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Helsinn Healthcare SA

The CHMP/EMEA has confirmed that the benefit/risk profile of Nimesulide is positive

London (ots)

Helsinn's Top Management today announced the
positive outcome of the EMEA procedure, according to Article 107,
initiated due to concerns over serious liver problems.
The Committee for Medicinal Products for Human Use (CHMP) today
confirmed Nimesulide's positive benefit/risk profile. The benefits of
these medicines outweigh their risks, but there is a need to limit
the duration of use and to restrict their use to ensure that the risk
of patients developing liver problems is kept to a minimum.
Medicines containing nimesulide in systemic formulations are
authorised in a number of European Union (EU) Member States to treat
acute pain, and the symptoms of painful osteoarthritis and primary
dysmenorrhoea (period pains). Nimesulide is therefore confirmed to be
an anti-inflammatory drug with scientific value proved for over 22
years of commercialisation, that is, since it was launched a on the
Italian market in October 1985.
The marketing authorisations for nimesulide-containing medicines
were suspended by the Irish competent authority in Ireland on 15 May
2007, because of reports of serious side effects affecting the liver.
After the Irish authority had notified the EMEA about the suspension,
the Committee for Medicinal Products for Human Use (CHMP) started an
assessment of the hepatic safety of these medicines in June 2007 to
reach a conclusion on whether the regulatory actions taken by Ireland
should be implemented throughout the EU.
Having considered all of the available evidence, the CHMP
concluded that the data did not support a suspension of all marketing
authorisations in Europe. It is also concluded that there was a need
for the marketing authorisations to be changed, with the information
provided to doctors and patients to be amended to limit the risk of
liver injury.
The CHMP therefore recommended that treatment with nimesulide
should be limited to a maximum of 15 days and that consequently all
packs containing more than 30 doses (tablets or sachets) should be
removed from the market. Doctors are advised to base their decision
to prescribe nimesulide on an assessment of the individual patient's
overall risks.
"Helsinn is proud of the result obtained, both for the importance
this drug represents within the Helsinn Group and for the wide use
and the benefit it provides to patients worldwide.
Nimesulide-containing medicinal products should be used in an
appropriate way as recommended by the CHMP" said Riccardo Braglia,
Chief Executive Officer.
About NIMESULIDE
NIMESULIDE is one of the most used non-steroidal anti-inflammatory
drugs in the EU. Present on the market since 1985,
nimesulide-containing products are currently available in
approximately 50 countries. To date, 500 million courses of treatment
have been made in 22 years of marketing.
About HELSINN HEALTHCARE
HELSINN HEALTHCARE SA, a privately owned pharmaceutical group with
headquarters in Switzerland, is the worldwide licensor of nimesulide.
HELSINN's core business is the licensing of pharmaceuticals in
various therapeutic niche areas (anti-inflammatory, gastroenterology,
oncology and supportive care). The company's business strategy is to
in-license early stage new chemical entities and complete their
development from the performance of pre-clinical/clinical studies and
CMC development to the attainment of market approvals in strategic
markets (U.S. and Europe).  HELSINN's products are eventually
out-licensed to its marketing partners for distribution. The active
pharmaceutical ingredients and the finished dosage forms are
manufactured at HELSINN's cGMP facilities and supplied worldwide to
its customers.
For more information about HELSINN, please visit the company's Web
site at www.helsinn.com.

Contact:

Massimo Tosi
M. Chem. Pharm., Senior Manager, Commercial Operations
Tel.: +41/91/985'21'14
Mobile: +41/79/701'49'61
E-Mail: mto@helsinn.com

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