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Home  /  Forum  /  Pharming  /  Is het Huwelijk Sanquin & Shire over?

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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

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Is het Huwelijk Sanquin & Shire over?

17 Posts
| Omlaag ↓
  1. [verwijderd] 24 november 2016 18:45
    Oud stukje wat wel eens de reden kan zijn dat er nog steeds grote problemen zijn.

    DE VOLKSKRANT, 22 NOVEMBER 2014

    Conquest of America is bloodcurdling for Sanquin
    Only too happy the Sanquin Blood Supply Foundation wants to enter the American market. But next to
    benefits, burdens await there. It costs millions to satisfy the Americans.
    The last two weeks, it was a matter of sweating, overtime and nodding politely for the plasma
    compartment of the Sanquin Blood Supply Foundation in Amsterdam-West. Employees were running
    to and fro with notes and at a specially designed data center translators were ready to have instructions
    and answers available as soon as possible for the man and the woman who held the fate of the Dutch
    blood supply: the two inspectors from the US Food and Drug Administration (FDA).
    In about three months the duo will come up with a view that is crucial for the future of the Sanquin
    Foundation. If the FDA approves the processes of Sanquin, the Amsterdam company can get to work
    for the US market. Does the FDA remain critical - such as during previous visits - financial and
    political problems for Sanquin could arise.
    It all started in 1998. In that year the Sanquin Blood Supply Foundation grew out of a merger of the
    blood banks and the Central Laboratory of the Blood Transfusion Service. Architect of this was late Els
    Borst, then Minister of Health and a former head of the blood bank in Utrecht.
    She devised a so-called hybrid organization, the public blood bank, a research institute and a
    commercial pharmaceutical business under one roof.
    "Sanquin is not a commercial enterprise. It is the only blood supplier in Europe with a monopoly:
    Dutch hospitals are required to purchase blood at Sanquin. As a result, the blood is much more
    expensive than elsewhere, "says Rob Slappendel Quality Manager at Amphia Hospital in Breda, also
    endowed professor of quality and safety in health care.
    According to Slappendel Sanquin earned a lot of money with the monopoly. For example, the
    foundation boasts a generous art collection including paintings by Karel Appel and Corneille. The high
    salaries of the directors in the last decade were a stumbling block for many donors who give blood for
    free.
    Sanquin spends more than 10 million euros in revenues from the blood trade on research, also for blood
    products which have been on the market since the Second World War, says Slappendel. "That's crazy.
    Drugs like aspirin, from the same era, are barely researched anymore. "
    The supposed wealth of Sanquin is not only the result of its monopoly on the market for donor blood,
    but also of its activities with plasma - the proteins in the blood. Pharmaceutical companies have a
    variety of drugs developed from this plasma, and have placed these on the market for a lot of money.
    On these products Sanquin has no monopoly, but the company managed to offer them for an
    unrealistically low price, by making extra length on blood products and by using the resources of the
    blood bank. "Commercial companies could not match the way Sanquin does business," says
    Slappendel. "They were outcompeted one after the other." This form of unfair competition was
    counteracted by the Minister in 2012. Sanquin had to to reduce the cost for plasma in a different way:
    via upscaling.
    Lucrative
    The first step in this direction has already been taken in 2007. Since that year Sanquin produced a
    lucrative drug called Cinryze for the US market, commissioned by an American company. This drug
    prevents strong swelling in a small group of patients. In 2011, Sanquin was granted permission to
    produce the agent on an industrial scale, out of American blood plasma.
    The deal tasted like more, especially when the company got into contact with another American player:
    Baxter. That company was interested in the processing of American plasma at the Dutch Sanquin
    factory in order to export back to the US. The deal closed by the two sides, intended to increase
    Sanquin’s plasma production between 2013 and 2016, from 300 thousand to two million liters per year.
    The required major investment of 30 million euros would prove more than worthwhile in subsequent
    years.
    Sanquin’s confidence incurred a dent shortly before the signing of this deal. The company did not only
    bring in the benefits of producing forthe US market, but the burden as well. Since the production of
    Cinryze started, the plasma division Sanquin no longer fell under the supervision of the Dutch
    inspection alone, but also of the American FDA.
    In March 2012 a so-called Untitled Letter from the FDA fell on the doormat Sanquin: a mild but
    definite reprimand. Especially the procedures to prevent bacterial contamination of the drug Cinryze,
    turned out to be not OK. The letter had no direct consequences, the product was clean, but it meant that
    Sanquin had to watch its step.
    In May 2013 the American inspectors once again knocked on the door of Sanquin. Again they found a
    mess. They recorded ice crystals on freezer doors, swapped test samples, poorly conducted
    investigations of infections and poor quality screening of the products. The US drug watchdog sent
    Sanquin a Warning Letter.
    The FDA works according to a simple principle: three strikes, you’re out. When no clear progress is
    being noted during the inspection following the warning, a hefty fine can follow or the production of a
    drug may be shut down.
    "It is for a good reason that the FDA is doing such long and intensive investigation at Sanquin. It looks
    at the whole factory, not just at the machines where American plasma is processed. Too long, the
    Sanquin management has acted too laconic concerning the US surveillance, and that avenges itself
    now. Sanquin is far from finished with this," said one person.
    Flop chicken
    The man who initiated the American expansion, former chairman Theo Buunen, had already
    disappeared quietly from the scene. After 28 years of service, in 2012 he went in early retirement and
    started a consulting company. In a farewell movie a former employee told that under Buunen, Sanquin
    had become a bit like a flop chicken, which long remained small and suddenly began to grow like a
    madman.
    Buunen did not leace empty-handed. He made use of a generous leave allowance, and received nearly
    500 thousand euros from his former employer. Anno 2014, Sanquin does not want Buunen to talk to the
    media beyond the company. And the same goes for the Buunen’s successor Aart van Os, who got the
    nice task to set things right after the departure of Buunen.
    Van Os proposed a three-year recovery plan, for which dozens of people had to be recruited and which
    costed millions. Because in addition to the production of Cinryze, the deal with Baxter was also in the
    game. The Americans want to pay only for the plasma processed by Sanquin when the FDA has given
    it its blessing.
    Van Os was not given the time to refloat Sanquin. He clashed with the supervisory board and his fellow
    board members on how the plasma division had to be reorganized to meet US standards. Van Os, from
    the pharmaceutical industry, was said to proceed faster and further than the rest of the Sanquin summit
    wished for. After two years, in June this year, he was forced to leave.
    Van Os’s successor, interim president Maarten le Clercq, now says that Sanquin 'needed to get used' to
    US inspections. "A European regulator tests the product and if that is OK, then that’s it. But US
    inspectors examine all steps in the production process. Only when those are flawless, the product is
    perfect in their eyes." And, says Le Clercq, Sanquin laconically responded to the first reprimand from

