BioPharma Terug naar discussie overzicht

Insmed, in de gaten houden

1. [verwijderd] 22 augustus 2005 18:37

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2. [verwijderd] 22 augustus 2005 18:45

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   Insmed Asks FDA Not to Approve Drug
   It's a race to the finish for two biotechnology companies that have developed a drug to help short people.
   
   One is in Henrico County. The other is in Brisbane, Calif. Both are seeking approval from the U.S. Food and Drug Administration for a drug that will stimulate growth.
   
   Insmed Inc., the local company, has filed a "citizen petition" to block approval of its competitor's drug. It asks the U.S. Food and Drug Administration to deny approval of Increlex, made by Tercica Inc.
   
   John A. Scarlett, president and CEO of Tercica, said in a statement released yesterday that he did not have access to the citizen petition.
   
   However, "we believe it was important to disclose this development [to shareholders]."
   
   The content of the petition is expected to be made public this week.
   
   No one at Insmed could be reached for comment yesterday.
   
   Insmed expects to hear from the FDA by Oct. 3 whether its drug, SomatoKine, is approved. Tercica is looking at an Aug. 31 decision.
   
   SomatoKine treats growth-hormone insensitivity syndrome, a rare childhood disease that results in short stature.
   
   Insmed is researching other uses for the drug that include treatments for muscle and nerve degeneration, extreme insulin resistance and an abnormal buildup or loss of fat related to the AIDS virus.
   
   Both companies are dealing with a possible "orphan drug exclusivity" designation.
   
   The label -- granted to products for diseases that affect fewer than 200,000 people -- gives companies the right to exclusively market drugs for seven years.
   
   If Insmed wins approval, SomatoKine would be the company's first and only drug on the market.
   
   Tercica is dealing with a similar situation. Increlex, developed to treat short stature and associated metabolic disorders, would be its first product.
   
   Source: Richmond Times - Dispatch
   
   
3. [verwijderd] 23 augustus 2005 19:19

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   vandaag weer +8%
   
   arak
4. [verwijderd] 23 augustus 2005 20:14

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5. [verwijderd] 23 augustus 2005 20:22

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   INSMED INC (NasdaqNM:INSM) Delayed quote data
   
   Last Trade: 1.49
   Trade Time: 2:04PM ET
   Change: 0.20 (15.50%)
   Prev Close: 1.29
   Open: 1.35
   Bid: 1.48 x 300
   Ask: 1.49 x 5100
   1y Target Est: 2.50
   
   Day's Range: 1.30 - 1.49
   52wk Range: 0.79 - 2.48
   Volume: 1,258,847
   Avg Vol (3m): 425,395
   Market Cap: 67.18M
   P/E (ttm): N/A
   EPS (ttm): -0.65
   Div Yield (ttm): N/A (N/A)
   
   
   
6. [verwijderd] 23 augustus 2005 20:24

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   koersverloop
   
   www.behr.nl/Beurs/H/insmed.inc.html
7. [verwijderd] 23 augustus 2005 20:35

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   Insmed producten
   
   rhIGF-I/rhIGFBP-3
   
   GHIS regulatory filling
   
   Diabetes phase II
   
   Severe Burn Injury phase II
   
   Hip Fracture phase II
   
   IGFBP-3
   
   Cancer discovery
   
   Discovery - Indicates the research phase of a drug candidate and the initiation of preclinical trials for safety, pharmacology and proof of efficacy in non-human animal models.
   
   Phase I - Indicates clinical trials for safety and pharmacology have been initiated or completed.
   
   Phase II - Indicates a clinical trial to determine dosing and efficacy has been initiated or completed.
   
   Phase III - Indicates a confirmatory trial to determine efficacy and safety as primary support for regulatory approval has been initiated or completed.
   
