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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 ... 55 56 57 58 59 ... 72 »» | Laatste | Omlaag ↓
  1. [verwijderd] 10 maart 2009 18:36
    [quote=ludwig mack]
    wat wil je van hem dan ?
    het produkt zelf mag niet gemarketeerd worden voor groeiverstoringen, maar voor wel voor indicatie als, zij het op speciaal voorschrift (dus nog geen echte marketing) maar alleen dan voor als en niet voor iets anders, en dan alleen voor de periode dat het produkt voor als nog geen fda goedkeuring heeft ........., dus nog in testfase.
    dat staat er.
    gr
    Mag je hem niet of zo?
  2. ludwig mack 10 maart 2009 18:45
    quote:

    SPIKY schreef:

    [quote=ludwig mack]
    wat wil je van hem dan ?
    het produkt zelf mag niet gemarketeerd worden voor groeiverstoringen, maar voor wel voor indicatie als, zij het op speciaal voorschrift (dus nog geen echte marketing) maar alleen dan voor als en niet voor iets anders, en dan alleen voor de periode dat het produkt voor als nog geen fda goedkeuring heeft ........., dus nog in testfase.
    dat staat er.
    gr
    Mag je hem niet of zo?
    sorry als ik een verkeerde indruk wekken zou .........., is niet de bedoeling. niet naar bio, noch naar allergewaardeerde crack.
  3. [verwijderd] 10 maart 2009 18:47
    Insmed Announces FDA Issues Statement Regarding Position on Allowing Patients With ALS Access to IPLEX(TM) Under an IND

    Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics (FOB) and biopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has issued a statement on its website in regards to the agency's position on allowing patients with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) access to IPLEX(TM) under an Investigational New Drug (IND) application. The statement can be accessed at: www.fda.gov/cder/drug/infopage/mecase...

  5. Mark__ 10 maart 2009 21:14
    Overzicht:

    Omzet van Insmed       dd dinsdag 10 maart 2009

    Openingskoers                    0,90

                             13.550  stuks à       0,90        0,5%
                             31.738  stuks à       0,91        1,2%
                                  400  stuks à       0,92        0,0%
                             11.940  stuks à       0,93        0,4%
                             57.978  stuks à       0,94        2,2%
                             23.000  stuks à       0,95        0,9%
                             15.700  stuks à       0,96        0,6%
                             24.260  stuks à       0,97        0,9%
                           110.472  stuks à       0,98        4,3%
                             34.549  stuks à       0,99        1,4%
                           237.625  stuks à       1,00        9,5%
                           359.786  stuks à       1,01      14,5%
                           265.649  stuks à       1,02      10,8%
                           272.249  stuks à       1,03      11,2%
                           241.668  stuks à       1,04      10,0%
                           213.776  stuks à       1,05        9,0%
                             46.900  stuks à       1,06        2,0%
                             64.581  stuks à       1,07        2,8%
                             71.717  stuks à       1,08        3,1%
                             71.315  stuks à       1,09        3,1%
                           100.285  stuks à       1,10        4,4%
                             64.100  stuks à       1,11        2,8%
                             58.143  stuks à       1,12        2,6%
                             38.177  stuks à       1,13        1,7%

    Laatste koers (19:58:13)    1,01

    Gemiddelde koers              1,0298
    Totale omzet                  2.429.558  stuks

    Flink wat volume rond de 1 dollar.
  6. [verwijderd] 10 maart 2009 21:16
    ** Comments on limited supply - Seems some dont read/listen properly
    Am on a short break with very crappy online acces (2k/sec and intermittent).
    For those who are invested but fail to remember information when they hear it:

    Insmed will sell its boulder facility where iplex was made to Merck per 31 march for 120mln, and will get 10mln for the ip rights to ins-19 and ins-20 biogenerics as well.

    This was commented in the Merck deal closing CC.
    The boulder facility was used to produce iplex and to develop biogenerics production setups. Iplex was produced there in sufficient quantities for iplex trial, however It was NOT fit for large production as needed for an adult indication, nor would it ever have been.

    home.xmsnet.nl/privatebanking/INSM/20...

