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INSM - Insmed - Deel 2

1. ludwig mack 9 juli 2006 17:41

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   sky, beamen .., waarom plaats je die onzin ? dit kun je toch niet serieus menen: diegen die de vraag stelt wil gewoon onrust zaaien en je neemt dat over en plaatst het hier. die procedure gaat om geld, niet om een ander van de markt te halen ! dat is toch onmogelijk: iplex is een NIEUW medicijn met goedkeuring !
   
   

   quote:

   SkySpam1 schreef:

   kan iemand dit beamen:
   
   Posted by: drbio45
   In reply to: rstor1 who wrote msg# 2482 Date:7/7/2006 6:43:14 PM
   Post #of 2490
   
   A branded drug has never been removed from the market because of patent litigation.
   
   It is Genentechs patent that Tercica has licensed. I am not sure but I believe that if there is a royalty that Insmed would be forced to pay, it would go to Genentech.
   
   Tercica only survives if Insmed is forced to shut down. I don't think they would get the royalty.
   
   

2. ludwig mack 9 juli 2006 17:46

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   quote:

   ik ben Diede. schreef:

   Waarom wordt de boel niet geschikt, lijkt voor beide partijen toch het beste?
   

   waarom schikken als je overtuigd bent iets NIEUWS toegevoegd te hebben. wat hebben jullie weinig vertrouwen in het aandeel dat je hebt. was dat niet zo was ik lang weg !
3. ludwig mack 9 juli 2006 17:59

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   interessant !
   ikzelf kan niet beoordelen of men een bedrijf zal laten vallen, maar is goed mogelijk, vooral omdat het eigenlijk alleen diensten verricht, als je begrijpt wat ik bedoel: veel wordt immers uitbesteed en dat met gekochte licencies, dus je verhaal kan wel kloppen.
   ik heb in ieder geval de zelfde keuze gemaakt :)
   
   
   

   quote:

   Do DD schreef:

   De verkopen in Q2 en Q3 bepalen het bestaansrecht van zowel INSM als TRCA.
   Gezien dat INSM een betere pijplijn heeft, DNA hele diepe zakken en waarschijnlijk DNA inderdaad ook wel een stuk pakt van de eventuele schadevergoeding die door INSM moet worden betaald, ziet de toekomst er inderdaad voor TRCA voor de langere termijn niet goed uit omdat ze niet maximaal profiteren van de IP rechten van DNA en geen pijplijn hebben.
   
   De grootste misrekening van TRCA en de markt was dat vrijwel niemand op goedkeuring voor iPlex voor IGFD had gerekend. TRCA zag zichzelf al in de zon zitten met de kans om 7 jaar lang te profiteren van Increlex en vervolgens met het verkregen geld bedrijven zoals INSM op te kopen en daarmee verder te groeien.
   Toen kwam december 2005! Knal. Hele strategie van TRCA op losse schroeven!
   Wat men nu aan het doen is is in mijn ogen te proberen om zo veel mogelijk aandeelhouderswaarde nog te creeren zodat het geld teruggesluisd kan worden naar haar aandeelhouders en de tent kan worden opgedoekt.
   
   Iedereen houdt momenteel zijn kruit droog tot begin augustus. Dan zal de markt de potentiele winnaar kiezen.
   
   E.
   Ik heb al gekozen, dat moge duidelijk zijn.
   

4. ludwig mack 9 juli 2006 18:11

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   anna, met je eerst observatie zit je heel juist, en anders dus dan psycho (inbreuk van patent voor zover het bewezen wordt dat er niets nieuws zou zijn toegevoegd, en er nu van inbreuk sprake zou kunnen zijn).
   jullie vertrouwen in het rechtssysteem vind ik wel erg ontluisterend; ik dan alleen meevoelen voor wat betreft de jury-rechtspraak, maar de andere opmerkingen, nee, kan ik niet volgen.
   
