Dendreon Announces Marketing Authorization for PROVENGE(R) in the European Union

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Anonymous

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Great Great news for the company:

SEATTLE--(BUSINESS WIRE)-- September 17, 2013 — Dendreon Corporation (Nasdaq: 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 patient's 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."
 






Next announcement should be an EU business partner. Groundwork being laid.

Wonder who the partner will be, and if the parent company would lay the foundation for a potential full acquisition in a few years.

Good things happening for a company with a great medicine!
 






how much will they pay for provenge therapy across the pond - profit margins at risk for both dndn and european "partner" until this is better understood, EU not out of financial "woods" yet
 






Get ready for the sobering news that NICE will reject Provenge use in the UK. Then, shortly after that, other EU countries will decide the benefit is too small to warrant reimbursement. Gaining EU approval was never the hard part. Gaining EU reimbursement will be. Get ready for more disappointment.
 












Anonymous said:
By granting marketing authorization the EU is agreeing to reimburse for Provenge.
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COST DENSITY.
How long until docs are reimbursed? How many docs are going to be able to or want lay out 60k or 70k per patient before being reimbursed. The US may have sped up reimbursement, but what is the reimbursement landscape in the EU as far as how quickly providers are reimbursed?
 


















Anonymous said:
In EU the doctors do not have to lay out a penny for Provenge and reimbursement is guaranteed by each countries medical plan.
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What are you talking about? In the US, reimbursement is guaranteed by it's country's medical plan too.(Medicare). When does Dendreon get its money for Provenge in the EU? Why and how is the EU different? If you don't have a real answer that is researchable it sounds lilke more of the same false and malicious inaccuracies.
 












Anonymous said:
What are you talking about? In the US, reimbursement is guaranteed by it's country's medical plan too.(Medicare). When does Dendreon get its money for Provenge in the EU? Why and how is the EU different? If you don't have a real answer that is researchable it sounds lilke more of the same false and malicious inaccuracies.
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30% of Provenge patients in the US are not eligible for Medicare since they are under 65. Medicare pays within 30 days.

In Europe, 100% of patients are covered by their country medical plan.

In the US, Provenge reimbursement has not been a problem for Provenge providers in the past two years since on average they are paid in less than 28 days. Provenge patients are pre-certified for insurance coverage. Pure fact.
 






Anonymous said:
30% of Provenge patients in the US are not eligible for Medicare since they are under 65. Medicare pays within 30 days.

In Europe, 100% of patients are covered by their country medical plan.

In the US, Provenge reimbursement has not been a problem for Provenge providers in the past two years since on average they are paid in less than 28 days. Provenge patients are pre-certified for insurance coverage. Pure fact.
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Really. 100% of patients in the EU are covered by their socialized medical system. Have you ever had any experience with the EUs med system? Ignoring the act that most EU countries don't have complete socialized med, the EU covers 100% of what they deem as appropriate treatment ( something with a longer record of success. This includes chemo, GENE drugs such as Avastin or Herceptin and even J&J and Medivation drugs which have Ben over there a long time. Provenge is too expensive and late in the game.

Oh, in so far as EMEA approval, everyone seems oblivious to the fact that Dendreon would need to file a type 2 variation and conduct studies according to EMEA regs. You can't 'data mine' anything from the US BLA
 






No one is saying reimbursement has been a problem.

SALES are a problem. Part of that is because of COST DENSITY. Yes in the EU and in the US doctors are reimbursed. Yes doctors may be reimbursed in 30 days. That means they have laid out money. FACT. Doctors will also have to lay out the money in the EU. You said that is not the case. Why did you say that?

There are some practices that just wont or can't lay out that money. Maybe some can or will for 1 patient or 2 patients. Maybe they have 5 patients. Cost density effects demand. FACT. This is the case in the US and it will be the same situation abroad. FACT.
 












Anonymous said:
30% of Provenge patients in the US are not eligible for Medicare since they are under 65. Medicare pays within 30 days.

In Europe, 100% of patients are covered by their country medical plan.

In the US, Provenge reimbursement has not been a problem for Provenge providers in the past two years since on average they are paid in less than 28 days. Provenge patients are pre-certified for insurance coverage. Pure fact.
Click to expand...

Thanks for stating the facts correctly. This is way over the head of our resident ignorant basher.
 






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