    Listen to it in total.. clarifies a lot. Fifteen very well spent minutes.

    Insmed would have either started their own production only plant, or outsource to a company like Lonza with whom they had discussions in the past.
    Insmed has the expertise including state of art purification methods, all such a partner would need to have is staff and big enough facility.




    I am very bullish on MMD, and as per today gut feeling on ALS has materialized quite solidly.


    FYI on insmed,
    gonna go much higher coming months
    insmeds confirmation on italian EAP is in today:

    FDA Position on Allowing Patients with ALS Access to Iplex under an IND fpor those whom applied before march 6th. As well as a lottery based trial form in future IND applications to ensure some form of further data collection.
    www.fda.gov/cder/drug/infopage/mecase...

    Based on this data:
    Iplex in ALS patients - RESULTS from italian Expaned Acces Program
    www.fda.gov/cder/drug/infopage/mecase...

    In the patients summarized above, the ALSFRS-R decline from pre-treatment through last available ALSFRS-R value is 0.38 points per month. In 25% of these patients, on-treatment ALSFRS-R values either did not change over time or slightly increased.
    To date, 54 patients have been treated for at least 6 months and have both pre-treatment and 6-month ALSFRS-R values. In this cohort, pre-treatment ALSFRS-R is 30.0 ± 7.9, 6-month ALSFRS-R is 25.7 ± 9.6, and the ALSFRS-R decline from pre-treatment through the last available ALSFRS-R value is 0.68 points per month. In 20% of these patients, on-treatment ALSFRS-R values did not change over time or slightly increased.



  7. [verwijderd] 11 maart 2009 12:10
    Insmed Announces Fourth Quarter and Full-Year 2008 Financial Results

    RICHMOND, Va., March 11, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics (FOB) and biopharmaceuticals, today reported results for the quarter and full-year ended December 31, 2008.

    Company Highlights

    Follow-on Biologics Program
    Insmed entered into a definitive agreement with Merck & Co., Inc. whereby Merck, through an affiliate, will purchase all assets related to Insmed's follow-on biologics platform.
    Insmed to receive a total of $130 million for the assets. After fees, taxes and other costs related to the transaction, Insmed expects net proceeds of approximately $123 million as a result of this agreement.
    Insmed will receive initial payments of up to $10 million for Insmed's lead follow-on biologic candidates and the remaining balance upon closing of the transaction, which continues to be targeted for March 31, 2009.

    IPLEX(TM)
    Completed the Phase 2 trial of IPLEX(TM) in Myotonic Muscular Dystrophy (MMD), and expect preliminary data in the second quarter of 2009;
    Completed an external assessment of the total market for MMD treatments that indicated that the market for MMD could be as high as between $800 million and $1.4 billion;
    Generated $10.5 million in cost recovery revenue from the IPLEX(TM) expanded access program (EAP) for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) in Italy during 2008. The EAP now includes 110 patients enrolled and 23 physicians;
    Gained royalty-free worldwide rights for IPLEX(TM) in connection with potential EAP ALS programs outside of Italy;
    The European Medicines Agency (EMEA) granted Premacure AB orphan designation for Insmed's IPLEX(TM) for the prevention of retinopathy of prematurity (ROP) in neonates of less than 32 weeks of gestational age. Premacure AB intends to initiate a phase 2 multicenter trial for IPLEX(TM) in the ROP indication during the second quarter of 2009.

    "The sale of our FOB assets to Merck represents a watershed moment for Insmed," said Dr. Geoffrey Allan, Ph.D., President and CEO Insmed. "This agreement demonstrates Insmed's world-class clinical capabilities, and provides us with a substantial cash infusion that positions us well for future growth. In the short-term, we expect to be cash neutral for the balance of 2009 as we continue moving ahead with our IPLEX(TM) programs for MMD and ALS. In addition, we intend to pursue a comprehensive and thoughtful analysis to determine the most appropriate use of the proceeds we will receive from Merck. Our objective, though, is to utilize this capital to grow our business, and create additional shareholder value, as we have done through the transaction with Merck."