   

   quote:

   -Anna- schreef:

   psycho mijn bron is tercica (PB 2004). Wat ik er nu van begrijp is dat genentech hun de meeste rechten verkocht heeft, exclusief. Dus royalties en schade die daaruit voortkomen zijn volgens mij dan voor tercica. Wat hier belangrijk is zijn zowel de royalties, als de schade die tercica heeft door het afpakken van marktaandeel. Het gaat hier niet alleen om het gebruik van het patent.
   
   Ik ben bang dat het voor zowel tercica als insmed een lange weg kan worden, zeker gezien de kleine markt, cash posities enz.
   
   Dat DNA gaat "kiezen" voor een partij gaat denk ik niet op. Er is al een lange historie met tercica en bij insmed heb ik een beetje het idee dat het management het liefst alles zelf wil doen en geen partners wil.
   
   Wat betreft het rechtsysteem ben ik het volledig met je eens.
   

5. [verwijderd] 9 juli 2006 18:59

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   Voor de echte liefhebbers.
   
   Why should TRCA get a broad patent.....
   by: mpetisth1
   Long-Term Sentiment: Strong Buy 07/09/06 12:29 pm
   Msg: 115312 of 115316
   
   Posted by: jellybean
   In reply to: mpetisth IHUB
   
   "The point that I am trying to make is that the '414 patent was interpreted with very broad claims. The court granted TRCA the right to any method of expressing full length IGF with the proper amino terminus sequence as a fusion partner or directly AND in any prokaryotic organism. These are the kinds of claims given to the first person to clone a gene and/or express the protein in a specific organism. In fact, Genentech tried to claim expression in yeast, which interfered with Chiron's patent. Those claims were proven to be invalid because Genentech did not show bioactivity of its protein before the patent was filed. Which is an interesting point that the judge seized on here. From her ruling: ""The Court construes the term "human IGF-I," in claim 1, and
   term "mature human IGF-I," in claim 9, to refer to bioactive
   material.""
   
   Genentech did not clone the IGF gene and there are clearly many cases in the literature of other people attempting to express IGF in E. coli as a fusion protein so this is not a new idea. Genentech used an e coli signal sequence ligated to a protease cleavage site ligated to the IGF gene. This was not new technology, and was not a novel idea. Why should TRCA get a broad patent claim? Genentech should be able to protect their exact method of expression because they invented it, but to extend the patent to prevent other companies from developing their own method is not right.
   
   You can come up with all kinds of arguments as to how Genentech's '414 patent differs from previously invented systems, but the fact is that other people were working on this problem. To give broad claims does not fit with what I know about patent law.
   
   In addition, we know that the patent is controversial as it was not allowed in Europe due to prior art. We know that it took over 6 years to get the patent issued, 6 years during which Insmed was developing its own methods."
   
   
   -----------
   
   P.
   Zo en nu gereed maken voor een mooie wedstrijd.
   Frankrijk moet winnen, maar Italie wint.
6. [verwijderd] 9 juli 2006 20:24

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   quote:

   psycho-pharma schreef:

   P.
   Frankrijk moet winnen, maar Italie wint.
   

   dit is pas moeilijk Psycho
   maar voorlopig heb je gelijk
   1 - 1
7. [verwijderd] 9 juli 2006 22:44

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   quote:

   psycho-pharma schreef:

   Frankrijk moet winnen, maar Italie wint.
   

   Altijd zeer vervelend als je gelijk krijgt.
   
   P.
   Zidane is genaaid door de Italianen.
8. [verwijderd] 9 juli 2006 22:47

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   Zidane heeft zich laten fokken. Zoals onze kroonprinses zou zeggen: 'dat was een beetje dom.'
   
   E.
   Maar wel jammer.
9. gustaaf1e 9 juli 2006 23:21

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   Ziedendiezidane
   
   G
10. Ortega 10 juli 2006 00:09

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    Het WK van de oplichters en maten-naaiers.
    
