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Publication:Worldwide Biotech
Date:Mar 1, 2007

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