    Financial Results for Fourth Quarter and Full-year 2008

    Revenues for the fourth quarter ended December 31, 2008 were $2.9 million, up from $2.1 for the corresponding period in 2007. The increase was mainly attributable to an $846,000 increase in cost recovery revenue from our EAP to treat patients with ALS in Italy.

    The net loss for the fourth quarter of 2008 was $4.0 million or $0.03 per share, compared with a net loss of $3.3 million or $0.03 per share in the fourth quarter of 2007.

    R&D expenses increased to $5.4 million from $4.6 million, reflecting an increase in clinical trial activity for our FOB and IPLEX(TM) programs. SG&A Expenses increased to $1.3 million from $0.9 million, due primarily to higher IPLEX(TM) distribution costs and increased legal costs associated with the Merck transaction.

    Interest income in the fourth quarter of 2008 fell to $47,000 from $264,000 in same period of 2007. This was due to the combination of a lower average cash balance on hand and lower interest rates during the most recent quarter. Interest expense increased slightly to $273,000 in the most recent period from $217,000 during the corresponding period of 2007.

    Revenues for the full-year 2008 totaled $11.7 million, up from $7.6 million in the corresponding period of 2007. This increase was primarily due to a $5.1 million improvement in cost recovery from the EAP to treat patients with ALS in Italy and the grant receipt of $1.0 million from the Muscular Dystrophy Association supporting the IPLEX(TM) MMD trial. This was partially offset by the absence of license income from Napo and the revenues lost from our withdrawal of IPLEX(TM) in the short stature market pursuant to the terms of our settlement agreement with Genentech Inc. and Tercica Inc., entered into in March 2007.

    The net loss for the 12 months ended December 31, 2008 was $15.7 million or $0.13 per share, compared to $20.0 million or $0.17 per share for the 12 months ended December 31, 2007. R&D Expenses increased to $21.0 million from $19.2 million, reflecting the higher activity as our clinical trials in the FOB and IPLEX(TM) areas advanced. SG&A Expenses fell to $5.1 million from $8.2 million, due to the elimination of litigation expenses following the March 2007 settlement and the removal of commercial expenses associated with our business restructuring plan.

    Interest income for the full-year 2008 was $0.5 million, compared to $1.2 million for the full-year 2007. This decrease was mainly due to lower interest rates and a lower average cash balance for the full-year 2008 as compared to the full-year 2007. Interest expense for the 12 months ended December 31, 2008 was $1.3 million, compared to $682,000 for the corresponding period of 2007. This higher interest expense was due to an increase in the debt discount amortization resulting from the quarterly payments of our 2005 convertible notes, which began in March 2008. The $500,000 loss on investments represents the full write down on the prior year Napo investment during 2008.

    As of December 31, 2008, we had total cash, cash equivalents and short-term investments on hand of $2.4 million, compared to $16.5 million on hand as of December 31, 2007. The $14.1 million decrease in cash, cash equivalents and short-term investments mainly reflected the use of $12.0 million for operating activities and $2.2 million for principal and interest repayment of our 2005 convertible notes, which began on March 1, 2008.

    Conference Call

    To participate in today's live 8:30 AM ET conference call, please dial 866-700-5192 (U.S. callers) or 617-213-8833 (international), and provide passcode 10018019. A live webcast of the call will also be available at phx.corporate-ir.net/playerlink.zhtml... Please allow extra time prior to the webcast to register, download and install any necessary audio software.

    The webcast will be archived for 30 days, and a telephone replay of the call will be available for seven days, beginning at 12:30 PM ET on March 11th at 888-286-8010 (U.S. callers) or 617-801-6888 (international), using passcode 38324430.

    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.

    P.
  15. [verwijderd] 11 maart 2009 16:06
    Korte samenvatting 2008 van cpneln en dit zijn idd de key issues:

    Key takeaways.........

