Indevus: 2003 das Comeback in die 1. Liga? - 500 Beiträge pro Seite

[Wallgrekk]

Indevus könnte 2003 wieder von sich
reden machen. Leider völlig vergessen,
taucht Indevus nun langsam wieder aus
der Versenkung auf.

Einst großer Hoffnungsträger in der Biotechnologie
Branche, zog PFIZER letztes Jahr leider unerwartet
kurzfristig die Pagoclone Kooperation mit Indevus zurück.

Alle Hoffnungen wurden begraben (siehe Chart!)



Wie man aber auch hier im Chart sehen kann,
konnten diejenigen, die dort eingestiegen sind, ihren
Einsatz seitdem verdreifachen!!

Um nochmal deutlich zu machen, zu welchen Kursen Indevus in der Lage ist, hier der 3 Jahres-Chart:



Oder noch besser:



Gerade in den letzten 3 Monaten haben die Anleger wieder das Vertrauen in die Aktie zurückgewonnen, u.a. durch gute Zahlen und neue Kooperationen und gute Ergebnisse beim neuen Medikament TROSPIUM.


Nun, am 26.04.03, also in knapp 10 Tagen findet
die American Urological Association in Chicago statt, wo INDEVUS die abschließende wichtige Phase III von Trospium vorstellen wird. Indevus hat mit Trospium anscheinend DAS Zukunftsmedikament gegen Inkontinentia (oder auch Reizblase)in seiner Pipeline. Das Ertragspotential liegt bei über 1 Mrd US$!. Die Marktkapitalisierung zu Zeit ca 120 Mio US$.
Indevus hat ein sehr gut funktionierendes Management und enorm viel Cash.

Jeder wartet momentan auf die FDA Zulassung, die jeden Tag kommen könnte. Sollte Indevus diese bekommen und einen starken Vertriebspartner finden, denke ich, daß wir noch in diesem Jahr alte Höchstkurse zwischen $10-$20 wiedersehen werden.

Viel Erfolg und viel Spaß,

Wall

Wie immer: Dies ist keine Kauf - oder Verkaufsempfehlung, sondern lediglich meine persönliche Einschätzung zu dieser Aktie!

[Wallgrekk]

Vorbörslich auf Island bid schon $3.02

Übrigens:

04/15/03 2.95 3.12 2.95 3.06 +0.14 319500 +4.79 %




Composite Indicator
Trend Spotter (TM) Buy

Short Term Indicators
7 Day Average Directional Indicator Buy
10 - 8 Day Moving Average Hilo Channel Hold
20 Day Moving Average vs Price Buy
20 - 50 Day MACD Oscillator Buy
20 Day Bollinger Bands Hold

Short Term Indicators Average: 60% - Buy
20-Day Average Volume - 284345

Medium Term Indicators
40 Day Commodity Channel Index Hold
50 Day Moving Average vs Price Buy
20 - 100 Day MACD Oscillator Buy
50 Day Parabolic Time/Price Buy

Medium Term Indicators Average: 75% - Buy
50-Day Average Volume - 231226

Long Term Indicators
60 Day Commodity Channel Index Buy
100 Day Moving Average vs Price Buy
50 - 100 Day MACD Oscillator Buy

Long Term Indicators Average: 100% - Buy
100-Day Average Volume - 239545

Overall Average: 80% - Buy





http://quotes.barchart.com/texpert.asp?sym=idev&code=BSTK

[Wallgrekk]

Bid $3.12!!

[Wallgrekk]

Kurs jetzt $3.17!

[Wallgrekk]

$3.20

[Voltaires]

@ wallgreek

Du weißt ja, das IPIC eine meiner Antiquitäten im Depot ist. Habe bis heute nur gesammelt. Nie getradet. Ende April werden wir sehen, was Sache ist. Wenns posiive news gibt, steigen vielleicht die Instis wieder ein. Und dann wirds richtig lustig. Vielleicht geht Alex Haig jr. mit Bush Sen. ja auch auf einen Osterspaziergang. Kann vielleicht nicht schaden.
So long

V.

[Wallgrekk]

eeey, Voltaires!

Gibt`s Dich auch noch??

Bin, was IPIC, oder INTERNEURON oder IDEV angeht
mal wieder super euphorisch....

Freu mich auch auf Ende April!

Long & strong....

(Das mit den Ausrufezeichen hab ich glaub immer noch nicht gelernt....)

[Wallgrekk]

Voltaires:

Von wegen Instis:

Schau mal hier rein....

http://iw.thomsonfn.com/iwatch/cgi-bin/iw_ticker?t=IDEV&rang…

[Voltaires]

@ wallgrekk

Respekt: Du hast ja ein elefantöses Gedächtnis Ausrufezeichen

So long

V.

[siam123]

[siam123]

-K: PGNT Announces License Amendment w/ Indevus [delayed]

Ridgeland, MS, APR 21, 2003 (EventX/Knobias.com via COMTEX) -- Paligent Inc (OTCBB: PGNT) filed an 8-K Friday to announce that on April 11, 2003, the Company and Indevus Pharmaceuticals, Inc. executed an Amendment to the License Agreement. In accordance with this amendment, a $500,000 milestone payment was accelerated and Indevus received an option, which is exercisable at any time prior to September 30, 2004, to acquire all of Paligent`s rights, title and interest to PRO 2000 Gel for an additional payment of $500,000.

PRO 2000 Gel is under development as a vaginal, topical microbicide designed to provide protection against human immunodeficiency virus (HIV) infection, as well as other sexually transmitted pathogens (e.g., herpes, chlamydia and gonorrhea infection).

GET KNOBIAS IN REAL-TIME: Delivery of this proprietary Knobias alert has been delayed by 20 minutes. To get all Knobias alerts in real-time daily, visit www.knobias.com/cmtx

ABOUT KNOBIAS: Knobias is a financial information provider serving retail investors and trading professionals. Knobias provides customers with COMPLETE DESKTOP SOLUTIONS, including Real-time desktop applications, Real-time news & alerts via RAiDAR and a complete fundamental database covering over 13,000 stocks.


CONTACT: Knobias.com, LLC
601-978-3399
601-978-3675
[e-mail]
www.knobias.com/cmtx

[Wallgrekk]

Schlußkurs 3.65 +9,3%

[siam123]

http://iw.thomsonfn.com/iwatch/cgi-bin/iw_ticker?ticker=IDEV…

[Wallgrekk]

Siam, guck mal:

http://quotes.barchart.com/texpert.asp?sym=idev

[siam123]

@Wallgrekk ,

sieht sehr gut aus !!!

Sag mal , was läuft da bei USXP , hat es überhaupt noch Zweck die Aktie zu halten , oder rausschmeißen???

[Wallgrekk]

Siam, das kann ich beim besten
Willen nicht beurteilen.
Ich weiß ja nicht, wieviel Du da reingesteckt
hast. Wenn es Geld ist, das bei Verlust nicht
schmerzt (bei solchen Werten sollte man auch nur
soviel reinsetzen), dann würde ich an Deiner
Stelle noch die restlichen 60 Tage oder wieviel
das auch immer noch bis zur evtl. Unterzeichnung des
$300mio. Vertrags sind, warten. Denn sollte dies geschehen,
denke ich, daß Kurse bis 0.1 durchaus realistisch sein
könnten.

