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    Indevus (IDEV) - 500 Beiträge pro Seite

    eröffnet am 25.10.05 15:28:32 von
    neuester Beitrag 24.05.06 13:32:19 von
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     Ja Nein
      Avatar
      schrieb am 25.10.05 15:28:32
      Beitrag Nr. 1 ()
      auch die alten IDEV-threads sind leider schon historisch (wann macht wo diesen unsinn endlich rückgängig?).

      nach der kurshalbierung im ersten halbjahr 2005 (sanctura-erwartungen nicht erfüllt, pliva ist auch abgesprungen) hat sich IDEV endlich stabilisiert. in den letzten zwei wochen läuft IDEV sogar mal wieder ausgezeichnet.
      dazu passend heute die meldung, dass mit PRO 2000 eine gesponsorte phase 3-studie beginnt.

      mr.A
      Avatar
      schrieb am 25.10.05 15:47:01
      Beitrag Nr. 2 ()
      Das mit den historischen Threads ist in diesem speziellen Fall vielleicht ganz gut, damit nicht herauskommt, wie blödsinnig vernarrt ich in Interneuron (früherer Name von Indevus) war. :rolleyes:
      Ansonsten hast Du völlig Recht. Wobei früher habe ich die guten Threads an ihrer großen Länge erkannt, jetzt ist es genau umgekehrt.

      Das das nichts mit Sancturia ala Trospium wird, das habe ich mir schon gedacht, weil der Markt für Blasenschwäche hochkompetativ ist. Hier in D war es ja auch nicht der Renner. Ich besitze, glaube ich, noch 35 Aktien, die ich damals beim Verkauf vergessen hatte. Willst du wirklich so lange warten oder hast Du Interesse an der Technik?

      So nun mülle ich den Thread noch ein wenig zu. ;)
      ______________________________________________________
      Indevus Announces Initiation of Phase III Trial of PRO 2000
      Tuesday October 25, 7:09 am ET
      Medical Research Council Sponsored Trial to Enroll Approximately 10,000 Women

      LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 25, 2005--Indevus Pharmaceuticals, Inc. today announced the initiation of a large, international Phase III clinical trial of PRO 2000, the Company`s topical, vaginal microbicide in development for the prevention of sexually transmitted infections, including HIV, herpes, chlamydia and gonorrhea. The trial is being sponsored by the Medical Research Council of the United Kingdom (MRC) and conducted by the UK Government-funded Microbicides Development Programme (MDP).

      The trial has opened for enrollment at clinics in Johannesburg, South Africa and the Masaka district of Uganda, and is expected to expand to additional sites in South Africa, Tanzania and Zambia. Approximately 10,000 women will be enrolled in the trial, which is expected to last approximately three to four years and include interim analyses of safety and efficacy data conducted by an independent data safety monitoring committee.

      "With the initiation of this study, two large safety and effectiveness trials of PRO 2000 with combined recruitment targets of approximately 13,200 participants are underway," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "In February of this year, we announced the initiation of an NIH-sponsored trial being conducted at sites in the U.S. and a number of African countries. Together the two trials represent approximately $100 million in funding.

      "We believe, upon successful completion of the trials, we would be in position to file marketing applications with regulatory authorities, including a New Drug Application with the U.S. Food and Drug Administration. In addition to the work being done on the two trials, we have begun discussions with potential public and private sector partners for the commercialization and distribution of PRO 2000," continued Dr. Cooper.

      "Nearly half of all people living with HIV worldwide are women, and the majority of new adult HIV infections are acquired from heterosexual intercourse," said Dr. Cooper. "The highest infections rates are found in sub-Saharan Africa, which is the primary area where both PRO 2000 trials are being conducted. Globally, there is a significant need among sexually active women for a female-controlled option for HIV / STD prevention.

      "We are pleased that the MRC has selected PRO 2000 as the only active agent in this significant international microbicide trial. The MRC trial is the result of a long-standing and productive public-private partnership," concluded Dr. Cooper.

      Each woman enrolled in this double-blind, placebo-controlled trial will be assigned at random to receive one of two PRO 2000 strengths (0.5% or 2%) or a placebo. The women will be asked to apply the study product prior to sexual intercourse. In addition, all participants will receive condoms and risk-reduction counseling. Researchers will evaluate the effectiveness of PRO 2000 relative to placebo in preventing HIV and other sexually transmitted infections, including gonorrhea, herpes and chlamydia.


