Archimedes Pharma Receives CHMP Positive Opinion for PecFent(R) for the Treatment of Breakthrough Cancer Pain

READING, England, June 25, 2010 /PRNewswire/ -- Archimedes Pharma ("Archimedes"), a leading specialty pharma company, today announced that its lead product, PecFent*, has received a Positive Opinion from the Committee for Human Medicinal Products (CHMP), of the European Medicines Agency (EMA). The CHMP is recommending PecFent, an innovative fentanyl nasal spray, be authorised for marketing in European Union countries for the treatment of breakthrough cancer pain (BTCP) - sudden, unpredictable episodes of intense pain that occur despite background pain medication.

Jeffrey H. Buchalter, President and Chief Executive Officer of Archimedes Pharma, commented: "This is a defining moment for Archimedes Pharma. Breakthrough cancer pain is a poorly served indication and affects up to 95% of all cancer patients with pain. Today's announcement by the CHMP is an important step towards bringing a new treatment option to these patients in Europe. It also marks a step change in scale for Archimedes Pharma's already successful European commercial operations and an important landmark in our development as a leading global specialty pharma company. Our clinical development programme delivered excellent results and we look forward to delivering this new option for patients in Europe as soon as we can following the grant of the Marketing Authorisation."

PecFent is an aqueous fentanyl citrate solution using Archimedes Pharma's proprietary PecSys(TM) technology to allow fentanyl to be retained on the nasal mucosa and is designed to produce rapid but controlled absorption into systemic circulation. The positive opinion is based on the results of Archimedes Pharma's comprehensive clinical development programme for PecFent which comprised three phase III studies including an active comparator study and a large long term safety and acceptability study. The programme included over 650 patients and more than 100 investigational sites from the US, UK, Germany, France, Spain and Italy, and in total 13 countries across four continents.

Archimedes Pharma submitted a New Drug Application (NDA) for PecFent with the US Food and Drug Administration (FDA) in August 2009 and is in the process of establishing its own US commercial organisation to market the drug in the US once approved.

*PecFent was previously known as NasalFent.

Notes to editors:

About Archimedes Pharma

Archimedes Pharma ("Archimedes") is a specialty pharmaceutical company already marketing and selling an expanding portfolio of specialist products to hospital-based prescribers in major European territories.

Focused on the oncology, pain, neurology and critical care sectors, Archimedes currently markets a range of products in the UK, France, Germany and Ireland, and will continue to expand its commercial presence in Spain and the US during 2010.

Products currently marketed in Europe by Archimedes include: Gliadel (1), a biodegradable wafer impregnated with carmustine for high-grade glioma; Zomorph (2), an oral sustained release morphine product for moderate to severe pain, particularly cancer pain; Oramorph, a liquid immediate release morphine product also indicated for moderate to severe pain; Apomorphine Injection (3), for motor fluctuations in advanced Parkinson's disease and Pabrinex (4), a high potency vitamin formulation used to treat the symptoms of malnutrition especially in patients with alcohol misuse problems.

Archimedes is also developing a robust, high value pipeline of in-house products in pain, Parkinson's disease and critical care. It applies its world-class drug delivery technologies to proven molecules which have yet to achieve their market potential due to their current mode of delivery. This approach reduces the company's development risk, while delivering significant clinical and commercial benefits.

    (1) For SmPC visit:
http://www.medicines.org.uk/EMC/medicine/13913/SPC/Gliadel+7.7mg+Implant/
    (2) For SmPC visit:
http://www.medicines.org.uk/EMC/medicine/6542/SPC/Zomorph+capsules/

(3) For SmPC visit: http://www.medicines.org.uk/EMC/medicine/21983/SPC/Apomorphine+10mg+ml+soluti on+for+injection+(Archimedes+Pharma+UK+Ltd)/

(4) For SmPC visit: http://www.medicines.org.uk/EMC/medicine/6571/SPC/Pabrinex+Intravenous+High+P otency+Injection/

(Due to the length of these URLs, it may be necessary to copy and paste the hyperlinks into your Internet browser's URL address field. Remove the space if one exists.)

PecFent(R)

Archimedes' company-transforming product is PecFent, an innovative and highly differentiated fentanyl citrate nasal spray, now approved for the treatment of breakthrough cancer pain.

PecFent is an aqueous fentanyl citrate solution utilising Archimedes' proprietary PecSys(TM) technology. The PecFent solution has a low viscosity and is easily delivered in a low volume of 100mcl using a nasal spray pump. The pump produces a fine mist of similarly sized spray droplets which are deposited into the front of the nostril. The calcium ions present on the nasal mucosa cause the pectin to form a thin gel layer, which allows fentanyl to be retained on the nasal mucosa, allowing a rapid but controlled absorption into the systemic circulation. The PecSys(TM) technology avoids problems associated with simple solutions used in nasal sprays, such as dripping or swallowing of the drug solution.

Archimedes' technologies - ChiSys(R), PecSys(TM) and TARGIT(R) - are also used in a number of partnered products in late-stage clinical development. ChiSys, an innovative drug delivery technology which enhances the residence time of molecules on mucosal membranes, has proven potential for vaccine delivery. Pre-clinical and clinical studies of nasally administered vaccines have demonstrated enhanced immune response. PecSys(TM) is Archimedes' patented drug delivery system built around its novel pectin technology, designed to maximise the potential of systemically absorbed drugs by enhancing drug performance and improving patient acceptance.

About Breakthrough Cancer Pain (BTCP)

Breakthrough cancer pain affects up to 95% of all cancer patients with pain and is characterised by sudden, unpredictable episodes of intense pain that occur despite background pain medication. This pain is rapid in onset, usually reaching maximum intensity in 5 minutes and lasting for 30 to 60 minutes.

For more information, please visit: http://www.archimedespharma.com

For further information, please contact:

Citigate Dewe Rogerson (UK and Europe): Chris Gardner/Amber Bielecka, +44-(0)207-638-9571, [email protected]

Tiberend Strategic Advisors, Inc. (USA): Gregory Tiberend / Tamara Bright, +1 212-827-0020, [email protected] / [email protected]

SOURCE Archimedes Pharma

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