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Sanofi (France) (SAN.PA) Release: National Institute for Clinical Excellence (NICE) Rejects Life-Extending Bowel Cancer Drug Two Weeks After Scottish Approval


3/25/2014 9:41:08 AM

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Guildford, England – 25 March 2014 – NICE has announced today that it is not recommending ZALTRAP®?(aflibercept) to the NHS in England and Wales for the treatment of advanced, metastatic colorectal cancer (mCRC).1 Based on the same basic evidence, aflibercept was approved for use in Scotland on 10 March.2

Dr Rob Glynne-Jones, Consultant Clinical Oncologist, Macmillan Lead Clinician in Gastro-Intestinal Cancer, Northwood commented:
“This is another example of NICE failing cancer patients who are in dire need of innovative medicines. With the future of the CDF uncertain, UK cancer patients will continue to die prematurely if the system remains unchanged. Zaltrap is a novel agent which has produced results that extend life in the later stages of colorectal cancer. It is therefore extremely disappointing that NICE has closed the door on this treatment, particularly when you consider that patients with advanced colorectal cancer have very few options.”

Steve Oldfield, Sanofi’s Managing Director UK and Ireland commented:

“We are extremely disappointed NICE has not approved aflibercept, particularly given that based on the same basic evidence, the Scottish Medicines Consortium accepted aflibercept. Sanofi wanted NICE to be able to approve aflibercept for patients in England and Wales and offered a patient access scheme as part of the appraisal. ”

There is significant clinical demand for aflibercept - since the inclusion of aflibercept on the Cancer Drugs Fund (CDF) in England in May 2013, there have been 321 requests for its use, making it the seventh most requested drug on the CDF within its licensed indication.3 However, funding of drugs on the CDF is not guaranteed and the fund itself is planned to terminate in 2016. Furthermore, the CDF does not apply to Wales and Northern Ireland.

Steve Oldfield added: “The lack of a long-term solution for access to innovative cancer medicines is seriously undermining the UK’s ability to maintain its status as a world leader in innovative medical technology. More importantly, it risks cancer patients in England and Wales being unable to access effective new medicines. NICE issued no positive final guidance for cancer medicines in 2013 – it’s clear that something needs to change.”

Colorectal cancer is the second most common cause of cancer death in the UK.4 In its advanced stages it can become difficult to treat and until now there have been limited treatment options available.5

Aflibercept was approved by the European Commission in February 2013 for use in combination with irinotecan/ 5-fluorouracil/ folinic acid (FOLFIRI) chemotherapy for the treatment of adults with mCRC that is resistant to or has progressed after an oxaliplatin-containing regimen.6 Aflibercept is proven to significantly improve overall survival (OS), progression free survival (PFS) and overall tumour response rate versus placebo plus FOLFIRI chemotherapy in patients with mCRC whose disease has progressed after an oxaliplatin-based regimen.7

As the first multiple anti-angiogenic agent of its kind, aflibercept has a novel mode of action that works in a different way to other available treatments8 licensed for use in the UK. Aflibercept works by preventing the formation of new blood vessels within and around a tumour,7 thereby stopping or slowing the spread of cancer.

The VELOUR trial is the only double-blind, randomised study to have demonstrated a statistically significant and clinically meaningful benefit in overall survival, progression free survival and response rate, in combination with FOLFIRI in this setting.7

The Cancer Drugs Fund (CDF)

In order to improve access to new cancer drugs, the Cancer Drugs Fund (CDF) was established in 2010. It provides an additional £200m each year to enable patients with cancer in England to receive access to drugs that are either not routinely available on the NHS or have not been approved or appraised by NICE. Aflibercept is listed on the Cancer Drugs Fund.

NICE’s appraisal of aflibercept:

NICE’s final negative guidance comes following an Appeal by Sanofi. The basis of the Appeal was that the NICE Committee did not apply special criteria introduced for drugs used at the end of life, despite published data demonstrating that aflibercept does meet these criteria.

