Positive Chmp Opinion For Javlor(r) In Metastatic Treatment Of Bladder Cancer After Failure Of A Pri

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27th June 2009, 02:08am - Views: 783





Community Health Laboratoires Pierre Fabre 1 image





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.


Community Health Laboratoires Pierre Fabre 2 image

    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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