Nitromed!!!Megasolide Biotech Aktie mit 1000% Potenzial - 500 Beiträge pro Seite

[ravemaster]

gestern wieder mit Intradyreversal trotz der bisherigen Anstiege.Gegen den schlechten Gesmtmarkt!!!!!!!!!!!!!!





Nitromed
Stand: 23.07.2004




Kennzahlen
ISIN US6547985035
Marktkapitalisierung etwa 36 Mio Dollar
Index Nasdaq Composite
Bitte direkt an der Nasdaq kaufen!




Aspekte / Hintergründe

Herz-Kreislauf-Erkrankungen sind die häufigste Todesursache in der westlichen Welt. Sie rangieren noch weit vor Krebs oder Verkehrsunfällen.
Nitromed ist ein Biotechwert, der in genau diese Richtung forscht.
Die Forschung konzentriert sich vor allem auf die Behandlung eines Herzfehlers, der vor allem bei Afroamerikanern gehäuft auftritt. Warum es mehr Afroamerikaner betrifft, weiß noch keiner.
Von diesem sind fünf Millionen Amerikaner betroffen. Bisher gibt es noch keine Behandlung. 50 % der Patienten sterben in den ersten fünf Jahren nach der Diagnose. Auch weiße können diesen Herzfehler bekommen, aber deutlich seltener und mit einer geringeren Sterbewahrscheinlichkeit. Die Zahl der Erkrankungen steigt stetig.
Das Hauptpräparat heißt BiDil, wird oral eingenommen und ist eine den Stickoxid-Haushalt verbessernde Medizin, die auf einer Kombination verschiedener chemischer Verbindungen basiert.
Stickoxid wird vom Körper selbst produziert, um die Gefäße und das Herz zu stabilisieren.
Die Entwicklung von auf Stickoxid basierenden Präparaten ist die Kernkompetenz von Nitromed. Dabei werden nicht nur neue Produkte entwickelt sondern auch bestehende in der Verträglichkeit verbessert.
Nitromed wird unterstützt von Merck und Boston Scientific.




Nitromed
(Frankfurt)
Nitromed
(Nasdaq)







Pro

Am 19. Juli meldete Nitromed, dass die Phase III Versuche an ihrem wichtigsten Forschungsvorhaben, dem Präparat BiDil beendet wurden, weil sich eine signifikante Verbesserung der Überlebenswahrscheinlichkeit ergeben habe. Patienten, die bisher ein Placebo bekamen, werden ab sofort mit dem Mittel behandelt. Innerhalb der nächsten zehn Wochen sollen die ersten Ergebnisse der FDA vorgelegt werden. Anfang 2005 soll die Phase III endgültig abgeschlossen sein.
Die Wirkung wird von einer unabhängigen Kommission bestätigt.
Insider haben in den letzten Monaten im großen Stil gekauft, bzw. ihre Optionsrechte ausgeübt.





Contra

Die Bilanz- und Bewertungskennzahlen kann man völlig vergessen – Die Spekulation beruht allein auf der Markteinführung von BiDil. Wenn sich die bisherigen Erfolge bestätigen, hat BilDil das Zeug zu einem Blockbuster und der Kurs wird sich mindestens verzehnfachen. Das Unternehmen ist komfortabel mit Eigenkapital ausgestattet, um auch Verzögerungen locker zu verkraften.

Fazit:

Hohe Chance, hohes Risiko!






Ahnliche Aktien sind 10x so hoch bewertet!!!
Imclone z.b. mit über 4 Miliarden trotz der Verluste der letzten Tage..

Nitromed hat zudem noch aus dem Börsengang Ende 2003 über 90 MIO
in Cash..

Die Versuchsreihe der Phase 3 wurde mit behördlicher Genehmigung vorzeitig wegen des Erfolges beendet um schneller das Medikament herstellen zu können.

Zudem zahlen Merck und Bosten Scientific insgesamt so
um 8 Mio jährlich für andere erfolgreiche Forschungen.

