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Home  /  Forum  /  uniQure  /  With the approval by the European Commission in November 2012.....

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With the approval by the European Commission in November 2012.....

157 Posts
Pagina: «« 1 ... 3 4 5 6 7 8 »» | Laatste | Omlaag ↓
  1. flosz 4 juni 2015 12:33
    02elf.net/gesundheit/krankenkassen-so...

    Health insurance companies should not pay for low innovativeness of medicines

    In May 2015, the Federal Joint Committee (G-BA) has fallen into a situation where he drug Glybera (active ingredient: Alipogentiparvovec, therapy costs about one million euros) first had to certify an additional benefit by law, although the risk-benefit ratio of the European Medicines Agency can not be evaluated yet. Medicines like Glybera to treat rare diseases (orphan drugs) are used to get, by law automatically added value attests, if it does not exceed the sales limit of 50 million euros a year. That makes no sense professionally. Even if a drug has been developed for the treatment of a rare disease, it should only be used if it has a real added value for the patient

    tinyurl.com/q5nwkg4
  2. flosz 5 juni 2015 09:14
    Der PZ-Innovationspreis geht in diesem Jahr an Takeda Pharma für den monoklonalen Antikörper Vedolizumab (Entyvio®). Der neue Arzneistoff wird bei chronisch-entzündlichen Darmerkrankungen eingesetzt. Im Rahmen des Fortbildungskongresses Pharmacon in Meran überreichte Sven Siebenand, stellvertretender Chefredakteur der Pharmazeutischen Zeitung, den Preis Apothekerin Cornelia Zanetti, Leiterin des Geschäftsbereiches chronisch-entzündliche Darmerkrankungen bei Takeda Pharma.

    Rund 20 neue Arzneistoffe aus dem Jahr 2014 standen der achtköpfigen Jury – bestehend aus Pharmazieprofessoren und Offizinapothekern – zur Auswahl. Zudem hatten alle Apothekenmitarbeiter die Möglichkeit, sich auf der Facebook-Seite der PZ an der Wahl des Siegers zu beteiligen.

    «Einige der neuen Wirkstoffe sind als Sprunginnovation einzustufen und wären ebenfalls würdige Preisträger gewesen», betonte Siebenand. Vedolizumab überzeugte die Jury, weil der Arzneistoff seinen antientzündlichen Effekt selektiv im Darm entwickelt. Positiv hervorzuheben sei, dass mit Vedolizumab nach langer Zeit wieder ein Vertreter aus der Substanzklasse der Integrin-Antagonisten auf den Markt gekommen ist. Dieses Wirkprinzip ist bei der Behandlung von chronisch-entzündlichen Darmerkrankungen wie Morbus Crohn und Colitis ulcerosa vollkommen neu.

    Erstmalig wurde in Meran auch ein PZ-Innovations-Sonderpreis verliehen. Dieser ging an das erste in Europa zugelassene Gentherapeutikum: Alipogentiparvovec (Glybera® von Chiesi). Dass es gelungen sei, einen ersten Wirkstoff dieser Therapieform zur Marktreife zu führen, war für die Jury der ausschlaggebende Grund für die Auszeichnung. Im Rahmen der Zulassung mussten dabei auch die Bedingungen für die Zulassung eines Gentherapeutikums festgelegt werden. «Damit ist wertvolle Vorarbeit für weitere potenzielle Gentherapeutika geleistet worden, die nun eventuell schneller auf den Markt gelangen können», sagte Siebenand.

    www.pharmazeutische-zeitung.de/index....
    tinyurl.com/noj3qeh

  5. flosz 14 juni 2015 19:14

    Poolse radio:

    Grzegorz Jasinski: The subject of our conversation are the latest treatments, very modern, but also very costly and sometimes risky.I would like to start by asking about Glybere, a treatment for hereditary lipoprotein lipase deficiency (LPLD), which surprised public opinion to its price tag in excess of one million euros.Is it already the new medicine, whether it is a step towards a new medicine, or it may lower, which will concern only certain diseases, but the whole of medicine will not change?

    Prof.Seppo Yla-Herttuala: Glybera is a tip of the iceberg, the first such drug, approved in the EU and it is clear that the millionth price is far too high.It can not be justified differently in that worldwide use of this therapy is at most 100 to 150 people.But I am convinced that if there will be a new type of real drugs when they are related to more common diseases, their price will reach at most a fraction of the current price Glybery.

