Wer weis was über Genelabs ?? - 500 Beiträge pro Seite

[Mr_Scaramanga]

GNLB heute an der Nasdaq >15% + !

[IWA Japan]

polier mal deinen goldenen colt!

[Mr_Scaramanga]

Genelabs Data Shows GL701 Improves or Stabilizes Lupus Disease Activity Data on Potential New Hormone Therapy Presented at ENDO(R) 2000
REDWOOD CITY, Calif., Jun 23, 2000 /PRNewswire via COMTEX/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB ) reported that its investigational drug GL701 (prasterone, dehydroepiandrosterone) can stabilize or improve disease symptoms for patients with systemic lupus erythematosus (SLE or lupus), based on statistically significant results from its second Phase III clinical trial. The data are being presented today at the Clinical Trial Symposium at ENDO 2000, the 82nd Annual Meeting of The Endocrine Society in Toronto, Canada.

(Photo: http://www.newscom.com/cgi-bin/prnh/19990728/GNLBLOGO )

Kenneth E. Schwartz, M.D., a board certified endocrinologist and Genelabs Senior Medical Director said, "This study is particularly significant because it shows that GL701 is potentially a promising new hormonal therapy as a first line treatment for people with lupus. Current treatment is primarily with chronic use of steroids, such as prednisone, which have many serious adverse consequences."

SLE is a serious autoimmune disease that primarily affects women, many of whom experience the initial onset of disease in their late teens and early twenties. It is characterized by systemic autoimmunity leading to inflammation that can affect a number of organ systems and by alterations in androgen/estrogen metabolism. Approximately 200,000 people in the United States and more than one million worldwide have lupus, according to U.S. government and private sector statistics.

The reported trial is the largest double blind, randomized, placebo-controlled clinical study of the safety and effectiveness for a lupus treatment ever completed. The study evaluated patients` disease activity; organ damage; quality of life, such as severity of fatigue and the ability to conduct daily activities; and bouts of heightened disease symptoms, called flares.

Study Results

The objective of this pivotal Phase III study was to determine whether GL701 would improve SLE disease activity and/or its symptoms in women with clinically active disease, which was principally measured by response to treatment. Response to treatment, the study`s primary endpoint, was defined as improvement or stabilization of SLE disease activity and symptoms in each of four scoring instruments, with allowance for minor variability and with no clinical deterioration. Patients in the group treated with GL701 had a statistically significant greater rate of response than the group that received placebo.

Patients treated with GL701 showed a 35 percent greater response rate than the placebo group (p=0.005): 66 percent of patients (87/132) responded to treatment with GL701 compared to 49 percent (65/133) for patients who received placebo. The study showed a trend toward a reduction in the incidence of disease flare, a serious manifestation of lupus, which was more than 24 percent lower in the GL701 patient group (31/132) compared to patients who received placebo (41/133).

Further evidence from the trial demonstrated that GL701 significantly increased bone density, compared to placebo, in patients receiving chronic corticosteroid therapy. Bone density measurements, using the Dual X-ray Absorptiometry (DXA) test, were taken at 8 of the trial`s 27 investigator sites. Thirty-seven SLE patients were evaluated for mean changes in bone density of both the lumbar spine and hip. These patients had been on steroids for at least six months prior to entry in the study. In this study, 18 lupus patients on chronic steroid therapy who received GL701 demonstrated a statistically significant increase in mean bone density in lumbar spine, compared to 19 patients receiving placebo (p=0.004). Mean bone density in the spine increased 1.83 percent in patients on GL701 vs. a decrease of 1.78 percent in placebo patients. GL701 also demonstrated improved changes in mean bone density of the hip. Total hip mean bone density increased 2.08 percent in patients receiving GL701 and decreased 0.16 percent in placebo patients (p=0.080).

GL701 appears to be well tolerated. In this trial adverse events were reported in both the placebo and the treatment group. Adverse events associated with GL701 were generally mild and expected and included acne, facial hair growth and hormonal changes. Some ailments commonly associated with lupus and reported as adverse events were less frequent in patients who were treated with GL701 compared with patients who received placebo. In patients receiving GL701, there was a statistically significant decrease in high-density lipoprotein (HDL) cholesterol. On the other hand, there was also a statistically significant reduction in triglycerides, a lipid that in high levels may increase risk of heart disease. Underscoring the serious nature of lupus, there were 5 deaths, including 2 suicides, among patients in the study. All of the deaths were in the placebo group. The findings from this Phase III trial confirmed the tolerability of GL701 seen in other studies in patients with lupus.

