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Home  /  Forum  /  BioPharma  /  INSM - Insmed - Deel 16

BioPharma« Terug naar discussie overzicht

INSM - Insmed - Deel 16

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1.439 Posts
Pagina: «« 1 2 3 4 5 6 ... 72 »» | Laatste | Omlaag ↓
  5. [verwijderd] 8 februari 2008 23:15
    Insmed Launches National Awareness Campaign Surrounding Follow-On Biologics

    Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it has launched a broad education campaign on the importance of establishing a regulatory pathway in the U.S. for large molecule protein-based drugs, known as follow-on biologics (FOBs), which are also commonly referred to as biosimilars or biogenerics.

    Insmed Launches National Awareness Campaign Surrounding Follow-On Biologics

    RICHMOND, Va., Feb 05, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it has launched a broad education campaign on the importance of establishing a regulatory pathway in the U.S. for large molecule protein-based drugs, known as follow-on biologics (FOBs), which are also commonly referred to as biosimilars or biogenerics.

    The scientific, regulatory, and legal framework for the approval of small-molecule generic drugs is well developed, and a regulatory system for approving FOBs was established in Europe in 2006. However, no regulatory pathway currently exists for FOBs in the U.S.

    Insmed has launched a number of public initiatives to promote awareness of the need for Congress to establish a pathway for approval of FOBs, which would enhance patient access to and reduce costs for expensive biotech drugs. Following Insmed CEO Geoffrey Allan's recent testimony before the U.S. Congress, Insmed has initiated multiple efforts to enhance awareness of this important issue, including:

    -- The commissioning and upcoming release of an economic study on the
    savings a FOBs market would provide to patients and healthcare
    providers;
    -- An enhanced Insmed website containing enhanced FOB resources and
    updates;
    -- Interactive advocacy program utilizing user-generated content and
    social networking platforms;
    -- Stakeholder outreach and events with patient, healthcare provider,
    employer, and policy groups.

    "We hope that this renewed attention and the inception of these initiatives will shed some light onto the significant need for Congress to adopt legislation so patients can receive affordable access to life-saving biotech drugs," said Geoffrey Allan, Ph.D., CEO of Insmed. "Given Europe's previously established regulatory pathway for FOBs, the U.S. is clearly lagging behind other nations in responding to this critical healthcare issue."

    "Insmed is very much at the forefront of the evolving FOB industry," continued Dr. Allan. "We have the capacity and intellectual capital to successfully develop FOBs, and are determined to continue working diligently to ensure an effective regulatory pathway is established as soon as possible, and are prepared to enter the market as soon as this becomes a reality."

    Insmed is currently developing a portfolio of FOBs and intends to initiate clinical trials for its first two FOBs in 2008. Members of Insmed's skilled biologics team have worked on over 50 therapeutic proteins. Their focused protein-based drug development backgrounds, coupled with the Company's FDA-approved protein manufacturing facility, and clinical and regulatory expertise, positions Insmed, upon the establishment of a regulatory pathway, to be an initial entrant into the U.S. FOBs market with a broad range of medicines following the expiration of patents covering the innovator products.

    According to published reports, an estimated $10 billion worth of biologic drugs are expected to come off patent by 2010 (with an additional $10 billion by 2015). FOBs would provide safe and effective therapies at a reduced cost following the expiration of the original product's patent.

  9. [verwijderd] 11 februari 2008 15:33
    Ze maken er wel werk van!

    Study by Leading Economist Identifies Potential for $378 Billion of Savings From Follow On Biologics

    RICHMOND, Va., Feb 11, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- A report released today, commissioned by Insmed Inc. (Nasdaq: INSM), identifies potential cost savings of approximately $378 billion over the next 20 years from making follow on biologics (FOBs) available in the U.S.

    The econometric study by economist Dr. Robert J. Shapiro, former Under Secretary of Commerce in the Clinton Administration, found that "...generic versions of the top 12 categories of biologic treatments with patent protections that have expired or that are due to expire in the near future could save Americans $67 billion to $108 billion over 10 years and $236 billion to $378 billion over 20 years."

