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Home  /   Forum   /   BioPharma   /   INSM - Insmed - Deel 15

BioPharma« Terug naar discussie overzicht

INSM - Insmed - Deel 15

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2.002 Posts
Pagina: «« 1 ... 32 33 34 35 36 ... 101 »» | Laatste | Omlaag ↓
  5. [verwijderd] 27 juni 2007 19:28
    quote:

    hobbelink schreef:

    [quote=marieke2]
    0.83 alweer, vingers gekruist
    Ik dacht dat ze 60 voorkeursstemmen moeten halen om goedkeuring te krijgen.
    Ik moet vandavond werken, kan het niet in het oog houden. Uitslag misschien pas rond tien uur?
    [/quote]
    Goedkeuring waarvan?
    In antwoord op uw vraag.

    Drug makers face generics obstacles

    Gregory Lopes

    Press Date: Monday, June 18, 2007
    Washington Times

    Manufacturers of generic drugs seem finally to have a golden opportunity to enter the huge biological-drug market as patents expire on more than $10 billion of brand-name pharmaceuticals.

    However, they have two major hurdles to overcome: Congress must create an approval process for generic versions of the complicated and expensive drugs; and Congress may require price-prohibitive clinical trials if it approves generics.

    Unlike chemically derived medications, biologics are made from living cell tissue and are used to treat rare disorders, making them far more expensive than conventional pharmaceuticals and more difficult to replicate. Avastin, a colorectal cancer biological made by Genentech, can cost patients $5,500 a month.

    An approval process does not exist, based on the premise that the drugs are too complicated to duplicate and thus ensure their safety.

    Sen. Edward M. Kennedy, Massachusetts Democrat, has scheduled a vote for June 27 in the Senate Health, Education, Labor and Pensions Committee on a bill that would require the Food and Drug Administration to create an approval process for generic biologics.

    The legislation, sponsored by Sens. Charles E. Schumer and Hillary Rodham Clinton, both New York Democrats, opens an approval process that does not require manufacturers to conduct lengthy and costly clinical trials on generic biologics. However, Mr. Kennedy and local biotech leaders favor such trials, which are required in Europe.

    Barr Pharmaceuticals and Teva Pharmaceuticals, two of the leading generic-drug manufacturers in the country, have been sizing up the biologic market for years and say they have the ability to create generic versions of biologics and sell them at cheaper prices. Each company has a generic version of a human growth hormone or insulin product in its pipeline, just waiting for the door to open as it did in Europe several years ago.

    "I believe a federal approval process for biosimilar drugs is long overdue and will happen soon," said Bruce Downey, chief executive officer of Barr Pharmaceuticals. "It will not only save consumers billions of dollars a year but will allow more patients access to these important medications."

    Mr. Downey is leading a coalition of drug companies, businesses and advocacy groups that include AARP, Ford Motor Co. and General Motors Corp. to lobby Congress to open the biotech industry to generic competition.

    Biological drugs appeared 20 years ago on the U.S. market but did not immediately make a significant impact. In fact, the biological drug market barely existed in 2004. But over the past several years, the drugs have taken off, with sales expected to reach $90 billion by 2009.

    Mr. Downey said generic biologics probably would be priced similarly to generic drugs on the market, which typically cost one-third the price of the brand-name drug. Pharmacy benefits manager Express Scripts Inc. estimates that generic biotech drugs could save Americans $71 billion in a decade.

    The biologic-drug industry is weighing in on the legislation, pushing strongly for clinical trials that could hold up a biogeneric for several years.

    "It is a matter of safety," said Jim Greenwood, president of the Biotechnology Industry Organization, the leading lobbying group for the nation's biotech companies. "Follow-on biologics cannot fully characterize the original drug, so there needs to be clinical trials."

    Mr. Greenwood said the government should find a way to approve generic biologic drugs but he is pressing Congress to include a requirement for clinical trials and against any shortcuts in the approval process. Even if a favorable regulatory market emerges for biogenerics, drug companies are facing an uphill climb.

    Financial analysts view clinical trials as a significant hurdle for generic manufacturers. Generic drugs have narrower profit margins than branded versions, so clinical trials could stop high-level competition among manufacturers.

    "We expect the market to open gradually," said Aaron Gal, a drug industry analyst with the investment research firm Bernstein Research in New York. "Biogenerics should account for about $1 billion in sales by 2011 but given the investment required profitability will probably be delayed until 2015."

    Mr. Greenwood is also looking for Congress to impose a new barrier to generic biologics, called data exclusivity.

    "We believe the clinical data from the innovator company should be protected for 14 years," he said. "If a patent expires, that's one set of circumstances, but on the other hand, if the generic manufacturer is using a slightly different molecule, they should do their own clinical trials to ensure the safety of the product."

    The bill before the Senate committee does not contain a provision for data exclusivity.

    Even if the coalition is able to persuade Congress to exclude clinical trials, cracking the biological-drug market could prove a more difficult task.

    A report on the generic biologic market by the life sciences company Kalorama Information stated: "The issues and trends surrounding the prescription biogeneric pharmaceutical market are staggering and in some cases seemingly insurmountable."