      Uhhh das Compliance
      Avatar
      schrieb am 25.10.05 16:06:29
      Beitrag Nr. 3 ()
      tja, habe hier sanctura deutlich überschätzt... und auch nicht ausreichend gewinne mitgenommen damals (war allerdings noch nicht bei interneuron dabei...), so daß ich jetzt trotz des aktuellen anstiegs noch auf verlust sitze.
      aber wer hier behauptet, er hat nie ne fehlentscheidung getroffen, der lügt. und es ist auch ganz gut, mal zu sehen, was aus prognosen geworden ist...

      denke nicht, daß ich so lang warten werde... und wenn die meldung der einzige grund war für die outperformance der letzten 2 wochen, wird`s erstmal wieder runtergehen.
      grundsätzlich ist natürlich schon die frage, wie interessant ist die pipeline, gibt es evtl. partnerschaften, ist IDEV dann doch etwas zu weit gefallen... bin mir aber nicht sicher.
      Avatar
      schrieb am 27.10.05 12:49:12
      Beitrag Nr. 4 ()
      hmmm, nach sehr kurzem sell on good news weiter deutlich gestiegen die letzten zwei tage...
      und der gesamte anstieg der letzten zeit unter deutlich erhöhten umsätzen.
      mit pro 2000 ist das nicht ausreichend zu begründen, habe pro 2000 auch nicht als "juwel" in der pipeline gesehen... eher schon ip 751, wo mich das stiefmütterchendasein in der letzten zeit enttäuscht hat...

      auch nicht zu begründen mit der schaffung eines neuen vorstandspostens...
      vermute da kommt noch irgendwas...
      Avatar
      schrieb am 28.10.05 13:36:31
      Beitrag Nr. 5 ()
      eine für sanctura positive meldung hatte ich zunächst übersehen.
      seit anfang oktober ist konkurrent detrol von der medicaid preferred drug list in florida gestrichen.

      interessant, siehe classification R1A:
      http://www.fdhc.state.fl.us/Medicaid/Prescribed_Drug/pharm_t…

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      Avatar
      schrieb am 28.10.05 14:15:31
      Beitrag Nr. 6 ()
      Dieses Oxybutynin ist nix anderes als generisches Ditropan, ein ehemaliger Marktführer.
      http://www.bizjournals.com/eastbay/stories/2005/01/31/daily3…
      Wenn das Sanctura aus klinischen Gründen bisher noch nicht gelaufen wird, dann wird es es sicher auch nicht zukünftig tun.

      PS: Gestern bin ich beim CC von CVTX eingeschlafen, deshalb muß ich den nochmal anhören. Viel Inhalt!
      Avatar
      schrieb am 28.10.05 23:13:43
      Beitrag Nr. 7 ()
      nicht das oxybutynin...
      detrol von pfizer ist gestrichen worden.

      na mal sehen, vielleicht wird xr (once daily) sanctura doch noch etwas leben einhauchen...
      Avatar
      schrieb am 02.11.05 00:44:54
      Beitrag Nr. 8 ()
      an den letzten 14 handelstagen ist IDEV 76% gestiegen, war dabei 12 mal im plus, und das ganze bei deutlich erhöhten umsätzen...
      irgendwas kommt da noch...
      Avatar
      schrieb am 08.11.05 18:12:54
      Beitrag Nr. 9 ()
      na , womöglich gute nachrichten zur pro 2000 studie.

      keiner glaubt , dass es die afrikanischen länder besonders interessiert , ob pro 2000 in usa schon zugelassen ist.....wenns denn hilft.
      und zeitgleich kam eine erschreckende meldung über zunahme d infektionen in china.....

      also die 2-3 jahre bis z zulassung in d usa müssen wir womögli gar nicht mehr abwarten.
      und um die bezahlung brauchen wir uns auch nicht zu sorgen , wenn denn d afrikanischen länder ihre karte ziehen und richtung europa halten.
      alles klar?