Aber das musst Du wirklich selbst entscheiden

[siam123]

Wenn es Geld ist, das bei Verlust nicht schmerzt , ist sehr nett gesagt

Gruß,

siam123
Ps.: ist schon ok !

[Wallgrekk]

Schöne 20k Order zu 3.50 auf Island!

[siam123]

[Wallgrekk]

Nachbörslich auf TH???!!!!

Symbol Last Trade Change After Hours
Change** Bid Ask Order Books
IDEV 4:00pm 3.85 +0.20 +5.48% +0.27 +7.54% 3.50 3.73

[siam123]

Last: 3.570
Close: 3.580
High: 3.820
Low: 3.450
Open: 3.450

[Wallgrekk]

Press Release Source: Indevus Pharmaceuticals, Inc.


Indevus Licenses Worldwide Rights to Anti-Fungal Compound, Aminocandin, from Aventis
Wednesday April 23, 8:40 am ET


LEXINGTON, Mass.--(BUSINESS WIRE)--April 23, 2003--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced that it has licensed exclusive worldwide rights from Aventis SA (NYSE: AVE - News) to aminocandin, a member of a new class of anti-fungal compounds for the treatment of a broad spectrum of systemic, invasive infections. The Company expects that aminocandin will be ready for Phase 1 clinical testing during 2003. In exchange for these rights and for Aventis` inventory of aminocandin, Indevus will make an up-front, licensing payment to Aventis, as well as milestone payments and royalties on future sales. Under this agreement, Indevus is responsible for all development and commercialization activities for both intravenous and oral formulations of aminocandin on a worldwide basis. Aventis has agreed to manufacture the key component of aminocandin, using its proprietary fermentation technology.
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"Our acquisition of aminocandin significantly enhances the Indevus product portfolio by adding a product candidate in an exciting new class of compounds called echinocandins that have the potential to treat millions of patients who suffer from a variety of invasive, debilitating and life-threatening fungal infections," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "We see a clear need for innovative agents in this underserved, widespread therapeutic category.

"Based on highly predictive pre-clinical studies of aminocandin, we believe the profile of this compound is very competitive with other classes of anti-fungal agents and with other echinocandins," said Dr. Cooper. "We believe that Aventis has established a comprehensive pre-clinical dossier on aminocandin, and we plan to initiate our development activities with aminocandin immediately, including clinical testing with the intravenous formulation later in 2003.

"One of the exciting features of aminocandin is that we believe it represents the first echinocandin with the potential to be administered orally," said Dr. Cooper. "We plan to vigorously pursue technological solutions related to an oral formulation in parallel with an intravenous clinical program. While aminocandin is an attractive drug candidate for Indevus as an intravenous product only, the potential for an oral version is compelling. An oral echinocandin could have enormous potential as prophylactic therapy for immunocompromised patients at risk for serious fungal infection and to extend the long-term therapy of infected patients upon discharge from the hospital."

Echinocandins are the first new class of anti-fungal agents to be developed and introduced in more than 40 years. They are designed to be fungicidal, that is, to destroy fungi, rather than simply to inhibit their growth, and to have broad-spectrum activity against the fungi that cause serious systemic infections.

According to reports from Datamonitor, Inc., an industry market research firm, the worldwide market for anti-fungal agents is currently valued in excess of $4 billion, of which approximately $2.5 billion relates to systemic, invasive fungal infections, and is projected to grow to $6.5 billion by 2008, of which approximately one-half is predicted to represent systemic infections.

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of EUR 17.6 billion, invested EUR 3.1 billion in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com

Indevus Pharmaceuticals is engaged in the development and commercialization of a portfolio of products and product candidates, including multiple compounds in late-stage clinical development. The Company`s core products under development include trospium for overactive bladder, pagoclone for panic/anxiety disorders, citicoline for ischemic stroke, IP 751 for pain and inflammation, and PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens.

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: uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly trospium; the early stage of products under development; need for additional funds and corporate partners, including for the commercialization of trospium and the development of pagoclone and citicoline; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; dependence on third parties for manufacturing and marketing; competition; risks associated with contractual arrangements; limited patent and proprietary rights; and other risks.

Indevus does not review or control the content of any third party websites referred to herein. Any reference to any third party website herein does not constitute an endorsement by Indevus of the content thereof.



--------------------------------------------------------------------------------
Contact:
Indevus Pharmaceuticals, Inc.
Michael W. Rogers, 781/861-8444
or
William B. Boni, 781/402-3410

[Voltaires]

So langsam aber sicher wird IPIC (o.k. ab jetzt sag ich IDEV) erwachsen. Und außerdem: Ein Einbeiniger fällt leichter als ein Tausendfüssler.

Ich glaub, ich bleib noch ein Weilchen long mit IDEV.

So long.

V.

[siam123]

http://iw.thomsonfn.com/iwatch/cgi-bin/iw_ticker?ticker=IDEV…

[Voltaires]

Na, dann schaun mer mal, was heute abgeht ...

Phase III Data on Trospium for Overactive Bladder Presented at American Urological Association
Monday April 28, 7:26 am ET

CHICAGO AND LEXINGTON, Mass.--(BUSINESS WIRE)--April 28, 2003--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced that new data were presented at the American Urological Association (AUA) annual meeting from the Company`s recently completed Phase III clinical trial with trospium for overactive bladder (OAB).

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The data showed that trospium met the dual, pre-specified clinical trial endpoints of reduction in frequency of urination (toilet voids) and reduction in number of urge incontinent episodes. Treatment with trospium also reduced the severity of urgency, a defining symptom of OAB, and was well tolerated.

"The advent of new treatments is re-focusing the medical community on pharmacotherapy as a way to address the growing prevalence of overactive bladder," said Norman Zinner, M.D., associate professor of urology at the University of California, Los Angeles (UCLA) and lead investigator on this trial. "The gold standard in treating OAB is the use of antimuscarinic agents, and while use of these agents has been shown effective to varying degrees, their lack of tolerability, related primarily to dry mouth, and their slow onset of action have resulted in relatively low compliance and regular switching among agents to find an optimal combination of efficacy and safety for individual patients.

"The efficacy, tolerability and early onset of action observed with trospium, combined with certain structural and metabolic properties of the drug, help define a differentiated profile for trospium among this class of compound," said Dr. Zinner. "By meeting the clinical and statistical challenge posed by the dual endpoints of this trial, and by demonstrating improvement across the board in multiple, complementary parameters, trospium offers significant promise in treating an important and increasingly widespread condition."

Study design

The randomized, double-blind, placebo-controlled trial conducted by Indevus is believed to be the first study in the OAB category to pre-specify and to achieve dual primary endpoints, comparing the reduction in the frequency of urination and the reduction in urge urinary incontinence episodes among drug-treated patients versus placebo patients. The 12-week trial measured the effects of 20 milligrams of trospium chloride versus placebo, twice daily, on symptoms of OAB. The trial included 523 patients, 262 treated with trospium and 261 treated with placebo, at 51 clinical sites in the U.S.

Patient entry criteria included urinary frequency of ten or more toilet voids per day, symptoms of OAB (including urgency) lasting at least six months, and an average of one or more incontinence episodes per day. Patients were excluded if the major reason for their urinary frequency or urine loss was stress incontinence. The average age of patients in both the trospium and placebo groups was 62 years, and women comprised 71 percent of the trospium group and 78 percent of the placebo group. More than 400 of these patients are participating in an ongoing nine-month open label extension of the study.

