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Archimedes Pharma Limited

Archimedes Pharma Announces Major Fund Raising of GBP65 Million

Reading, England, March 2, 2010 (ots/PRNewswire)

Archimedes Pharma
("Archimedes"), the leading specialty pharma company, today announced
that it has raised GBP65 million (approx US$100 million) in new
funding. The round was led by new investor Novo Growth Equity, the
growth equity fund of Novo A/S, and included participation by major
current investor, Warburg Pincus, a global private equity firm.
Archimedes also announced the appointment of a new President and
Chief Executive Officer, Jeffrey H. Buchalter, formerly President and
Chief Executive Officer of US-based Enzon.
The funding round is the largest raised by a private European
biopharma company in the last 15 years and is Novo Growth Equity's
first investment since it was established at the beginning of 2009.
The funds will be used to establish Archimedes' operations in the US
and support the growth of the successful specialty pharma business in
Europe. The funds will also be used to support the global commercial
launch of PecFent*, Archimedes' innovative, simple-to-use, fentanyl
nasal spray for the treatment of breakthrough cancer pain. PecFent
has been filed for approval in Europe and the US and is expected to
be approved for commercial sale in both regions during 2010. PecFent
is supported by an extensive phase III clinical development programme
in which the product met all primary and secondary end-points.
Crucially, the phase III studies demonstrated that PecFent showed
onset of pain relief within five minutes of dosing, statistically
significant improvements in pain relief versus immediate release
morphine, together with high levels of patient acceptability and
consistent effectiveness in use.
Jeffrey H. Buchalter has over 20 years experience in the
pharmaceutical industry and has held senior positions at a number of
multinational pharmaceutical companies. He was most recently
President and CEO of Enzon Pharmaceuticals, the US biopharmaceutical
company focused on the development, manufacturing and
commercialisation of therapies for patients with cancer and other
life-threatening conditions. Prior to this, he was CEO of ILEX
Oncology, where he led the transformation from a drug development
company to a high quality oncology franchise with established
commercial operations. He has also held key positions at Pharmacia,
Wyeth and Schering Plough.
Simon Turton, Managing Director of Warburg Pincus, said: "We have
supported Archimedes since its foundation in 2004 and are delighted
to invest again in such an exceptional company as it enters a new
stage in its growth. We are particularly pleased to welcome Jeff as
President and CEO and to the Board of Archimedes. His vast experience
and knowledge of the pharmaceutical industry, and specifically
oncology, will be instrumental in accelerating the Company's success
through an international platform. This major injection of funding
and the appointment of Jeff as the new President and CEO mark the
beginning of a new phase in Archimedes' growth plans."
Ulrik Spork, Managing Partner of Novo Growth Equity, said: "We
have been impressed with the successful track record of Archimedes
over the last five years, and are very pleased to contribute to the
further transformation of the Company with the launch of PecFent,
Archimedes' nasal fentanyl spray, in Europe and US. Archimedes
represents an ideal investment opportunity for us and supports our
strategy to take major stakes in promising late stage life sciences
companies with near-term commercial potential."
Jeffrey H. Buchalter, President and Chief Executive Officer of
Archimedes, commented: "Archimedes is at a transformational stage in
its development. It has built up a successful specialty pharma
business in Europe and has filed its lead product, PecFent, for
product approval in both Europe and the US. I am delighted to join as
President and CEO to accelerate the expansion of Archimedes' business
in Europe, support the commercialisation of PecFent, and build the
operations in the US market."
The board of Archimedes will now include Simon Turton and Piyush
Shukla of Warburg Pincus; Ulrik Spork and Goran Ando of Novo A/S; and
Jeffrey H. Buchalter.
*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, 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 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.
Archimedes submitted a centralised Marketing Authorisation
Application with the European Medicines Agency (EMA) for PecFent in
April 2009 and submitted a New Drug Application (NDA) with the US
Food and Drug Administration (FDA) in August 2009. The product is
expected to be approved for commercial sale during 2010 in both
territories.
PecFent
Archimedes' transformational product is PecFent, an innovative
and highly differentiated fentanyl citrate nasal spray, for the rapid
relief of breakthrough cancer pain, based on Archimedes' PecSys(TM)
technology. Phase III data illustrates that PecFent 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.
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
excessive levels of drug and 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.
For more information, please visit:
http://www.archimedespharma.com.
Jeffrey H. Buchalter
Jeffrey H. Buchalter has over 20 years experience in the
pharmaceutical industry. He was previously President and CEO of Enzon
Pharmaceutical Inc. since 2004 and also served as Chairman of the
Board of Directors until May 2009. Prior to this, Jeffrey was
President and CEO of ILEX Oncology, Inc. where he led the company's
transformation from a drug development contract research organization
to a product-driven pharmaceutical company. Before joining ILEX
Oncology Inc., Jeffrey held key roles at Pharmacia, Wyeth (formerly
American Home Products) and Schering-Plough Corporation.
Jeffrey received the American Cancer Society's Joseph F. Buckley
Memorial Award and an invitation from former President George Bush to
serve as a collaborating partner in the National Dialogue on Cancer.
Jeffrey was recently appointed Chairman to the Board of Trustees of
The National Children's' Cancer Foundation (NCCF); he is also a
member of the Board of Directors of TopoTarget A/S, a publicly held
Danish biopharmaceutical company.
Jeffrey has a B.S. in finance from Seton Hall University, and an
M.B.A. in marketing from Temple University.
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 http://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  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
http://www.novo.dk.
For further information, please contact:
Capital MS&L:
Mary Clark, Supriya Mathur, Tel: +44(0)20-7307-5347

Contact:

CONTACT: For further information, please contact: Capital MS&L:
MaryClark, Supriya Mathur, Tel: +44(0)20-7307-5347