    Ruud..
  2. [verwijderd] 24 november 2016 18:45


    the FDA: "We have underestimated the issue a little," the president said.
    Of this underestimation Sanquin is reaping the bitter fruits. By the highly expensive operation to satisfy
    the FDA, the money flows rapidly from the usually well stocked cash box. This year, the plasma
    production for Baxter should have come on stream, and the big pay off would start. That will happen at
    the earliest, in the course of next year.
    The entire company is affected by the situation: jobs that are not related to satisfying the FDA are not
    currently filled. Also a new building for the US plasma production was delayed and employees were
    told that they provisionally could not or hardly buy new equipment.
    Intern at Sanquin it was even rumored that the public blood could go 'bankrupt' as a result of the US
    thwarted ambitions, but according to the management this is a gross exaggeration. "Sanquin is a
    healthy company, but to continue, we have to watch the pennies," says Le Clercq.
    "Sanquin will not go bankrubt in any case," says professor Rob Slappendel. "They will just make the
    blood more expensive." According to Slappendel, it’s the Dutch hospital patient who pays for the
    mismanagement of Sanquin - thanks to the hybrid construction.
    Chop up
    Jan Bult, president of industry association of commercial plasma producers PPTA, said that the
    Netherlands cannot not avoid having to split up Sanquin. "The manufacturing of drugs is an expensive
    affair. The Netherlands is too small a market to absorb all costs. It will always wringe, financially and
    administratively, if you execute such different activities in one concern. That was years ago, and the
    growth of the market for plasma drugs has only increased the dilemma of Sanquin."
    With the departure of the two inspectors on Friday, for Sanquin three nerve-racking months have
    begun. The report of the duo will disappear into the unfathomable bureaucracy of the FDA, at which
    the decision will be taken at senior level.
    Both Baxter and the British Shire, which currently sells Cinryze in the US, let know by mail support
    Sanquin, and await. They know that the chance are low that the FDA will actually cease the production
    of Cinryze, because it is an orphan drug. There are no other providers, so that American patients would
    run out of drugs.
    But they also know that new perils only sharpen the debate on the future of Sanquin. Chairman Le
    Clercq expects he’s not finished with the Americans yet: "Surveys of this kind always contain new
    recommendations. But we assume that we have done enough to satisfy the FDA, for the time being."

    -2-
    Ruud..
  7. [verwijderd] 24 november 2016 21:21
    Declan, niet nodig deze draad, achterhaalde info.
    Mod sluiten ajb.

    Problemen van Sanquin tav fda opgelost
    www.sanquin.nl/actueel/?desktop=true
    Positief nieuws van FDA
    Geplaatst op 14 oktober 2016 in categorie Meer dan bloed
    De FDA heeft aangegeven dat Sanquin de eerder gevonden knelpunten afdoende heeft weten aan te pakken.