    But how quickly can we expect next from this type of medicine?Is now the process will be faster if we will have to continue to wait very long?
    Prof.Seppo Yla-Herttuala: At the moment we have two very promising, close to the approval of gene preparations.One, USA, has anti-tumor activity, the other is to act against a strong immune deficiency states, it is one of the so-called rare diseases.Work on the preparation are carried out in Europe, precisely in Milan.

    Meer via:

    translate.google.nl/translate?hl=nl&a...

    Seppo Yla-Herttuala van:
    www.nature.com/mt/journal/v20/n3/pdf/...
    www.nature.com/mt/journal/v20/n10/pdf...
    www.nature.com/mt/journal/v23/n2/pdf/...
    www.eurekalert.org/pub_releases/2013-...
  6. flosz 31 juli 2015 14:54
    Since AmpliPhi entered into an asset purchase and amended license agreement with Celladon in June 2012 to provide for an additional up-front cash payment in return for reducing its royalties to 1.5%, the revenue stream from Mydicar would not have been that significant. This is not the case however for Glybera, for which the company would receive mid-single-digit royalties from uniQure (NASDAQ:QURE) (which acquired the drug from Amsterdam Molecular Therapeutics B.V.) should it be approved. These royalties could add up for a drug that's projected to do up to $300 Mil+ a year in sales with an astronomical price tag of over Euro 1.1 Mil per patient. The recent determination by the European Medicines Agency (EMA) that the drug lacks efficacy (see First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report) puts future European royalties from Glybera in doubt, lowers the chances of FDA approval, and could leave the company with only the pre-clinical bacteriophage assets underpinning the value of the stock.
    seekingalpha.com/article/3365075-ampl...

    Btw: commentaar @schrijver art.is reeds verzonden.
  7. flosz 11 augustus 2015 11:16
    $XENE Earnings Call Transcript: Glybera $QURE tinyurl.com/njk85qc

    Finally I will provide a very quick update on Glybera this is the first product whose active ingredient was derived from our platform to receive commercial approval, it's currently the only gene therapy product to receive approval in Europe. Glybera specifically indicated for the treatment of a subset of adult patients diagnosed with the orphan lipid disorder known as Lipoprotein lipase deficiency or LPLD, confirmed much by testing, these patients suffered from severe multiple episodes of pancreatitis despite dietary fat restriction. Glyberawas developed by our licensee uniQure Biopharma being commercialized by uniQure's partner Chiesi, although we are not giving specific guidance about Glybera, we do understand that Chiesi has submitted price and reimbursement dossiers in key European countries to make Glyberia accessible to patients who will provide additional information as we receive it.
  11. flosz 27 augustus 2015 21:37
    twitter.com/johncfierce/status/636928...

    UniQure mulls options for $1M gene therapy after FDA demands extra trial
    The path to bringing a gene therapy to market in the U.S. just got a little rockier. Having expected to swing for approval in the U.S. on the basis of one pivotal trial, uniQure ($QURE) has now learnt the FDA is demanding another clinical study.

    Glybera appeared to have a clear path forward as recently as June. At that time, uniQure said the plan was to initiate a clinical trial in 2016 and use the data in a filing with the FDA. However, the FDA has scuttled the plan by telling uniQure it wants to see data from another clinical trial in the BLA filing. What happens now is unclear. UniQure is still planning to start up a U.S.-based trial early next year to meet the post-approval requirements of its European marketing nod, but is "assessing its options" for pursuing approval from the FDA.

    Investors reacted badly to the setback, sending shares in uniQure down by as much as 14% in premarket trading. With a big-ticket collaboration with Bristol-Myers Squibb ($BMY) to its name, uniQure is far from being reliant on Glybera. But the treatment for the genetic disease lipoprotein lipase deficiency (LPLD) is both uniQure's best near-term shot at getting a product on the market and a possible harbinger for what is to come for the gene therapies that are following it down the R&D pipeline.

    As the advanced party in the gene therapy field, Amsterdam, the Netherlands-based uniQure is used to setbacks. Glybera won approval in Europe in 2012 but a regulatory request for 6-year follow-up data held back its introduction. The recurring question throughout Glybera's slow crawl through the regulatory machinery has been how to assess the safety and efficacy of a new type of product that treats such a tiny patient population. For the FDA, the answer appears to lie in more data. For uniQure and its €1.1 million ($1.2 million) gene therapy, the upshot is more delays and uncertainty.
157 Posts
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