Regulatory News:
Ipsen (Paris:IPN) today announced that the European Commission granted
marketing authorisation for Adenuric® (febuxostat) for the treatment of chronic hyperuricaemia in gout.
Adenuric® thus
pioneers the first major treatment alternative for gout, a severe
debilitating disease, for more than 40 years.
"Recent surveys confirm that management of gout is often
suboptimal, with less than half of patients receiving appropriate
lifestyle advice or urate lowering treatment" said Michael Doherty
Professor of Rheumatology at the University of Nottingham (UK) and
Co-chair of the 2006 EULAR Task Force for the Recommendations on
Diagnosis and Management of Gout. "Recent European (EULAR)
Recommendations emphasise the aim of "cure" by lowering serum urate
levels below the saturation point for crystal formation. For some
patients, the existing urate lowering therapies have limitations in
terms of suitability or side effects. The availability of a new
effective therapy that allows the therapeutic target to be achieved will
improve the physicians armamentarium and ultimately benefit the
population of patients with gout."
Adenuric® (febuxostat)
80 mg and 120 mg tablets are 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).
Adenuric® will be
marketed by Ipsen in France. Outside France, the commercialisation of
the product will be partnered.
About the marketing authorisation
(The European Public Assessment Report (EPAR) summary will be accessible
at http://www.emea.europa.eu).
This decision follows the filing by Ipsen, of an application for
marketing authorisation for Adenuric® in the European Union in 2006. A positive opinion, recommending to grant
a marketing authorisation was adopted by the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on
21 February 2008.
The EU submission,included 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 >1.5
- ≤2.0 mg/dl) had response rate of 44 and 45
% respectively with febuxostat 80 and 120 mg.
About Adenuric® (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.
The recommended oral dose of Adenuric® is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dl (357 µmol/l) after 2-4 weeks, Adenuric® 120 mg once daily may be considered. Adenuric® works sufficiently quickly to allow retesting of the serum uric acid
after 2 weeks. The therapeutic target is to decrease and maintain serum
uric acid below 6 mg/dl (357μmol/l). Gout
flare prophylaxis of at least 6 months is recommended at initiation of
treatment with Adenuric®.
Febuxostat is licensed to Ipsen for Europe from Teijin Pharma Limited
Tokyo. 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 the market and a total worldwide
staff of nearly 4,000. Its development strategy is based on a
combination of specialty products, which are growth drivers, in targeted
therapeutic areas (oncology, endocrinology and neuromuscular disorders)
and primary care products which contribute significantly to its research
financing. The location of its four Research & Development centres
(Paris, Boston, Barcelona, London) and its peptide and protein
engineering platform give the Group a competitive edge in gaining access
to leading university research teams and highly qualified personnel.
More than 700 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. This strategy is also
supported by an active policy of partnerships. In 2007, Research and
Development expenditure was about €185
million, in excess of 20% of consolidated sales, which amounted to €920.5
million while total revenues amounted to €993.8
million. 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 "Service de Règlement
Différé" ("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
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