      viel glück
      Avatar
      schrieb am 08.11.05 23:03:23
      Beitrag Nr. 10 ()
      na, da hab ich dann doch meine zweifel... kann mir beim besten willen nicht vorstellen, daß die ersten massenbestellungen afrikanischer länder der grund für den kursanstieg sind ;0)...
      vielleicht doch möglicherweise ein produktdeal, meinetwegen pro2000... oder eine pharmafirma hat gar interesse an dem kompletten laden, wer weiß?!
      Avatar
      schrieb am 14.12.05 00:35:12
      Beitrag Nr. 11 ()
      nachdem die berg- und talfahrt im letzten monat mal wieder nach unten ging und etwa die hälfte der kursgewinne des vorherigen monats zunichte machte, kommt heute wieder richtig leben in den titel.

      vorbörslich gab es heute die jahreszahlen. umsatz 2005 $33,3 mio (+78%) haupsächlich durch SANCTURA upfront/milestone zahlungen, produktverkäufe, royalties. es blieb ein jahresverlust von $53,2 mio. r&d-kosten betrugen $30,6 mio, im letzten quartal über $13 mio, worin allerdings die upfront-zahlungen an schering für NEBIDO enthalten sind (7,5 mio). Im Quartal blieb ein verlust von $12,6 mio bei umsätzen von $10,1 mio.

      dies alles war im rahmen der erwartungen und sicherlich nicht auslöser von >17% kursanstieg.
      interessant ist der weitere ausbau der pipeline. im fokus ist z.zt. der bereich testosteron replacement therapie. nachdem im juli bereits die us-rechte an scherings NEBIDO erworben wurden (aktualisierte planung NDA im 1.quartal 2007), wurde nun mit Delatestryl ein bereits vermarktetes testosteron replacement für die behandlung von hypogonadism gekauft.
      dies dient in erster linie der besseren ausnutzung der sales force und der vorbereitung des in etwa 2 jahren zu erwartenden NEBIDO-launchs.
      mit pro 2000 und SANCTURA XR hat IDEV weitere produkte in phase 3 der entwicklung, für SANCTURA XR ist die NDA für`s 2.halbjahr 2006 geplant.

      eine phase 2 studie läuft mit pagoclone zur behandlung des stotterns, hier werden resultate mitte 2006 erwartet.
      IP 751 hängt weiterhin in der luft.

      die gründe für die kursbewegungen der letzten zeit sind weiterhin nicht deutlich erkennbar.
      Avatar
      schrieb am 01.01.06 08:51:29
      Beitrag Nr. 12 ()
      frohes neues allen idev investierten.
      die 5 haben wir und massive insiderkäufe.
      pago wurde wieder rausgekramt und hilft evtl. gegen stottern?
      mal sehen was denn 2006 so bringt:)
      Avatar
      schrieb am 04.01.06 21:25:46
      Beitrag Nr. 13 ()
      Hier wird ja nicht gerad viel geschrieben über den aufgehenden Stern INDEVUS, was aber andererseits auch gut ist;)

      bizjournals.com
      Indevus files to sell up to 10 million shares
      Thursday December 29, 2:06 pm ET


      Indevus Pharmaceuticals Inc. has filed a shelf registration with the U.S. Securities and Exchange Commission to sell up to 10 million shares of its common stock from time to time.
      Terms of the offering would be established at the time of the offering, according to the company.


      Lexington, Mass.-based Indevus (Nasdaq: IDEV - News) currently does not have any commitments to sell shares under the registration statement. Indevus stated the registration is meant to provide it with the flexibility to raise capital when it is deemed necessary.

      Indevus focuses on acquiring, developing and commercializing treatment products focused on urology, gynecology and men`s health. During the past year, Indevus announced it had secured U.S. in licensing rights to Schering AG`s Nebido, a testosterone treatment for males.

      Indevus pulled in $33.3 million in revenue during the fiscal year ending Sept. 30, up from $18.7 million in revenue during the same period in fiscal 2004. Net losses reached $53.2 million, an improvement over $68.2 million in net losses last year.

      Over the past year, the company`s stock has traded between $2.42 and $6. Shares were trading at $5.41 this week.

