Glenmark Pharmaceuticals Ltd will soon start Phase II
trials of its new anti-diarrhoeal drug `crofelemer'' following
approval from the Drug Controller General of India (DCGI).
trial is expected to commence this year and will involve
60 adult patients suffering from acute diarrhoea in a
prospective, randomised, parallel group using a controlled
double-blind placebo method. The trial will be concluded
within three months from the start of dosing.
company has signed a development and commercialisation
alliance with Napo Pharmaceuticals Inc for production
and marketing of this novel anti-diarrhoeal product, the
company said in a statement.
the terms of the agreement, Napo will be responsible for
marketing crofelemer in over 140 countries, including
India, for three indications, viz, AIDS diarrhoea, infectious
diarrhoea and paediatric diarrhoea. Napo will provide
low-cost and large-scale manufacturing in FDA-approved
manufacturing facilities and upon marketing will pay royalties
expects to launch the drug in 2008 in the first territory.
It is also working on a development plan for the other
indications of AIDS-related diarrhoea and paediatric diarrhoea.
are happy with the progress that crofelemer is showing;
if approved, the drug has the potential to meet a large
and unsatisfied need for safe and effective medication
for the treatment of diarrhoea," said Glenn Saldanha,
managing director and CEO, of Glenmark.
Pharmaceuticals Inc., based in California, US, is focused
developing and commercialising proprietary pharmaceuticals
for the global marketplace, in collaboration with local
partners. In order to address major global unmet medical
needs in developed and developing countries. The company
has a subsidiary in Mumbai, and recently made its debut
in the main market of the London Stock Exchange.