MEDIA RELEASE PR35214
Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer After Failure of a
Prior Platinum-Containing Regimen
CASTRES, June 26 /PRNewswire-AsiaNet/ --
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
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