   
8. [verwijderd] 23 augustus 2005 20:37

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   Severe Burn Injury
   
   Severe burn injury is an additional treatment target. Annually, approximately 10,000 people in the United States (30,000 worldwide) suffer from traumatic burns over greater than 20% of their body surface. Major tissue damage along with, very low IGF-I levels, are associated with disruption of biological processes that are essential for efficient and successful healing and protection from burn complications. Furthermore, the length of time spent in a burn center and the time required to conduct the skin grafting required to cover the burn wound are directly related. Research has shown that IGF-I plays a significant role in tissue repair and that IGF-I supplementation can potentially promote the healing process and reduce hospital stay.
   Additionally, data indicate that SomatoKine may have a positive effect on the immune system of severely burned patients. After severe burn, patients typically experience immune system deficiencies that impair their ability to resist infection as shown by an adverse shift in cytokine production by T lymphocytes. However, lymphocytes collected from six severely burned SomatoKine treated patients showed an approximately 280% increase in the production of interleukin-2, and a 25-90% increase in the production of interferon gamma, both vital immune system proteins. Thus, these changes may increase the ability of the burned patient to effectively be more resistant to infection.
   SomatoKine may have a normalizing effect on protein synthesis and immune function. These effects may offer the potential to provide critical protection from serious infection and protein wasting responses that occur in severe burn patients.
   
   
9. [verwijderd] 23 augustus 2005 20:38

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10. [verwijderd] 24 augustus 2005 16:06

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    weer + 8%
12. [verwijderd] 28 september 2005 11:09

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    Jongens en meisjes, als je weer een parel ontdekt, kijk even een paar bladzijden terug, vaak blijk je niet de eerste te zijn. Kost 40 seconden.
    
    Psycho
    houd van historisch perspectief
13. [verwijderd] 28 september 2005 11:42

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    SAN FRANCISCO, Sept 27 (Reuters) - Insmed Inc. (INSM.O: Quote, Profile, Research) on Tuesday said the U.S. Food and Drug Administration had asked for more data before the agency clears the company to apply for final approval on a growth therapy for children.
    In a statement, the company said was asked for more data on iPlex (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency.
    
    The FDA is not requiring the company to conduct additional preclinical or clinical trials. The U.S. agency has informed Insmed that they are still considering iPlex's orphan exclusivity status, the company said.
    
    © Reuters 2005. All Rights Reserved.
    
    NYSE and AMEX quotes delayed by at least 20 minutes. Nasdaq and all other quotes delayed by at least 15 minutes. Reuters does not endorse the views or opinions given by any third party content provider.
    
    yahoo.reuters.com/financeQuoteCompany...
    
    Nog even wachten??
14. [verwijderd] 18 oktober 2005 00:05

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    insmed gaat knallen morgen
    finance.yahoo.com/q?s=INSM
    
    after houre's 1.34 + 16%
15. [verwijderd] 18 oktober 2005 10:09

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    quote:

    peteranja schreef:

    insmed gaat knallen morgen
    finance.yahoo.com/q?s=INSM
    
    after houre's 1.34 + 16%
    

    Uiteindelijk 1,28
    
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    In de gaten houden bij opening.
    
    Nieuws van gisteren laat;
    CHICAGO, Oct 17 (Reuters) - Insmed Inc.(INSM.O: Quote, Profile, Research) said on Monday it has responded to concerns by U.S. regulators over approval of its iPlex treatment for children with growth problems.
    
    yahoo.reuters.com/financeQuoteCompany...
    
    Jay
16. [verwijderd] 18 oktober 2005 16:24

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    wat een telleurstelling
17. [verwijderd] 29 november 2005 19:35

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    (….)The FDA has established December 12, 2005 as its target to complete its 60-day review of the iPlex New Drug Application (NDA).(…)
    
    Nu, 8 handelsdagen voor de ‘due date’ is de koers nog lekker laag ($1,30). Op ‘approvable letter’ nieuws steeg de prijs van $1.09 naar $1.64 (+ 50.5%) in een dag; daarna geleidelijk terug.
    
    Indien deze stijging mogelijk is op ‘approvable letter’ nieuws, dan ben ik benieuwd naar de stijging op formele FDA-approval. Prijs kan niet anders dan over de kop gaan.
    
    Zeker ook, als in begeleidende berichten, biz.yahoo.com/bizwk/051123/b3961102.h... markt getallen worden gebruikt die ver de $700 mio overstijgen (alleen voor groei factoren markt). Uiteraard nog te bezien welk marktaandeel INSM verwerft (en dan zijn de andere mogelijkheden van iPlex en de kansen op goedkeuring nog niet eens in ogenschouw genomen, te weten; Diabetes Type I / II, Heupfracturen & ernstige brandwonden). www.insmed.com/secondary.asp?title=Ov...
    