Study findings

Patients treated with trospium experienced statistically significantly fewer toilet voids per day at the end of the 12-week trial than did patients on placebo. The improvement (decrease) in number of toilet voids for the trospium group compared with the placebo group was observed at each measurement date during the trial (weeks 1, 4 and 12). At week 12, trospium patients had 2.37 (p (less than) 0.0001) fewer toilet voids per day, compared to baseline, and placebo patients had 1.29 fewer toilet voids per day compared to baseline.

Trospium patients also experienced statistically significantly fewer episodes of urge urinary incontinence per day at the end of the 12-week trial than did placebo patients. This improvement (decrease) in incontinence episodes for the trospium group was observed beginning at week 1 and continued throughout the study. Trospium patients had 59 percent (p (less than)0.0001) fewer incontinence episodes per day at the end of the study, compared to baseline, and placebo patients had 44 percent fewer incontinence episodes at the end of the study, compared to baseline.

Trospium patients increased their volume voided per void beginning at week 1 and continuing through week 12 (p (less than) 0.0001), with an increase of 32.1 milliliters (mL) at week 12, compared to an increase of 7.7 mL in placebo patients. Treatment with trospium also led to a significant improvement (decrease) in average urgency severity, another key symptom of OAB, beginning at week 1 and continuing through week 12 (p=0.0001). These findings are consistent with the expected pharmacodynamic effects of trospium and the increase of maximum bladder capacity caused by anticholinergic relaxation of the detrusor muscle.

Trospium was well tolerated as evidenced by its adverse event profile that included the most common adverse events associated with the antimuscarinic class of drugs, dry mouth and constipation. The incidence of dry mouth observed in trospium patients was 21.8 percent, while constipation was observed in 9.5 percent of these patients.

Background

Trospium belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.

Trospium possesses a quarternary ammonium structure. In animal studies, the compound does not appear to cross the blood-brain barrier. At therapeutic concentrations in vitro, trospium does not interact with drugs metabolized by the Cytochrome P-450 system, a metabolic pathway commonly associated with drug-drug interactions, and it is excreted largely unchanged in the urine.

Trospium has been extensively studied and is currently marketed as a prescription drug product in Europe, where it is one of the leading products for overactive bladder and urinary incontinence. Indevus licensed exclusive U.S. rights to trospium from Madaus AG, a German pharmaceutical company, in late 1999. As part of its ongoing development program, the Company is conducting additional clinical trials in the U.S. to explore further certain attributes of trospium. Indevus is continuing to evaluate a broad range of commercialization opportunities for trospium in the U.S. These include a strategic corporate partnership that would help maximize the potential of trospium in the OAB market.

The American Foundation of Urologic Disorders estimates that more than 17 million Americans, 85 percent of whom are women, suffer from OAB in the U.S. OAB is defined as urge incontinence, urgency and frequency of urination and is the leading cause of nursing home admissions, with an estimated 50 percent of nursing home residents suffering from this condition.

In 2002, the market for drugs to treat OAB was approximately $1 billion and growing at over 30 percent annually, according to IMS data. Independent consultants Wood Mackenzie forecast sales of OAB medicines to grow at a compound annual rate of 22.5 percent this decade. The current OAB market is defined by patients who are highly dissatisfied, with over 70 percent of patients discontinuing therapy after six months, according to data from NDC Healthcare.

Indevus Pharmaceuticals is engaged in the development and commercialization of a portfolio of products and product candidates, including multiple compounds in late-stage clinical development. The Company`s core products under development include trospium for overactive bladder, pagoclone for panic/anxiety disorders, citicoline for stroke, IP 751 for pain and inflammation, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, and aminocandin for systemic, invasive 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: uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly trospium; the early stage of products under development; need for additional funds and corporate partners, including for the commercialization of trospium and the development of pagoclone and citicoline; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; dependence on third parties for manufacturing and marketing; competition; risks associated with contractual arrangements; limited patent and proprietary rights; and other risks.
Contact:

Indevus Pharmaceuticals, Inc.
Michael W. Rogers, 781/861-8444
William B. Boni, 781/402-3410


Source: Indevus Pharmaceuticals, Inc.

[Voltaires]

Mensch Wallkreek, verpaßt Du etwa das Beste?
Übrigens: Das Folgende fand ich gerade im Yahoo-Board von IDEV. Dem ist übrigens nichts hinzuzufügen:


"... will make every effort to control/manipulate the price action today. You may even see the stock take a hit during the day but eventually it will continue to trend upward. Remember this is just the beginning of good news...the real news, partnership and approval will follow. And let`s not forget the other products which have been quiet for some time. I think we`ve got a winner here. Life is good and going to get better! Okay enough hype let the games begin... "

[Wallgrekk]

Voltaires, wie könnte ich so etwas
verpassen....

[Wallgrekk]

4.05/4.14 vorbörslich....

[Wallgrekk]

4.15/4.22

[stoss]

Hallo


kann die Meldung jemand übersetzen

Danke

[Voltaires]

Am Freitag vor Börseneröffnung (wie immer) sollen die Zahlen fürs 2. Quartal kommen. Quelle knobias.com
Vielleicht gibts dann ja was Neues von der Partnerfront.

So long.

V.

[Michelsen]

Indevus in USA am Freitag 4,11 $
In Frankfurt heute 3,41 € ???


Mi

[Voltaires]

@ Michelsen
Lustig, gell? Jetzt schon bei 4,37 und der Kurssetzer schläft in FaM immer noch. Oder ist der Euro schon bei 1,26? Immer dasselbe ...

So long.
V.

[Voltaires]

upps!!!
habe ihn wohl gerade geweckt.

[Wallgrekk]

Es läuft sehr gut, wir sind
jetzt auch charttechnisch an eine
wichtige Marke gekommen.

Ich denke wir könnten innerhalb der nächsten
2-3 Wochen in Richtung 6 Dollar laufen...

[Wallgrekk]

Die $4.5 ist doch recht
hartnäckig!



Heute gab`s einen fetten Blocktrade über 175k!

Long & strong weiterhin!

[Voltaires]

@ Wallgrekk

... und schwupp ham wir rüberjemacht!
Nur blöd, dass die Performance wegen des $ bei uns in Euroland nicht so üppig ausfällt.

So long. So good.
V.

[Voltaires]

Nochmal schwupp ...
über 5$. So kann´s weitergehn.

So long
V.

[Wallgrekk]

Wenn das so weitergeht, müsste
ich ziemlich bald einen Verdoppler
haben...
(zu €2.85/88 eingekauft!)

Sauber!!

[Wallgrekk]

Allerdings bei Chartbetrachtung
liegt rund um die $6 Marke ein Widerstand.

Ob der geknackt wird ohne bedeutsame News -
ich glaub`s erstmal nicht...
bleibe aber weiterhin bullish!

[Voltaires]

@ wallgrekk

Allerdings bei Chartbetrachtung
lag rund um die $6 Marke ein Widerstand.

Wenn von der FDA in puncto Trospium und aus der Forschung zu PRO 2000 gute news kommen, dann ...