    Respect voor Zidane en niet voor dat oplichtersvolk.
    
    vanBasten voor de tweede keer een WK schandalig verziekt.
12. [verwijderd] 10 juli 2006 06:32

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    BY JEFFREY KELLEY
    TIMES-DISPATCH STAFF WRITER Jul 10, 2006
    
    Geoffrey Allan, chairman and CEO of Insmed Inc., says that if the company hadn't bought Celtrix Pharmaceuticals and its diabetes drug SomatoKine, "we would have probably ended up as a failed company."
    P. KEVIN MORLEY/TIMES-DISPATCH
    RELATED
    Insmed Corporation gets used to biotech
    
    The facts of the case
    
    Geoffrey Allan has seen failure. He's witnessing success. And he's closely monitoring an uncertain future.
    
    "It's all about building a company, taking the risk and living through all of those hardships where you wonder where the next paycheck is coming from - and staying with the game," said Allan, chairman and chief executive of Henrico County-based biotechnology company Insmed Inc. "Insmed and its employees have been through those battles."
    
    The positive outcome has been the Dec. 12 federal approval of Insmed's lead drug, iPlex. Success has also come at the cost of a failed product line and an overhanging patent-infringement case that threatens production and sales of the drug - and revenue the treatment could bring.
    
    Insmed's drug treats children who suffer from a rare but severe growth disorder.
    
    But the company's tale isn't complete until introducing its competitor, Tercica Inc., a Brisbane, Calif., firm that makes and sells a drug similar to iPlex, called Increlex.
    
    Tercica had its drug approved by the U.S. Food and Drug Administration in late August, nearly four months before the FDA approved iPlex.
    
    Both companies started selling the drug this year - though Tercica had a five-month head start. The treatments could help as many as 6,000 patients who suffer from a severe form of a disease that causes children to grow more slowly than normal.
    
    The market is estimated at $150 million to $200 million. About 30,000 U.S. children could have a less-severe type of the disorder, and both drugs could have potential in this larger market.
    
    Increlex and iPlex treat a relatively small number of people. But each drug has capabilities in far more common conditions - indications that also carry larger sales potentials.
    
    Insmed is researching ways to use iPlex to treat the buildup and loss of fat related to HIV, muscle and nerve degeneration, diabetes and extreme resistance to insulin - a condition that can lead to obesity, high blood pressure and elevated levels of fat in the blood. John A. "Chip" Scarlett, president and CEO of Tercica, said his company has interests beyond growth disorders, but didn't want to give specifics.
    
    Insmed will release data on iPlex clinical trials on other uses for the drug in coming months. Allan said no new iPlex treatments will gain approval until after 2008.
    
    "It's always been that iPlex would create a franchise around metabolic illnesses," said Allan, 53, a native of England. "It's a very broad-pronged approach to look at a variety of indications."
    
    There is, no doubt, some uncertainty in Insmed's future as the company faces a trial in November on charges it infringed on patents held by Tercica.
    
    Despite insecurity - which comes with the territory in high-risk, high-reward biotech companies - local biotechnology officials point to Insmed as a symbol of the Richmond area's potential for growth in the life-sciences industry.
    
    "Having the drug approved by the FDA by anyone's standard is a huge success. I don't care what state you're in - that's big news," said Mark A. Herzog, executive director of the Virginia Biotechnology Association. "It's a big step forward for the modern biotech community."
    
    He believes Richmond has not seen such a promising pharmaceutical company since A.H. Robins Co., the medical firm founded here in 1889 that became part of Wyeth.
    
    . . .
    
    Insmed has shifted shapes many times since its founding in Charlottesville in 1988, when it spun out of the University of Virginia to develop diabetes drugs.
    
    Allan joined Insmed in 1994, and the com- pany became one of the first tenants in the Virginia BioTechnology Research Park in 1995. Some five years later, Insmed purchased Celtrix Pharmaceuticals Inc., a then-struggling public company that made a diabetes drug called SomatoKine.
    
