Sanofi Announces Men With Advanced Prostate Cancer in England Will Continue to Have Access to Cabazitaxel (Jevtana®)

GUILDFORD, England, May 28, 2015 /PRNewswire/ --

− Sanofi works with NHS England on interim agreement until NICE re-appraisal − 

Sanofi announced today that it has reached agreement with NHS England that cabazitaxel will once more be available on the NHS to clinically eligible men with advanced prostate cancer. Cabazitaxel was de-listed from the Cancer Drugs Fund (CDF) by NHS England on 12^th March^[1], however in order to support access to cabazitaxel during the transition period to a formal NICE appraisal outcome, Sanofi and NHS England have come to an agreement that will enable provision of cabazitaxel to patients in England.

Tarja Stenvall, General Manager for Sanofi in the UK and Ireland, said: "We are very pleased that we have come to an agreement with NHS England to find a solution to enable access to cabazitaxel in England. We aim to do our very best by patients and our commitment to reach this agreement with NHS England was no exception. However, this is an interim measure until the outcome of the NICE re-appraisal which, if positive, will ensure access in the longer term."

NICE has agreed to review the Technology Appraisal for cabazitaxel and we expect a result in 2016. Sanofi has submitted a Patient Access Scheme as part of the re-appraisal of cabazitaxel by NICE. Sanofi also plans to re-submit cabazitaxel to the Scottish Medicines Consortium in 2015 to allow patients in Scotland access to this important medicine.

Nick James, Professor of Clinical Oncology at the Queen Elizabeth Hospital Birmingham, commented, "This is absolutely the right outcome for men with advanced prostate cancer living in England. Having used cabazitaxel for some years, I see it as an effective therapy for a significant subgroup of men with relapsed prostate cancer. I'm therefore delighted that cabazitaxel will continue to be available for my patients in the immediate future."

One in 20 men in the UK will die of prostate cancer.^[2],[3] In time, most prostate cancers become resistant to hormone therapy and continue to grow despite treatment.^[4] Cabazitaxel is the only active treatment for advanced prostate cancer which is not responsive to any available hormone therapies following initial chemotherapy (docetaxel).^[5],[6],[7] Cabazitaxel fulfils an important unmet need in certain patients and has been proven to extend survival in advanced prostate cancer.^[5]

Hugh Gunn, spokesperson for patients' charity TACKLE Prostate Cancer, also commented on the decision: "Today's news is a real boost for men who have advanced prostate cancer. The fact that cabazitaxel is available again will give hope for some men as it provides another line of treatment when other options have run out."

About cabazitaxel 

Cabazitaxel is a taxane (plant-based) chemotherapy that may be active in cancer cells which are resistant to standard chemotherapy.^[8],[9]  Cabazitaxel works by inhibiting cell division, causing cancer cell death.^[8] Cabazitaxel is the only active treatment option for advanced prostate cancer which is not responsive to available hormonal therapies following initial chemotherapy (with docetaxel).^[5],[6],[7] It is licensed in the UK and the rest of Europe for use in men with advanced prostate cancer and was available on the CDF from 2012 until its recent de-listing in March 2015. Patients treated with cabazitaxel can experience side effects. Further information is available here: http://www.medicines.org.uk/emc/medicine/24431

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 futureapproval 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. NHS England. National Cancer Drugs Fund List ver4.0.http://www.england.nhs.uk/wp-content/uploads/2015/03/ncdf-list-mar-15.pdf [Accessed 19 May 2015]
2. Office for National Statistics. Reference table: Mortality Statistics: Deaths Registered in 2012 (Series DR) Table 5. Available at: http://www.ons.gov.uk/ons/taxonomy/index.html?nscl=Health+and+Social+Care#tab-data-tables [Accessed 19 May 2015]
3. Cancer Research UK, Prostate Cancer Statistics. Available at:  http://www.cancerresearchuk.org/cancer-info/cancerstats/types/prostate/ [Accessed 19 May 2015]
4. National Cancer Institute. 2014. Hormone Therapy for Prostate Cancer. Available at: http://www.cancer.gov/cancertopics/factsheet/Therapy/hormone-therapy-prostate  [Accessed 19 May 2015]
5. 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
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. Attard G et al. Update on tubulin-binding agents. Pathol Biol (Paris) 2006;54:72-84
9. 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

Date of Preparation: May 2015
Job bag: SAGB.ONC.15.05.0557