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INSM - Insmed - Deel 16

1.439 Posts
Pagina: «« 1 ... 17 18 19 20 21 ... 72 »» | Laatste | Omlaag ↓
  3. [verwijderd] 7 juli 2008 12:58
    quote:

    crackedtooth schreef:

    !! Lehman Valution Model on TRCA , includes valuation on iplex indication MMD !! Ihub summary
    Recent takeover of Tercica by Ipsen for 663 Million us dollars.
    Leading council was Lehman Brothers.

    investorshub.advfn.com/boards/manage_...
    Crack, is die 600 miljoen dollar gebasseerd op de 50% van de Ipsen/Tercica.

    Lijkt mij dat aangezien de optin 50-50 dat ze van een totale omzet van 1,2 miljard uitgaan, waarvan 600 miljoen voor Ipsen/Tercica en 600 miljoen voor Insmed.

    gr. Gismo
  5. [verwijderd] 7 juli 2008 17:23
    quote:

    ludwig mack schreef:

    kan document niet openen, ben geen lid, maar trca is natuurlijk meer waard dan 50/50 met insmed, waarbij ze, trca, eigen producten hebben ..... of begrijp ik je / het verhaal verkeerd?
    Ja, ik doel op die $625 miljoen die terica/ipsen als inkomsten opnemen.

    Summary of Tercica KEY Products
    Increlex - Peak US Sales: $225 million ( 2018)
    Somatuline - Peak US Sales $415 million (2019)
    Combo - Peak US sales $700 million - 2019
    MMD - Peak Sales $625 million (2022)
  6. [verwijderd] 7 juli 2008 18:50
    quote:

    gismo74 schreef:

    [quote=ludwig mack]
    kan document niet openen, ben geen lid, maar trca is natuurlijk meer waard dan 50/50 met insmed, waarbij ze, trca, eigen producten hebben ..... of begrijp ik je / het verhaal verkeerd?
    [/quote]

    Ja, ik doel op die $625 miljoen die terica/ipsen als inkomsten opnemen.

    Summary of Tercica KEY Products
    Increlex - Peak US Sales: $225 million ( 2018)
    Somatuline - Peak US Sales $415 million (2019)
    Combo - Peak US sales $700 million - 2019
    MMD - Peak Sales $625 million (2022)
    TRCA buyout assesment INCLUDES MMD (!)
    (thx msft901)

    Fictional name for Tercica was Thunderbird
    Fictional name for Ipsen was Dolphin
    Fictional name for Insmed xyz (insmed named as optin for MMD)

    Summary of Thunderbirds KEY Products
    Increlex - Peak US Sales: $225 million ( 2018)
    Somatuline - Peak US Sales $415 million (2019)
    Combo - Peak US sales $700 million - 2019
    MMD - Peak Sales $625 million (2022)

    MMD sales are projected significantly higher than increlex (about three fold)

    MMD thunderbird notes:
    -MMD chances approval are way too conservative in lehman report at 25%, considering how phase I, IIb data came out and from online testimonials. (also considering that iplex is not a cure as such, but rather counters the effects of the illness)
    -MMD sales projections should 750 million (low end of the 800mln-1.3billion report earlier this year)
    -MMD optin early 2009 (~15 million), low end, more likely ~30mln

    Even considering all those low end estimates, net present value NPV for MMD indication $ 65 million ( 15% discount)

    Pdf links:

    www.xs4all.nl/~surg3on/INSM/200807Leh...

    www.xs4all.nl/~surg3on/INSM/200807Leh...

    www.xs4all.nl/~surg3on/INSM/200807Leh...

    Corresponding SEC links:

    www.sec.gov/Archives/edgar/data/12621...
    www.sec.gov/Archives/edgar/data/12621...
    www.sec.gov/Archives/edgar/data/12621...

    ----------------------------------------
    INSM (the company with the MMD indication rights)
    investorshub.advfn.com/boards/board.a...

    Trca valuation $ 663 million - Their pipeline estimates

    Their pipeline breakdown in the takeover documents specifically mentions iplex
    www.xs4all.nl/~surg3on/INSM/200807_tr...

    Their timeframe for iplex coincides wih insmed guidance
    www.xs4all.nl/~surg3on/INSM/200807_tr...