Hoffe, Du bist so long wie ich.
So long.
V.

[Voltaires]

Ein interessanter Beitrag zur Zeitschiene NDA in bezug auf Trospium gibts hier

ttp://messages.yahoo.com/bbs?.mm=FN&action=m&board=7076959&tid=ipic&sid=7076959&mid=35547

So long.
V.

[Wallgrekk]

Hi Voltaires!

Weiterhin long zu € 2.85!

[Harry_Blhlafonte]

Interessante aktie.

[Voltaires]

Der "Schmierstoff" Pro 2000 geht in Phase II. Auch nicht schlecht, auch wenn der Kurs keine Freudensprünge macht.
Quelle:
http://biz.yahoo.com/bw/030619/195257_1.html
Wenn Pro 2000 freigegeben werden würde (so ca. 2006 schätze ich), dann sehen wir uns locker im 3-stelligen Bereich.

So long.
V.

[grast]

schöne grüße an alle idev longs.
die von 1 auf 6,40 dollar dabei sind.

hab schon mal ein viertel glattgestellt.
(pago gebranntes kind)

viel glück

[Voltaires]

So, weiter geht´s ...

FDA Accepts for Review New Drug Application for Trospium Submitted by Indevus
Monday June 30, 8:27 am ET

LEXINGTON, Mass.--(BUSINESS WIRE)--June 30, 2003--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company`s New Drug Application (NDA) for trospium for the treatment of overactive bladder (OAB). The NDA was submitted to the FDA by the Company on April 28, 2003.

The NDA for trospium includes the results of 32 clinical studies involving over 2,700 subjects and patients, including 12 double-blind, placebo- or active-controlled studies, 12 clinical pharmacology and pharmacokinetic studies and 8 uncontrolled studies.

Trospium belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.

So long.
V.

[Tadschik]

Indevus - kursziel laut Taipan 9 US$

jetzt wirds interessant..was die charttechnik anzeigt..

[grast]

neuen???
dann sind die erst 422 mille wert.
so viel setzen die (hoffentlich) bald allein im quartal mit trospium um.
kopfschüttel...
naj,jetzt kommt erst mal cash in die tresore
und denn wern mer mal weitersehn,nich

[aut_uno]

Wo gibt es Infos zu INDEVUS PHA.
Steht was an?
Gute Performance heute, wer kann mir mitteilen weshalb.
Habe Indevus in meiner Watchlist, welche Infos sprechen für einen Kauf?

Thanks a lot for information ,

aut_uno

[grast]

www.biospace.com
finance yahoo
was ansteht?die zulassung v trospium in usa.
fett cash in die tresore.und mal sehen ob neue testreihen gestartet werden.oder ne sales force?
den rest must du selber entscheiden.do your own research.
marktkap. 270 mille
aktuell.der ganz große wurf ist kurzfristig nicht mehr drin.
viell ne verdopplung.

[BrauchGeld]

Hi

Warum bewegt sich die Aktie nicht,bei den aussichten ?Ein paar Produkte in der Endphase und eins kurz vor der Zulassung.
Apropo Zulassung weiß jemand wann ein Termin ansteht bezüglich Trospium ?

Grüsse
M.B.

[Voltaires]

@ brauch geld

Termin für Trospium: Wohl irgendwann im 1. Quartal 04.
Viel wichtiger: Vermarktungspartner für Trospium (oder Aufkäufer für IDEV. Und dazu wird Entwscheidung wohl noch in 03 erwartet. Termine aber reine Spekulation. Doch bei IDEV kommen die Dinge oft unverhofft. Gute wie leider auch schlechte (siehe Redux).

Aber wie auch immer: Gut Ding will Weile haben. Ich würd dabei bleiben. Denn wenn was kommt, dann richtig!

So long.

V.

[Voltaires]

nur mal so zwischendurch:

IDEV in NASDAQ BIOTEC INDEX effective 11-24-03

habe ich aus dem Yahoo-Board.

So long.
V.

[Voltaires]

Jetzt ist es auch amtlich:
Indevus Added To NASDAQ Biotechnology Index
Friday November 14, 8:56 am ET

LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 14, 2003--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI - News) effective Monday, November 24, 2003.

So long.
V.

[grast]

schöne 250 000 stk order an der nasdaq eben...
und soo schöön grüüün....
idev longs hier?
gruß,grast

[Voltaires]

Heute bei Yahoo gefunden. Könnte interessant sein, wegen des Gels Pro 2000 von IDEV.Ansonsten bleibt nur noch zu summen: "IDEV – wann kommst Du ..."



Gels können gegen HIV schützen

London (pte) - Millionen Menschen weltweit könnten sich bald mit einem einfachen Gel oder einer Creme gegen HIV schützen. Experten berichten von rund 60 in Entwicklung befindlichen Mikrobioziden. 14 sind derzeit Gegenstand klinischer Tests. Gels oder Cremen werden innerlich angewendet und sollen das Virus am Eindringen in den Körper hindern. Im Vorfeld einer von 28. bis 31. März stattfindenden Konferenz http://www.microbicides2004.org.uk erscheint es denkbar, dass diese Gels den Kampf gegen HIV grundlegend verändern werden. Das Medical Research Council http://www.mrc.ac.uk und das Imperial College London http://www.imperial.ac.uk werden laut BBC http://www.bbc.co.uk demnächst abschließende Tests mit zwei potenziellen Mikrobioziden starten. Insgesamt sollen 12.000 Frauen in Südafrika, Sambia, Tansania, Uganda und Kamerun an der dreijährigen Studie teilnehmen. Bei einem entsprechenden Verlauf der Tests könnten diese Mikrobiozide noch vor Ende dieses Jahrzehnts auf den Markt kommen. Rund 40 Mio. Menschen weltweit sind HIV positiv. Viele der Betroffenen wurden angesteckt, weil keine Möglichkeit des Schutzes bestand. So können Frauen vor allem in Entwicklungsländern ihre Partner nicht dazu überreden, Kondome zu benutzen. Gels oder Cremen ermöglichten einen einfachen Schutz gegen Ansteckung. Experten gehen davon aus, dass auch ein teilweiser Schutz durch Mikrobiozide bereits Millionen neuer Infektionen verhindern könnte. Mikrobiozide töten das Virus entweder bevor es in den Körper gelangt, verhindern seine Verankerung im Körper oder schaffen eine Barriere, die das Eindringen in den Körper verhindert.

So long
V.

[Almeida]

Reuters

Indevus, Pliva seal Sanctura marketing agreement Wednesday April 7, 3:03 am ET


NEW YORK, April 7 (Reuters) - Indevus Pharmaceuticals (NasdaqNM:IDEV - News) said on Wednesday it had signed a co-promotion and licensing agreement with Pliva dd (PLV.ZA) for the U.S. marketing of an overactive bladder treatment.
Tropsium chloride, whose brand name is Sanctura, is currently under review by the U.S. Food and Drug Administration (News - Websites) .

Under the agreement, Pliva will pay Indevus $30 million upon signing and $120 million upon approval of the drug by the FDA.

In addition, Indevus could receive up to $45 million in future payments contingent upon certain milestones related to the development of a once-a-day formulation of Sanctura, as well as a payment of $20 million related to a long-term commercialisation milestone in 2013.