Erst seit Ende 2003 an der Nasdaq,daher wohl noch so günstig zu haben.

Das Medikament wird im Januar vermarktet,Miliardenschwerer
Blockbuster...

[ravemaster]

NitroMed Stops Heart Failure Study -A-HeFT- in African Americans Due to Significant Survival Benefit of BiDil; Company Makes BiDil Available to All Patients in Study
NitroMed Stops Heart Failure Study -A-HeFT- in African Americans Due to Significant Survival Benefit of BiDil; Company Makes BiDil Available to All Patients in Study



BW5475 JUL 19,2004 3:58 PACIFIC 06:58 EASTERN



( BW)(MA-NITROMED)(NTMD) NitroMed Stops Heart Failure Study -A-HeFT-in African Americans Due to Significant Survival Benefit of BiDil;Company Makes BiDil Available to All Patients in Study

Business Editors/Health/Medical Writers

LEXINGTON, Mass.--(BUSINESS WIRE)--July 19, 2004--


NitroMed Will Hold Conference Call Today, Monday, July 19 at 9:00 a.m. Eastern Time to Discuss A-HeFT

NitroMed, Inc. (NASDAQ:NTMD) announced today it has halted thePhase III clinical trial of BiDil, its lead drug in development forthe treatment of African Americans with heart failure. The trial wasstopped because of the significant survival benefit seen with thedrug. The action followed the unanimous recommendations of both theData Safety and Monitoring Board (DSMB) and the Steering Committee forthe trial.
The African American Heart Failure Trial, or A-HeFT, was designedto evaluate the efficacy of BiDil, when taken daily in addition to thebest current therapy. BiDil is an orally administered nitric oxideenhancing medicine which combines isosorbide dinitrate andhydralazine. Over 1,000 patients in 170 sites across the United Stateswere enrolled in the double blind placebo controlled trial. TheAssociation of Black Cardiologists is a joint sponsor of the study.
Early this morning, the Company notified the study investigatorsat the 170 active clinical sites throughout the country that the trialis to be halted immediately. All patients in the A-HeFT trial will nowhave the opportunity to be treated with BiDil.
"The reported benefit of BiDil and the recommendation of the DSMBwere so compelling that the A-HeFT Steering Committee unanimouslyrecommended that the trial be stopped," said Dr. Anne Taylor, Chairmanof the A-HeFT Steering Committee and Professor of Medicine, Universityof Minnesota School of Medicine. The DSMB is an independent committeeof experts who oversees the trial to ensure patient safety. Based onthe size and consistency of the survival benefit, the committeebelieved it would be unethical for physicians to continue to withholdBiDil from patients taking a placebo in the study.
Although the data reviewed were preliminary and will require morerobust analysis, the statistically significant survival benefit wasconsistent with and confirmed by the A-HeFT primary composite endpointof mortality, first hospitalization for heart failure and quality oflife. The preliminary data also indicated that serious adverse eventsand cardiovascular events in particular, were less frequently observedin the BiDil arm of the trial. BiDil is not yet approved for marketingby the FDA. NitroMed expects that the data from the trial will beavailable in the fourth quarter of 2004.
Dr. Manuel Worcel, NitroMed´s Chief Medical Officer, observed,"The survival benefit with BiDil in African American heart failurepatients is consistent with the survival benefit observed in anearlier clinical study, V-HeFT I, where patients were given BiDil ontop of then current therapies digoxin and diuretics. In the A-HeFTtrial, patients were given BiDil in addition to the full spectrum ofmodern therapies which may include beta blockers, angiotensinantagonists and aldosterone inhibitors -- as well as digoxin anddiuretics."
"A-HeFT is the largest database ever in African-Americans withheart failure and highlights the importance of African Americanparticipation in clinical trials. The Association of BlackCardiologists is proud to be the co-sponsor of the trial," saidMalcolm Taylor, M.D., Chair of the Association of Black CardiologistHeart Failure Steering Committee and member of the A-HeFT SteeringCommittee.
Michael D. Loberg, Ph.D., President and C.E.O., NitroMedcommented, "Today´s news indeed accelerates our timetable and, Ibelieve, lowers our development risk to commercialization. Althoughthe data need further analysis, NitroMed will work closely with theFDA to conclude the necessary A-HeFT data analysis and to ensure acomplete and prompt filing of the data as an amendment to ourpreviously submitted new drug application (NDA). At the same time, weintend to have the necessary commercial resources in place to supporta product launch by early 2005."

