Patients With Advanced Prostate or Colorectal Cancer Face an Uncertainty in Their Future Treatment After NHS England Decision

GUILDFORD, England, March 13, 2015 /PRNewswire/ --

• Cabazitaxel (Jevtana^®) and aflibercept (Zaltrap^®▼), have been cut from the Cancer Drugs Fund (CDF) by NHS England, denying some cancer patients with no other active treatment options, access to vital, life-changing medicines
• NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review

NHS England has confirmed that it is de-listing both cabazitaxel (Jevtana^®) and aflibercept (Zaltrap^®▼) from the Cancer Drugs Fund (CDF), so that neither of these medicines will be available to new patients in England on the NHS. However regarding cabazitaxel NHS England have agreed to engage in talks to explore immediate ways of maintaining access to patients until it is reviewed by NICE.

Tarja Stenvall, General Manager for Sanofi in the UK, commented, "We are hugely disappointed that cabazitaxel and aflibercept have been cut from the CDF and that new patients in England will no longer have access to these crucial cancer treatments. However NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review. Our concern is for patients who should continue to have access to cabazitaxel until a longer term solution is reached and who may feel confused and uncertain until this happens."

One in 20 men in the UK will die of prostate cancer.^[1],[2] In time, most prostate cancers become resistant to hormone therapy and continue to grow despite treatment.^[3] Cabazitaxel is the only active treatment for advanced prostate cancer which is not responsive to any available hormone therapies following initial chemotherapy (docetaxel).^[4],[5],[6] Cabazitaxel fulfills an important unmet need in certain patients and has been proven to extend survival in advanced prostate cancer.^[4]

Hugh Gunn, spokesperson for prostate cancer patients' charity TACKLE, commented, "Today's news is a terrible blow for men with prostate cancer. I am shocked that men in England cannot get the same drugs as men in other European countries, especially when we have a Cancer Drugs Fund to supposedly pay for them. For many men - myself included - cabazitaxel was going to be the next treatment option. In fact, the last treatment option we had left. At the moment I'm well, but in a few months time I might not be; for the first time in my entire cancer journey I'm frightened."

Professor Amit Bahl, Consultant Clinical Oncologist at Bristol Haematology and Oncology Centre commented, "The decision to de-list cabazitaxel is highly detrimental to patients as it is an important treatment for some men with prostate cancer who may have no other treatment options available to them. It is incomprehensible that as clinicians we will no longer be able to treat patients with important therapies proven to extend survival. Having treated several patients with cabazitaxel I am very aware of the real life difference it makes to their survival and quality of life and would like future patients to have the opportunity to avail this treatment."

NHS England's de-listing decision is surprising, given that English cancer patients are still faring poorly compared to their European counterparts.^[7] Cabazitaxel is available across Europe, with countries under much greater financial pressure than the UK providing funding. The UK spends less on cancer drugs per inhabitant than in other European countries - especially on newer drugs.^[10] In England, cancer drug spend is just 8p a day per person.^[8] The CDF, set up in 2010 to facilitate better access to cancer drugs, only accounts for 0.3% of the total NHS spend and only 2.5% of the NHS drugs bill and yet 1 in 2 people will get cancer.^{[9],[10],[11],[12]}

In addition aflibercept, a treatment that extends life in the later stages of metastatic colorectal cancer (mCRC),^[13] has also been de-listed from the CDF. Deemed cost effective in Scotland by the Scottish Medicines Consortium (SMC)^[14] yet rejected by NICE, the discrepancy in availability across the UK has resulted in calls for NICE to re-evaluate their decision as rapidly as possible.

Dr Rob Glynne-Jones, Lead Clinician in Gastrointestinal Cancer at Mount Vernon Hospital and Chief Medical Advisor of Bowel Cancer UK, commented, "As a cancer specialist, it is extremely disappointing to find that the option of aflibercept has now been taken away from me. It is one of the tools of our trade - an effective anticancer drug, which in some circumstances can improve a patient's chance of long-term survival. Our results show that aflibercept can enable surgery to take place in some unresectable cancers. This de-listing decision will significantly restrict patient choice - particularly for patients with Ras mutant tumours, where there is little effective treatment in second line - thus inevitably widening the gap in survival for English patients with colorectal cancer compared with the rest of the world."

