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INSM - Insmed - Deel 15

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  4. [verwijderd] 25 juli 2007 11:46

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    quote:

    Frederik C schreef:

    tinyurl.com/38gh59

    Goede post op YMB mbt patent en onderzoek NDGA en de verschillende kankers...L.Shiry participeert in het onderzoek.

    Goldfine, Maddux, Youngren ea zijn de inventors!

    Geluk, F
    NDGA = INSM-18 = INSM-18 is an orally available, small molecule, tyrosine kinase inhibitor. It has demonstrated dual inhibition of the IGF-1 and HER2 receptors. Two single-dose Phase I clinical studies in healthy volunteers have been previously completed with this drug candidate. In both studies, the drug was safe and well-tolerated. Additionally, a dose-escalation Phase I-II clinical study designed to define the maximum tolerated dose of INSM-18 in patients with relapsed prostate cancer has been completed at the University of California, San Francisco. This study consisted of a 28-day treatment period at each dose level to investigate the effect of INSM-18 on levels of prostate specific antigen (PSA). An analysis of the data collected from the study is currently being conducted, and the results will be used to design further Phase II clinical studies.
    www.insmed.com/updates/secondary.asp?...

    Geluk, F.
  5. [verwijderd] 25 juli 2007 15:36

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    RICHMOND, Va., Jul 25, 2007 (BUSINESS WIRE) --
    Insmed Inc. (Nasdaq:INSM) today announced that it will release its
    2007 second quarter and first half results before the market opens on
    Thursday, August 2, 2007.
    Management will host an investment community conference call
    beginning at 11:00 a.m. (ET) to discuss the financial results, provide
    a business update and answer questions.
    Individuals interested in listening to the live conference call
    may do so by dialing 877-407-0782 toll free within the U.S. and
    Canada, or 201-689-8567 for international callers.
  6. sappas 25 juli 2007 15:36

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    Insmed Announces Second Quarter and First Half Earnings Release Date and Conference Call
    RICHMOND, Va., Jul 25, 2007 (BUSINESS WIRE) --

    Insmed Inc. (Nasdaq:INSM) today announced that it will release its 2007 second quarter and first half results before the market opens on Thursday, August 2, 2007.

    Management will host an investment community conference call beginning at 11:00 a.m. (ET) to discuss the financial results, provide a business update and answer questions.

    Individuals interested in listening to the live conference call may do so by dialing 877-407-0782 toll free within the U.S. and Canada, or 201-689-8567 for international callers.

    A telephone replay will be available approximately two hours after the call for two weeks by dialing 877-660-6853 from the U.S., or 201-612-7415 for international callers. The account # is 286 and conference id # 249996.

    Individuals interested in listening to the conference call via the Internet may do so by visiting www.insmed.com. A replay will be available on the Company's Web site for 90 days.

    About Insmed Incorporated

    Insmed is a biopharmaceutical company focused on the development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.

    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, 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 product candidates may fail in the clinic or may not be successfully marketed or manufactured, the Company may lack financial resources to complete development of product candidates, the FDA may interpret the results of studies differently than the Company, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

    SOURCE: Insmed Inc.

    Groetjes,

    Sappas
  7. ludwig mack 25 juli 2007 15:42

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    0,72 ( 15:40 ) 0,01 / 1,41%


    Laatste volume 800
    Volume 23.916

    Slot 0,71 24-7-2007
    Open 0,72 15:30
    Hoog 0,72 15:39
    Laag 0,72 15:30

  8. [verwijderd] 25 juli 2007 17:05

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    Hopelijk over een paar dagen nieuwe poging om met dr Allan te spreken

    nog aanvullingen op vragen die ik wil stellen?
    weet niet of ik ze allemaal beantwoord krijgt, maar we zien wel

    V1.4a

    Thank you for the support of the stock through the buys made by yourself and Mr Grover/Tully.
    Very pleased with the way the rop news was brought. Good to have the company report such scientific items from third parties in the way it did. Hope it is done now and than in the future as well.
    Also very solid presentation with CEUT the other day, good improvement over previous ones.

    AFollow on biologics, insmed is commenting this as a very promising area
    for the company.
    What advantages does insmed have over others there, is there proprietary
    technology/science ?
    ,I understood the factory setup, what percentage of cost of running it at full speed is already necessary to keep it running to produce iplex already?