    Wordt een mooie After Klaas Party!
    
    PS. In de laatste 60 dagen GEEN insider trading (geen kopen, noch verkopen). Dus, het vertrouwen is daar!
    PS.II Short interest naar beneden met 0.15% - www.nasdaqtrader.com/asp/short_intere...
    
    Geluk, F.
18. [verwijderd] 30 november 2005 14:16

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    thanx voor de tip!
19. [verwijderd] 1 december 2005 09:53

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    Presentatie op zaterdag 10 december, 2 dagen voor vermoedelijke FDA approval van iPlex, van goede resultaten die zijn verkregen met het andere parade paardje proteine, IGFBP-3. Deze presentatie spitst zich toe op behandeling van borst kanker!
    
    www.sabcs.org/ProgramSchedule/12_10_0...
    
    www.sabcs.org/ProgramSchedule/PosterS...
    
    [5081] Synergistic interaction between recombinant human insulin-like growth factor-binding protein 3 (rhIGFBP-3) and letrozole in estrogen positive breast cancer.
    
    Alami N, Banerjee K, Page V, Brossard M, Shiry L, Brodie A, Leyland-Jones B. McGill University, Montreal, QC, Canada; Insmed Inc., Richmond, VA; University of Maryland, Baltimore, MD
    
    Background: Progression of hormone-sensitive breast cancer is a result of stimulation by estrogen acting through the estrogen receptor (ER),thereby regulating the transcription of several target genes and growth factors.Accumulating evidence for cross-talk between estrogen and insulin-like growth factor (IGF) system has been reported.IGF receptor-mediated signaling is modulated by IGF-binding proteins (IGFBPs 1-6) which regulate IGF bioavailability. IGFBP-3 is the highest affinity carrier protein for IGFs. IGFBP-3 inhibits cell proliferation largely through sequestering circulating IGFs and preventing their interaction with IGF receptors. IGFBP-3 has also apoptotic effects independent of IGF-binding.Both IGFs and estrogen act as mitogens promoting cell proliferation in breast carcinomas.Currently, the use of letrozole, a non-steroidal aromatase inhibitor that blocks estrogen synthesis, has proved to be a significant improvement in postmenopausal hormone-dependent breast cancer treatment.This study was specifically designed to explore the ability of rhIGFBP-3 to enhance the letrozole efficacy, previously demonstrated by Brodie et al. in a postmenopausal cancer model.
    
    Material and Methods: Estrogen-dependent human breast cancer cells stably transfected with aromatase,MCF-7Ca,were used. Cells were treated with rhIGFBP-3, at concentrations: 0.02 to 200 g/ml, either alone or in combination with 1 M letrozole, in the presence of 1 nM androstenedione. Their in vitro effects were assessed by MTT assay following 6 days exposure.
    
    Results: Treatment with rhBP-3, as single agent, inhibited the AD-induced growth of MCF-7Ca cells in a dose-dependent manner. The IC50 obtained was 90 g/ml. Letrozole alone reduced cell proliferation by 50% at concentrations 1-5 M. The combination of various concentrations of rhBP-3 with a constant dose of letrozole elicited a strong dose-dependent enhancement of letrozole activity in MCF-7Ca cells. Synergistic interactions (CI<1) were observed with all the rhBP-3 doses, as evaluated by the combination index-isobologram method(Chou and Talalay). Preliminary observations in the MCF-7Ca xenograft model using rhBP-3 and letrozole, either alone or in combination, are consistent with our in vitro results.
    
    Discussion: rhIGFBP-3 displayed synergistic interactions with letrozole in the MCF-7Ca model. Our findings provide further evidence that co-targeting IGF and ER may have important clinical therapeutic implications in breast cancer. Our previous work examining rhBP-3 downstream signaling effects in ER+ and ER- models, differences in IGFI-dependent and independent p-MAPK signaling were observed. Ongoing work is directed towards correlating rhBP-3 and letrozole effects on IGFR and ER signaling pathways in the MCF-7Ca model, both in vitro and in vivo.
    
