Archimedes Pharma Receives European Marketing Authorisation for PecFent(R) for the Treatment of Breakthrough Cancer Pain

READING, England, September 1, 2010 - Archimedes Pharma Ltd., a leading international specialty
pharma company, today announced that the European Commission has granted
marketing authorisation for its lead product, PecFent*, an innovative
fentanyl nasal spray for the treatment of breakthrough cancer pain (BTCP) in
adults who are already receiving maintenance opioid therapy for chronic
cancer pain.

Breakthrough cancer pain is sudden, unpredictable episodes of
pain that are severe to excruciating in intensity; it affects 24% to 95%
(average 62%) of all cancer patients despite background pain medication.[i]
Episodes can often reach maximum intensity in five minutes typically lasting
30-60 minutes.[ii] Most people who have breakthrough cancer pain experience
several episodes a day.[ii]

PecFent contains fentanyl, a highly potent opioid analgesic
and uses an Archimedes Pharma nasal drug delivery system (PecSys(TM)) to
deliver fentanyl in a rapid but controlled manner designed to match the time
course of the typical breakthrough pain episode. In two randomized,
well-controlled, double blind, phase III clinical trials, PecFent
demonstrated onset of pain relief as early as five minutes as well as
clinically meaningful pain relief within 10 minutes.[iii],[iv],[v]

Jeffrey H. Buchalter, President and Chief Executive Officer of
Archimedes Pharma, commented: "The grant of European marketing authorisation
for PecFent provides a new therapy to improve the treatment options for adult
patients with breakthrough cancer pain. This is also a transformative
milestone for Archimedes Pharma as we have established commercial operations
in Europe and look forward to launching PecFent in major European markets in
the coming months."

Prof. Marie Fallon, St Columba's Hospice Chair of Palliative
Medicine, University of Edinburgh, Edinburgh Cancer Research Centre (CRUK)
Western General Hospital, Edinburgh, UK, commented: "The availability of this
significant innovation is very important. Being a nasal spray, its ease of
use allows patients to treat their breakthrough cancer pain episodes
conveniently, wherever they are, and its unique delivery system provides fast
onset of pain relief meaning so they can manage these episodes effectively.
This is absolutely crucial for cancer patients and PecFent offers real hope
for an improvement in their quality of life."

The marketing authorisation is based on the largest ever
clinical development programme in breakthrough cancer pain, which involved
three Phase III studies including an active comparator study and a large
long-term safety and acceptability study.[vi] The programme included more
than 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
the product to the US Food and Drug Administration (FDA) in August 2009 and
is in the process of establishing a 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 is an international specialty pharmaceutical company
focused on the oncology, pain, neurology, and critical care sectors.
Archimedes Pharma is marketing an expanding portfolio of specialist products
to hospital-based prescribers in Europe and the US and has established
commercial organizations in the UK, US, France, Germany, Ireland, and Spain.

Products currently marketed in Europe by Archimedes Pharma
include: Gliadel, a biodegradable wafer impregnated with carmustine for
high-grade glioma; Zomorph, 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 for motor fluctuations in advanced Parkinson's
disease; and Pabrinex, a high potency vitamin formulation used to treat the
symptoms of malnutrition especially in patients with alcohol misuse problems.

Archimedes Pharma is also developing a robust, high-value
pipeline of in-house pain therapeutics, Parkinson's disease and critical
care. It applies its world-class drug delivery technologies to proven
molecules that 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.

PecFent(R) (www.pecfent.com)

Archimedes Pharma's company-transforming product PecFent, an innovative
fentanyl citrate nasal spray, is now licensed in the European Union for the
treatment of breakthrough cancer pain in adults who are already receiving
maintenance opioid therapy for chronic cancer pain.

PecFent is an aqueous fentanyl citrate solution utilising
Archimedes Pharma's proprietary PecSys(TM) technology. The PecFent solution
has a low viscosity and is easily delivered in a low volume of 100
microlitres using a nasal spray pump. The pump produces a fine mist of
similarly sized spray droplets that are deposited into the front of the nose.
The calcium ions present on the nasal mucosa cause the pectin in the solution
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 most
nasal sprays, such as dripping or swallowing of the drug solution

In the clinical trial program, the use of PecFent in the
treatment of breakthrough cancer pain was associated with the occurrence of
adverse events typical of opioid medication in this population. The most
frequently reported were vomiting, nausea, disease progression and
constipation. The majority of such events were mild to moderate in intensity,
and adverse effects assessed as treatment-related led to study withdrawal in
3.9% of patients.

