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New Phase III NasalFent data reinforce superiority over the standard of care for breakthrough cancer pain

Update: Lazanda (fentanyl nasal spray) Now FDA Approved - June 30, 2011

Meets Primary and Secondary Endpoints Faster onset of pain relief than morphine Earlier time to clinically meaningful pain relief than morphine Patients prefer NasalFent over morphine

READING, 1 June 2009 – Archimedes Pharma Limited, the UK based, pan-European specialty pharmaceutical company, today released additional Phase III data for NasalFent®, its innovative and highly differentiated fentanyl citrate nasal spray for the rapid relief of breakthrough cancer pain.

The expanded results from the Phase III 044 study clearly demonstrate that NasalFent is superior to immediate release morphine sulphate (IRMS), the most commonly prescribed medicine for breakthrough cancer pain. NasalFent was proven to provide significantly earlier pain relief than IRMS, an important factor for breakthrough cancer pain patients, who need rapid relief from these debilitating pain episodes.

Breakthrough cancer pain affects up to 95% of all cancer patients 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.

The new data confirmed:

• A statistically significantly greater number of pain episodes treated with NasalFent showed onset of effect within 5 minutes (P<0.05) and clinically meaningful Pain Relief within 10 minutes (P<0.05); • A statistically significant reduction in pain from baseline, as assessed by Pain Intensity Difference was seen across pain episodes from 10 minutes (P<0.05) and at all time points up to and including 60 minutes (P<0.001).

These additional data released today also demonstrate that patients were more satisfied treating their pain with NasalFent than with IRMS. Scores for speed of relief, reliability and overall satisfaction were statistically significantly higher for NasalFent at both 30 minutes and 60 minutes after dosing. Using an assessment scale agreed with Regulatory Authorities, patients found NasalFent easy to use and convenient, with eight out of ten patients being either “satisfied” or “very satisfied” with the ease of use and convenience of the device.

NasalFent also demonstrated an excellent safety, tolerability and acceptability profile, with 94% of patients who entered the double blind phase completing the study. Moreover, NasalFentshowed consistent effectiveness with 98.4% of episodes being treated without the need for additional “rescue medication”.

Professor Marie Fallon, St Columba's Hospice Chair of Palliative Medicine, University of Edinburgh, Edinburgh Cancer Research Centre (CRUK) Western General Hospital Edinburgh, UK stated: “These data are hugely exciting. This is the first time a simple-to-use fentanyl product has been shown to be superior to the standard treatment for breakthrough cancer pain. NasalFent offers the prospect of greatly improving the management of this distressing and common complication of cancer”.

Study 044 was conducted in 8 major western European countries and in India, involving 35 expert investigational sites. A total of 135 patients were screened and 110 (82%) entered the open dose titration phase. 84 (76%) patients participated in the double-blind, double-dummy portion of the study. Data from study 044 will be submitted for presentation at a number of scientific meetings in 2009 including the European Society of Medical Oncology in September.

Richard de Souza, CEO of Archimedes, commented, "This expanded 044 Phase III data set provides yet more evidence to reinforce NasalFent’s superiority for the treatment of breakthrough cancer pain over immediate release morphine sulphate, both in terms of the speed at which onset of pain relief is achieved, and its impressive levels of patient acceptability.”

Data from Archimedes’ third phase III study, 045, a long-term safety study including over 500 patients will be available shortly.

For further information, please contact:

Archimedes Pharma: Michael Clark, +44 118 931 5050 Capital MS&L (for corporate enquiries: Mary Clark, Joanna Whineray, +44 20 7307 5330 Trout International LLC (for investor enquiries): Mike Booth, +44 20 7936 9326

Note to Editors

About Archimedes Pharma Archimedes Pharma (“Archimedes”) is a pan-European specialty pharmaceutical company 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, Ireland and Belgium, and will continue to expand its commercial presence through partnering and acquisition activities during 2009.

Products currently marketed in Europe by Archimedes include: Gliadel, a biodegradable wafer impregnated with carmustine, for high-grade glioma; Zomorph, an oral sustained release morphine product for pain; Oramorph, a liquid immediate release morphine product also for pain; Zibor, a second generation Low Molecular Weight Heparin for thromboprophylaxis; and Pabrinex, 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.

NasalFent NasalFent is an innovative and highly differentiated aqueous fentanyl citrate nasal spray utilising Archimedes’ proprietary PecSys™ technology. NasalFent has a low viscosity and is easily delivered in a low volume of 100mcl using a conventional 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 in nasal mucosal fluid cause the pectin to form a thin gel layer resulting in modulated drug absorption, allowing rapid but controlled absorption into the systemic circulation and an increased duration of action. PecSys technology avoids problems associated with simple solutions used as nasal sprays such as supratherapeutic levels of drugs and dripping or swallowing of drug solution. NasalFent is in development for rapid relief of breakthrough cancer pain.

Breakthrough cancer pain affects up to 95% of all cancer patients and is characterised by sudden, unpredictable episodes of intense pain typically lasting 30-60 minutes and which occur despite background opioid pain medication. Initial Phase III data illustrates that NasalFent has a potential best-in-class profile among fentanyl products for breakthrough cancer pain and is the first product to demonstrate onset of pain relief within five minutes of dosing. NasalFent has been filed for regulatory approval with the EMEA and an NDA will be filed for in the US in Q3 2009. Launch is being targeted from mid-2010.

For more information, please visit:

Joey Whineray Consultant Capital MSL 81 Whitfield Street London W1T 4HG t. +44 (0) 20 7307 5337 f. +44 (0) 20 7307 5331


Posted: June 2009