    And if , than to what extent would there be a carryover to other compounds?
    If however nothign of this is the case, than what does set insm aside from
    others? What are the cost efficiencies?

    What kind of possible partners is insm looking for? Foreign companies without approved production facilities? Or bigger US generic players? Or?

    Have some other production of compounds been successfully attempted?

    D) Italy:
    Current patient number count , in march there were some 50 identified, are those slow to get through the redtape?.. or are some choosing not to get on the program afterall?
    Are there still some talks on a trial setup with the Italian ministry of health or does further data have to come first?
    What are the main discussion points?.,,. Financing structure?.. trial sctructure?
    When is some form of agreement anticipated if any?
    Will such any potential future trial remove any revenue from the expanded acces program?
    Is cephalon still involved there? Or only through the agreement due to patent of use in Europe for als ?

    C)Python and Down production agreements… are those suspended due to the settlement?
    Ie no needed for a workaround anymore.. Are those still in play for other alternatives?

    D) The expected full phase II trials financing, is the company expecting
    some grants and third party financing as seen on the IIa trials?
    (financing either by grants or usage of facilities)
    Or will insmed have finance those completely on its own?
    What is the company's current estimate considering expanded cash burn
    including those full II trials, from the current 1.5mln cashburn pm ?
    Considering industry avg cash burn for those trials, how long into 2008 do
    you expect current balance sheet to suffice?
    (And i understand no promises can be made)

    What could you estimate to be the amount of cost that could be associated per indication to read phase IIb results ?
    How would you imagine that would relate to phase III cost? (ie compared to 50% )

    E) todays EMEA paper on the withdrawel of iplex application. The remarks on
    more patient data being needed was clear enough.
    I did wonder about the comments on product comparability.(p 17)
    (link:
    www.emea.europa.eu/humandocs/PDFs/EPA... )
    Are the EMEA doubts on iplex stability and consistency of formulation
    completely due to the twice moving of the production and lack of samples
    to test for comparability? Or does the EMEA keep a more strict guideline on
    the production process? all this considering the fda had no such problems.

    Could the application have been considered a denial?
    Did the SME status provide more information than usual to the company on the status?

  9. ludwig mack 25 juli 2007 18:46

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    mooie lijst van vragen al ...

    wellicht zijn naar zijn enthousiame vragen voor wetgeving voor generieke medicijnen: hoe kan hij daar nu al op vooruit lopen, als de wet er nog niet eens door is;
    hoe nu reeds deals te maken en met wie, hoe ziet hij die concurrentie;
    hoe start hij fabriken voor dat doel op, financieringen?

    dank en groet

  10. [verwijderd] 25 juli 2007 19:40

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    quote:

    ludwig mack schreef:

    mooie lijst van vragen al ...

    wellicht zijn naar zijn enthousiame vragen voor wetgeving voor generieke medicijnen: hoe kan hij daar nu al op vooruit lopen, als de wet er nog niet eens door is;
    hoe nu reeds deals te maken en met wie, hoe ziet hij die concurrentie;
    hoe start hij fabriken voor dat doel op, financieringen?

    dank en groet

    stukje kan ik je al antwoorden

    wetgeving is vooral gunstig omdat er dan standaard richtlijnen komen voor de fda
    dat is het voornaamste...plus hoe je generieke kan vergelijken met de originele ivm meer complexe structuren...
    dus gaat vooral om rechtzekerheid als je een aanrfaag doet..

    en qua fabrieken heeft insm in laatste ceut presentatie al aangegeven dat ze twee a drie compoiunds kunnnen producren naast iplex in hoeveelheden die de hele vraag zouden kunnen dekken met hun huidige apparaten
  15. [verwijderd] 25 juli 2007 22:46

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    quote:

    ludwig mack schreef:

    bedrijfseconomisch hebben ze dus ondercapaciteit; ze hebben enige maanden geleden toch een fabriek gesloten ........
    je verwart dingen
    luister de presentatie plus slides op
    www.xs4all.nl/~surg3on/insm

    ze hebben overcapaciteit
    dit gaat over hun huidige boulder facility
    daar kunnen ze dus stuk of 3 drugs maken met meer dan voldoende productie om volledige US vraag ernaar te voldoen
  16. [verwijderd] 26 juli 2007 10:23

