LONDON, September 21 /PRNewswire/ --     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 http://www.helsinn.com.

ots Original text: Helsinn Healthcare AG

Internet: http://www.presseportal.ch

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