For at least six months following the approval of Sanctura, Indevus will receive a commission based on net sales, a portion of which will pay for its own sales force and marketing costs.

The two companies will promote the drug through a joint sales force of approximately 500 representatives.

[Almeida]

10:34am 04/07/04

Indevus Pharma climbs on marketing pact with Pliva (IDEV)

By Mark Cotton

NEW YORK (CBS.MW)-- Shares of Indevus Pharmaceuticals (IDEV) climbed 7.3 percent to $6.49 after announcing a promotion and licensing agreement with Pliva, via its subsidiary Odyssey Pharmaceuticals, to commercialize Sanctura, a treatment for overactive bladder, currently under review by the U.S. Food and Drug Administration. Under the terms of the agreement, Indevus will receive $30 million from Pliva upon signing and a further $120 million once Sanctura is approved by the FDA. Indevus said it may receive up to an additional $45 million in future payments dependent on the achievement of certain milestones related to the development of a once-a-day formulation of Sanctura, as well as a payment of $20 million related to the achievement of a long-term commercialization target of 2013. In addition, Indevus will receive a commission based on net sales of Sanctura for at least six months following the approval of Sanctura, a portion of which will fund its own sales force and certain advertising and promotional costs.

[Almeida]

April 07, 2004 10:42 AM US Eastern Timezone

PLIVA Signs Deal for Exclusive US Rights to SANCTURA

ZAGREB, Croatia--(BUSINESS WIRE)--April 7, 2004--PLIVA d.d. ("PLIVA") announced today a significant step in the strategic expansion of its US proprietary business through the signing of an exclusive license and commercialisation agreement between its specialty branded subsidiary, Odyssey Pharmaceuticals, Inc., and Indevus Pharmaceuticals, Inc. for the co-promotion of SANCTURA(TM) (trospium chloride) in the US. SANCTURA is currently under late stage review by the US Food and Drug Administration for the treatment of overactive bladder (OAB) and will compete in an estimated USD 1.1bn US market (IMS Jan 2004).


PLIVA will make an upfront payment of USD 30m upon signing the agreement and a milestone payment of USD 120m following FDA approval of the product, anticipated in mid-2004. The agreement also entitles Indevus to receive sales commission or royalty payments based on net sales. Other potential payments to Indevus are USD 45m, contingent upon the successful development of an extended release, once-a-day formulation, to which PLIVA will have exclusive rights in the US, and USD 20m tied to the achievement of a long-term commercialisation milestone in 2013. The once-a-day formulation is currently under development by Shire Pharmaceuticals, which will be funded by Indevus. PLIVA and Indevus will co-promote SANCTURA with a joint sales force of between 400 and 500 sales representatives who will target urologists and high prescribing primary care physicians for the OAB market.

Zeljko Covic, President of the PLIVA Management Board and Chief Executive Officer, commented: "We are very excited about the addition of SANCTURA to our portfolio as it represents an excellent strategic fit with PLIVA`s existing urological franchise and capabilities. It is a very significant addition to our specialty branded business and will further strengthen the US market position, while providing a platform for ongoing development of a sustainable, long-term proprietary business. In the US the OAB market is comprised of about 34 million individuals, of whom less than 20% are being treated due to the low levels of patient and prescriber satisfaction with existing treatments. We believe SANCTURA will address many of these unmet needs and that it thus has significant potential within an attractive and fast growing marketplace."

SANCTURA, which has been extensively studied and marketed in Europe for many years, complements the existing Odyssey portfolio, sales force capabilities and proprietary focus. This transaction allows PLIVA to build upon this existing strong business, which will increasingly focus on high value products within the urological, respiratory and metabolic disorders therapeutic areas. Complemented by the existing high potential generics business, the growing proprietary business will also help fund the continued development of PLIVA`s most promising proprietary research projects. PLIVA plans to enhance transparency strategy by implementing a dual reporting system for both the generics and proprietary businesses in 2005.

Glenn L. Cooper, M.D. Chairman, President and Chief Executive Officer of Indevus added: "We are enthusiastic about our agreement with PLIVA, as it reflects a mutual recognition of the potential of SANCTURA and provides significant benefit for both companies. We believe SANCTURA will have an important place in the large and expanding US market for overactive bladder and are very excited to have PLIVA as a partner in the commercialisation of SANCTURA."

About SANCTURA: Currently under development in the US, SANCTURA belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.

About the market: OAB is defined as urge incontinence, urgency and frequency of micturition. Approximately 34 million Americans, suffer from bladder control problems, which can lead to urinary incontinence. Datamonitor estimates this market will grow by about 20% per year reaching approximately USD 3bn by 2008.

About PLIVA: With more than 80 years of experience in the pharmaceuticals arena, PLIVA has successfully transformed itself into a multinational corporation, with operations in CEE, the US and Western Europe. The company`s vision is to be a research driven, fully integrated global pharmaceutical company dedicated to providing innovative products for a better quality of life. PLIVA is currently the largest CEE headquartered pharmaceutical company by sales, whose most prominent discovery is the blockbuster antibiotic azithromycin, sold under the trademarks of Zithromax and Sumamed.

About Odyssey: Odyssey Pharmaceuticals was established by PLIVA in 2000, and is devoted solely to the supply and marketing of brand-name pharmaceuticals. Odyssey launched its first branded product, Urecholine(R) (bethanechol chloride tablets, USP), in April 2000, which was followed by the introduction of Nystatin Vaginal Tablets. Odyssey acquired the trademark for Vivactil(R) (protriptyline HCl tablets, USP) from Merck, and the NDA and trademarks for Antabuse(R) (disulfiram tablets, USP) and Surmontil(R) (trimipramine maleate) from American Home Products, Inc.

About Indevus: Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialisation of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in development: SANCTURA for overactive bladder, pagoclone for panic and generalized anxiety disorders, citicoline for ischemic stroke, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens and aminocandin for systemic fungal infections.

[Almeida]

Hier nun auch eine deutschsprachige Kurzfassung:

Pliva vereinbart Sanctura-Lizenzabkommen mit Indevus

Das kroatische Pharma-Unternehmen Pliva D.D. vereinbarte mit Indevus Pharmaceuticals ein US-Lizenzabkommen für Sanctura (Tropsium chloride), ein Medikament zur Behandlung von Patienten mit überaktiven Blasen. Derzeit prüft die FDA eine Zulassung des Produkts.

Im Rahmen des Abkommens erhält Indevus eine Vorabzahlung von 30 Mio. Dollar und weitere 120 Mio. Dollar bei erfolgreicher US-Zulassung des Arzneimittels. Zudem kann Indevus Meilensteinzahlungen in Höhe von bis zu 65 Mio. Dollar und erhalten. Für mindestens sechs Monate erhält Indevus eine umsatzabhängige Kommission.

© finanzen.net

*******

Der Deal ist allerdings sehr umstritten, wie man auch an dem Nasdaq-Kursverlauf gestern sieht.

Für englischsprachige Interessenten: Bei Yahoo Finance gibt es ein sehr gut informiertes Diskussionsboard zu IDEV.