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    Posted by: read_this_n0w
    In reply to: None Date:7/25/2007 4:36:23 PM
    Post #of 5317

    ALS outline by the company, courtesy of a reply to dr mccarthy

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

    Ron Gunn at INSMED sent me this release and indicated I could post it to the forum:

    INSMED Company Statement Regarding IPLEX™
    (rhIGF-I/rhIGFBP-3) ALS Expanded Access Treatment Program in Italy

    This Company Statement is intended to communicate the activities of our ongoing IPLEXTM Expanded Access Treatment Program (EAP) for patients with Amyotrophic Lateral Sclerosis (ALS) in Italy.

    IPLEX (rhIGF-I/rhIGFBP-3)
    IPLEX is the trademark for the drug known as rhIGF-I/rhIGFBP-3. IPLEX is a synthetic complex of the growth factor, insulin like growth factor-I also known as IGF-I and the major protein in the bloodstream, IGFBP-3, which regulates the actions of IGF-I. IPLEX was approved by the US Food and Drug Administration in 2005 for a rare growth disorder unrelated to ALS. Until the initiation of the EAP, IPLEX had never been investigated for the treatment of ALS.
    ALS, often referred to as Lou Gehrig’s disease, is a progressive neurodegenerative disorder that affects nerve cells in the brain and spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle movement action progressively affected patients in the later stage of the disease may become totally paralyzed.
    IGF-I is a neurotrophic factor which has been shown to be essential for normal development of the nervous system. In animal models, IGF-I has been shown to protect motor neurons from injury and promote muscle and nerve regeneration.
    IGF-I has been studied as a potential treatment for patients with ALS over the last decade. Two randomized controlled trials have been conducted with a product known as MyotrophinTM which is a synthetic version of IGF-I. The larger trial showed slowing of the progression of functional impairment and improvements in quality of life. The second, smaller trial, showed similar trends but these trends did not reach statistical significance. A third trial is currently underway in the United States with Myotrophin, the results of which may be reported sometime this year. Therefore at this point in time, it is unclear as to whether IGF-I is effective in slowing disease progression in patients with ALS.
    There is evidence that IPLEX is different from the synthetic forms of IGF-I. The binding protein IGFBP-3, which is a component of IPLEX, modulates the activity of IGF-I. One of the roles of IGFBP-3 is to prolong the length of time that IGF-I circulates in the bloodstream. Incorporating IGFBP3 also blocks the hypoglycemic action (blood glucose lowering action) of IGF-I which allows higher doses of IGF-I to be administered. In order to be an effective treatment of ALS it is important for IGF-I to cross the blood brain barrier. It is possible that by having higher amounts of IGF-I circulating in the bloodstream for a longer period of time, greater amounts of IGF-I may penetrate into the brain. In addition, it could be possible that the IGFBP-3 contained in IPLEX helps to transport IGF-I directly into the brain. For these reasons it is important to study the effects of IPLEX as a treatment for ALS.
    Expanded Access Program in Italy
    The Agenzia Italiana del farmaco (AIFA) first contacted Insmed in the summer of 2003 about providing IPLEX to patients in Italy. AIFA stated that the Italian Court had examined the clinical documents of an adult patient believed to be suffering from ALS and had decided that he must be treated with IGF-I. We agreed to provide IPLEX at a price to cover our cost to the first patient in Italy in the summer of 2004.
    In the fall of 2006, we began receiving several new requests from physicians of patients in Italy diagnosed with ALS who received court orders stipulating IPLEX treatment. At that time we, with AIFA’s guidance, established a formal Expanded Access Program to provide IPLEX to physicians for their patients. As part of this program, physicians are required to collect and provide safety information as well as information pertaining to the progression or improvement in the functional manifestations of the disease prior to beginning treatment and every 3 months thereafter. The functional manifestations of the disease are being evaluated using an ALS Functional Rating Scale which is designed to evaluate speech, salivation, swallowing, handwriting, cutting foods and handling utensils, dressing and hygiene, turning in bed and adjusting bed cloths, walking, climbing stairs and respiratory function. The purpose for collecting this information is to help ensure the safety of patients and to gain an understanding as to whether or not IPLEX treatment provides benefit to these patients.
    There are approximately 30 patients who are currently enrolled in the EAP with additional patients being added periodically. These patients are located throughout Italy from the Calabria region in the south to the Lombardy region in the north and in Sicily and Sardinia as well. Most patients have been receiving 1 injection of 1 vial of IPLEX per day. For a 60 kg person this is equal to 0.5 mg/kg of IPLEX which contains approximately 0.10 mg/kg of rhIGF-I. Patients in the Myotrophin studies received 2 injections of 0.05 mg/kg of rhIGF-I a day for a total daily dose of 0.10 mg/kg. Therefore, to date, most of the patients in the EAP have received the same total daily amount of rhIGF-I as the patients in the Myotrophin studies. So far this dose has been well tolerated and we have not had any reports of serious side effects related to the treatment. We are in the process of having physicians increase the dose to 1 mg/kg and maintain the patients at this dose in order to evaluate the effectiveness of the drug.
    For most of these patients, the process for obtaining IPLEX begins with patients petitioning the Italian Court for treatment. Following a court decision stipulating IPLEX treatment, Insmed is contacted by the treating physician or the patient’s pharmacist. We in turn, provide instructions to the physician and/or pharmacist along with the relevant documentation for the physician and pharmacist to fill out. Once all of the required documents and import licenses are in place we ship IPLEX to the patient’s pharmacy.
    Insmed recognizes that ALS is a devastating disease and that there are patients throughout the world who are in need of an effective treatment. However, the Expanded Access Program is restricted exclusively to Italy through license agreements with companies who hold the patent rights for the manufacture and use of IGF-I products in the treatment of ALS. Insmed does not currently have the rights to manufacture or distribute IPLEX for the treatment of ALS outside of Italy. Therefore we are unable to provide IPLEX to physicians for the treatment of their patients anywhere else in the world.

