registered
with the Chinese GIPAP, helping more than 1 000 patients in need receive treatment
with Glivec at no cost. In a separate development
involving Glivec, Novartis sub-mitted unconventional applications to regulatory
authorities around the world during 2005 and early this year, seeking to expand
access to Glivec beyond CML and GIST to include a cluster of rare conditions.
In studies, Glivec had shown efficacy in treating these rare disorders
but the limited number of patients with each disease precluded the large, randomized
clinical trials usually required for regulatory approval.
To provide access to treatment for these patients, Novartis assembled data from
published studies into regulatory applications. Regulatory agencies, including
the US Food and Drug Administration, have agreed to consider the unusual application
– but there’s no guarantee of success. “Our commitment
has been to ensure that any patient who could benefit from Glivec also could get
the medicine,” says David Epstein, Head, Oncology Business Unit, at the Novartis
Pharmaceuticals Division. “We did this first through patientassistance programs
for patients with CML and GIST. Once we saw that the drug was effective in these
other rare indications, we felt an obligation to explore and to push approval
for them as well,” he adds. “We have a bond with these
patients and we have to keep doing whatever we can for them, to the extent of
our scientific capability.” |
| CHANGING
THE FACE OF MALARIA During 2005, Novartis also
stepped up its commitment to change the face of malaria. We expanded production
capacity dramatically and doubled shipments of the pioneering antimalarial medicine
Coartem which the company provides on a non-profit basis for public-sector
use in developing countries where the disease is endemic.
More than 33 million Coartem treatment courses were produced last year and deliveries
reached 9 million treatments, from 4.4 million in 2004. Since 2001, when Novartis
created the partnership with the WHO to distribute Coartem at cost, more
than 20 million treatments have been provided to patients in the developing world.
In addition to Zambia, the initial country in Africa to adopt Coartem as
first-line therapy against malaria, major deliveries were made last year to Angola,
Ethiopia, Nigeria, Mozambique and Sudan. To meet rising
demand, Novartis and partners on three continents continued a scale-up of manufacturing
capacity virtually unprecedented in commercial drug production for a new chemical
entity. The scale-up will make it possible to keep pace with further increases
in demand expected this year – to more than 100 million treatment courses of Coartem,
according to the latest forecasts from the WHO. This
represents a 25-fold increase from 2004. Late last year, Novartis received an
order from Uganda for more than 15 million Coartem treatment courses, the
biggest order yet for the drug, or any artemisininbased combination therapy (ACT). |
| “This
scale-up is the most rapid increase in capacity for any drug I know – and it is
especially remarkable for a product provided on a not-for-profit basis,” says
Daniel Vasella, M.D., Chairman and Chief Executive Officer of Novartis. “Effective
drugs are available now, but solving the problem of malaria is much more than
just a question of drug availability. These countries are facing a lack of physicians
and nurses, the lack of an efficient distribution system and of other preventive
steps against unnecessary infection,” Dr. Vasella adds.
“Governments, health minis-tries, international organizations and industry all
have roles to play in addressing and resolving this challenge.”
MOST EFFECTIVE TREATMENT A
publication last year in Britain’s leading medical journal, The Lancet,
suggested that Coartem is the most effective available treatment for malaria
in children in areas of Africa where resistance to conventional antimalarial drugs
is high. Coartem achieved a parasitological cure rate of 99%, significantly
higher than the three comparator drugs, which achieved parasitological cure rates
between 58% and 89%, respectively. Developed and
produced by Novartis and its Chinese partners, Coartem currently is the
only fixed-dose ACT prequalified by the WHO for procurement by United Nations
agencies. Yet for much of last year, tight supplies
of key raw materials prompted questions about the ability of Novartis and its
partners to satisfy demand, as African countries |
|