NDA Clinical Sections Submitted

Genelabs is seeking approval of GL701 as a first line therapy for women with active SLE to stabilize or improve their disease signs and symptoms, and also for SLE patients who are corticosteroid dependent, to reduce their corticosteroid dose -- the primary endpoint of the first Phase III clinical trial of GL701 conducted by Genelabs.

James A.D. Smith, Genelabs President and Chief Executive Officer said, "Based on the encouraging results of our two pivotal trials of GL701 for SLE, we recently submitted the clinical sections of the New Drug Application (NDA) for marketing approval in the United States and we are on schedule to submit the remaining sections in the second half of this year. The FDA has granted fast track designation for GL701 and has agreed that our NDA would be submitted on a rolling basis. If approved, GL701 will be the first new treatment for lupus patients in 40 years."

About SLE

Lupus causes the immune system to attack the body`s own tissue, which can lead to discomforting inflammation, arthritis pain, tissue injury and major organ damage. Common signs and symptoms of disease that lupus sufferers experience -- severe fatigue, arthritis, facial rash and photosensitivity -- can lead to a poor quality of life. More serious, life-threatening symptoms include inflammation of the lungs, heart and brain tissue, and organ damage, most often involving the kidneys.



HEADSHOT !

[Dukati]

Hallo,

bin seit einigen Tagen auch in Genelabs investiert. Genelabs war vergangene Woche der "stock pick of the week" bei Castortroy.

Wie schätzt ihr die Entwicklung von Genelabs ein ?

Dukati

[Kelbi]

Genelabs Techn. beimischen Datum: 12.04.2001


Der Report21 erwartet bei Genelabs Technologies (WKN 883117) eine positive Entwicklung. Genelabs Technologies sei ein klassisches Gentechnologieunternehmen. Ziel des Unternehmens sei die Behandlung von Krankheiten auf der Ebene der DNA also nicht auf der symptomatischen sondern auf der kausalen Ebene. Im Gegensatz zu vielen anderen Unternehmen sei Genelabs in der Entwicklung bereits deutlich fortgeschritten. Im abgelaufenen Geschäftjahr habe Genelabs einen Umsatzrückgang um 12% auf 7,1 Mio. US-$ verzeichnen müssen. Gleichzeitig sei der Verlust um 21% auf 12,3 Mio. US-$ erhöht worden. Nach den vorliegenden Informationen verfüge das Unternehmen noch über Cash in Höhe von 34,7 Mio. US-$. Nachdem die Zulassung für das erste Präparat für den amerikanischen Markt unmittelbar bevorstehe, erwarte man im laufenden Jahr bereits einen deutlichen Umsatzzuwachs, der sich in den nächsten Jahren noch verstärken sollte. Positiv stimmte weiterhin, dass innerhalb der letzten Monate mehr Insider die Aktie gekauft als verkauft hätten. Der Aktiekurs selbst sei zwar vom Crash nicht verschont geblieben, habe seit dem Höchstkurs Anfang diesen Jahres jedoch nur etwa 50% abgegeben. Man empfehle die Aktie von Genelabs mittelfristig orientierten Anlegern mit einem Stop-Loss bei 4,0 US-$ zur Depotbeimischung.

Die Empfehlung ist uralt, aber gibts irgendwo neue Infos, insbesondere was die Zulassung angeht?

Gruß

Kelbi

[Bocknase]

Weiß denn keiner, warum der Kurs von GNLB in den letzten Tagen so anzieht ?

[Bocknase]

Ich weiß was über Genelabs !!!

Genelabs Expects New FDA Action on Aslera(TM) NDA
Updated: Wednesday, May 29, 2002 07:30 AM ET Printer-friendly version

REDWOOD CITY, Calif., May 29 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB, news, msgs) stated today that the company currently expects a new U.S. Food and Drug Administration (FDA) action on its New Drug Application (NDA) for Aslera(TM) (GL701) no later than the end of August 2002. As part of Genelabs` on-going discussions with the FDA, the company has submitted additional clinical data and analyses to the agency. Genelabs recently learned that these submissions have been classified as a proposed treatment of women with systemic lupus erythematosus to limit bone loss while on low-dose glucocorticoids.

