READING, 3rd April 2007 ??? Archimedes Pharma Ltd (???Archimedes???), a European specialty pharmaceutical company, today announces that LigoCyte Pharmaceuticals (???LigoCyte???) has begun Phase I trials of a Norovirus vaccine utilising Archimedes??? proprietary enabling ChiSys?? intranasal drug delivery system. Intranasal vaccines based on ChiSys combine the advantages of simple, convenient, needle-free and painless administration with immunization through both systemic and mucosal immune responses. LigoCyte???s Norovirus vaccine is the first intranasal vaccine to enter humans for this serious condition.

Archimedes has a strategic alliance with LigoCyte for the development of two vaccines, the other being for anthrax, currently in pre-clinical development. Archimedes will receive a stream of revenues, including R&D payments, milestones and royalties through the development, manufacture and commercialisation of the products. Financial details were not disclosed.

This investigational Norovirus vaccine clinical study highlights the potential of the ChiSys technology, which enhances immune responses through increasing contact time of the vaccine with the nasal membrane. A number of pre-clinical and clinical studies in a range of infectious diseases, including influenza and diphtheria, have already demonstrated that ChiSys vaccines result in a mucosal response and significantly greater systemic immune response than would otherwise be obtained. The ability to conveniently and effectively deliver immunisation without injection is of great value for diseases where healthcare systems may be overwhelmed or where those qualified to give injections are affected.

ChiSys also has proven applicability outside vaccine development. It is the enabling technology behind a nasally-delivered morphine product, Rylomine???, which is being developed by Javelin Pharmaceuticals. Rylomine is currently in Phase III clinical trials for moderate-to-severe postoperative orthopaedic pain.

Richard de Souza, Archimedes??? CEO, said: ???Today???s announcement is a further endorsement of the utility of our enabling intranasal drug delivery technologies. ChiSys and PecSys??? not only provide an important revenue stream for Archimedes but also bring the opportunity for us to develop our own products to drive into our established commercial operations in Europe. Our own lead product, Nasalfent for the treatment of breakthrough cancer pain, uses PecSys to optimise nasal delivery of fentanyl citrate and recently entered Phase III trials in the US.???

Enquiries
Archimedes Pharma:
Michael Clark
Tel +44 (0)118 931 5050
Mobile +44 (0)7973 111683

Citigate Dewe Rogerson:
Chris Gardner
Tel: +44 (0)207 638 9571

For more information on Archimedes, visit: www.archimedespharma.com
 
 
Notes to Editors 

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??, 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.

About ChiSys??
ChiSys?? is a highly effective transmucosal enhancement technology, able to overcome many of the limitations of previous intranasal drug delivery systems. Based around chitosan, a bioadhesive polysaccharide excipient derived from natural sources, ChiSys?? increases the residence time of drugs on mucosal surfaces and has been proven to increase nasal bioavailability of hydrophilic small molecule drugs, peptides and proteins.
Not only does this offer the potential to commercialise molecules previously thought to be clinically unviable by the nasal route, it offers patients a more acceptable, more convenient and more effective means of delivering currently available injectable therapeutics. Additionally, ChiSys?? has proven potential for vaccine delivery, with pre-clinical and clinical studies demonstrating that chitosan is able to enhance the immune response of nasally administered vaccines. A number of regulatory filings (IND/CTA) have been made for products using ChiSys?? technology, including vaccines. Pre-clinical studies and clinical trials are currently in progress to develop ChiSys??- based formulations for a broad range of therapeutic applications.

About Norovirus
Norovirus infection, well known as the ???stomach flu,??? is the most common cause of acute gastroenteritis, afflicting nearly 23 million people annually in the US alone. Norovirus infection is characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea, and occasionally fever. Dehydration is the most common complication, particularly in the elderly, young and immunocompromised populations. Severe clinical outcomes are associated with these at-risk populations, where infection can disrupt primary treatment regimens and, in severe cases, can lead to death. Noroviruses are highly infective, easily transmitted, and difficult to kill. Extensive outbreaks occur in community environments, particularly hospitals, hotels, schools, and nursing homes, resulting in mounting socioeconomic cost to businesses dealing with epidemic outbreaks. The military is also affected, as outbreaks represent a significant readiness issue for naval vessels and land-based military installations.

About PecSys???
PecSys??? is Archimedes??? patented drug delivery system built around its novel pectin technology and is specifically designed for the delivery of drugs to mucosal surfaces, especially the nasal cavity. PecSys??? maximises the potential of systemically absorbed drugs by enhancing drug performance and improving patient acceptance. The technology is in the form of a low viscosity aqueous solution which forms a gel when it comes into contact with the nasal mucosa. Drugs contained within the gel are absorbed across the mucosa, which thus offers a highly effective means of modulating drug delivery. This type of delivery modulation is especially useful for changing the absorption profile of compounds that are rapidly and extensively absorbed into the systemic circulation, which normally result in early and high peak plasma concentrations (Cmax) and consequently undesirable side effects. PecSys??? is applicable to well-absorbed (typically lipophilic) small molecules in a range of therapeutic areas, for instance migraine, nausea and pain. Intranasal products using PecSys??? are currently in Phase III clinical development both internally and in partnership with major pharmaceutical companies.