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

June 25, 2010

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, amber.bielecka@citigatedr.co.uk

Tiberend Strategic Advisors, Inc. (USA): Gregory Tiberend / Tamara
Bright
, +1 212-827-0020, gtiberend@tiberendstrategicadvisors.com /
tbright@tiberendstrategicadvisors.com

SOURCE Archimedes Pharma


Source: newswire



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