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Nelfinavir contamination judged to be no risk: EMEA and Roche statements

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Simon Collins
Global Moderator
Posts: 651
Nelfinavir contamination judged to be no risk: EMEA and Roche statements
Posted on: July 24 2008, 05:26 pm

The EMEA have just issued a statement saying that based on recent toxicology studies that no patients were put at increased risk of cancer and that the proposed safety registries are no longer required.

Pasted below are the EMEA statement and PDF link together with a statement from Roche UK issued this afternoon.

The results will be presented as a late breaker in Mexico.


European Medicines Agency
Press office
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09
London, 24 July 2008
Doc. Ref. EMEA/CHMP/382256/2008


Studies assessed by the EMEA indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate

Following a review of a number of toxicology studies, the European Medicines Agency (EMEA) confirms that there is no increased risk of development of cancer for patients who have taken contaminated Viracept (nelfinavir).
Viracept is an antiviral medicine, used in combination with other antiviral medicines to treat adults, adolescents and children over three years of age who are infected with human immunodeficiency virus (HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS).
In June 2007, the European Commission, on the recommendation of the EMEA, suspended the marketing authorisation for Viracept because some batches of the medicine had become contaminated with high levels of ethyl mesilate, a known genotoxic substance, which may damage the DNA.
Evidence was subsequently provided by Roche, the marketing authorisation holder, that the manufacturing problems that led to the contamination had been resolved. In October 2007 the EMEA’s Committee for Medicinal Products for Human Use (CHMP) recommended that the suspension of the marketing authorisation be lifted. As part of this the CHMP requested a number of toxicology studies to be conducted to better assess the potential harm to patients using Viracept contaminated with ethyl mesilate.
The studies carried out by Roche showed that it is possible to calculate a threshold value below which ethyl mesilate does not cause any irreversible damage (mutations) in the DNA. The CHMP noted that patients or children born to mothers who had taken contaminated Viracept were exposed to ethyl mesilate levels well below this threshold, and therefore that there was no increased risk of developing cancer for these patients compared with those patients who were not exposed to the contaminant.
The Committee therefore concluded that there was no need to monitor patients who had been exposed to high levels of contaminated Viracept through specific patient registries.
-- ENDS --
More information on Viracept is available in a question-and-answer document.
The EMEA has previously communicated on Viracept. Press releases were issued on 6 June 2007, 21 June 2007 and 20 September 2007.
Viracept had been authorised as an oral powder 50 mg/g, 250 mg tablets and 250 mg film-coated tablets. The marketing authorisation holder is Roche Registration Limited. More information can be found in the European public assessment report for Viracept:
This press release, together with other information on the work of the EMEA, can be found on the EMEA website:

Media enquiries only to:
Martin Harvey Allchurch or Monika Benstetter
Tel. (44-20) 74 18 84 27, E-mail



Studies assessed by European health authority conclude that impurity in Roche's Viracept®(nelfinavir mesylate) did not increase patients' risk of cancer

Welwyn Garden City, 24 July 2008.

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 and has been available in the United Kingdom since early July. 
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 August, 2008.

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 registries.
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.

About Viracept
Viracept (nelfinavir), a protease inhibitor is supplied by Roche outside the US, Canada and Japan. Viracept was first introduced by Roche in 1998.

About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Find out more at

Mike Nelson, Roche
+41 (79) 572 5165

Dafni Kokkidi,
+44 (0)20 7611 3591

Kathleen Charters
Posts: 69
Re: Nelfinavir contamination judged to be no risk: EMEA and Roche statements
Reply #1 on: September 9 2014, 04:15 pm

thank you for this information Simon.
Simon Collins
Global Moderator
Posts: 651
Re: Nelfinavir contamination judged to be no risk: EMEA and Roche statements
Reply #2 on: September 16 2014, 12:08 pm

Hi Kathleen - this is a pretty old story - from 2008 Smiley

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