GUERBET (EPA:GBT) Guerbet - Lipiodol®480 Injection 10mL approved for reimbursement in Japan when used for Transcatheter Arterial Chemo-embolization (TACE)

Transparency directive : regulatory news

27/11/2013 18:01

PRESS RELEASE

Lipiodol(r)480 Injection 10mL approved for reimbursement in Japan when used
for Transcatheter Arterial Chemohemo-embolization (TACE)

Villepinte, November 27, 2013

Guerbet Japan announced that Lipiodol [LIPIODOL(r) 480 Injection 10 mL] (ethyl
ester of iodinated fatty acids of poppy-seed oil injection, hereinafter
referred to as "Lipiodol") is approved for National Health Insurance
reimbursement for Transcatheter Arterial Chemo-Embolization (TACE) (1) for
hepatocarcinoma cellular when used with [Farmorubicin(r) for Injection
10 mg/50 mg] (non-proprietary name: epirubicin hydrochloride, hereinafter
referred to as "Farmorubicin", Pfizer Japan Inc.).

This approval for insurance reimbursement follows Ministry of Health, Labor and
Welfare (MHLW) approval of a new Lipiodol indication for "adjustment of drugs
and medical devices" received on September 13th 2013.

Steven Bleyl, Representative Director of Guerbet Japan commented "We are
grateful as this approval came as a result of a strong collective effort by
doctors associations, Ministry of Health Labour and Welfare together with
Guerbet teams."

It is estimated that there are 45,000 hepatocarcinoma cellular patients in
Japan on a yearly basis, and TACE is performed for unresectable HCC which
amounts to 30% of patients (2).

1) Transcatheter arterial chemoembolization (TACE) is a minimally invasive
procedure performed in interventional radiology to restrict a tumor's blood
supply. Drugs are injected selectively into an artery directly supplying a
tumor.

2)Jpn J Clin Oncol 2013;43(3)328-336, Liver vol. 48-3 117-140 (2007), Liver
vol. 51-8 460-484 (2010)

About Lipiodol
Discovered in 1901 by Marcel Guerbet, Lipiodol(r) is now commercialized widely
in over 47 Countries, in Europe, Asia, Africa, Middle East, North and Latin
America.
The authorized indications for Lipidol(r) may vary from country to country.

About Guerbet
A pioneer in the field of contrast agents with more than 80 years of
experience, Guerbet is the only pharmaceutical group fully dedicated to
medical imaging worldwide. As such it has a complete offering of contrast
agents for X-ray, MRI and interventional radiology, along with a range of
injectors and related medical devices to provide improved patient diagnosis
and treatment.

To promote the discovery of new products and ensure its future growth, Guerbet
devotes significant resources to research and development every year
(approximately 10% of sales). Guerbet (GBT) is listed on NYSE Euronext Paris
(Eurolist Compartment B - Mid Caps) and had sales of EUR 403 million in 2012
with a total workforce of 1,400 employees.

For additional information about Guerbet please go to www.guerbet.co.jp and
www.guerbet.com

Press Contacts:

Anne-Laure Delasalle, Communications Director
Tel: + 33 (0)1 45 91 50 03
anne-laure.delasalle@guerbet-group.com

Media Contact in Japan
Steven Bleyl
Tel: +81 (0) 3.3288.5421
steven.bleyl@guerbet-group.com

This press release may contain forward-looking statements based on current
assumptions and forecasts made by Guerbet Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performances of the company and the estimates given here. These factors
include those discussed in Guerbet's public reports which are available on the
Guerbet website at www.guerbet.com. The company assumes no liability whatsoever
to update these forward-looking-statements or to conform them to future events
or developments.

Lipiodol(r) is a trade mark registered by Guerbet

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GUERBET (EPA:GBT) Guerbet - Lipiodol®480 Injection 10mL approved for reimbursement in Japan when used for Transcatheter Arterial Chemo-embolization (TACE)

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