In 2009, NICE agreed new criteria for appraising drugs that can extend life for people with advanced cancer. Up to 28 February 2014, NICE had reviewed 46 medicines under these criteria, of which only 12 resulted in positive recommendations for use in the NHS.9 Bowel cancer patients have fared particularly badly, with NICE issuing ‘not recommended’ guidance for the four most recently appraised medicines suitable for this patient group.1,10 This is set against a backdrop of cancer outcomes in the UK remaining the worst against comparator nations,11* despite the introduction of government reforms.

Upcoming changes to the NICE appraisal process

NICE is set to announce draft proposals for changes to its appraisal criteria to introduce a system of “value-based assessment”. However, there have been a number of concerns raised that this new system may not improve access to drugs and could be discriminatory against older patients.

Contacts

Helen Rix & Olivia Bailey, Oncology Communications, Sanofi UK
07740 410875, GFD-OncologySpecilatiesComms@sanofi.com

Guy Houghton, Just:: Health Communications
020 8877 8427, Guy@justhealthcomms.com

About Sanofi Oncology
Based in Cambridge, Massachusetts, USA and Vitry, France, Sanofi Oncology is dedicated to translating science into effective therapeutics that address unmet medical needs for cancer and organ transplant patients. Starting with a deep understanding of the disease and the patient, Sanofi Oncology employs innovative approaches to drug discovery and clinical development, with the ultimate goal of bringing the right medicines to the right patients to help them live healthier and longer lives. We believe in the value of partnerships that combine our internal scientific expertise with that of industry and academic experts. Our portfolio includes 10 marketed products and more than 15 investigational compounds in clinical development, including small molecules and biological agents.

About Sanofi

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

Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

References

1. Aflibercept in combination with irinotecan and fluorouracil-based therapy for treating metastatic colorectal cancer that has progressed following prior oxaliplatin-based chemotherapy. NICE technology appraisal guidance 307. March 2014
2. aflibercept 25mg/mL concentrate for solution for infusion (Zaltrap®). Scottish Medicines Consortium. 7 February 2014
3. NHS England. Cancer Drug Fund. Reporting period April to June 2013. Notifications – NHS England by drug and indication. Available at www.england.nhs.uk/wp-content/uploads/2013/08/cdf-month-rep.xlsx. Last accessed March 2014
4. Cancer Research UK. CancerStats. Key facts. Bowel Cancer. Available at http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/bowel-cancer/. Last accessed March 2014
5. Cidon E, The Challenge of Metastatic Colorectal Cancer, Clin Med Insights Oncol, 2010; 4: 55-60
6. ZALTRAP Summary of Product Characteristics
7. Van Cutsem, E. Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients with Metastatic Colorectal Cancer Previously Treated with an Oxaliplatin-Based Regimen. Journal of Clinical Oncology 2012; September: 1-9
8. Papadopoulous N et al., Binding and Neutralization of Vascular Endothelial Growth Factor (VEGF) and Related Ligands by VEGF Trap, ranibizumab and bevacizumab, Angiogenesis 2012; 15: 171-185
9. The National Institute for Health and Care Excellence. NICE and Cancer Drugs: The Facts. Available at http://www.nice.org.uk/newsroom/nicestatistics/niceandcancerdrugsthefacts.jsp. Last accessed March 2014
10. National Institute for Health and Clinical Excellence. Cetuximab, bevucizamab and panitumumab for the treatment of metastatic colorectal cancer after first-line chemotherapy. NICE Technology Appraisal Guidance 242. Issued: January 2012. Available at: www.nice.org.uk/nicemedia/live/13651/57924/57924.pdf?. Last accessed March 2014
11. International Cancer Benchmarking Partnership. ICBP Publications: Module 1, Scientific Publications. Available at http://www.cancerresearchuk.org/cancer-info/spotcancerearly/ICBP/icbp-publications/. Last accessed March 2014

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