    Because the two companies were involved in similar drug research, Celtrix was a good fit, said Kevin P. Tully, Insmed's chief financial offer. The company went public after the acquisition, trading under the Nasdaq symbol INSM.
    
    Buying Celtrix, Insmed officials would later learn, was a good move.
    
    In September 2002, Insmed dropped development of its drug for diabetes and polycystic ovary syndrome, which failed in trials. The company cut its work force in half to about 25 employees.
    
    But the acquisition had given Insmed another drug to research. Without Celtrix and SomatoKine, Allan said, "we would have probably ended up as a failed company in 2002."
    
    That year, a California company formed after licensing technology from Genentech. The patents and technology were for a drug called recombinant human insulinlike growth-factor-1, or rhIGF-1.
    
    The company was Tercica.
    
    Within a month of Insmed's product failures, the company had turned its focus to SomatoKine, which could be used to treat children with growth-hormone deficiency.
    
    The drugs from Tercica and Insmed could treat this condition, replacing the nonexistent hormone with the similar rhIGF-1 - the active ingredient in both iPlex and Increlex.
    
    Developing such a treatment was the "fastest, least cash-intensive" path to get approval from the FDA, Allan said.
    
    And the move paid off.
    
    The FDA greenlighted SomatoKine within three years, and the drug's name was changed to iPlex.
    
    The Insmed of today, Allan says, is truly the product of the past six years of development. The company has about 45 employees at 4851 Lake Brook Drive in Glen Allen. A few miles east of the Rocky Mountains, Insmed employs 85 workers in a Boulder, Colo., manufacturing facility called Insmed Therapeutic Proteins.
    
    The lease on the brick Henrico building is up in October, and Insmed plans to move its lab spaces to Colorado but will keep administrative operations in Richmond.
    
    The company has a sales force of about 20.
    
    . . .
    
    Risks to Insmed's future are clear.
    
    "It's a business of managing and balancing risk, but in several areas," said Tully, the CFO. In addition to drug research, Insmed is involved in manufacturing, sales, finance and ongoing litigation, he said, "and each one of these areas has its own level of acceptable risk."
    
    Analysts expect the patent-infringement trial later this year to be a large hurdle.
    
    Last week a California court ruled that Insmed's process for making iPlex infringes on parts of patents held by Tercica. The rulings mean the dispute will have to be resolved at trial in November.
    
    But as is the case in many patent suits, a monetary settlement would be more likely if Insmed is found to have infringed upon Tercica's technologies. An appeals process may follow any outcome.
    
    Insmed also must successfully develop other product lines for iPlex and differentiate the drug from Tercica's Increlex, Andrew S. Fein, an analyst at C.E. Unterberg Towbin in New York, wrote in a recent research note.
    
    Wall Street hasn't shown much excitement for Tercica or Insmed in the past year.
    
    Shares of Insmed hit a 52-week high of $3.35 in January after approval of iPlex, but they have since plummeted 61.5 percent, closing Friday at $1.29. Tercica, meanwhile, hit its one-
13. [verwijderd] 10 juli 2006 06:34

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    Deel 2
    
    Shares of Insmed hit a 52-week high of $3.35 in January after approval of iPlex, but they have since plummeted 61.5 percent, closing Friday at $1.29. Tercica, meanwhile, hit its one-year high of $12.77 in September after approval of Increlex, but shares have fallen 64.8 percent to close at $4.50 on Friday.
    
    "You have two companies going head to head in a small patient population," said Matthew S. Osborne, an analyst who covers both firms at Lazard Capital Markets in New York.
    
    Insmed's future, he said, depends on a favorable outcome in the patent-infringement case and successful development of iPlex for conditions outside of growth disorder.
    