    Saturday, December 10, 2005 5:00 PM
    
    Poster Session V: Treatment: Endocrine Therapy (5:00 PM-7:00 PM)
    
    Geluk, F.
20. [verwijderd] 2 december 2005 12:35

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    RT $1.25, down $ 0.03.
    
    Naar aanleiding van een vraag van een van de posters op het Yahoo-forum, heeft een van de “longs” de moeite genomen om, zonder al te technisch te worden, uit te leggen waarom een FORMEEL FDA approval op de 12de December hoogst waarschijnlijk is.
    Omdat, indien ze inderdaad de FDA approval krijgen op de 12de, de prijs nu nog lekker laag is, dacht ik dat deze ‘post’ tussen alle andere ‘clutter’ er even uitgelicht moest worden.
    
    <<by: kabbamonte (55/M/Cripple Creek, CO on good) 12/02/05 03:42 am Msg: 34695 of 34699
    
    We have discussed this a zillion times already, you can set your counter back to 30,000 or so and work forward.
    
    Basically, it is all about orphan status for the US. The implication is that if INSM gets approval with orphan status, most likely on a "shared" basis with TRCA, then that would be because it was considered to be a "superior drug", although it may or may not be considered a "different drug" from TRCA. The most popular opinion here is that doctors would choose to prescribe the "superior drug" (mainly because of once a day injections vs two for TRCA, and fewer hypoglycemic reactions).
    
    Beyond that, if both drugs are covered by insurance, and economics of price are not a consideration for either one, it makes sense that most of the market share would come to INSM.
    
    TRCA has a jump n marketing by a few months, and on one hand they are going ahead like INSM don't matter. Also discussed at great length is a potential dark cloud over pending litigation between TRCA and INSM, should INSM get the good news. However, with FDA backup on their decision, many here feel that TRCA's litigation would be tantamount to harrassment and not amount to much. However, the last thing INSM needs is to have money tied up with such matters. TRCA just got $75 million financing arrangement which gives them leeway to pursue litigations.
    
    Many posts here can get quite more biological and technical, but you may tune in to the archive on recent webcast by INSM, which goes into the IPLEX vs INCRELEX comparisons.
    
    and, just in case you don't know, INSM has already received an "approvable" letter from FDA and INSM made a quick supplemental submittal of some extra data requested from them. We assume that was info that would help them with "orphan" decision.
    
    So, basically, it seems very likely that IPLEX will be "approved." However, without orphan status attached, that means IPLEX cannot be marketed in the US for 7 more years (not sure if that means Canada and Mexico, too), but may be marketed overseas subject to whatever regulatory hurdles over there.
    
    This would be a mixed blessing sort of news, which would also put INSM in much more economic hardship and certainly draw out the process beyond the patience of many.
    
    There are many posts on the "to the moon" and "to the dungeon" prospects of the price. I think we are all in discussion fatigue and it's all up to FDA right now, no matter who says what at this point.
    
    I think Insmed's pipeline has the "to the moon" potential. Orphan status for this application opens the door to very lucrative possibilities. >>
    
    Dacht dat de potentieel geinteresseerden hiermee gebaat zouden zijn!
    
    Geluk, F.
    
21. [verwijderd] 3 december 2005 15:38

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    RT $1.30, UP $0.05 (4.00%)
    
    Het blijft een indrukwekkend rijtje institutionele beleggers die ook nog steeds in het bezit zijn van aandelen INSM.
    
    Indien er niet iets van vertrouwen bestond, op de uitslag van de FDA op de 12de December, dan zou al lang alles verkocht zijn en zouden insiders en institutionals niet een aandeel van meer dan 20% in de toatle float op dit mment hebben! Er blijkt zelfs ook nog vrijdag door deze partijen te zijn bijgekocht!
    thomson.finance.lycos.com/lycos/iwatc...
    
    Ook voor dit aandeel voorzie ik komende week, zeer volatiele handel; Daytraders' paradise!
    
    Voor de iets langere termijn (komende 2/3 weken), bij FDA approval $4 en meer (zeker ook als de pipeline in ogenschouw wordt genomen).
    www.insmed.com/secondary.asp?title=Ov...
    bij FDA afwijzing, zal de koers waarschijnlijk terugvallen tot $0,80 is de verwachting.
    
    Geluk, F.