[Voltaires]

Tja,

hätte mir auch einen etwas klangvolleren Markennamen als Coop-Partner gewünscht. Aber wenn ich es richtig verstehe, haben beide Seiten ein 6-monatiges Rücktrittsrecht. Vielleicht spielt IDEV mit dieser Vereinbarung nur auf Zeit, bis ein anderer Partner gefunden wurde (oder die Fa. geschluckt wird). Andererseits: ca. 200 Mio. sind ja auch nicht von Pappe. Aber muss das gerade so ein kroatischer Noname (hab ich noch nie was von gehört, ihr vielleicht) sein?

So long.
V.

[Almeida]

Ein guter Beitrag aus dem Motley Fool Biotechnology Discussion Board:

Indevus` Big Score (Maybe)

By Charly Travers
April 8, 2004

Yesterday, small biotech Indevus Pharmaceuticals (Nasdaq: IDEV) announced that it has reached an agreement with the European pharmaceutical company PLIVA to market Indevus` drug Sanctura (Trospium). The deal is especially noteworthy because PLIVA is paying Indevus $30 million now and another $120 million if the Food and Drug Administration (FDA) approves the drug next month.


The cash payments totaling $150 million are a huge amount for Indevus, a company with a market cap just under $300 million. Given the magnitude of this potential payment compared to the company`s market cap, it is interesting that the stock price has barely budged compared to the $6.05 closing price the day before the deal was announced.


The FDA decision on Sanctura can be expected right around May 28. That is the Prescription Drug User Fee Act action date by which the FDA should choose whether or not to approve the drug. This can almost be viewed as make or break for Indevus, at least with respect to the company`s near-term fortunes. The other drugs in its pipeline are years from commercialization. Therefore, an extreme price move on this decision is probably to be expected.


If the FDA signs off on Sanctura, Indevus would pocket another $120 million and would have an approved drug that should be pretty competitive in the overactive bladder market despite competition from companies like Pfizer (NYSE: PFE). Under that scenario, I think we could expect the stock to take off from its current level. On the other hand, if the FDA turns the drug down or asks for additional data, then a standard biotech stock nosedive is probably to be expected. In this situation the magnitude of the decline would depend upon the ability to address the FDA`s concerns in a timely manner.


Sanctura has points in its favor. It has been on the market in Europe for years; unlike some of the approved drugs in this segment, it does not cross the blood-brain barrier; and clinical data suggest that it has a lower incidence of dry mouth than the competitors. That said, guessing what the FDA will do can be playing with fire, and in this case, it looks like the market is being cautious.


Fool contributor Charly Travers does not own shares of Indevus.

*****

@ Voltaires

PLIVA ist nur für uns ein Noname - aber eben auch für die Amerikaner. U.a. daher wohl der gestrige merkwürdige Kursverlauf, der die Indevus-Freunde vom Yahoo-Board schier zur Verzweiflung gebracht hat.

PLIVA ist offenbar ein relativ großes Pharma-Unternehmen mit Sitz in Kroatien, bisher mit Vertriebstätigkeit überwiegend im Ostblock, aber auch schon im Westen.

Die Wahl dieses Partners, der Indevus für die Vertriebsrechte wahrlich eine Menge Geld zahlt, ist auch eine Globalisierungsfolge, nur anders herum, als wir es bisher gewohnt sind.

Hier der Link zur Pliva Homepage:

http://www.zse.hr/listed1/plva-r-a.html

[Almeida]

Hier noch ein guter Beitrag aus dem Yahoo-Board von einem User, der am Conference Call gestern teilgenommen hat, zur Frage, warum PLIVA als Vertriebspartner gewählt wurde:

CC NOTES
by: zurdoc1 04/08/04 10:55 am
Msg: 51069 of 51139

WHY PLIVA WAS CHOSEN AS A PARTNER:

Criteria used for chosing a partner included 1)maximizing market potential, 2)someone who IDEV could works side-by-side with and make a meaningful contribution for Sanctura, and 3)financial package.

Pliva fit the bill for fulfilling the first portion of the criteria. Sanctura will be Pliva’s most important US product. The major pharmas that IDEV spoke with in the partnering process would not give IDEV confidence than Sanctura would be one of their more important drugs. Because Sanctura is Pliva’s most important product in the US, Pliva’s sales force will be pushing Sanctura as strong as IDEV’s. Both will be targeting the docs who write the most prescriptions for oab (urologists, ob/gyn and some primary care). Pliva has one other urology drug they market here in the US, urocholine, which is for urinary outflow obstruction. So they have some presence in the urology field already. They also market trospium in the Scandinavian countries, so they are familiar with the drug already.

Secondly, IDEV will remain at the table for the marketing process of Sanctura. IDEV will have their own sales force who will work in combination with Pliva’s sales force for marketing Sanctura. IDEV’s sales force will number ~280 strong with the balance of the 500 total coming from Pliva. They will target the

Lastly, Pliva is giving generous upfront money for Sanctura. Although a portion is earmarked for development and marketing costs for Sanctura, a large portion will be for general corporate use. Meaning trials for IP-571, pagoclone, aminocandin, etc. can now go forward without further delay. The pipeline got a serious boost with the cash.

[Almeida]

Hier der Link zur Vertriebsfirma für "Sanctura" (US-Tochter von PLIVA):

http://www.odysseypharm.com/

[Almeida]

Hier noch ein interessanter Artikel zum neuen Deal:

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher…

[Almeida]

Hier ein kurzes Follow-Up:

1) Wer am 8.April kaufte, liegt jetzt gut 20 % im Plus.

2) Ein Nachkauf bei ca. 8 $ (Nasdaq) hat ein sehr gutes Chance-Risiko-Verhältnis, da von einer Zulassung (FDA-Approval) von Trospium ("Sanctura") in den USA im Laufe des kommenden Monats auszugehen ist. Dann werden weitere 120 Mill. $ Cash für Indevus fällig (Upfront-Payment von Pliva). Der Kurs wird in diesem Fall am Yahoo-Board von den langjährigen Indevus-Spezialisten bei 10-12 $ gesehen.

3) Sanctura wird schon jetzt von Indevus in der amerikanischen Fachpresse (z.B. Urology Times) intensiv beworben.

4) Eine persönliche Recherche von mir in zwei großen Berliner Apotheken ergab gestern: Der Wirkstoff Trospiumchlorid ist hier absolut das Mittel der Wahl bei Harninkontinenz im Sinne einer "Overactive Bladder" (OAB; Blasenschwäche). Wird sehr häufig verschrieben.

5) Der Markt für Medikamente gegen OAB in den Vereinigten Staaten wird allgemein bei derzeit ca. 1 Mrd. § jährlich (!) gesehen. Bereits bei einem Marktanteil von 10 - 20 % für Sanctura werden alle Beteiligten sehr gut verdienen (andernfalls würde Pliva auch nicht 150 Mill. $ für die Vertriebsrechte zahlen).

6) Nach einer Zulassung besitzt Indevus fünf Jahre lang ein Schutzrecht in den USA, das sich nach Entwicklung einer Variante, die nur einmal täglich eingenommen werden muß, auf 17 Jahre verlängert. Mit dieser Entwicklung hat Indevus Shire Pharm. beauftragt.

Gruß, Almeida

[Almeida]

Nachtrag zu Punkt 5)

Urology. 2004 Mar;63(3):461-5. Related Articles, Links

Costs of urinary incontinence and overactive bladder in the United States: a comparative study.

Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T.