    Tom Werner, chief financial officer at Hospira Inc., a generic-drug company in Illinois, acknowledges the difficulty facing manufacturers intent on entering the biologics field. Hospira entered the generic biologics market in Europe to establish a position in an already regulated environment in anticipation of action in the United States.

    "You will see a market, but it's going to be very different from the current generic-drug market for pharma drugs," he said. "These are far more expensive. We'll only focus on oncology and renal. I think you have to specialize."

    Geluk,F.
  7. [verwijderd] 27 juni 2007 20:25
    Ik ga deze week hopelijk nog met insm bellen, ben nu afsrpaak aan het maken
    Aantal vragen van mijzelf zal ik zeker stellen

    oa over voordelen insm mbt biogenerics, update cash burn phase II, korte vraag over emea withdrawel, korte vraag over italie

    zal op sommige dingen antwoord krijgen, anderne misschien niet..

    iets prangend nog wat ik vergeten ben?
  9. [verwijderd] 27 juni 2007 20:52
    quote:

    crackedtooth schreef:

    Ik ga deze week hopelijk nog met insm bellen, ben nu afsrpaak aan het maken
    Aantal vragen van mijzelf zal ik zeker stellen

    oa over voordelen insm mbt biogenerics, update cash burn phase II, korte vraag over emea withdrawel, korte vraag over italie

    zal op sommige dingen antwoord krijgen, anderne misschien niet..

    iets prangend nog wat ik vergeten ben?
    Crack,
    Kun je nog wat proberen los te krijgen over ALS voorderingen. Zeker n.a.v. de berichtgeving op het ALS Forum afgelopen weken. Is er al zicht op wanneer wordt er met de Phase 2 begonnen wordt...

    Thx, Gismo

    Verder wachten we nog een PR vanavond n.a.v. de biogenerics vote vandaag?
  13. ludwig mack 27 juni 2007 21:20
    quote:

    gismo74 schreef:

    [quote=crackedtooth]
    Ik ga deze week hopelijk nog met insm bellen, ben nu afsrpaak aan het maken
    Aantal vragen van mijzelf zal ik zeker stellen

    oa over voordelen insm mbt biogenerics, update cash burn phase II, korte vraag over emea withdrawel, korte vraag over italie

    zal op sommige dingen antwoord krijgen, anderne misschien niet..

    iets prangend nog wat ik vergeten ben?
    [/quote]

    Crack,
    Kun je nog wat proberen los te krijgen over ALS voorderingen. Zeker n.a.v. de berichtgeving op het ALS Forum afgelopen weken. Is er al zicht op wanneer wordt er met de Phase 2 begonnen wordt...

    Thx, Gismo

    Verder wachten we nog een PR vanavond n.a.v. de biogenerics vote vandaag?

    mooie actie crack !
    extra info, altijd graag.
  14. [verwijderd] 27 juni 2007 21:24
    quote:

    crackedtooth schreef:

    Ik ga deze week hopelijk nog met insm bellen, ben nu afsrpaak aan het maken
    Aantal vragen van mijzelf zal ik zeker stellen

    oa over voordelen insm mbt biogenerics, update cash burn phase II, korte vraag over emea withdrawel, korte vraag over italie

    zal op sommige dingen antwoord krijgen, anderne misschien niet..

    iets prangend nog wat ik vergeten ben?
    Leuk dat je hem persoonlijk te spreken krijgt Crack. Ik hoop dat hij je nog wat extra informatie kan geven, wat hij je mag geven.

    Ze hebben in ieder geval met met hun portemonnee gesproken de laatste tijd. De ene na de andere "insiders buy". Daar zeggen ze in ieder geval mee dat alles goed gaat en wat de PPS betreft het dieptepunt bereikt is. Althans dat is wat ik er van maak.

    succes Crack en ik lees graag wat Allen te melden heeft.

    RJ

  17. [verwijderd] 27 juni 2007 22:18
    Daar is t'ie dan!

    Path for generic biologics clears US Senate panel

    By Lisa Richwine

    WASHINGTON, June 27 (Reuters) - A U.S. Senate panel voted on Wednesday to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines.

    Brand-name manufacturers would receive 12 years of exclusive marketing time before generic competition could start under a bill that cleared the Senate Health, Education, Labor and Pensions Committee by a voice vote.

    The House of Representatives has yet to consider a similar bill. Senate supporters hope both chambers can agree on an approach and include it in a broad Food and Drug Administration bill expected to pass in the coming months.

    Biologic medicines are derived from living things, and manufacturers say they are much tougher to produce than traditional, chemical-based medicines.

    The costs of biotech medicines often reach tens of thousands of dollars per patient each year. They treat a range of diseases including cancer, multiple sclerosis and rheumatoid arthritis.

    Generic competition could save patients and taxpayers billions of dollars, said committee chairman Edward Kennedy.

    "The bill reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public," he said. Continued...

    © Reuters 2007. All Rights Reserved.
    tinyurl.com/392zvb

    Geluk, F.
2.002 Posts
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