Bleaker Future for Men With Prostate Cancer This World Cancer Day

GUILDFORD, England, February 4, 2015 /PRNewswire/ --

• Removing Jevtana (cabazitaxel) from the Cancer Drugs Fund means that from 12^th March, some men with hormone resistant advanced prostate cancer have been left with no treatment options following initial chemotherapy  

Today marks World Cancer Day, which this year focuses on 'achieving treatment for all'.^[1] However, in less than five weeks' time, men with hormone resistant advanced prostate cancer in England who could benefit from Jevtana (cabazitaxel) will not be able to access it.^[2] This is as a result of a decision made by NHS England last month to de-list it from the Cancer Drugs Fund.^[2] Jevtana fulfills an important unmet need in certain patients and has been proven to extend survival in advanced prostate cancer.^[3] By de-listing this drug, NHS England is denying some patients with no other options, access to a vital, life-changing treatment.

Recent findings published by the Office for National Statistics demonstrate that more men with prostate cancer are surviving for longer (five years after diagnosis - 87.6% in 2013 vs 83.6% in 2008).^[4] However, in time, some prostate cancers become resistant to hormone therapy and continue to grow despite treatment.^[5] Jevtana is the only active treatment option for advanced prostate cancer which is not responsive to available hormonal therapies following initial chemotherapy (with docetaxel).^[3],[6],[7]

The decision to de-list Jevtana and another 25 uses of cancer medicines^[2] is surprising, given that English cancer patients are still faring poorly compared to their European counterparts.^[8] The gap in 5-year cancer survival rates between England and the European average has remained at about 10% since 1994.^[8] Jevtana is available across Europe, with countries under much greater financial pressure than the UK such as Kazakhstan, Lithuania, Romania, Greece and Portugal providing funding. The UK spends less on cancer drugs per inhabitant than in other European countries - especially on newer drugs.^[9] In England, this is just 8p a day per person.^[10],[11] The Cancer Drugs Fund, 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.^[12]-[14]

Dr. Alison Birtle, Consultant Clinical Oncologist, Lancashire Teaching Hospitals NHS Foundation Trust, commented "It's deeply distressing that on World Cancer Day, I will see some men with prostate cancer who I know may have a poorer outcome in future due to the imminent de-listing of Jevtana. Jeremy Hunt talks about improved survival in prostate cancer as if it's a done deal, but we have to keep fighting for men with this disease who have very few treatment options and no place to go when hormone therapy stops working."

Hugh Gunn, spokesperson for prostate cancer patients' charity Tackle, added, "It is unfair that men in England with prostate cancer cannot get the same drugs as men in other European countries, especially when we have a Cancer Drugs Fund to supposedly pay for them. Prostate cancer kills one man every hour in England. It is a huge problem and these drugs are needed to keep men with this disease alive, have as much time as possible to fulfill their role in society and enjoy time with family and friends."

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.^[15] Over 40,000 men are diagnosed with prostate cancer each year.^[15]

Most men with advanced prostate cancer eventually become resistant to hormonal therapy^[16]and their disease can progress after docetaxel chemotherapy. Before Jevtana, multiple medicines had been tested in this area without success demonstrating that this is a very difficult to treat population.^[16]

Jevtana 

Jevtana is a novel taxane (plant-based) chemotherapy that may be active in cancer cells which are resistant to standard chemotherapy.^[17],[18]Jevtana works by inhibiting cell division causing cancer cell death.^[17]

Jevtana is the only active treatment option for advanced prostate cancer which is not responsive to available hormonal therapies following initial chemotherapy (with docetaxel).^[3],[6],[7]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 Jevtana in the last 18 months.^[19]

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.^[20]

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. World Cancer Day, About World Cancer Day. http://www.worldcancerday.org/about-world-cancer-day-2015 [Accessed 28 January 2015]
2. NHS England. National Cancer Drugs Fund List ver3.0. http://www.england.nhs.uk/wp-content/uploads/2015/01/ncdf-list-dec14.pdf [Accessed 28 January 2015]
3. 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
4. Office for National Statistics http://www.ons.gov.uk/ons/dcp171778_382524.pdf
5. National Cancer Institute. 2014. Hormone Therapy for Prostate Cancer. Available at: http://www.cancer.gov/cancertopics/factsheet/Therapy/hormone-therapy-prostate  [Accessed 28 January 2015]
6. Antonarakis ES, et al., AR-V7 and Resistance to Enzalutamide and Abiraterone in Prostate Cancer, N Engl J Med 2014; 371:1028-1038
7. 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
8. 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
9. IMS MAT Sept 14 - L01 Antineoplastic agents, LO2 endocrine therapy, L1G monoclonal antibody antineoplastics, L1H protein kinase inhibitor antineoplastics, L1X all other antineoplastics    
10. IMS XBPI/HPAI MAT Nov14 data on file: 15-01-23 Data pack info, spend calculations
11. Office for National Statistics. http://www.ons.gov.uk/ons/dcp171778_270487.pdf [Accessed 28 January 2015]
12. NHS England, NHS allocations for 2013/14 http://www.england.nhs.uk/allocations-2013-14/ [Accessed 28 January 2015]
13. NHS England, CDF budget 2014 http://www.england.nhs.uk/2015/01/12/cancer-drug-budget/ [Accessed 28 January 2015]
14. Emma Hawe and Lesley Cockcroft, 2013, OHE Guide to UK Health and Health Care Statistics, Second Edition, Page 137
15. Prostate Cancer UK, Facts and Figures. Available at: http://prostatecanceruk.org/information/prostate-cancer-facts-and-figures  [Accessed: 28 January 2015]
16. National Institute for Health and Clinical Excellence. Docetaxel for the treatment of hormone refractory metastatic prostate cancer. Technology Appraisal 101. London: NICE, 2006
17. Attard G et al. Update on tubulin-binding agents. Pathol Biol (Paris) 2006;54:72-84
18. 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
19. 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: 28 January 2015]
20. Cancer Research UK, Cancer Drugs Fund. Available at: http://www.cancerresearchuk.org/about-cancer/cancers-in-general/cancer-questions/cancer-drugs-fund [Accessed: 28 January 2015]

Date of Preparation: February 2015
Job bag: SAGB.ONC.15.01.0102

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