      Published December 29, 2005 by the Boston Business Journal

      MFG Homm13
      Avatar
      schrieb am 07.01.06 01:35:15
      Beitrag Nr. 14 ()
      IDEV setzt seinen weg nach norden fort und klettert heute unter guten umsätzen auf ein neues jahreshoch.
      Avatar
      schrieb am 10.01.06 18:35:57
      Beitrag Nr. 15 ()
      Hallo Ihr wenigen,

      nun will ich doch auch mal was beitragen. Es ist wirklich nicht viel los hier! Heute wurde aber bekannt, daß der CEO sich 10.000 Stück kaufen will. Das sollte ja eigentlich nur Gutes heißen, oder wie seht Ihr das.:rolleyes:

      Wie weit könnte es denn noch gehen? Ich habe schon meine Stopps nach unten gesetzt, sicher ist sicher. Habe schon einmal einen Absturz mitgemacht. Eigentlich sollten ja auch bald die neuen Zahlen rauskommen. Womit wird denn gerechnet?

      Viele Fragen und hoffentlich auch ein paar Antworten und Meinungen!
      ;)
      Grüße
      keil1055
      Avatar
      schrieb am 10.01.06 21:00:51
      Beitrag Nr. 16 ()
      Indevus Announces Closing of Delatestryl(R) Transaction
      Monday January 9, 6:30 pm ET


      LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 9, 2006--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced the closing of the previously announced acquisition of the U.S. rights to Delatestryl from Savient Pharmaceuticals, Inc. Delatestryl, (testosterone enanthate) is a marketed injectable testosterone replacement therapy for the treatment of male hypogonadism.
      ADVERTISEMENT


      Commercial preparations are well underway and the Indevus specialty sales force will begin promoting Delatestryl on January 16th. The Company`s detailing efforts will be directed towards urologists, endocrinologists and other high prescribing physicians.

      Hypogonadism is characterized by a deficiency in endogenous testosterone production resulting in abnormally low levels of circulating testosterone. Testosterone deficiency is accompanied by symptoms of different severity which include sexual dysfunction, reduced muscle mass and strength, depressed mood and osteoporosis. Testosterone replacement therapy is not indicated for age-related decline in serum testosterone ("andropause") because there is insufficient information to support safe or effective use in this geriatric population. Delatestryl is contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate.
      Avatar
      schrieb am 11.01.06 00:15:40
      Beitrag Nr. 17 ()
      [posting]19.640.780 von Keil1055 am 10.01.06 18:35:57[/posting]cooper`s aktienkauf dürfte eher eine reaktion gewesen sein auf butler`s verkauf von 5.647 aktien, zumal cooper`s kauf direkt bekannt wurde und nicht erst am nächsten tag... vielleicht wollte er einfach ein zeichen setzen.

      die zahlen des ersten quartals werden weniger interessant sein als die weitere entwicklung der pipeline, die den eindruck eines gemischtwarenladens macht...
      die sanctura-umsätze sollten weiter gemächlich steigen... hier liegen hoffnungen auf sanctura xr, NDA im 2. halbjahr geplant.
      mit nebido haben wir inzwischen einen weiteren hoffnungsträger, und die ein oder andere überraschung könnte der rest beisteuern (ergebnisse pagoclone mitte 2006, neuigkeiten zu pro 2000, IP 751).


      zunächst mal freuen wir uns über die $6! die habe ich heute noch nicht erwartet...
      Avatar
      schrieb am 17.02.06 23:36:34
      Beitrag Nr. 18 ()
      es sei kurz darauf hingewiesen, daß IDEV nach der korrektur im januar mittlerweile wieder fahrt aufgenommen hat und heute ein neues jahreshoch erreicht.

      dies hat nicht zu tun mit den kürzlich präsentierten quartalszahlen, die keine überraschung brachten:
      http://biz.yahoo.com/bw/060209/20060209005419.html?.v=1

      es darf also weiter gerätselt werden...
      Avatar
      schrieb am 07.03.06 14:07:51
      Beitrag Nr. 19 ()
      Indevus Files New Patent Application for the Use of Pagoclone in Premature Ejaculation
      Tuesday March 7, 7:02 am ET


      LEXINGTON, Mass.--(BUSINESS WIRE)--March 7, 2006--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced that it has filed a New Patent Application with the U.S. Patent Office covering the use of pagoclone as a treatment for premature ejaculation (PE). The patent filing is based on evidence of pharmacologic activity contained in the Company`s existing clinical databases.
      ADVERTISEMENT


      "Premature ejaculation is one of the most common sexual dysfunctions in men, affecting approximately 30% of the adult male population," stated Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "There are currently no approved oral drugs in the United States for the treatment of PE. The normal ejaculatory response is controlled by multiple neurotransmitters, including serotonin and GABA. There is evidence that drugs that stimulate or increase the levels of GABA in the brain may delay the ejaculatory response."