Irene A. Chow, Ph.D., chairman and chief executive officer, stated, "In working with the FDA toward Genelabs` goal of approval of the Aslera NDA, one of our meetings with the agency occurred in December 2001. The FDA sent us a letter in January 2002 suggesting that we submit additional clinical data and analyses. Over the course of the past several months, as we have continued to work with the FDA, we have submitted additional information to the agency, including information submitted in February 2002 in response to the January letter. While it is not possible to predict the outcome of our current discussions with the FDA on the approvability of the Aslera NDA, I am pleased Genelabs is now able to provide guidance regarding a timeframe for the agency`s next action."

Genelabs submitted an NDA for Aslera in September 2000 and received a not-approvable letter in June 2001. Since that time, the company has been actively working with the agency toward resolution of the deficiencies identified by the FDA in the not-approvable letter. Aslera is being developed by Genelabs and is exclusively licensed to Watson Pharmaceuticals, Inc. in North America.

Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the discovery and development of novel pharmaceutical products to improve human health. We have built drug discovery and clinical development capabilities that can support various research and development projects, while concentrating these capabilities on two core programs: developing a late-stage product for lupus and discovering novel drug candidates targeting DNA. Our research efforts are currently directed toward anti-microbial drug discovery and we have synthesized many lead compounds targeting DNA in bacteria, fungi and viruses. Our clinical development efforts are concentrated on Aslera(TM), for which we have an exclusive license from Stanford University.

[Bocknase]

@ KELBI, DUCATI und Mr. SCARAMANCA

Habt Ihr die Auferstehung von GENELABS total verschlafen,
oder seid Ihr nicht mehr investiert, daß Euch der Kursver-
lauf nicht mehr interessiert ????

Bollinger-Band nach oben klar durchbrochen, wie wird es
weitergehen ??
Wenn es Euch noch gibt, dann äußert Euch doch bald mal !!!
Habe vor fast einem Jahr den Wert für 2,40 € gekauft, wie
stehen die Chancen bezüglich der weiteren Entwicklung ??



Gruß BOCKNASE

[Bocknase]

Diese Meldung wird den Kurssturz von gestern heute auf
jeden Fall relativieren !!!

Genelabs Gets FDA Approvable Letter for Prestara NDA
Updated: Thursday, August 29, 2002 10:15 PM ET Printer-friendly version

Dow Jones Newswires

REDWOOD CITY, Calif. -- Genelabs Technologies Inc. (GNLB, news, msgs) shares plunged nearly 25% on Nasdaq Thursday, but hours after the market closed the company said it received an approvable letter from the Food and Drug Administration.

The biopharmaceutical company said Thursday evening that the FDA issued the letter on Wednesday for the NDA for Prestara, formerly known as Aslera or GL701, a potential lupus treatment.

Genelabs is developing the drug and has licensed it exclusively to Watson Pharmaceuticals Inc. (WPI, news, msgs) in North America.

In Genelabs` Study GL95-02, a positive effect on bone mineral density was observed in women with mild to moderate systemic lupus erythematosus while on low-dose glucocorticoids, the company said. Final FDA approval is subject to the successful completion of an additional clinical trial that provides sufficient evidence to confirm this positive effect.

In a teleconference Thursday with the FDA, the agency indicated that bone mineral density should be the primary endpoint in this clinical trial which could have a six-month treatment duration, Genelabs said.

The company said it plans to have a formal meeting with the FDA as soon as possible to finalize details of the clinical trial design and to discuss the remaining issues.

The FDA`s response to this drug hasn`t always been so favorable. Genelabs first submitted an NDA in September 2000, but received a non-approvable letter from the FDA in June 2001.

When Genelabs received the non-approvable letter, it said the FDA cited various issues primarily relating to the interpretation of efficacy and safety data submitted in the application. Since then, the company has been working with the FDA to resolve the issues.

The company met with the FDA last December, and received a letter from the agency in January requesting additional clinical data and analyses. The company submitted additional information in February.