Department of Health Economics, University of California, Berkeley, School of Public Health, Berkeley, California 94720, USA.

OBJECTIVES: To update the cost of urinary incontinence (UI) for year 2000 and compare it with the cost of overactive bladder (OAB). METHODS: Using the cost-of-illness framework, disease epidemiologic data were combined with treatment rates, consequence probabilities, and average cost estimates. All costs reflect the costs during 2000. RESULTS: The total cost of UI and OAB was 19.5 billion dollars and 12.6 billion dollars, respectively (year 2000 dollars). With UI, 14.2 billion dollars was borne by community residents and 5.3 billion dollars by institutional residents. With OAB, 9.1 and 3.5 billion dollars, respectively, was incurred by community and institutional residents. CONCLUSIONS: OAB affected 34 million individuals compared with 17 million with UI. Despite the differences in epidemiology, the total and per-person costs of UI were higher than the OAB costs because OAB individuals without incontinent episodes incurred fewer costs, on average.

[Wallgrekk]

Press Release Source: Indevus Pharmaceuticals, Inc.


Indevus Pharmaceuticals Announces Second Quarter Fiscal 2004 Results
Tuesday May 11, 8:02 am ET
Investor Conference Call Planned for May 11, 2004, 9:00 A.M. Eastern Time


LEXINGTON, Mass.--(BUSINESS WIRE)--May 11, 2004--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced its consolidated results of operations for the three and six-month periods ended March 31, 2004.
ADVERTISEMENT


The Company reported a net loss of $11,370,000 or $0.24 per share diluted, for the three-month period ended March 31, 2004, compared to a net loss of $2,966,000, or $0.06 per share diluted, for the three-month period ended March 31, 2003. For the six-month period ended March 31, 2004, the Company reported a net loss of $23,394,000 or $0.49 per share diluted, compared with a net loss of $8,397,000, or $0.18 per share diluted, for the six-month period ended March 31, 2003. These increased net losses are primarily the result of continuing development and pre-marketing activities related to SANCTURA(TM) (trospium chloride) for overactive bladder.

At March 31, 2004, the Company had cash, cash equivalents and marketable securities totaling approximately $57,636,000. Upon signing a commercialization agreement on April 7, 2004 with PLIVA d.d. for the U.S. commercialization of SANCTURA, Indevus received a payment of $30 million from PLIVA.

The Company will hold an investor conference call on Tuesday, May 11, 2004, beginning at 9:00 A.M. eastern time. Details follow below.

Product Development Update

"Our most important recent development was the co-promotion and licensing agreement we signed with PLIVA d.d. for the U.S. commercialization of SANCTURA, which is under review by the U.S. Food and Drug Administration (FDA) as a treatment for overactive bladder," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus.

"We are enthusiastic about our agreement with PLIVA, as it reflects a mutual recognition of the potential of SANCTURA and provides significant benefit for both companies," said Dr. Cooper. "For Indevus, it is a transformational event, establishing the foundation for both near and longer term generation of product revenue. Furthermore, an integrated sales and marketing function, as provided for in the agreement, will enhance our ability to acquire additional late-stage or marketed products.

"We believe SANCTURA will have an important place in the large and expanding U.S. market for overactive bladder, and we are pursuing pre-commercialization and market preparation activities for the product," said Dr. Cooper. "We are also working with the FDA to help complete the regulatory review process in a timely fashion to allow for product launch as soon as possible. As a result of the recent submission of additional data related to SANCTURA, we received a letter from the FDA on February 12, 2004, establishing a 90-day extension to the original Prescription Drug User Fee Act (PDUFA) action date of February 27, 2004, moving that date to May 28, 2004.

"We are very excited to have PLIVA as a partner in the commercialization of SANCTURA," said Dr. Cooper. "The commitment of PLIVA under this partnership reflects their analysis of the prospects for SANCTURA and their strong focus on its market success. We also highly value PLIVA`s considerable expertise in urology, a critical factor in positioning the product in the U.S. overactive bladder market. Finally, we recognize the importance of SANCTURA in PLIVA`s plans to move forward with its expansion in the U.S."

"During the second quarter, we also initiated a Phase I clinical trial with aminocandin, a member of a new class of anti-fungal compounds called echinocandins under development for the treatment of a broad spectrum of systemic, invasive infections," said Dr. Cooper. "This trial will test the safety and tolerability of escalating single doses of aminocandin administered intravenously in healthy volunteers. Results of the trial are expected in the second half of 2004.

"This trial will build upon an extensive pre-clinical dossier on aminocandin compiled by Aventis SA, from whom Indevus licensed exclusive worldwide rights to this compound in 2003," said Dr. Cooper. "In vitro and animal studies with aminocandin have demonstrated activity against a broad range of fungi and the ability to protect against systemic fungal infections in an immune-compromised host. We also believe aminocandin has the potential to be administered orally, and we have initiated feasibility studies related to the development of an oral formulation.

"We also plan to initiate a Phase III trial with pagoclone for generalized anxiety disorder in the second half of 2004," said Dr. Cooper. "Simultaneously, we are proceeding with discussions related to new worldwide development and commercialization partnerships for this compound.

"We are also completing the scale-up of manufacturing in anticipation of beginning a multi-dose Phase I trial with IP 751, a non-psychoactive synthetic derivative of tetrahydrocannabinol, in the second half of 2004," said Dr. Cooper. "IP 751, under development to treat pain and inflammatory disorders, appears to suppress the key inflammatory cytokines which are implicated in such disorders.

"Clinical development of PRO 2000, our microbicide designed to prevent the sexual transmission of the human immunodeficiency virus (HIV) that causes AIDS, is continuing with ongoing enrollment in a Phase II clinical trial sponsored by Imperial College in London and the European Commission," said Dr. Cooper. "Additional Phase II / III clinical trials sponsored by the National Institutes of Health and the Medical Research Council are planned for initiation late this year and next.

"Finally, we are pursuing additional in-licensing opportunities to expand our product pipeline," said Dr. Cooper. "With a presence in urologists` offices through our new sales and marketing force, we will certainly be seeking products in the field of urology, although we will continue to seek attractive late-stage product opportunities in multiple therapeutic areas."

Indevus - PLIVA Agreement

The agreement between Indevus and PLIVA provides for payments to Indevus from PLIVA that include $30 million received upon signing and $120 million due no later than FDA approval of SANCTURA. In addition, Indevus could receive up to $45 million in future payments contingent upon the achievement of certain milestones related to the development of a once-a-day formulation of SANCTURA, as well as a payment of $20 million related to the achievement of a long-term commercialization milestone in 2013.

For at least six months following the approval of SANCTURA, Indevus will receive a commission based on net sales of SANCTURA, a portion of which will fund its own sales force and certain advertising and promotional costs. PLIVA and Indevus will co-promote SANCTURA through a joint sales force of approximately 500 sales representatives. Indevus will establish a sales force initially numbering approximately 280 representatives who will promote SANCTURA to urology specialists, obstetricians and gynecologists, and certain primary care physicians.

At any time beginning six months after the approval of SANCTURA, each company has the right to convert the agreement into a royalty-bearing structure, whereby Indevus will receive royalties from PLIVA based on net sales of SANCTURA, and PLIVA will be responsible for promotional, advertising and sales force-related costs. Should this right be exercised, Indevus will retain a specialty sales force promoting SANCTURA to urology specialists, obstetricians and gynecologists, and high prescribers.