      "Pagoclone is a selective, non-sedating GABA-A receptor partial agonist, studied extensively in the past for anxiety disorders and currently being studied by Indevus in a Phase II trial for the treatment of stuttering," continued Dr. Cooper. "We have found evidence within our existing database that patients have described ejaculatory delay on pagoclone. Based on these observations and the pharmacologic rationale, we intend to form an internal project team to explore the clinical and regulatory path to proof of concept studies of pagoclone as an on-demand oral therapy for men with PE. Pagoclone for PE would be an excellent strategic addition to our urology and men`s health franchise."

      About Pagoclone

      Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor partial agonist. In clinical studies in anxiety disorders, it has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing the sedation or withdrawal effects seen with benzodiazepine agents. Pagoclone trials have enrolled over 1,600 patients to date. In early 2005, Indevus was granted a new U.S. patent covering the use of pagoclone for the treatment of stuttering. The Company recently completed enrollment in an approximately 130 patient Phase II clinical trial to study pagoclone for the treatment of persistent developmental stuttering. The Company expects to report results of this trial in mid-June of 2006.

      About Indevus

      Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men`s health. The Company currently markets SANCTURA® for overactive bladder and DELATESTRYL® for the treatment of male hypogonadism. The Company has multiple compounds in clinical development, including SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.

      Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company`s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company`s filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA® and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA, SANCTURA XR and NEBIDO®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.



      Contact:
      Indevus Pharmaceuticals, Inc.
      Michael W. Rogers, 781-861-8444
      Executive Vice President and CFO
      or
      Brooke D. Wagner, 781-402-3410
      VP, Corporate Communications

      --------------------------------------------------------------------------------
      Source: Indevus Pharmaceuticals, Inc.
      Avatar
      schrieb am 07.03.06 14:08:19
      Beitrag Nr. 20 ()
      Indevus Provides Update on Two Clinical Programs
      Monday March 6, 3:12 pm ET
      Company Completes Enrollment in Phase II Trial for Pagoclone and First Phase III Trial for SANCTURA XR(TM)


      LEXINGTON, Mass.--(BUSINESS WIRE)--March 6, 2006--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today reported that enrollment has been completed in the Company`s Phase II trial for pagoclone, in development for stuttering, and the first of its two ongoing Phase III trials for SANCTURA XR. SANCTURA XR is the once daily formulation of SANCTURA®, which is currently marketed for overactive bladder.
      ADVERTISEMENT


      "I am very pleased to report the completion of enrollment in both of these trials," said Glenn L. Cooper, M.D., chairman, president, and chief executive officer of Indevus. "Completing enrollment puts us on track to report data on the pagoclone trial by the middle of June of this year and report data on the first SANCTURA XR trial by the end of June."

      "It is important that we recognize the large number of people who worked diligently on enrolling patients in these two trials," Dr. Cooper continued. "I would like to thank not only the Indevus regulatory, development and clinical staff for their dedication and focus but also the investigators working on both programs for their effort and support."

      Pagoclone

      The Phase II trial enrolled approximately 130 patients in the largest controlled pharmaceutical trial ever conducted in stuttering. The trial is an 8-week, double-blind, placebo-controlled study evaluating the improvement in stuttering in adults receiving pagoclone versus placebo. Data is expected to be reported by the middle of June.

      SANCTURA XR

      The first of two Phase III trials is fully enrolled with approximately 600 patients. Enrollment of the second trial is expected to be completed within the next 60 days. Both Phase III trials are 12-week, double-blind, placebo-controlled studies, evaluating the effect of SANCTURA XR in reducing frequency, urgency, and incontinence episodes in patients with overactive bladder. Consistent with previous guidance, the Company expects to file a New Drug Application with the U.S. Food and Drug Administration by the end of the calendar year.

      About Indevus

      Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men`s health. The Company currently markets SANCTURA® for overactive bladder and DELATESTRYL® for the treatment of male hypogonadism. The Company has multiple compounds in clinical development, including SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.