    Though he views Insmed's once-daily iPlex as superior to twice-daily Increlex, Osborne remains uncertain on the patent case. "There's something to be said for the owner of a patent," he said of Tercica, "and that's what's at stake right now."
    
    Analysts at Cowen and Company believe Tercica will have its patent rights upheld and "will eventually come to dominate the [severe growth-disorder] market."
    
    Lazard places a buy rating on Insmed and hold on Tercica; Cowen rates Tercica a market outperform.
    
    In surveys of 68 children's doctors, Osborne has found more than half are already using Tercica's Increlex to treat a less-severe form of the growth disorder, which may affect 30,000 patients as opposed to only 6,000.
    
    "So we expect the same for Insmed's iPlex," he said, even though neither drug is currently approved to treat the condition.
    
    Tercica is undergoing clinical trails to get FDA approval for the less-severe growth disorder; Insmed is not.
    
    Regulatory approval will allow Tercica to broaden marketing efforts of Increlex beyond its current severe growth-disorder indication, said Scarlett, the company's CEO.
    
    Without approval, Insmed will not be able to market iPlex for the less-severe growth disorder and will have to rely on the doctor's advice.
    
    While some analysts have questioned the safety of Increlex, Scarlett rebuts such theories. The thinking may stem from the way in which the drug's active ingredient was first given to patients many years ago - into a vein, which may have put dangerous levels of the drug into the blood, he said.
    
    "Today, I think we have a product that is very safe and also a product that has shown excellent efficacy," he said. Insmed has added a protein to iPlex, which the company believes makes the drug safer. Scarlett said an additional protein "doesn't seem to be called for."
    
    Tercica has long noted that Increlex has gained FDA approval, which in and of itself means the drug is safe for consumer use. Scarlett maintains that iPlex and Increlex have also never been tested head to head, so it is difficult to compare the two.
    
    As for Insmed, Osborne sees the company turning a potential profit - its first - in late 2008. Fein, at C.E. Unterberg, projects Insmed's 2009 revenue at $125 million.
    
    If one of the alternate uses for iPlex fails in clinical trials, there are further indications for the drug to fall back on, Allan said. "Even if we miss on one or two, then it will not be a blow to the company," he said.
    
    For Allan, "even if I leave the company tomorrow, to see it become a commercial success will still be a huge payoff for me. And I don't mean financially."
    
    "We took on a plan. We executed on that plan. And we were successful," he said. "Not everybody can come back from a failed product and regenerate itself. And we did that."
    
    Insmed Inc.
    Top executive: Geoffrey Allan, chairman and CEO
    
    Main product: iPlex, which treats children with a rare but severe growth disorder
    
    Revenue, 2001-March 2006: $2.7 million
    
    Net Loss, 2001- March 2006: $165.4 million, primarily due to research expenses
    
    Locations: 4851 Lake Brook Drive, Glen Allen; manufacturing facility in Boulder, Colo.
    
    52-week range: $0.86-$3.35
    
    Market close, July 7: $1.29
    
    Contact staff writer Jeffrey Kelley at jkelley@timesdispatch.com or (804) 649-6348.
    
    www.timesdispatch.com/servlet/Satelli...
    
    The facts of the case
    
    On Nov. 6, Insmed will begin an 11-day trial in California on charges of patent-infringement leveled by Tercica and its rights-licensor, Genentech Inc., a company considered the pioneer of the biotechnology industry.
    
    Tercica claims Insmed has infringed on its technologies.
    
    Insmed has denied the claims, though analysts say a negative outcome could have an effect on its ability to develop and sell iPlex.
    
    In addition, Tercica last month filed an unfair-business-practices lawsuit in a federal court in Richmond just days after a similar suit was tossed out by a California judge.
    
    In the claim, Tercica says its drug has borne the brunt of false and misleading statements to the public, investors and physicians made by Insmed. The local company said it will defend against the allegations.
    
    www.timesdispatch.com/servlet/Satelli...
    
