PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.
Mark Frohlich, EVP, R&D, CMO, commented on the regulatory process for Provenge in the EU. He stated, "We also continue to make progress advancing the global market opportunity for Provenge. In Europe, we have filed our application with the EMA as Provenge is an autologous cellular therapy requires review by both the Community for Advanced Therapies or CAT. In addition, the Committee for Medicinal Products for Human Use, or CHMP, we will be participating in an oral explanation with the CAT, mid-year. We have recently learned that for procedural reasons a possible subsequent oral explanation with CHMP would not occur for a month or two after the CAT oral explanation. We therefore now anticipate a regulatory decision in the second-half of 2013. As we have previously disclosed, we are evaluating partner strategies in Europe and continue to enroll patients in the European open label study."
Source: Q1 2012 earnings conference call, 5/09/13.
Continued focus on expanding clinical data:
Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) continues to provide important insights into the treatment of advanced prostate cancer with PROVENGE, particularly as it relates to investigational uses of PROVENGE in combination or sequenced with other treatments
Actively evaluating partnering strategies for European expansion; continuing to enroll patients in the sipuleucel-T European Union open-label study; expect a mid-2013 regulatory decision in Europe
Completed enrollment of PROVENGE and ADT sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
Completed enrollment of PROVENGE and Zytiga® (abiraterone) sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
Initiating an early detection registry, in which men with castrate resistant prostate cancer but without known metastases, will be imaged regularly for evidence of metastatic disease
Source: press release, 2/25/13. http://investor.dendreon.com/releasedetail.cfm?ReleaseID=742694
Announced the election of John H. Johnson to the position of president and chief executive officer (CEO) and Mitchell H. Gold, MD, as executive chairman, who will serve in that role until June 30, 2012, at which point he will continue to serve as a director and Mr. Johnson will become chairman.
At the end of the fourth quarter, completed in-servicing for more than 840 total sites, of which:
More than 590 sites have infused PROVENGE® (sipuleucel-T).
Approximately 615 sites have either infused the product or have their patients scheduled for their first PROVENGE regimen.
Improved PROVENGE reimbursement landscape for customers and patients:
Reported average time to payment is less than 30 days for physicians, which is better than industry standard, reflecting an improved reimbursement landscape due to a national coverage decision and activation of a Q-code that accelerates electronic adjudication of claims.
The Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to now cover the infusion costs associated with the administration of PROVENGE. With this decision, the coverage of PROVENGE is now consistent with all other infused biologics.
A recent analysis suggests that approximately 75% of patients had minimal or no out-of-pocket costs for PROVENGE.
Filed the marketing authorization application (MAA) for PROVENGE with the European Medicines Agency, which was validated in January.
Began enrollment in its clinical study evaluating PROVENGE and abiraterone.
Source: press release, 2/27/12. http://investor.dendreon.com/releasedetail.cfm?ReleaseID=651674
Announced plans to seek European marketing authorization for PROVENGE with an anticipated filing by end of 2011/early 2012.
Source: press release, 3/1/11. http://investor.dendreon.com/releasedetail.cfm?ReleaseID=553629
Mitch H. Gold, M.D., President, CEO, Director, commented on the plans for the EU regulatory submission and the work currently being conducted. He stated, "As you know we plan to seek licensure from the EMEA and we have begun interacting with ex-US physicians educating them on our clinical data. We will have the opportunity to present our IMPACT data at the annual ECHO/ASMO meeting in October later this year as well as other global scientific conferences. In addition we will continue our investment in further Provinge clinical studies and our other ACI program candidates. Our global strategy and pipeline plans are two areas of critical importance for the long term success of Dendreon and we plan to provide guidance on both of these plans later this year or early next year."
Source: Q2 2010 earnings conference call, 8/03/10.
|Provenge (sipuleucel-T) (2) PCa NA||Urology||Prostate cancer (neo-adjuvant)||Active Cellular Immunotherapy (ACI)||Tumor cells|
Mechanism of action: Sipuleucel–T is made with mature, autologous antigen presenting cells (APC’s) that have been co-cultured with a recombinant fusion protein containing prostatic acid phosphatase (PAP). The cells are returned to the patient via infusion thus eliciting a specific and long lasting immune response against the cancer.