      About SANCTURA

      SANCTURA is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The most commonly reported side effects in Phase III U.S. clinical trials were dry mouth (20.1 percent for SANCTURA vs. 5.8 percent for placebo) and constipation (9.6 percent for SANCTURA vs. 4.6 percent for placebo). Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to SANCTURA should not use SANCTURA.

      Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company`s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company`s filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA® and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA, SANCTURA XR and NEBIDO®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.



      Contact:
      Indevus Pharmaceuticals, Inc.
      Michael W. Rogers, 781-861-8444
      Executive Vice President and CFO
      or
      Brooke D. Wagner, 781-402-3410
      VP, Corporate Communications

      --------------------------------------------------------------------------------
      Source: Indevus Pharmaceuticals, Inc.
      Avatar
      schrieb am 07.03.06 14:19:38
      Beitrag Nr. 21 ()
      Indevus Files New Patent Application for the Use of Pagoclone in Premature Ejaculation
      Tuesday March 7, 7:02 am ET


      LEXINGTON, Mass.--(BUSINESS WIRE)--March 7, 2006--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced that it has filed a New Patent Application with the U.S. Patent Office covering the use of pagoclone as a treatment for premature ejaculation (PE). The patent filing is based on evidence of pharmacologic activity contained in the Company`s existing clinical databases.
      ADVERTISEMENT


      "Premature ejaculation is one of the most common sexual dysfunctions in men, affecting approximately 30% of the adult male population," stated Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "There are currently no approved oral drugs in the United States for the treatment of PE. The normal ejaculatory response is controlled by multiple neurotransmitters, including serotonin and GABA. There is evidence that drugs that stimulate or increase the levels of GABA in the brain may delay the ejaculatory response."

      "Pagoclone is a selective, non-sedating GABA-A receptor partial agonist, studied extensively in the past for anxiety disorders and currently being studied by Indevus in a Phase II trial for the treatment of stuttering," continued Dr. Cooper. "We have found evidence within our existing database that patients have described ejaculatory delay on pagoclone. Based on these observations and the pharmacologic rationale, we intend to form an internal project team to explore the clinical and regulatory path to proof of concept studies of pagoclone as an on-demand oral therapy for men with PE. Pagoclone for PE would be an excellent strategic addition to our urology and men`s health franchise."

      About Pagoclone

      Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor partial agonist. In clinical studies in anxiety disorders, it has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing the sedation or withdrawal effects seen with benzodiazepine agents. Pagoclone trials have enrolled over 1,600 patients to date. In early 2005, Indevus was granted a new U.S. patent covering the use of pagoclone for the treatment of stuttering. The Company recently completed enrollment in an approximately 130 patient Phase II clinical trial to study pagoclone for the treatment of persistent developmental stuttering. The Company expects to report results of this trial in mid-June of 2006.

      About Indevus

      Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men`s health. The Company currently markets SANCTURA® for overactive bladder and DELATESTRYL® for the treatment of male hypogonadism. The Company has multiple compounds in clinical development, including SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.

      Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company`s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company`s filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA® and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA, SANCTURA XR and NEBIDO®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.



      Contact:
      Indevus Pharmaceuticals, Inc.
      Michael W. Rogers, 781-861-8444
      Executive Vice President and CFO
      or
      Brooke D. Wagner, 781-402-3410
      VP, Corporate Communications

      --------------------------------------------------------------------------------
      Source: Indevus Pharmaceuticals, Inc.
      Avatar
      schrieb am 08.03.06 13:23:14
      Beitrag Nr. 22 ()
      nach dem stottern nun die nächste hochinteressante indikation für pagoclone, premature ejaculation. auch diese ist auf verbaler ebene häufig hier im board zu beobachten, insbesondere bei den jüngeren börsenazubis... ich erspare mir den hinweis auf entsprechende beispiele.

      kursrelevant dürfte diese meldung kurz- und mittelfristig nicht sein, interessant aber allemal.
      auch die vollzugsmeldung bzgl. der rekrutierung in den beiden studien sagt eigentlich nur, daß die entwicklung planmäßig verläuft... das ist beruhigend.
      Avatar
      schrieb am 24.05.06 13:32:19
      Beitrag Nr. 23 ()
      die pagoclone phase 2 daten gegen das stottern sind veröffentlicht.
      durchaus zufriedenstellend auf den ersten blick.

      http://biz.yahoo.com/bw/060524/20060524005403.html?.v=1


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