Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer After...

Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer
After Failure of a Prior Platinum-Containing Regimen

CASTRES, France, June 26 /PRNewswire/ -- Laboratoires Pierre Fabre
announce today that the Committee for Medicinal Products for Human Use
(CHMP), the scientific advisory committee of the European Medicines Agency
(EMEA), has issued a positive opinion supporting approval and is recommending
to grant marketing authorisation for JAVLOR(R) as monotherapy in metastatic
treatment of bladder cancer (advanced or metastatic transitional cell
carcinoma of the urothelial tract after failure of a prior
platinum-containing regimen).
CHMP has issued a positive opinion based on two phase II study results
and on the only phase III randomized study ever conducted in the indication
of metastatic treatment of bladder cancer after failure of a prior
platinum-containing regimen.
When the EMEA will grant the marketing authorization, JAVLOR(R) will
become the first monotherapy approved in Europe for the treatment of adult
patients with advanced or metastatic transitional cell carcinoma of the
urothelial tract after failure of a prior platinum-containing regimen, where
the expectation is important for both oncologists and patients. In Europe the
burden of bladder cancer is significative with an estimated 100.000 new cases
and 50.000 deaths annually; most of cases are related to the use of tobacco
products.
Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA, stated:
"The favourable opinion of the CHMP for JAVLOR(R) confirms the therapeutic
interest of our anticancer product, strengthened by the clinical data of our
file. Again, it rewards the quality of work done by our colleagues dedicated
to R&D. JAVLOR(R) will introduce innovative therapy to physicians and
patients in an area considered as an unmet medical need".
This approval is a significant milestone for Laboratoires Pierre Fabre as
JAVLOR(R) represents one of the leading products of their pipeline and these
positive results reward their important efforts in oncology research.
About JAVLOR(R) (vinflunine):
Discovered by scientists at the Pierre Fabre Research Center, vinflunine
is a new bi-fluorinated MTI (Microtubule inhibitor) obtained by chemistry
exploiting the reactivity of Vinca scaffold in superacidic media. Such
strategy, finalized in collaboration with experts at the University of
Poitiers (France), enabled the selective introduction of two fluorine atoms
in a part of that structure previously inaccessible by classic chemistry,
thereby leading to the first bi-fluorinated vinca alkaloid.
Besides its original structure, JAVLOR(R) exhibits unique pharmacological
properties and is also devoid of any unpredictable major toxicity and does
not induce cumulative toxicity.
Its every 3 weeks administration enables convenient hospital treatment on
an out patient basis (a 20 minutes infusion without any IV premedication).
JAVLOR(R) 25 mg/ml solution for infusion has been approved as monotherapy
for the treatment of adult patients with advanced or metastatic transitional
cell carcinoma of the urothelial tract after failure of a prior
platinum-containing regimen.
About Laboratoires Pierre Fabre
Pierre Fabre group, France's second biggest independent pharmaceutical
laboratory, achieved a turnover of 1.75 billion euros in 2008.
Approximatively 10,000 people including 1,400 in the research sector, are
employed.
Its therapeutical areas are ethical products, healthcare products and
dermocosmetics with the brands Avene, Ducray, A Derma, Galenic, Klorane and
Rene Furterer. In 2008, Pierre Fabre Medicament dedicated 33% of its annual
turnover to R&D in five main therapeutic directions: oncology, the Central
Nervous System, cardiology, internal medicine /urology and dermatology.
To learn more about Pierre Fabre, please refer to
http://www.pierre-fabre.com.
SOURCE Pierre Fabre SA

Press Contacts: Nathalie Barondiot, +33(0)1-49-10-83-80 / +33(0)6-18-00-35-59,
nathalie.barondiot@pierre-fabre.com; Catherine de Rohan Chabot,
+33(0)1-53-53-20-51 / +33(0)6-89-45-87-95,
catherine.de.rohan.chabot@pierre-fabre.com