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INSM - Insmed - Deel 16

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  5. [verwijderd] 8 februari 2008 23:15

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    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

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    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.
  15. [verwijderd] 14 februari 2008 22:05

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    Feb 13, 2008 (Wall Street Horizon via COMTEX News Network) --
    Insmed Inc. (INSM)
    Expected next earnings release:
    Announcement date: 3/13/2008 - After Market
    Earnings Quarter: Q4
    Announcement Status: Unconfirmed
  17. ludwig mack 15 februari 2008 10:07

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    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

    • ludwig mack

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    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 ;-)
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Aalberts 466 7.106
AB InBev 2 5.531
Abionyx Pharma 2 29
Ablynx 43 13.356
ABN AMRO 1.582 52.080
ABO-Group 1 23
Acacia Pharma 9 24.692
Accell Group 151 4.132
Accentis 2 267
Accsys Technologies 23 10.829
ACCSYS TECHNOLOGIES PLC 218 11.686
Ackermans & van Haaren 1 192
Adecco 1 1
ADMA Biologics 1 34
Adomos 1 126
AdUX 2 457
Adyen 14 17.804
Aedifica 3 925
Aegon 3.258 323.047
AFC Ajax 538 7.088
Affimed NV 2 6.305
ageas 5.844 109.901
Agfa-Gevaert 14 2.062
Ahold 3.538 74.349
Air France - KLM 1.025 35.265
AIRBUS 1 12
Airspray 511 1.258
Akka Technologies 1 18
AkzoNobel 467 13.049
Alfen 16 25.181
Allfunds Group 4 1.516
Almunda Professionals (vh Novisource) 651 4.251
Alpha Pro Tech 1 17
Alphabet Inc. 1 418
Altice 106 51.198
Alumexx ((Voorheen Phelix (voorheen Inverko)) 8.486 114.826
AM 228 684
Amarin Corporation 1 133
Amerikaanse aandelen 3.837 243.750
AMG 971 134.235
AMS 3 73
Amsterdam Commodities 305 6.744
AMT Holding 199 7.047
Anavex Life Sciences Corp 2 495
Antonov 22.632 153.605
Aperam 92 15.048
Apollo Alternative Assets 1 17
Apple 5 384
Arcadis 252 8.798
Arcelor Mittal 2.034 320.944
Archos 1 1
Arcona Property Fund 1 286
arGEN-X 17 10.350
Aroundtown SA 1 221
Arrowhead Research 5 9.750
Ascencio 1 28
ASIT biotech 2 697
ASMI 4.108 39.597
ASML 1.766 109.815
ASR Nederland 21 4.507
ATAI Life Sciences 1 7
Atenor Group 1 522
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 32 13.834
Axsome Therapeutics 1 177
Azelis Group 1 67
Azerion 7 3.447

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