    Does prove they see MMD as a significant part of "their" pipeline.
    Consider their guidance very conservative though with annual $ 600 mln of sales

    P.
  10. [verwijderd] 9 juli 2008 13:15
    Let op !!

    Recs: 4 biopharm ASIA 2008 Sep 8 - 11 Sheraton Towers Hotel, Singapore
    Conference 2: BIOSIMILARS • Global regulatory and legal updates with real-life case studies by Insmed and Hospira, learn how they penetrated through the regulatory maze


    www.euroforum.fr/marlin/30000000861/M...

  12. [verwijderd] 9 juli 2008 14:17
    quote:

    psycho-pharma schreef:

    [quote=crackedtooth]
    learn how they penetrated through the regulatory maze


    [/quote]

    Zinsinhoudelijk bekeken, moet het ze dan gelukt zijn, op het moment van spreken.

    Dus tussen nu en 8 september een heavy PB.

    Psycho
    jullie blijven er echt geloof in houden he...grote waardering van mijn kant,ik zou het niet volhouden.....na 2-3 dagen wordt ik meestal al gek als ie niet gaat.
  13. Henk Snaph 9 juli 2008 14:34
    quote:

    Durfinvest schreef:

    [quote=psycho-pharma]
    [quote=crackedtooth]
    learn how they penetrated through the regulatory maze


    [/quote]

    Zinsinhoudelijk bekeken, moet het ze dan gelukt zijn, op het moment van spreken.

    Dus tussen nu en 8 september een heavy PB.

    Psycho
    [/quote]jullie blijven er echt geloof in houden he...grote waardering van mijn kant,ik zou het niet volhouden.....na 2-3 dagen wordt ik meestal al gek als ie niet gaat.
    Als jij je nou eens bij je 100-den procenten aandelen houdt en ons hier met rust laat met je super-dom gel*l zijn wij ook tevreden.

    Henks
  14. ludwig mack 9 juli 2008 15:06
    quote:

    psycho-pharma schreef:

    [quote=crackedtooth]
    learn how they penetrated through the regulatory maze


    [/quote]

    Zinsinhoudelijk bekeken, moet het ze dan gelukt zijn, op het moment van spreken.

    Dus tussen nu en 8 september een heavy PB.

    Psycho
    wat doet het scherm gek nu ........., als het een verandering is, is het geen verbetering ;-(

    ja, psycho, het is een publicity stelling door de organisatoren van het seminar, en wetgeving en het proces daartoe is openbaar, dus iets geheel nieuws verwacht ik niet; stemming zou toch pas najaar zijn .......; dan zou het moeten gaan om huidige wetgeving en dat men in het octrooirecht een hiaat heeft gezien, bij afloop van dat octrooi of eerder ........ nou, vreemd dat alle bedrijven die daar belang bij hebben daar al die jaren niet aan gedacht hebben ......, en insmed nu dus wel ........dus ik vind de stelling zeer twijfelachtig.
    groet
  15. [verwijderd] 9 juli 2008 15:07
    quote:

    Henk Snaph schreef:

    [quote=Durfinvest]
    [quote=psycho-pharma]
    [quote=crackedtooth]
    learn how they penetrated through the regulatory maze


    [/quote]

    Zinsinhoudelijk bekeken, moet het ze dan gelukt zijn, op het moment van spreken.

    Dus tussen nu en 8 september een heavy PB.

    Psycho
    [/quote]jullie blijven er echt geloof in houden he...grote waardering van mijn kant,ik zou het niet volhouden.....na 2-3 dagen wordt ik meestal al gek als ie niet gaat.
    [/quote]

    Als jij je nou eens bij je 100-den procenten aandelen houdt en ons hier met rust laat met je super-dom gel*l zijn wij ook tevreden.

    Henks
    Mag toch wel mijn respekt mededelen ?....en ik meen het !
  16. ludwig mack 9 juli 2008 15:12
    crack, je bent er verguld mee, weet je meer?

    door de mazen van de regelgeving, die weer op de wet is gebaseerd .......................; ja over dat laatste is wellicht wat te vinden. regelgeving is door een ministerie uitgevaardigd, en daar zit zeker een truc........ mogelijk ............

    nou nou insmed, here you go, go go go up.

    ;-)
  18. [verwijderd] 10 juli 2008 14:12
    Print page Email page
    « Previous Release

    Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company
    Company Intends to Request Meeting with FDA Regarding Possible Phase III Trial Based on Human Data Demonstrating Bioequivalence of INS-19 to Neupogen(R)

    RICHMOND, Va., July 10, 2008, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals for unmet medical needs, today announced that it has demonstrated the bioequivalence of INS-19, the company's recombinant human granulocyte colony stimulating factor (G-CSF), compared to Neupogen(R), an FDA-approved G-CSF product for the treatment of neutropenia that recorded 2007 sales of approximately $1 billion.

