Basel, Switzerland (ots/PRNewswire)
- The European
Committee for Human Medicinal Products (CHMP) has confirmed that the
presence of an impurity called ethyl methanesulfonate (EMS) in
Roche's Viracept (nelfinavir mesylate) did not increase patients'
risk of developing cancer.
The discovery of the EMS impurity in some batches of nelfinavir
led to a global recall of this HIV medication in June 2007. Since
then, the product has been made available again in the EU.
The conclusions announced today were based on tests with EMS,
which have been validated by independent experts including
toxicologists and HIV-treating clinicians. The results were also
reviewed by patient advocates and non-governmental organisations.
"Roche has acted promptly and responsibly in generating this new
research on EMS," said Dr Anton Pozniak, Consultant Physician in HIV,
Chelsea and Westminster Hospital, London, UK. "The results of the
studies - validated by a panel of independent toxicologists and
clinicians - as well as the conclusions of the CHMP should provide
reassurance to patients who were exposed to elevated levels of EMS,
and to their healthcare providers."
In collaboration with the CHMP, Roche designed and commissioned
in-depth animal studies to better define the potential impact of EMS.
These studies demonstrated that patients who were accidentally
exposed to the highest levels of EMS in nelfinavir received doses of
the impurity significantly below the threshold at which DNA damage -
and therefore cancer or birth defects - can occur.
"Our primary focus throughout this process has been on protecting
the safety of patients," said William M. Burns, CEO, Roche
Pharmaceuticals Division. "Roche undertook this important research
because so little was known about EMS at the time the recall was
initiated. We welcome the CHMP's conclusions and expect that the
rapid generation and dissemination of the data will make an important
contribution to the industry as a whole."
The full data will be shared with the broader HIV and research
communities via scientific conferences and peer-reviewed journals in
the coming months. An initial presentation has been accepted as
late-breaker poster at the XVII International AIDS Conference, 3-8
Additionally, Roche had initiated the first steps to establish
patient registries as part of its efforts to monitor and track
patients who may have been exposed to contaminated batches of
nelfinavir. However, in light of the new research, the CHMP has
concluded that there is no need to follow these patients in
Following the discovery of elevated levels of EMS in some batches
of nelfinavir, Roche in June 2007 undertook a total global recall in
areas of the world where it supplies the drug. This was followed by
the suspension of nelfinavir's licence in August 2007. In agreement
with the CHMP, Roche undertook a comprehensive review and correction
of its manufacturing procedures, which led to nelfinavir's licence
being reinstated in October 2007.
Viracept (nelfinavir) is an HIV protease inhibitor supplied by
Roche outside the US, Canada and Japan. Viracept was first introduced
by Roche in 1998. Although newer protease inhibitors have become
available for the treatment of HIV, it is viewed as a useful medicine
for patients who are intolerant to ritonavir (since it does not
require ritonavir boosting), pregnant women, and patients in
resource-limited settings, since the formulation is heat-stable and
does not require refrigeration.
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolic disorders and diseases
of the central nervous system. In 2007 sales by the Pharmaceuticals
Division totalled 36.8 billion Swiss francs, and the Diagnostics
Division posted sales of 9.3 billion Swiss francs. Roche has R&D
agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai, and invested
over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group
employs about 79,000 people.
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ots Originaltext: Roche Pharmaceuticals
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Contacts: Mike Nelson, Roche, +41-79-572-5165. Dafni Kokkidi,