Notes to Editors

Prostate cancer

Prostate cancer is the most common male cancer in the UK; in the UK one in eight men will get prostate cancer during their lives.^[2] Over 40,000 men are diagnosed with prostate cancer each year.^[2]

Most men with advanced prostate cancer eventually become resistant to hormonal therapyand their disease can progress after docetaxel chemotherapy.^[3] Before Cabazitaxel, multiple medicines had been tested in this area without success demonstrating that this is a very difficult to treat population.^[3]

Cabazitaxel

Cabazitaxel is a taxane (plant-based) chemotherapy that may be active in cancer cells which are resistant to standard chemotherapy.^[15],[16]  Cabazitaxel works by inhibiting cell division causing cancer cell death.^[15]

Cabazitaxel is the only active treatment option for advanced prostate cancer which is not responsive to available hormonal therapies following initial chemotherapy (with docetaxel).^[4],[5],[6]It has been licensed in the UK and the rest of Europe for use in men with advanced prostate cancer and available on the CDF since 2012. There have been 707 requests submitted to the CDF for cabazitaxel in the last 18 months.^[17]

Colorectal cancer

If diagnosed early, colorectal cancer is highly treatable but only 9% of patients in the UK are diagnosed at the very earliest stage of the disease.^[18]  Metastatic or advanced colorectal cancer is a difficult-to-treat disease with limited treatment options and poor outcomes.^[19] The goal is now targeted therapy which aims for high efficacy but with reduced side effects.^[20]

Aflibercept 

Aflibercept is a targeted biologic agent. It is an anti-angiogenic that works in a different way to other available treatments for mCRC licensed for use in the UK.^[21]

Cancer Drug Fund  

The Cancer Drugs Fund (CDF) was set up as an interim measure by the coalition Government to facilitate better access to cancer drugs. Drugs on the CDF list are those that either haven't yet been approved by the National Institute for Health and Care Excellence (NICE) and aren't available within the NHS in England, or following appraisal haven't been deemed cost effective.^[22]

The CDF will run until the end of March 2016 when a new way of setting prices for cancer drugs, which aims to make more drugs routinely available in the NHS, will be introduced.

Patients who are already receiving treatment can continue until their doctor feels it is appropriate for them to stop.

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. Office for National Statistics. Reference table: Mortality Statistics: Deaths Registered in 2012 (Series DR) Table 5. http://www.ons.gov.uk/ons/taxonomy/index.html?nscl=Health+and+Social+Care#tab-data-tables [Accessed 04 March 2015]
2. Prostate Cancer UK, Facts and Figures. Available at: http://prostatecanceruk.org/prostate-information/about-prostate-cancer#facts-and-figures [Accessed: 04 March 2015]
3. National Institute for Health and Clinical Excellence. Docetaxel for the treatment of hormone refractory metastatic prostate cancer. Technology Appraisal 101. London: NICE, 2006
4. De Bono JS, Oudard S, Ozguroglu M et al., Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomized open-label trial. Lancet 2010;376:1147-54
5. Antonarakis ES, et al., AR-V7 and Resistance to Enzalutamide and Abiraterone in Prostate Cancer, N Engl J Med 2014; 371:1028-1038
6. Efstathiou E, et al., Effects of Abiraterone Acetate on Androgen Signaling in Castrate-Resistant Prostate Cancer in Bone, J. Clin. Oncol. 2012; 30: 637-643
7. National Audit Office, page 41, figure 14 http://www.nao.org.uk/wp-content/uploads/2015/01/Progress-improving-cancer-services-and-outcomes-in-England.pdf [Accessed 04 March 2015]
8. Sanofi Data on File SAGB.ONC.15.01.0089a
9. NHS England, NHS allocations for 2013/14 http://www.england.nhs.uk/allocations-2013-14/ [Accessed 04 March 2015]
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11. Emma Hawe and Lesley Cockcroft, 2013, OHE Guide to UK Health and Health Care Statistics, Second Edition, Page 137
12. Cancer Research UK, All Cancers Combined Stats. http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/Allcancerscombined/ [Accessed 04 March 2015]
13. 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. J. Clin. Oncol. 2012; 30: 3499-506
14. SMC Zaltrap Resubmission Decision: Available at: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/878_13_aflibercept_Zaltrap/aflibercept_Zaltrap_Resubmission [Accessed: 04 March 2015]
15. Attard G et al. Update on tubulin-binding agents. Pathol Biol (Paris) 2006;54:72-84
16. Pivot X et al. A multicenter phase II study of XPR6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients. Ann Oncol 2008;19:1547-1552
17. NHS England, The Cancer Drug Fund, Quarterly figures - including notifications and Individual Cancer Drug Fund Requests. Available at: http://www.england.nhs.uk/ourwork/pe/cdf/ [Accessed 04 March 2015]
18. Cancer Research UK, Bowel Cancer Campaign Overview 2014; October 24 http://www.cancerresearchuk.org/health-professional/early-diagnosis-activities/be-clear-on-cancer/bowel-cancer-campaign/campaign-overview [Accessed: 04 March 2015]
19. Cidon E, The Challenge of Metastatic Colorectal Cancer, Clin Med Insights Oncol, 2010; 4: 55-60
20. Goldberg, The Continuum of care: a paradigm for the management of metastatic colorectal cancer, Oncologist 2007; 12:1: 38-50
21. Papadopoulos 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
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Contacts
Alison Spink, Oncology Communications, Sanofi UK
+44(0)7725-765-406, Alison.Spink@sanofi.com

Laura Chambers, Just:: Health Communications
+44(0)20-8877-8400, CDF@justhealthcomms.com