    John McCarty, PhD
    Treatment Investigator,
    ALS Therapy Development Institute

  17. [verwijderd] 26 juli 2007 12:38

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    Het loop al sinds 2004 lees ik. Dat is een stuk langer dan ik dacht, mooie info. Bedankt

    In the fall of 2006, we began receiving several new requests from physicians of patients in Italy diagnosed with ALS who received court orders stipulating IPLEX treatment. Hoopvol heel hoopvol
  18. [verwijderd] 26 juli 2007 13:06

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    quote:

    junkbond schreef:

    Het loop al sinds 2004 lees ik. Dat is een stuk langer dan ik dacht, mooie info. Bedankt

    In the fall of 2006, we began receiving several new requests from physicians of patients in Italy diagnosed with ALS who received court orders stipulating IPLEX treatment. Hoopvol heel hoopvol
    ook belangrijk

    Patients in the Myotrophin studies received 2 injections of 0.05 mg/kg of rhIGF-I a day for a total daily dose of 0.10 mg/kg. Therefore, to date, most of the patients in the EAP have received the same total daily amount of rhIGF-I as the patients in the Myotrophin studies. So far this dose has been well tolerated and we have not had any reports of serious side effects related to the treatment. We are in the process of having physicians increase the dose to 1 mg/kg and maintain the patients at this dose in order to evaluate the effectiveness of the drug.
  19. ludwig mack 26 juli 2007 15:17

    • ludwig mack

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    quote:

    crackedtooth schreef:

    [quote=ludwig mack]
    bedrijfseconomisch hebben ze dus ondercapaciteit; ze hebben enige maanden geleden toch een fabriek gesloten ........
    [/quote]

    je verwart dingen
    luister de presentatie plus slides op
    www.xs4all.nl/~surg3on/insm

    ze hebben overcapaciteit
    dit gaat over hun huidige boulder facility
    daar kunnen ze dus stuk of 3 drugs maken met meer dan voldoende productie om volledige US vraag ernaar te voldoen
    jeeh, sorry, overcapaciteit natuurlijk, vergiste me ;-(
    gr
  20. ludwig mack 26 juli 2007 15:34

    • ludwig mack

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    0,70 ( 15:30 ) -0,01 / -1,27%


    Laatste volume 6.000
    Volume 6.100

    Slot 0,71 25-7-2007
    Open 0,70 15:30
    Hoog 0,70 15:30
    Laag 0,70 15:30
2.002 Posts
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