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Lazanda

Generic name: fentanyl
Treatment for: Pain

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

NDA Submitted for NasalFent

Archimedes Announces US Filing of NasalFent for the treatment of Breakthrough Cancer Pain

Reading, UK, 7 September 2009 - Archimedes Pharma ("Archimedes"), the pan-European specialty pharmaceutical company, today announced that it has filed a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for its lead development product, NasalFent, an innovative and highly differentiated fentanyl nasal spray for the rapid relief of breakthrough cancer pain.

This US filing was submitted on 31 August under the 505(b)2 route. In April 2009, Archimedes submitted a Marketing Authorisation Application with the European Medicines Evaluation Agency, where it remains under active review.

Richard de Souza, Chief Executive Officer of Archimedes, commented: "This year has been fundamental in building momentum around NasalFent. Earlier in the year we reported exciting clinical results that demonstrate NasalFent’s clear advantages over existing competitor treatments, either on the market or in development. We successfully filed the product for approval in Europe in April and I am delighted to announce that our development plans remain on track with the filing of NasalFent in the USA."

For further information, please contact:

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

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 The Group’s lead development product is NasalFent, an innovative and highly differentiated fentanyl citrate nasal spray, for the rapid relief of breakthrough cancer pain, based on Archimedes’ PecSys™ technology. 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. Archimedes submitted a centralised Marketing Authorisation Application with the European Medicines Evaluation Agency (EMEA) for NasalFent in April 2009 and submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in August 2009. It is targeted for launch from mid-2010.

NasalFent is an aqueous fentanyl citrate solution utilising Archimedes’ proprietary PecSys™ technology. The NasalFent solution 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 equally 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 absorption 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, for example supratherapeutic levels of drugs and dripping or swallowing of drug solution.

Archimedes technologies - ChiSys®, PecSys™ and TARGIT® - 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™ 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.

Posted: September 2009

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