Adenuric(R) Represents the First Major Treatment of Gout for More Than Forty Years
Regulatory News:
Ipsen (Paris:IPN) announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMEA)
provided a positive opinion for Adenuric(R) (febuxostat) 80 mg and 120
mg tablets for the treatment of chronic hyperuricaemia in gout and
recommended it for marketing authorisation. The CHMP recommendation
will now be forwarded to the European Commission for final marketing
approval, which typically occurs within 60 to 90 days. Following
marketing approval, Adenuric(R) will become, since 1964, the first
significant treatment alternative for chronic hyperuricaemia available
to gout patients.
Adenuric(R) is to be indicated for the treatment of chronic
hyperuricaemia for conditions in which urate deposition has already
occurred (including a history, or presence of, tophus and/or gouty
arthritis). The detailed recommendations for the use of this product
will be described in the Summary of Product Characteristics (SPC), to
be made available after the medication receives marketing
authorisation from the European Commission.
Once the product receives its marketing authorisation and its
price is agreed, Febuxostat will be marketed by Ipsen in France under
the brand name Adenuric(R). Outside France, the commercialisation of
the product will be partnered.
Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen,
said, "We are very proud to receive this positive opinion for
Adenuric(R) from the EMEA, and look forward to bringing this new
molecule to market, pending European Commission approval. This
innovative drug pioneers the first major treatment of gout for more
than 40 years. It confirms Ipsen´s ability to continue to bring to the
market important new treatment options for severely debilitating
diseases."
About Adenuric(R) (febuxostat)
Gout, a particularly painful type of arthritis, is the most
frequent arthritis in men. It is caused by elevated levels of uric
acid in the body: hyperuricaemia. Febuxostat, an oral, once-daily
medication, is a novel non-purine, selective inhibitor of xanthine
oxidase studied for its effects on lowering levels of serum uric acid
(sUA) in patients with gout. Febuxostat is licensed to Ipsen for
Europe from Teijin Pharma Limited, Tokyo.
The EU submission includes two of the largest industry sponsored
studies to date studying treatment of chronic gout patients. The goal
of chronic gout treatment is per EULAR guidelines (European League
Against Rheumatism) to reduce and maintain sUA levels below 6 mg/dL.
Febuxostat demonstrated superior ability to lower and maintain in
patients, serum uric acid at a level inferior to 6 mg/dl compared to
conventionally used doses of allopurinol (febuxostat 80 and 120 mg: 51
& 63 % resp. vs. allopurinol: 22%). In addition, one phase III study
showed that gout patients with mild to moderate renal impairment
(serum creatinine greater than1.5 - <=2.0 mg/dl) had response rate of
44 and 45 % respectively with febuxostat 80 and 120 mg.
CHMP press release can be accessed at http://www.emea.europa.eu.
In 2003, Ipsen entered into a Research and Development partnership
with Teijin Pharma Limited, the core company of Teijin Group´s
pharmaceutical and home healthcare business. The Teijin group is a
Japanese industrial conglomerate specialising in the businesses of
fibres, films, plastics and information technology (IT) as well as
pharmaceuticals and home healthcare. This partnership covers the
development and subsequent commercialisation of four of Ipsen´s
products by Teijin Pharma in Japan and the development and marketing
by Ipsen in Europe (i.e. European Union and Russia) of febuxostat, a
product owned by Teijin Pharma and known as TMX-67.
About Ipsen
Ipsen is an innovation driven international specialty
pharmaceutical group with over 20 products on the market and a total
worldwide staff of nearly 4,000. The company´s development strategy is
based on a combination of products in targeted therapeutic areas
(oncology, endocrinology and neuromuscular disorders) which are growth
drivers, and primary care products which contribute significantly to
its research financing. This strategy is also supported by an active
policy of partnerships. The location of its four Research and
Development centres (Paris, Boston, Barcelona, London) gives the Group
a competitive edge in gaining access to leading university research
teams and highly qualified personnel. In 2006, R&D expenditure was EUR
178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR
861.7 million while total revenues amounted to EUR 945.3 million (in
IFRS). 700 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. Ipsen´s shares are
traded on Segment A of Eurolist by EuronextTM (stock code: IPN, ISIN
code: FR0010259150). Ipsen´ s shares are eligible to the "Systeme a
Reglement Differe" ("SRD") and the Group is part of the SBF 120 index.
For more information on Ipsen, visit our website at www.ipsen.com.
Forward-looking statements
The forward-looking statements and targets contained herein are
based on Ipsen´s management´s current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may
cause actual results, performance or events to differ materially from
those anticipated herein. Moreover, the Research and Development
process involves several stages at each of which there is a
substantial risk that the Group will fail to achieve its objectives
and be forced to abandon its efforts in respect of a product in which
it has invested significant sums. Therefore, the Group cannot be
certain that favourable results obtained during pre-clinical trials
will be confirmed subsequently during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the safe
and effective nature of the product concerned, or that the regulatory
authorities will be satisfied with the data and information provided
by the Company. Ipsen expressly disclaims any obligation or
undertaking to update or revise any forward looking statements,
targets or estimates contained in this press release to reflect any
change in events, conditions, assumptions or circumstances on which
any such statements are based, unless so required by applicable law.
Ipsen´s business is subject to the risk factors outlined in its
information documents filed with the French Autorite des Marches
Financiers.