CONFERENCE CALL TODAY - INFORMATION

NitroMed will hold a conference call today, Monday, July 19 at9:00 a.m. Eastern to discuss the A-HeFT trial and to answer questions.Participating in the call with NitroMed management will be Dr. AnneTaylor, Chairman of the A-HeFT Steering Committee and Dr. Clyde Yancywho is a member of the Steering Committee.
The conference may be heard live via the investor relationssection of our website at www.nitromed.com. The call can also beaccessed by telephone by dialing 800-299-0433. The participant passcode is 89324651.
Replay of the broadcast will be available on the website and bycalling 888-286-8010 and using pass code 27882245.

A-HeFT First Heart Failure Trial in African Americans

A-HeFT is the first and only heart failure trial conducted in anall African American patient population, testing the effects of BiDil,when administered in addition to current heart failure therapy. Thetrial was expected to be completed in early 2005.

African Americans and Heart Failure

Heart failure -or end-stage cardiovascular disease- affectsapproximately five million Americans. There is no cure for thisdisease and more than 50% of patients die within five years ofdiagnosis. African Americans suffer a disproportionate incidence ofcardiovascular disease. With respect to heart failure, they areaffected at a rate greater than that of the corresponding whitepopulation and are more likely to die from it. They also present withthe disease at a much younger age. This dramatic ethnic difference inhealth outcomes has been attributed to a variety of factors, includingaccess to medical care, management of heart failure and socioeconomicfactors. Recent analyses of heart failure clinical trials, however,show that the mortality rate and the hospitalization rate for AfricanAmericans is significantly higher than for non-African Americans, evenafter adjustment for such factors. Based on data from the CensusBureau and the Centers for Disease Control, it is estimated thatannually there are 750,000 African Americans with heart failure in theUnited States, and this number is expected to grow to approximately900,000 persons by 2010.

About BiDil(R)

As the lead product in development for NitroMed, BiDil is anorally-administered nitric oxide-enhancing medicine that is beinginvestigated for its potential to reduce mortality and hospitalizationand improve the quality of life of African Americans diagnosed withheart failure. BiDil is a combination of two drugs, isosorbidedinitrate and hydralazine. Isosorbide dinitrate is a nitric oxidedonor. Hydralazine is an antioxidant and vasodilator agent, whichmeans that it dilates blood vessels and protects the nitric oxideformed by isosorbide dinitrate from deactivating. Neither drugseparately is indicated for heart failure. Because heart failure is achronic disease, if approved, BiDil, like other medicines taken forchronic heart disease, will be taken for the duration of the patient´slife.

The Design of A-HeFT

A-HeFT was designed to demonstrate that BiDil, when administeredtogether with standard heart failure therapies, can provide acombination of reduced mortality and hospitalization for heart failureand improved quality of life for African Americans with heart failure.The trial was designed as a randomized, double blind, placebocontrolled study targeted to enroll 1,100 black men and women withmoderate to severe heart failure, categorized as New York HeartAssociation (NYHA) heart failure functional classifications III andIV. Eligible patients were also required to have a reduced ability ofthe heart to pump blood efficiently, as characterized by a decreasedejection fraction as well as enlarged left ventricles. Patients wereenrolled in the study at 170 clinical sites throughout the UnitedStates.
The study treatment included either BiDil or a placebo in additionto the patient´s standard course of treatment for their heart failure,which may have included angiotensin converting enzyme(ACE)-inhibitors, angiotensin receptor blockers, beta-blockers,diuretics, spironolactone and digitalis.