    Human bioequivalence studies utilize well-established, FDA-recognized methodology with rigorous standards. Results of this clinical study demonstrated bioequivalence between INS-19 and Neupogen(R). G-CSF concentration profiles for the two products were identical. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen(R). These human INS-19 and Neupogen(R) data complement Insmed's extensive analytical testing and comparative data from pre-clinical assessments.

    "These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said Dr. Geoffrey Allan, President and CEO of Insmed. "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. Demonstration of bioequivalence is typically the sole clinical requirement to support FDA approval of generic drugs today. Thus, based on these data, Insmed intends to request a meeting with the FDA to discuss potentially initiating a Phase III clinical trial program for INS-19."

    Insmed has one of the most robust follow-on biologics pipelines in the industry. Building upon the success of INS-19, the Company has also completed pre- clinical pharmacological and pharmacokinetic studies for its second follow-on biologic product, INS-20, which has demonstrated comparability to FDA-approved Neulasta(R). Based on these data, Insmed intends to initiate a Phase I bioequivalence study of INS-20 in humans in the fourth quarter of 2008. Insmed intends to seek approval of both products in the U.S. and launch the products on expiration of the relevant innovator patents.

    Study Design

    The study was a single-center, randomized, double-blind, two-way, crossover bioequivalence design in healthy volunteers. Thirty-two volunteers enrolled, and all completed the study as planned. Each volunteer received a single dose of either INS-19 or Neupogen(R), underwent a wash-out period, and returned to the clinic for a single dose of the alternate product. Blood samples were collected to characterize the pharmacokinetic and pharmacodynamic responses to each dose administration. Point estimates and 90% confidence intervals (CI) for the mean ratios of the products' maximum G-CSF concentrations (Cmaxs) and areas under the G-CSF concentration curves (AUCs) were calculated, and bioequivalence was assessed.

    Study Results

    Results of this clinical study demonstrated bioequivalence between INS-19 and Neupogen(R). G-CSF concentration profiles for the two products were identical. The Cmaxs following INS-19 and Neupogen(R) administration were 44.7 +/- 2.1 and 45.5 +/- 1.9 ng/mL, respectively (mean +/- standard error). The AUCs for INS-19 and Neupogen(R) were 341 +/- 16 and 343 +/- 14 ng/mL*hr, respectively. In comparing INS-19 to Neupogen(R), the CI for the ratio of Cmaxs was 92-103% and the CI for the ratio of AUCs was 94-103%. These data demonstrate that the pharmacokinetic behaviour of the products was statistically indistinguishable. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen(R).

    About Insmed

    Insmed Inc. is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit www.insmed.com.

    The Follow-on Biologics Market

    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. Follow-on biologics would provide safe and effective therapies at a reduced cost following the expiration of the original product's patent. A recent 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."

    About INS-19

    Recombinant human G-CSF is a synthetic version of a human G-CSF that is produced in bacteria. G-CSF mimics the biological effects of naturally occurring G-CSF and is used to treat certain medical conditions where a person's neutrophils are too low (neutropenia), such as in cancer patients who are receiving certain chemotherapeutic regimens, patients receiving bone marrow transplants, or in patients who have chronically low neutrophils for other reasons. Pre-clinical studies demonstrate that INS-19 and FDA-approved Neupogen(R) are comparable in both their pharmacological and toxicological profile. Detailed analytical characterisation also demonstrates that the products have a high degree of similarity.

    Forward-Looking Statements

    This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, strategic alternatives, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that strategic alternatives may never be consummated, product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our entrance into the follow-on biologics market may be unsuccessful, our common stock could be delisted from The NASDAQ Capital Market and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including t
  20. ludwig mack 10 juli 2008 16:23
    Last Trade: 0.4501
    Trade Time: 10:06AM ET
    Change: 0.0502 (12.55%)
    Prev Close: 0.3999
    Open: 0.43
    Bid: 0.4500 x 600
    Ask: 0.4600 x 5100
    1y Target Est: 2.00
    Day's Range: 0.4300 - 0.4600
    52wk Range: 0.39 - 1.07
    Volume: 225,257
    Avg Vol (3m): 281,092
    Market Cap: 54.87M
    P/E (ttm): N/A
    EPS (ttm): -0.122
    Div & Yield: N/A (N/A)
1.439 Posts
Pagina: «« 1 ... 17 18 19 20 21 ... 72 »» | Laatste |Omhoog ↑

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