Phase of Development: Filed
Event Type: Regulatory EMA: CHMP Opinion (Estimate)
Dendreon Announces Marketing Authorization for PROVENGE® in the European Union
SEATTLE--(BUSINESS WIRE)-- September 17, 2013 Dendreon Corporation (DNDN) today announced that the European Commission (EC) has granted marketing authorization for PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows recent positive opinions from both the European Medicines Agency (EMA) Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE be granted marketing authorization in the EU.
The marketing authorization provides approval for the commercialization of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein.
John H. Johnson, chairman, president and chief executive officer of Dendreon said, The marketing authorization of PROVENGE in the EU represents an important achievement for Dendreon. As the first personalized immunotherapy approved for the treatment of mCRPC in Europe, PROVENGE may help extend the lives of appropriate prostate cancer patients.
With sipuleucel-T, we have the potential to create a new treatment paradigm in advanced prostate cancer, with the integration of this novel therapy to harness a patients own immune system to fight their cancer, said Prof. Karim Fizazi, M.D., Ph.D., Head of the Department of Cancer Medicine, The Institut Gustave Roussy, Villejuif, and Full Professor in Oncology, the University of Paris, France.
The European marketing authorization for PROVENGE was granted based upon data from three randomized, placebo-controlled, multi-center Phase III studies, which enrolled 737 patients. In the pivotal Phase III IMPACT study, an improvement in overall survival (OS) was observed, with a median survival of 4.1 months longer in patients who received PROVENGE versus those who received placebo (HR=0.775, 95%-CI 0.614, 0.979, P =0.032). Similar effects were observed in the two supportive studies.
This milestone demonstrates the importance of providing a new therapeutic option with a differing mechanism of action than other approved treatments for appropriate prostate cancer patients in the EU, said Mark Frohlich, executive vice president of research and development and chief medical officer of Dendreon. We continue to enroll patients in the EU open-label study, and plan to have a presence at the upcoming European Cancer Organization (ECCO) and European Society for Medical Oncology (ESMO) conferences.
Source: press release, 9/17/13. http://files.shareholder.com/downloads/DNDN/2688897051x0x691078/965100e2...
Dendreon Receives Positive Opinion for PROVENGE® in the European Union
SEATTLE--(BUSINESS WIRE)-- June 28, 2013--Dendreon Corporation (DNDN) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization in the European Union (EU), for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. The CHMPs recommendation follows a positive recommendation by the Committee for Advanced Therapy (CAT).
We are pleased with this outcome and look forward to a final regulatory decision by the European Commission later this year, said Mark Frohlich, Executive Vice President of Research and Development and Chief Medical Officer of Dendreon. By using the bodys own immune system to fight cancer, PROVENGE is a novel therapy that addresses a genuine unmet patient need. If approved, PROVENGE would help extend the lives of appropriate prostate cancer patients in Europe.
The CHMP will make a final recommendation to the European Commission (EC) within the coming months on the marketing authorization application for PROVENGE in the EU. A regulatory decision is anticipated from the EC in the second half of this year.
PROVENGE is the first immunotherapy to have demonstrated an overall survival improvement in prostate cancer. The positive CHMP opinion for PROVENGE is great news for advanced prostate cancer patients and physicians in Europe, and we look forward to the European Commissions final decision on this novel treatment option, said Prof. Karim Fizazi, M.D., Ph.D. Head of the Department of Cancer Medicine, The Institut Gustave Roussy, Villejuif, and Full Professor in Oncology, the University of Paris, France.
John H. Johnson, Dendreons chairman, president and chief executive officer, said, This recommendation represents a significant milestone for Dendreon as we advance the global market opportunity for PROVENGE. We are finalizing our plans for a capital-efficient launch in Europe, including evaluating our partnering options. We look forward to bringing the innovative treatment of PROVENGE to patients around the world."
Source: press release, 6/28/13. http://files.shareholder.com/downloads/DNDN/2517479436x0x673510/b9719906...