    1. "The sale of our FOB assets to Merck represents a WATERHSHED MOMENT for Insmed," said Dr. Geoffrey Allan, Ph.D., President and CEO Insmed."

    2. "This agreement demonstrates Insmed's world-class clinical capabilities, and provides us with a SUBSTANTIAL CASH infusion that positions us well for FUTURE GROWTH."

    3. " In the short-term, we expect to be CASH NEUTRAL for the balance of 2009 as we continue moving ahead with our IPLEX(TM) programs for MMD and ALS."

    4. " In addition, we intend to pursue a comprehensive and thoughtful analysis to determine the most appropriate use of the proceeds we will receive from Merck. Our objective, though, is to utilize this capital to GROW our business, and CREATE SHAREHOLDER VALUE, as we have done through the transaction with Merck."

    ------------------------

    2008 annual report
    investorshub.advfn.com/boards/read_ms...
  17. [verwijderd] 11 maart 2009 16:48
    Komt allemaal goed joh

    Ik volg het boekje nu al een paar uur .

    Ik weet bijna zeker dat 1 partij een verkoopgolf probeerde te veroorzaken . Er wordt echter zeer weinig in de laat bijgezet , zodat er weinig op te kopen valt . De actie heeft dus geen zin gehad .

    Het zal me niets verbazen als straks het blok op 1$ in 1 keer wordt opgeslokt of terug getrokken .

    RT 0,91
  18. Mark__ 11 maart 2009 17:28
    Ben echt benieuwd hoe de koers zich gaat ontwikkelen.. De Q4 resultaten over 08 zijn bekend en prognose voor 09 is gematigd positief. Zoals zo vaak met INSM na bekendmaking van de kwartaalcijfers zakt het aandeel verder weg.

    Verwacht dat INSM (welke ik al ruime tijd in de porto heb) na opnieuw de $1 te hebben doorbroken niet direct doorschiet naar de hogere dollar regionen. Optimisme is goed maar ik vind dat er hier nu wel een zeer positieve sfeer rondom dit aandeel op het forum hangt.

    Opwaarts potentieel is er zeker, maar niet binnen korte termijn.
  19. [verwijderd] 11 maart 2009 17:36
    quote:

    Mark__ schreef:

    Ben echt benieuwd hoe de koers zich gaat ontwikkelen.. De Q4 resultaten over 08 zijn bekend en prognose voor 09 is gematigd positief. Zoals zo vaak met INSM na bekendmaking van de kwartaalcijfers zakt het aandeel verder weg.

    Verwacht dat INSM (welke ik al ruime tijd in de porto heb) na opnieuw de $1 te hebben doorbroken niet direct doorschiet naar de hogere dollar regionen. Optimisme is goed maar ik vind dat er hier nu wel een zeer positieve sfeer rondom dit aandeel op het forum hangt.

    Opwaarts potentieel is er zeker, maar niet binnen korte termijn.
    Idd, daarom voor mij ook een reden om nog een poosje de aandeeltjes aan te houden.
  20. [verwijderd] 11 maart 2009 20:34
    Gefeliciteerd mensen er was nog een kans om bij te kopen.
    Nu bij deze allen succes.
    Ik kijk wel mee.

    Spannend

    Groet,

    quote:

    Patrick Holdings schreef:

    [quote=Mark__]
    Ben echt benieuwd hoe de koers zich gaat ontwikkelen.. De Q4 resultaten over 08 zijn bekend en prognose voor 09 is gematigd positief. Zoals zo vaak met INSM na bekendmaking van de kwartaalcijfers zakt het aandeel verder weg.

    Verwacht dat INSM (welke ik al ruime tijd in de porto heb) na opnieuw de $1 te hebben doorbroken niet direct doorschiet naar de hogere dollar regionen. Optimisme is goed maar ik vind dat er hier nu wel een zeer positieve sfeer rondom dit aandeel op het forum hangt.

    Opwaarts potentieel is er zeker, maar niet binnen korte termijn.
    [/quote]

    Idd, daarom voor mij ook een reden om nog een poosje de aandeeltjes aan te houden.
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