Genelabs shares closed Thursday at $1.39, down 46 cents or 24.9% on Nasdaq volume of 866,900 shares, well above the average daily volume of 257,926 shares.


-Ralph Tasgal; Dow Jones Newswires; 201-938-5400

Copyright 2002 Dow Jones & Company, Inc.

All Rights Reserved





Gruß BOCKNASE

[Bocknase]

Wie heute zu sehen ist, lag ich gestern mit meinem Posting
genau richtig. Na, vielleicht hat ja einer rechtzeitig zu-
geschlagen. Allerdings waren die Umsätze heute in Frankfurt
äußerst dünn.
Ich denke, es geht erst einmal weiter bergauf bis Ende Sep-
tember.
Warum interessiert sich eigentlich niemand für Genelabs ??
Ist die Firma, oder das Produkt zu suspekt ??
Ich bin vor 12 Monaten bei 2.40€ eingestiegen und möchte
wenigstens warten, bis sich der Wert verdoppelt hat. Die
Chancen dafür stehen momentan recht gut.


Gruß BOCKNASE

[Bocknase]

Eigenartig, wird denn keiner aufmerksam auf diese Firma ??

.................................................

Gibt es denn den Mr.Scaramanca noch ???

[Bocknase]

24.03.2003
Genelabs spekulativer Kauf
sunday-biotech

Dem spekulativ ausgerichteten Anleger empfehlen derzeit die Analysten von "sunday-biotech" die Aktien von Genelabs Technologies (ISIN US3687061073/ WKN 883117) zum Kauf.

Genelabs´ von der Stanford University lizenzierter Entwicklungskandidat, der in den USA "Prestara" und in Europa "Anastar" genannt werde, sei das synthetisch hergestellte Hormon Prasteron, das in Lupus-Patienten im Vergleich zu Gesunden in abnormal niedrigen Konzentrationen vorkomme.

Beim Lupus erythematodes, auch kurz Lupus oder Hauttuberkulose genannt, sei das Immunsystem aus noch unbekannten Ursachen verändert und bekämpfe den eigenen Körper. Die Folge hiervon seien Hautveränderungen, Entzündungen der Gefäße, Gelenke, Nerven, Muskeln oder verschiedener Organe.

Als Partner für Prestara sei bereits im November 2000 Watson Pharmaceuticals präsentiert worden, die Meilensteinzahlungen und Tantiemen an Genelabs abführen und dafür die Vermarktungsrechte in Nordamerika erhalten würden. Genelabs hoffe mittels der gegebenenfalls ab 2004/05 fließenden Umsätze die Entwicklung seiner anderen Kandidaten vorantreiben zu können.

Das Schwergewicht von Genelabs´ Pipeline liege auf der Entdeckung und Entwicklung von pharmazeutischen Verbindungen, die auf der Ebene der DNA angreifen würden. Bakterien, Pilze und andere infektiöse Keime sollten durch die Blockierung ihres Erbmaterials unschädlich gemacht werden. Genelabs halte einige Patente in Zusammenhang mit den Hepatitis-Viren E und G.

Genelabs´ Konzept sei nicht neu. Man lizenziere ein relativ weit entwickeltes Medikament, mit dem viel früher Umsätze generiert werden könnten, als mit den eigenen Kandidaten. Die Umsätze würden dann dazu dienen, die eigene weniger weit entwickelte Pipeline voranzutreiben.

Genelabs gehöre mit einem Börsenwert von ca. 65 Millionen US-Dollar eher zu den Micro-Caps. Ein Kurs-Umsatz-Verhältnis zwischen 3 und 5 herangezogen, würde dies einer Umsatzerwartung von 20 bis 30 Millionen US-Dollar mit dem neuen Medikament entsprechen.

Da Prestara durchaus einen höheren Umsatz erzielen könnte, seien somit eine Risikoprämie für die Nicht-Zulassung und eine Aufsplittung der Gewinne mit dem Vermarkter bereits eingepreist. "sunday-biotech" halte daher Genelabs für eine gute Beimischung in einem gestreuten Biotech-Depot.

Das Rating der Analysten von "sunday-biotech" für die Aktien von Genelabs lautet auf "spekulativ kaufen". Der Stoppkurs sollte bei 0,95 Dollar platziert werden

Lassen wir uns mal überraschen !!!

Gruß Bocknase