Under the agreement, Indevus will be responsible for funding the development of the once-a-day formulation of SANCTURA. Indevus will purchase trospium from Madaus AG, the European innovator and manufacturer of the product, and will supply it to PLIVA. PLIVA will be responsible for product distribution and will record revenue for sales of the product.

Financial Results

Consolidated revenues were $876,000 for the three-month period ended March 31, 2004, compared to $2,871,000 for the three-month period ended March 31, 2003. For the six-month period ended March 31, 2004, consolidated revenues were $1,803,000 compared to $3,693,000 for the six-month period ended March 31, 2003. Fiscal 2004 and 2003 revenues were derived primarily from royalty and other payments from Eli Lilly & Company on sales of Sarafem(TM), launched by Lilly in August 2000. The decreases in the fiscal 2004 periods are primarily the result of the absence of contract revenue and accelerated sales milestone payments recognized as royalty in the fiscal 2003 periods following the Company`s renegotiated agreement with Eli Lilly and Company. These fiscal 2003 payments include $2,184,000 in accelerated milestones and $777,000 in contract and license fee revenue received from Lilly.

The Company`s consolidated costs and expenses for the three-month period ended March 31, 2004 were $11,133,000 compared to $5,996,000 for the three-month period ended March 31, 2003. For the six-month period ended March 31, 2004, consolidated costs and expenses were $23,018,000, compared to $12,440,000 for the six-month period ended March 31, 2003. Increased expenses during the fiscal year 2004 three and six-month periods over the comparable fiscal year 2003 periods relate primarily to SANCTURA and include clinical trial costs, costs related to the development of extended release formulations of trospium and pre-marketing costs.

Investor Conference Call

Indevus will host an investor conference call today, May 11, 2004, at 9 a.m. eastern time. To access the live call, please dial [phone] from the U.S. and Canada, and [phone] from international locations. An archived recording of the call will be available beginning two hours after its completion and lasting through May 18, 2004. To access the archived call, please dial [phone] from the U.S. and Canada and [phone] from international locations. For archived calls, enter the conference ID number, 6655921.

Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in development: SANCTURA for overactive bladder, pagoclone for panic and generalized anxiety disorders, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, aminocandin for systemic fungal infections and citicoline for ischemic stroke.

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; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA; risks associated with contractual agreements; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the commercialization of SANCTURA and for the development of our other 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.

INDEVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three and six months ended March 31, 2004 and 2003
(Amounts in thousands except per share data)
(Unaudited)

For the three For the six
months ended months ended
March 31, March 31,
------------------- ------------------
2004 2003 2004 2003
--------- --------- --------- --------

Total revenues $876 $2,871 $1,803 $3,693

Costs and expenses:
Cost of revenues 209 596 524 806
Research and development 5,142 3,240 12,696 7,017
Marketing, general and
administrative 5,782 2,160 9,798 4,617
--------- --------- --------- --------
Total costs and expenses 11,133 5,996 23,018 12,440
--------- --------- --------- --------

Loss from operations (10,257) (3,125) (21,215) (8,747)

Investment income 180 159 402 350
Interest expense (1,293) - (2,585) -
Minority interest - - 4 -
--------- --------- --------- --------


Net loss $(11,370) $(2,966) $(23,394) $(8,397)
========= ========= ========= ========

Net loss per common share:
Basic and diluted $(0.24) $(0.06) $(0.49) $(0.18)
========= ========= ========= ========

Weighted average common shares:
Basic and diluted 47,397 46,886 47,304 46,881
========= ========= ========= ========



INDEVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)

March 31, Sept. 30,
2004 2003
--------- ---------

Cash, cash equivalents and
marketable securities $57,636 $84,087
Other assets 8,800 5,984
--------- ---------
Total assets $66,436 $90,071
========= =========

Convertible notes 72,000 72,000
Other liabilities 9,966 11,817
Minority interest 9 13

Capital 308,546 306,932
Accumulated deficit (324,085) (300,691)
--------- ---------
Total stockholders` equity (15,539) 6,241
--------- ---------
Total liabilities and
stockholders` equity $66,436 $90,071
========= =========



--------------------------------------------------------------------------------
Contact:
Indevus Pharmaceuticals, Inc.
Michael W. Rogers, 781-861-8444
or
William B. Boni, 781-402-3410



--------------------------------------------------------------------------------
Source: Indevus Pharmaceuticals, Inc.

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[kopfeck]

Hallo

Also wenn ich mit meinen schlechten Englisch Kenntnissen richtig liege, sind
die Zahlen sind ja nicht so berauschend.
Haben aber den Kurs auch nicht so richtig geschadet, liegt das an der zu erwartenden
Zulassung.

Gibt’s neue Einschätzungen, zum weiteren Kurverlauf .


Kopfeck

[ipollit]

Rally eröffnet? IDEV kommt in Bewegung...



man beachte das Volumen... und neues 52W-Hoch



in den nächsten Tagen wird über Sanctura entschieden, der Anfang sieht schonmal vielversprechend aus

mfg ipollit

[red-eagle]

FDA: Entscheidung am Freitag (24.05.2004)


Eine spannende Woche sieht „Global Biotech Daily“ für Indevus Pharmaceuticals (WKN 883147) . Bereits am Freitag war der Kurs der Aktie, die die Experten vor einigen Monaten schon einmal vorgestellt hatten, um 17 Prozent nach oben und damit auf neue Zwei-Jahres-Hochs geklettert. Anfang April hatte das Unternehmen eine Vereinbarung mit dem Pharmaunternehmen PLIVA bezüglich des experimentellen Medikaments Sanctura gegen Blasenschwäche gemeldet: Per sofort hatte Indevus dadurch Anfang April Anspruch auf eine 30-Millionen-Dollar-Zahlung. Eine weitere Meilensteinzahlung über 120 Millionen Dollar folgt, sobald das Medikament von der FDA zugelassen wird. Damit bekäme das Unternehmen bei einer Marktzulassung auf ein Mal mehr als ein Drittel der momentanen Marktkapitalisierung, die aktuell 410 Millionen Dollar beträgt, bar in die Kassen. Hinzu käme, dass die möglichen Umsatzerlöse mit dem Pharma-Partner geteilt würden. Am kommenden Freitag (28. Mai) wird die FDA über die Zulassung des Medikaments entscheiden. Laut „Global Biotech Daily“ räumen Branchenexperten dem Präparat gute Chancen auf die Zulassung ein: Sanctura ist bereits seit Jahren auf dem europäischen Markt erhältlich und konnte den Experten zufolge in verschiedenen Testreihen seine Vorteile gegenüber bereits auf dem Markt befindlichen Produkten unter Beweis stellen. Die Spezialisten selbst gehen ebenfalls davon aus, das Indevus Pharma am Freitag endgültig grünes Licht von der FDA erhält und der Kurs deutlich davon profitieren kann. In den vergangenen Tagen stiegen mit dem Kurs auch die Umsätze in der Aktie rasant an. Daraus schließt GBI Daily, dass sich offenbar gut informierte Kreise bereits eindecken. Interessenten sollen deshalb nicht zu lange warten und mit einigen Stücken sofort den Fuß in die Tür stellen.

Gruß RE