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
12th 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).
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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
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forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
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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
- 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]
- 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]
- Cancer Research UK, Prostate Cancer Statistics. Available at:
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/prostate/
[Accessed 19 May 2015]
- 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]
- 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
- Antonarakis ES, et al., AR-V7 and Resistance to
Enzalutamide and Abiraterone in Prostate Cancer, N Engl J
Med 2014; 371:1028-1038
- 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
- Attard G et al. Update on tubulin-binding agents. Pathol
Biol (Paris)
2006;54:72-84
- 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