Pharmaceuticals Sector - Solvay

22
Solvay Global Annual Report 2005
The new cell culture production
plant in the Netherlands has been
completed and is now at the
validation stage. Clinical trials of
the H5N1 mono vaccine should
commence in the course of 2006.
Production using this cell culture
technology can be launched
considerably faster and is much
more fl exible than the traditional
egg-based vaccine production
method.
In order to stem the threat of bird
fl u, it is vital that the World Health
Organization (WHO), national
governments, the wider medical
community and pharmaceutical
companies work together in a
coordinated framework.
Solvay Pharmaceuticals continues
to collaborate closely with all these
players on this key dossier.
Gastroenterology
Cilansetron:
Solvay Pharmaceuticals
suspends registration
process in the USA,
negotiations continue
in Europe
Solvay Pharmaceuticals announced
in November that it was
suspending the registration process
for cilansetron with the US
regulatory agency, the FDA.
Whilst Solvay is convinced of the
qualities of the new compound,
the extent of the additional clinical
work needed and the size of the
estimated market has led it to
give priority to developing other
compounds in its research and
development pipeline.
Nevertheless, in the United
Kingdom, the reference country
for European-level registrations,
discussions with the Medicines and
Healthcare Products Regulatory
Agency concerning cilansetron
continue in order to precisely defi ne
the clinical expectations. Effi cacy
and safety trials have included
over 4 000 patients of both sexes
worldwide suffering from irritable
bowel syndrome with diarrhoea
predominance. Cilansetron has
demonstrated benefi cial effects for
both men and women, with improved
intestinal functioning and better
quality of life.
Women’s Health
and Men’s Health
Pharmaceuticals Sector
ANDROGEL ® ,
already successful
in the United States,
extends distribution
into new territories
In 2005, Solvay Pharmaceuticals
negotiated additional rights to
ANDROGEL ® on a number of new
markets from its owner, Besins
International.
ANDROGEL ® is an odor-free,
locally-applied gel. Applied once a
day, it provides an ideal response
to unsatisfi ed clinical needs in the
treatment of hypogonadism
(testosterone defi ciency), a particularly
unpleasant male ailment.
This product has already proved
its success in North America (2005
sales reached EUR 239 million).
We now have sales rights for the
whole of Africa, Africa, Central
and Eastern Europe, key Western
European countries and the Middle
East, Asia and Latin America.
The US litigations concerning
hormone replacement therapy are
declining, with a far from negligible
number of plaintiffs withdrawing
their claims against Solvay before
any decision on the merits.
There has been no development
in the discussions with the American
Food and Drug Administration
on the administrative status of
ESTRATEST ® .