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10-year follow-up data on Lemtrada® ▼(alemtuzumab) detailing clinical efficacy in people with relapsing-remitting multiple sclerosis (MS) to be presented at the American Academy of Neurology (AAN) 2016 Annual Meeting

Date: April 16, 2016

Oxford, UK. ­– Sanofi Genzyme, the specialty care global business unit of Sanofi, today announced that a new long-term analysis detailing 10 years of clinical efficacy of Lemtrada® (alemtuzumab) in people with relapsing-remitting multiple sclerosis (RRMS) will be presented at the 68th American Academy of Neurology (AAN) 2016 Annual Meeting in Vancouver, Canada, 15-21 April 2016.

Results from the on-going, long-term extension study of the phase 2 CAMMS223 study showed that over 10 years of follow-up, 76 percent of patients were shown to be free from 6-month confirmed disability worsening (increase of ≥1.0 EDSS point [or ≥1.5 points if baseline EDSS=0]) and 78 percent had an Expanded Disability Status Scale [EDSS] score that was either stable or showed greater than or equal to one point improvement in EDSS vs baseline.1 In addition, a low annualised relapse rate (ARR) was maintained (0.08) over the period.1 The long-term safety observed in this group of patients was in line with that of other Lemtrada clinical trials.1

People who entered the CAMMS223 study had not previously received other treatments for RRMS and the majority of those who were followed for 10 years received a maximum of three courses of Lemtrada.1

“These data provide further evidence of the long term response with Lemtrada in treatment-naïve patients with relapsing-remitting MS”, said Professor Alasdair Coles, Lead Investigator, University of Cambridge School of Clinical Medicine, Cambridge, UK. “It is remarkable that such infrequent dosing with Lemtrada offers stability or improvement of disability over ten years. These findings confirm that Lemtrada is a valid treatment approach for people with multiple sclerosis, without the need for continuous treatment.”

“We are very pleased with these new data, which are part of our extensive clinical development programme and our commitment to the field of MS,” commented Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme. “Being able to offer this treatment option, which was discovered and developed in the UK to clinicians and their patients, is of incredible importance to us.”

The data on Durable Efficacy of Alemtuzumab Over 10 Years: Long-Term Follow-Up of Patients with RRMS from the CAMMS223 Study will be presented as poster presentation on Monday, 18 April 2016 between 8:30 AM - 7:00 PM (P3.053) Pacific Daylight Time.

More than 100,000 people in the UK have Multiple Sclerosis (MS)2, with around 85 percent diagnosed with RRMS.3 Lemtrada is the second of Sanofi Genzyme’s treatments for MS to receive approval for use from NICE and on the NHS in England and Wales .4

About Lemtrada (alemtuzumab)

Lemtrada is a humanised monoclonal antibody therapy which selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has transient impact on other immune cells. The reduction in the level of circulating T and B cells by alemtuzumab and subsequent repopulation may reduce the potential for relapse. It can also help to slow down or reverse some of the signs and symptoms of MS.5 Patients treated with Lemtrada had reduced annualised relapse rate compared to patients treated with subcutaneous interferon beta-1a injected three times per week, and treatment experienced patients were less likely to experience accumulation of their disability with Lemtrada compared with subcutaneous interferon beta-1a. Lemtrada is administered in two short treatment courses. The first treatment course includes one infusion per day for five days (course one). A year later a second course is administered one infusion per day for three days (course two).5

Lemtrada had been in clinical development for MS for more than 10 years and is supported by an extensive multicentre, multi-country clinical programme.6,7,8 Lemtrada was developed as part of research at the University of Cambridge and more than 1,500 patients participated in Lemtrada clinical trials, of which nearly 900 received Lemtrada.6,7,8

EU Indication and Usage

Lemtrada was granted EU marketing authorisation in September 2013 to treat adult patients with active RRMS defined by clinical or imaging features.9

In 2014, the National Institute for Health and Care Excellence (NICE) recommended Lemtrada should be reimbursed on the NHS, as an option for treating adults with active RRMS, within its marketing authorisation.4 The Scottish Medicines Consortium (SMC) also accepted Lemtrada for use within NHS Scotland for the treatment of adult patients active RRMS, defined by clinical or imaging features.10 The Health Service Executive (HSE) has also issued a positive reimbursement decision for Lemtrada and it is available in Ireland, within its marketing authorisation, for treating adults with active RRMS.

Sanofi Genzyme has introduced a risk management plan to ensure that Lemtrada is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet for Lemtrada, including the appropriate precautions to be followed by healthcare professionals and patients.

For full prescribing information about Lemtrada, the Summary of Product Characteristics can be found here:
http://www.medicines.org.uk/emc/medicine/28917/SPC/LEMTRADA+12+mg+concentrate+for+solution+for+infusion/

About Sanofi Genzyme

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme® is a registered trademark of Genzyme Corporation. All rights reserved.

References

  1. Coles et al. Durable Efficacy of Alemtuzumab Over 10 Years: Long-term Follow-up of Patients With RRMS From the CAMMS223 Study. American Academy of Neurology (AAN) Annual Meeting 2016. Poster presentation P3 053.
  2. MS Society. About MS. https://www.mssociety.org.uk/what-is-ms/information-about-ms/about-ms?utm_source=what-is-ms&utm_medium=link&utm_campaign=Landing-page-analysis&utm_content=about-ms. Accessed April 2016.
  3. MS Society. Relapsing-Remitting MS (RRMS). https://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms. Accessed April 2016.  
  4. National Institute for Health and Care Excellence. Final appraisal determination (FAD). Alemtuzumab for treating relapsing–remitting multiple sclerosis. https://www.nice.org.uk/guidance/ta312/documents/multiple-sclerosis-relapsingremitting-alemtuzumab-fad-document2 Accessed April 2016.
  5. Patient Information Leaflet (PIL). http://www.medicines.org.uk/emc/medicine/28914 Accessed April 2016.
  6. Cohen et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a RCT phase III trial. The Lancet 2012; 380: 1069-1078
  7. Coles et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a RCT phase III trial. The Lancet 2012; 380: 1829-1839
  8. Coles, A.J. Alemtuzumab more effective than interferon b-1a at 5-year follow-up of CAMMS223 Clinical Trial. Neurology 2012; 78: 1069-1078
  9. EPAR Summary for the public. Lemtrada (alemtuzumab) European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003718/WC500150523.pdf Accessed April 2016.
  10. SMC guidance. alemtuzumab,12mg, concentrate for solution for infusion (Lemtrada®) https://www.scottishmedicines.org.uk/files/advice/alemtuzumab_Lemtrada_FINAL_April_2014_amended_24.04.14_02.07.14_for_website.pdf Accessed April 2016.

Date of Preparation: April 2016    GZUK.LEMT.16.04.0338

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