    =============
    10 nov 16 Thieu Vaessen • Ondernemen
    Problemen Sanquin bij productie van geneesmiddel Cinryze
    fd.nl/ondernemen/1175183/problemen-sa...
    Productie weer hervat
    Sanquin stelt dat de technische problemen intussen zijn opgelost en dat de productie weer volledig is hervat. Shire verwacht echter dat de levering aan artsen en patiënten pas begin volgend jaar weer op niveau is. In het derde kwartaal heeft het farmaconcern ingeteerd op zijn voorraden. Toch nam de verkoopomzet van Cinryze met 12% af.

    =============
    In November 2016, one of the Group’s principal competitors, Shire, announced to its patients and physicians that it is unable to supply its plasma-derived C1 inhibitor product Cinryze® for prophylaxis of HAE, because of a production issue at its supplier Sanquin in the Netherlands. This shortage of supply is expected by Shire to be rectified by early 2017. At the current time, RUCONEST® is the only alternate product with published data showing good efficacy in prophylaxis although it has not yet obtained approval for the indication in the USA, and it may be that some physicians feel it is a suitable alternative for patients unable to obtain their supply of Cinryze®. It is too early to say whether this will improve sales of RUCONEST® but this may be the outcome of this situation, in which case the financial and trading position of the Group would be improved.
    www.pharming.com/downloads/prospectus...
  10. [verwijderd] 24 november 2016 22:05
    quote:

    voda schreef op 24 november 2016 21:50:

    Nog even, en het aantal Up roepers neemt heel erg snel af! (Volgens mij maar 3, en dezelfde personen). Nog eventjes geduld! (ja ja, er is nog liedje met die tekst) :-)

    Liep niet goed af met die gasten.
    Weltrusten voda,
    Neem een lekkere slaapmuts in het smachtlokaal.

    Pharming wordt een winnaar!!!
    Eigenlijk niet heel mijn ding: UP! UP! UP! UP! UP! UP!UP!UP!UP!UP!UP!
  11. forum rang 10 voda 24 november 2016 22:14
    quote:

    lower schreef op 24 november 2016 22:05:

    [...]

    Weltrusten voda,
    Neem een lekkere slaapmuts in het smachtlokaal.

    Pharming wordt een winnaar!!!
    Eigenlijk niet heel mijn ding: UP! UP! UP! UP! UP! UP!UP!UP!UP!UP!UP!
    Eigenlijk bij nader inzien dus, het busje komt zo! :-)

    www.youtube.com/watch?v=vhgfF2YY_zY

  15. [verwijderd] 25 november 2016 08:00
    quote:

    voda schreef op 24 november 2016 22:36:

    Nog een leuk linkje van onze Ruud! :-)

    Over het melken van de konijntjes...

    www.iex.nl/Forum/Topic/1242213/1/Koni...
    Mooie info.
    De Vries heeft ooit aangeggeven in een BNR interview dat er slechts een 100 konijnen worden gemolken. Het zijn top-atleten die nieuw zeelandse witjes, en.m.wikipedia.org/wiki/New_Zealand_W...
    Ben benieuwd wanneer SIPI vol gaat draaien.
  16. [verwijderd] 25 november 2016 11:47
    quote:

    lower schreef op 25 november 2016 08:00:

    [...]

    Mooie info.
    De Vries heeft ooit aangeggeven in een BNR interview dat er slechts een 100 konijnen worden gemolken. Het zijn top-atleten die nieuw zeelandse witjes, en.m.wikipedia.org/wiki/New_Zealand_W...
    Ben benieuwd wanneer SIPI vol gaat draaien.
    Het zijn er volgens mij inmiddels minstens 150 tot 200.
    En dan te bedenken dat uit de melk van deze konijntjes zo'n geweldig en veilig medicijn kan worden geproduceerd. En genoeg voor héél veel patiënten. Bovendien zeer houdbaar: eerst in vriesvorm en daarna ook nog twee jaar als het aangemaakt is en in de flaconnetjes zit.
    Afgelopen jaar is er al veel extra voorraad geproduceerd. (de kosten gaan namelijk altijd voor de baat uit.)
  17. [verwijderd] 25 november 2016 12:55
    Bedeol met deze info,als je het goed doorleest, dat de problemen gewoon niet weg zijn.
    FDA houd zover we kunnen na gaan nog steeds alles tegen aan de grens.
    Sanquin meldt dat ze niet kunnen zeggen waar het precies fout gaat in het proces en het nu wel goedkeuring heeft maar nog steeds niet weet of het product voldoet aan de eisen.
    Shire is muis stil of iemand moet inmiddels info hebben die dit ontkracht.

    Dus misschien wel oud maar nog steeds relevant en onder gesneeuwd.

    Ruud..
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