    
14. [verwijderd] 10 juli 2006 09:17

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    For Allan, "even if I leave the company tomorrow, to see it become a commercial success will still be a huge payoff for me. And I don't mean financially."
    
    "We took on a plan. We executed on that plan. And we were successful," he said. "Not everybody can come back from a failed product and regenerate itself. And we did that."
    
    Dit klinkt naar een overname en/of een wisseling van de wacht in het management.
    
    E.
15. [verwijderd] 10 juli 2006 09:21

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    Zou je er uit kunnen halen,misschien het nieuws waar coinstarz op doelde?
16. [verwijderd] 10 juli 2006 09:28

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    hoop in ieder geval dat de verkopen boven verwachting zijn.Behalve geruchten weten we daar natuurlijk helemaal niets van af.Na dit stuk inmiddels gelezen te hebben vraag ik me eerlijk gezegd af,of Iplex wel zo superieur is ten opzichte van icrelex en of de meeste artsen wel voor iplex gaan kiezen.Onzekerheid alom momenteel, en tevens een verklaring waarom we zo ver terug gezakt zijn.
    
    
17. [verwijderd] 10 juli 2006 09:53

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    quote:

    Do DD schreef:

    For Allan, "even if I leave the company tomorrow, to see it become a commercial success will still be a huge payoff for me. And I don't mean financially."
    
    "We took on a plan. We executed on that plan. And we were successful," he said. "Not everybody can come back from a failed product and regenerate itself. And we did that."
    
    Dit klinkt naar een overname en/of een wisseling van de wacht in het management.
    
    E.
    

    Mijn verwachting zal meer liggen richting een grote Europese partner. Na de toelating van de MAA in Europa is het toch langzamerhand tijd voor een grote partner...
    
    Gr. Gismo
18. [verwijderd] 10 juli 2006 10:50

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    Wanneer worden onze stalen zenuwen beloond??
    
    Patrick.
19. [verwijderd] 10 juli 2006 11:03

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    Geef toch toe mensen dat 'ware geruchten' meestal vervat zitten in de koersvariatie; wie nu nog gelooft dat er geen voorkennis is, komt zelf ongeloofwaardig over... (tov mij dus)
20. [verwijderd] 10 juli 2006 11:06

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    Allemaal,
    
    Dat artikel in de krant heeft nog iets mafs:
    
    Zoals jullie je ongetwijfeld zullen herinneren heeft TRCA onlangs aangekondigd dat ze 251 patienten in Azie op het oog hadden alsof het heel wat was. Waarom doe je zoiets als je tegelijkertijd geweldige offlabel verkopen zou halen met Increlex in een populatie van 30.000?
    Kortom: ik geloof dat TRCA weer haar verfijnde PR technieken tegenover de brave G.Allan (die alles presenteerde alsof het een groot avontuur was) van INSM heeft gezet en de reporter heeft ingepakt.
    
    It's all about the money. Tadadadum...
    
    E.
21. [verwijderd] 10 juli 2006 11:45

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    quote:

    gismo74 schreef:

    [quote=Do DD]
    For Allan, "even if I leave the company tomorrow, to see it become a commercial success will still be a huge payoff for me. And I don't mean financially."
    
    "We took on a plan. We executed on that plan. And we were successful," he said. "Not everybody can come back from a failed product and regenerate itself. And we did that."
    
    Dit klinkt naar een overname en/of een wisseling van de wacht in het management.
    
    E.
    [/quote]
    
    Mijn verwachting zal meer liggen richting een grote Europese partner. Na de toelating van de MAA in Europa is het toch langzamerhand tijd voor een grote partner...
    
    Gr. Gismo
    

    hoop het
    coin dacht of euro filing, evt6 partner
    
    maar we zullen zien, eu partner zeer goed mogelijk dit jaar, maar wanneer alleen..we shall see
    
    enig positief nieuws deze week zou prettig zijn om de bodem die vorige week gezet is te bevestigen