9. Second step : to engineer antigens designed to stimulate and maximize cell-mediated immunity Aim : to raise the quality and the quantity of the immune response = The key to robuste immune response RESEARCH ACTIVITY Creation of the “ Antigen Delivery Cassette™ ”
29. INFUSIONS CENTERS Increase of number of Infusion centers by 9 fold in 2011for DENDREON to be near their patients
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31. EMERGING COMPETITORS FOR PROSTATE CANCER Trade name Type of treatment Company Phase PROSTVAC® Viral vector Bavarian Nordic Phase II completed GVAX GM-CSF gene-transfected cell vaccines BioSante Pharmaceuticals Phase III DCVAX Prostate Cellular vaccine Northwest Biotherapeutics Phase III TROVAX® Viral vector Oxford Biomedical Phase III IPILIMUMAB Monoclonal antibodies BMS Phase III ABIRATERONE Hormonotherapy Janssen-Cilag Phase III
32. PIPELINE Extension of Indication : Androgen Dependent Prostate Cancer (phase 3 : awaiting data on overall survival) Potential Raise of the market for PROVENGE® Dendreon website
36. BREAST CANCER and HER/neu Total : 207,090 The HER2 protein is overexpressed in about 30% of all breast cancers (USA) Total : 207,090 www.cancer.gov
37. One drug already targetting HER2 : Trastuzumab HERCEPTIN® Recombinant humanised IgG1 monoclonal antibody BREAST CANCER and HER/neu
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39. BLADDER CANCER & HER2/neu Bladder cancer : 70,530 new cases in 2010 (USA) The 4th most frequent cancer in men HER2 expression in bladder cancer : very variable between the different studies (from 9 to 81%) WHY TO CONDUCT A CLINICAL TRIAL IN BLADDER CANCER AND NOT IN BREAST CANCER? HER2 Cancer market : HERCEPTIN® No indication in the bladder cancer Neuvenge® targeting HER2 in breast cancer : Vs HERCEPTIN? Neuvenge® targeting HER2 in bladder cancer : Vs placebo?
76. 2006 March 2007 April 2009 Initial clinical results showed immune response April 2010 Building a manufactory facility in New Jersey to accommodate production for a phase III trial FDA accepted Dendreon’s BLA filling for Provenge® FDA voted 17-0 that Provenge is reasonably safe and that the trial data showed substantial evidence that it is effective Dendreon received a letter from the FDA demanding more results and information before approval Dendreon announced that the results for the Phase III trial of Provenge were positive FDA approved Provenge for use in the treatment of advanced prostate cancer. DISCOVERY OF PROVENGE®
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Notes de l'éditeur
Transplantation following high dose chemotherapy or radiation
http://www.cancer.gov/cancertopics/types/prostate
http://www.cancer.gov/cancertopics/types/prostate
www.xconomy.com
Just after the approval : only patients who participated in the trials where treated NJ : additional capacity expected in march 2011
CMS = CENTERS FOR MEDICARE AND MEDICAID SERVICE Svt les assurances privees suivent les tx de remboursement de medicaid et medicare plus de patients pourront avoir acces au ttmt
Abiratérone inhibe la synthèse des androgènes (inh CP17)
entraine l'internalisation du récepteurs HER2, ce qui le rend inactif ; bloque leur dimérisation donc aucune activité kinase n’est possible ; stimule la formation de tétramère de protéine Her2, une conformation non propice à l’activité kinasique. Chacun de ces trois mécanismes empêchent l'activation des récepteurs HER2 et donc la prolifération cellulaire
In November 2003, we licensed to Kirin Brewery Co., Ltd. our worldwide patent rights relating to the use of certain HLA-DR antibodies being developed by Kirin for which Kirin agreed to pay us $20 million and released its rights to our active immunotherapy product candidates, including Provenge, in Asia and Pacific Rim countries. This agreement ended our previous collaboration with Kirin. The $20 million is to be paid to us in cash In December 1998 and April 2000, Kirin exercised options under the collaborative license agreement to receive rights to our Provenge prostate program and Mylovenge multiple myeloma program. Kirin was solely responsible for the development and clinical trials of these prostate and multiple myeloma programs in Japan. We received a $1.0 million non-refundable, up-front fee on the exercise of each of these options.
biological product cellular therapy product more than minimally manufactured
HR= Hazard Ratio : rapport du risque instantané dans le groupe traité sur le risque dans le groupe contrôle Doit etre inf a 1 pour etre benefique
2/10/2004 AMM taxotere pour cancer prostate en assoc avec prednisone en fr
ASENTAR + VITAMINE D? LE VIRER???
Qualifying a CMO can be done faster than plant construction Dendreon expects to save 12 to 18 months by outsourcing to support filing.
One drug on the market : provenge ca a comblé un besoin médical pour les patients réfractaires à la chimiotherapie (ou souffrant de trop d’EI)
met en évidence le profit généré par l’activité indépendamment des conditions de son financement (les charges financières), des contraintes fiscales (impôts et taxes), et du renouvellement de l’outil d’exploitation (amortissements).
Quality assurance : processus extremement complexe qui exige une traçabilité sure RD : recherche de nouveaux Ag d’intérêt. futurs essais cliniques
Development of new ACI products New jobs in pharmacoeconomy to evaluate new markets
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