Archimedes Pharma's 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 that
enhances the residence time of molecules on mucosal membranes, has proven
potential for vaccine delivery. Pre-clinical and clinical studies of nasally
administered vaccines incorporating ChiSys have demonstrated enhanced immune
response. PecSys(TM) is Archimedes Pharma's patented drug delivery system
built around its novel pectin technology and is designed to maximise the
potential of systemically absorbed drugs by enhancing drug performance and
improving patient acceptance.

Please also refer to the complete Summary of Product
Characteristics available at www.pecfent.com.

About Breakthrough Cancer Pain (BTCP)

Breakthrough cancer pain affects up to 24% to 95% (average
62%) 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 five minutes and lasting for 30 to 60 minutes.

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

About Warburg Pincus

Warburg Pincus is a leading global private equity firm. The
firm has more than $30 billion in assets under management. Its active
portfolio of more than 100 companies is highly diversified by stage, sector
and geography. Warburg Pincus is a growth investor and an experienced partner
to management teams seeking to build durable companies with sustainable
value. Founded in 1966, Warburg Pincus has raised 12 private equity funds
which have invested more than $35 billion in approximately 600 companies in
more than 30 countries. Since the firm's first European transaction in 1983,
Warburg Pincus has invested more than $6 billion in European companies,
including investments in Archimedes, Eurand and ProStrakan. Additional life
science investments include Allos Therapeutics, Ganic Pharmaceuticals,
InterMune, Rib-X Pharmaceuticals and ZymoGenetics. The firm has offices in
Beijing, Frankfurt, Hong Kong, London, Mumbai, New York, San Francisco,
Shanghai and Tokyo. For more information, please visit
www.warburgpincus.com.

About Novo A/S and Novo Growth Equity

Novo A/S is the holding and investment company of the Novo
Group, and is wholly owned by the Novo Nordisk Foundation. Novo A/S was
formed in 1999 to actively manage the assets of the foundation. It employs
about 30 people and has approximately USD 15 billion of assets under
management. These includes significant shareholdings in the publicly listed
Novo Nordisk A/S (NYSE: NVO) and Novozymes A/S (NVZMF.PK), Novo A/S provides
seed, venture and growth capital to development stage companies within life
science and biotechnology, as well as manages a broad portfolio of financial
assets. Novo A/S is committing up to USD 300 million annually to its
investments in seed, venture and growth equity life science companies. Of
this, nearly two-thirds are directed to the Novo Growth Equity activities
focusing on investment in promising late stage companies with near term
commercial potential. For further information please visit
www.novo.dk.

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[i] Svendsen KB, Andersen S, Arnason S, et al. Breakthrough pain in
malignant and non-malignant diseases: a review of prevalence, characteristics
and mechanisms. Eur J Pain. 2005;9:195-206.

[ii] Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and
characteristics. Pain. 1990;41:273-281.

[iii] Portenoy, R. Burton, A. Wallace, M. et al. The Efficacy, Onset of
Action and Tolerability of Fentanyl Pectin Nasal Spray (FPNS) With PecSys(R)
in the Treatment of Breakthrough Cancer Pain (BTCP): A Multicentre, Placebo-
Controlled, Double-Blind Crossover Study. Poster presented at the 11th
Congress of the European Association for Palliative Care (EAPC); 7-10 May
2009; Vienna, Austria.

[iv] Burton, A. Wallace, M. Taylor, D. et al. Fentanyl Pectin Nasal Spray
(FPNS) With PecSys®: Onset of Action, Consistency, and Acceptability in
Breakthrough Cancer Pain (BTCP). Poster Presented at the Annual Meeting of
the American Pain Society, 7-9 May 2009; San Diego, CA.

[v] Fallon, M. Gatti, A. Davies, A. et al. Efficacy, Safety and Patient
Acceptability of Fentanyl Pectin Nasal spray Compared with Immediate- Release
Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain: A
Multicentre, Double-Blind, Double-Dummy, Multiple-Crossover Study. Poster
Presented at the joint 15th Congress of the European Cancer Organisation and
34th Congress of the European Society for Medical Oncology; 20-24 September
2009; Berlin, Germany.

[vi] Torres, L. Radbruch, L. Reale, C. et al. Long-term Safety,
Tolerability and Consistency of Effect of Fentanyl Pectin Nasal Spray in
Opioid-Tolerant Patients in the Treatment of Breakthrough Cancer Pain. Poster
Presented at the joint 15th Congress of the European Cancer Organisation and
34th Congress of the European Society for Medical Oncology; 20-24 September
2009; Berlin, Germany

For further information, please contact: Citigate Dewe Rogerson (UK and Europe): Chris Gardner / Amber Bielecka, +44-207-638-9571, amber.bielecka at citigatedr.co.uk; Tiberend Strategic Advisors, Inc. (USA): Gregory Tiberend / Tamara Bright, +1-212-827-0020, gtiberend at tiberendstrategicadvisors.com / tbright at tiberendstrategicadvisors.com