    According to other published reports, an estimated $10 billion worth of biologic drugs are expected to come off patent by 2010, with an additional $10 billion by 2015. FOBs would provide safe and effective therapies at a reduced cost following the expiration of the original product's patent.

    Dr. Shapiro's report, entitled The Potential American Market for Generic Biological Treatments and the Associated Cost Savings, also finds that "...the economic and medical benefits from generic biologics should be as great or perhaps even greater as those from generic forms of traditional pharmaceuticals... Moreover, the potential savings from the discounted prices that generics provide will be larger with biogenerics, because original biologics are so much more expensive than other brand pharmaceuticals..."

    The scientific, regulatory and legal framework for the approval of small- molecule generic drugs is well developed, and a regulatory system for approving FOBs was established in Europe in 2006. However, no regulatory pathway currently exists for FOBs, which are also commonly referred to as biosimilars or biogenerics, in the U.S.

    "Dr. Shapiro's comprehensive analysis presents a compelling case for the need for Congress to adopt legislation so patients can receive affordable access to life-saving biotech drugs in a timely manner," said Geoffrey Allan, CEO of Insmed, a developer of follow-on biologics and biopharmaceuticals. "The cost savings to the health care system have the potential to be enormous, while the environment for new market participants could introduce competition to these monopolistic markets, similar to that seen in the traditional pharmaceutical generics industry."

    The release of Dr. Shapiro's report is part of Insmed's broad education campaign on the importance of establishing a regulatory pathway in the U.S. for large molecule protein-based drugs, known as follow-on biologics (FOBs), which are also commonly referred to as biosimilars or biogenerics.

    Insmed is currently developing a portfolio of FOBs and intends to initiate clinical trials for its first two FOBs in 2008. Members of Insmed's skilled biologics team have worked on over 50 therapeutic proteins. Their focused protein-based drug development backgrounds, coupled with the Company's FDA- approved protein manufacturing facility, and clinical and regulatory expertise, positions Insmed, upon the establishment of a regulatory pathway, to be an initial entrant into the U.S. FOBs market with a broad range of medicines following the expiration of patents covering the innovator products.

    Dr. Shapiro is the chairman of Sonecon, LLC, a private firm that advises U.S. and foreign businesses, governments and non-profit organization.

    His full report is available on Insmed's website at: www.insmed.com. Journalists may contact Dr. Shapiro by calling 202-213-7233 or e-mailing jprocter@gibraltar-llc.com.

    P.
  17. ludwig mack 15 februari 2008 10:07
    quote:

    crackedtooth schreef:

    [quote=psycho-pharma]
    Farrar Doug van Insmed heeft weer wat aan insider buying gedaan: 29.309 aandelen.

    investor.insmed.com/secfiling.cfm?fil...

    P.

    [/quote]

    incorrect.. is een form 5 en geen form 4.
    het is een aankoop uit eind 2007.

    Form 5 is een puntjes op de i zetten filing
    is dat zo? leer ik graag. denk dat het te maken heeft met langzaam aankopen met heel kleine aantallen, waarbij per aankoop beneden een bep. percentage gebleven wordt, waardoor je per kwartaal of per jaar werkt en moet melden.
  18. ludwig mack 15 februari 2008 10:11
    quote:

    Rieltijm schreef:

    En een nieuwe YT video van het Insmed front. Dit keer Dr Robert Shapiro over de kostenbesparing FOB, nav het rapport wat hij maakte voor Insmed.

    nl.youtube.com/watch?v=gAW56_4gxS8

    Ries (ps. looking good !)
    ja, en dan bewust voor een boekenkast gaan staan, dat straalt kennis uit ;-)
1.439 Posts
Pagina: «« 1 2 3 4 5 6 ... 72 »» | Laatste |Omhoog ↑

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