About NitroMed, Inc.

NitroMed is an emerging pharmaceutical company that discovers,develops and seeks to commercialize proprietary pharmaceuticals basedon the therapeutic benefits of the naturally occurring molecule nitricoxide. The Company uses its expertise in nitric oxide biology andchemistry in an effort to develop both novel drugs, as well as safer,more effective versions of existing drugs. Research and developmentefforts focus on major diseases that are characterized by a deficiencyin nitric oxide, such as cardiovascular and inflammatory diseases.Collaborative partnerships are a key element of the Company´s businessstrategy. NitroMed has agreements with Merck to jointly develop nitricoxide-based COX-2 inhibitors and with Boston Scientific to jointlydevelop nitric oxide coated cardiovascular stents. Its lead COX-2inhibitor being developed with Merck is in Phase II clinical trials.

Forward Looking Statements

Any statements in this press release about future expectations,plans and prospects for the Company, including statements regardingthe Company´s timeline for seeking to obtain regulatory approval forBiDil(R), and its expectations regarding development risk, as well asstatements containing the words "believes," "anticipates," "plans,""expects," "will," and similar expressions, constitute forward-lookingstatements within the meaning of The Private Securities LitigationReform Act of 1995. Actual results may differ materially from thoseindicated by such forward-looking statements as a result of variousimportant factors, including risks relating to: difficulties or delaysrelating to obtaining required regulatory approvals to develop, marketand sell BiDil; the Company´s ability to successfully completeclinical trial data analysis of BiDil; the Company´s dependence oncorporate collaborators to develop, manufacture, market and sellproducts based upon its technologies; the Company´s failure to obtainor maintain intellectual property protection and required licenses forits technologies and products under development; the Company´s abilityto obtain the substantial additional funding required to conductresearch and development, manufacturing, marketing and sales of itsproducts under development; and other factors discussed in itsQuarterly Report on Form 10-Q for the quarter ended March 31, 2004 andother filings that it periodically makes with the SEC. In addition,the forward-looking statements included in this press releaserepresent the Company´s views as of the date of this release. TheCompany anticipates that subsequent events and developments will causethe Company´s views to change. However, while the Company may elect toupdate these forward-looking statements at some point in the future,the Company specifically disclaims any obligation to do so. Theseforward-looking statements should not be relied upon as representingthe Company´s views as of any date subsequent to the date of thisrelease.

--30--MP/bo* CONTACT: NitroMed, Inc. Kathleen O´Donnell, 781-266-4192 KEYWORD: MASSACHUSETTS INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL CONFERENCE CALLS PRODUCT SOURCE: NitroMed, Inc.

(c) 2004 Business Wire. All reproduction, other than for an individual user`s reference, is prohibited without prior written permission.



Autor: © Business Wire , 12:58 19.07.04

[bioperformer]

Hallo ravemaster,

bitte bei aller Begeisterung für das Unternehmen keine falschen Bezugsgrößen in den Raum stellen.

Nitromeds Marktkapitalisierung beträgt bei einem derzeitigen Kurs von 19 US$ bereits 487.255.000 US$.

In Anbetracht des derzeitigen Marktbedingungen, der in den beiden letzten Wochen gesehenen Kursexplosion, aber auch der o.g. Marktkapitalisierung sehe ich momentan wenig Spielraum für weitere größere Kurszuwächse.
Eine Kursverzehnfachung würde das Unternehmen gar mit 4,873 Milliarden bewerten, was schon mehr als provokant zu bezeichnen wäre.




Gruß vom Bio

[ravemaster]

die Marktkapitalisierung ist aus dem Bericht des Frankfurter Börsenbriefes.
Hast aber recht.

Sehe trotzdem noch das angesprochene Potenzial.
Abzüglich des Cash ist max. 400 Mio bisher.

Andere Bios sind halt mit 4 Mia. und mehr bewertet.

Jedes verkaufte Stück wird derzeit in USA vom Markt aufgesogen..

Sehe ich wie eine Neuemission...