Cellegy: solider Biotech mit Potential - 500 Beiträge pro Seite

[Ciscosys]

Fazit: Halte Cellegy Pharmaceutical für einen soliden Biotechwert mit enormen Potential. Persönliche Einschätzung: strong buy

Details: Cellegy (clgy) ist noch eine unendeckte Perle im hochbewerteten Biotechbereich. Sie wird in Berlin unter WKN 903551 gehandelt, sollte aber nur direkt an der Nasdaq gekauft werden, da in Berlin die Umsaätze zu gering sind.

Informationen sind unter www.cellegy.com zu erhalten.

Zur Aktie in Kürze:

Cellegy hat zwei (!!) Produkte in Phase III.
Tostrex ist ein Gel, das auf die Haut afgetragen wird und dem Körper Testosteron zuführt. Testosteron-Mangelerscheinung ist ursächlich für viele Krankheiten. Marktpotential für Testosteronmedikamente ca. 5 Millarden $ im Jahr.

Anogesic verspricht Hilfe gegen Analfissuren und Hämorrhoiden. Markteinführung Frühling 2001. Potential ca. 1,3 Milliarden $ pro Jahr.

Im Moment ist die Firma mit ca. 100 Mio. $ bewertet. Michael Forrest, CEO von Cellegy, hält eine Marktkapitalisierung von 1 Milliarden nach Einführung des ersten Medikamentes für marktüblich. Also könnte sich die Aktie in einem Jahr verzehnfachen.

Für 2002 ist ein Gewinn von 16 cents pro Aktie anvisiert.

Cellegy weist noch keine nennenswerte Kapitalbeteiligung eines großen Pharmaunternehmens auf. Auch dieses verleit der Aktie Fantasie.

Einzige Gefahr ist die in der Branche übliche Zulassungsablehnung durch die FDA.

Also: Wer Mut hat geht ein kalkulierbares Risiko ein und kauft.

[Ciscosys]

Kurze Nachlese: clgy heute in den USA plus 9 %...

[Ciscosys]

Auch wenn es im Moment noch niemanden interessiert, aber Cellegy ist in den letzten Tagen von 6 auf jetzt 9 US$ gestiegen.

Das sind plus 50%. Welche Biotech-Aktie war besser?

[Ciscosys]

Gerücht!!!

Schering ist an einer Übernahme von Cellegy bis Ende des Jahres interessiert.

Schering geht in wenigen Wochen in den USA an die Börse, um eine Währung für Übernahmen im Biotech-Bereich zu haben. Dieses als Fakt gestern im Euro am Sonntag.

Cellegy, an dem noch kein U beteiligt ist, schließt ein Übernahme in diesem Jahr nicht mehr aus.

Es würde Sinn machen, wenn Schering, als ein führender Hormonhersteller (Antibaby-Pille), Cellegy als ein zukünftiger Marktführer für Testosteron übernehmen würde.

Letzteres ist natürlich nur ein Gerücht und mit Vorsicht zu genießen, mir leuchtet es aber als sinnvoll ein, zumal Cellegy mit einem größeren 3stelligen Wachstum und einem KGV von ca. 50 (2002) noch extrem billig ist.

Kommentare?

[puhvogel]

Hmmm...
Wie kommst Du denn zu einem solchen Gerücht? Quelle?
Ich habe ja nun auch ein paar davon, aber dass Schering jetzt an die NYSE geht, um nun gerade Cellegy zu kaufen, halte ich doch für eher unwahrscheinlich.
In der Tat gab aber im Anschluß an die Tagung der Darmchirurgen vor zwei Wochen ziemlich rücksichtslose Kaufe. In der Tagung wo eigentlich nur die alten Daten nochmal veröffentlicht wurden. Bin mal gespannt ob die an 9-10 $ Barriere abprallen oder sie durchstoßen.

Cellegy besitzt meines Wissens aber kein Allgemein -Patent auf Testosteron, insofern muß man an dem 5 Mrd Markt einige deutliche Abstriche machen. Das 50er-KGV bekommen die auch nur , wenn die laufenden Trials erfolgreich bestanden werden.
Der Puhvogel

[VietnamRabbit]

!

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[Ciscosys]

Erstmal freue ich mich, daß es doch ein paar Cellegy-Informierte auf dem Board gibt und ich nicht alleine rumstochere...

Puhvogel, nein, Schering geht natürlich nicht nur wegen Cellegy nach USA. So war das doch auch nicht gesagt. Aber Cellegy könnte auch ein "Opfer" von Schering sein, ist ja nicht teuer...

Das Gerücht erfuhr ich von einem Bekannten, der bei einem amerikanischen Pharmaunternehmen in Deutschland arbeitet. Der sagte mir in einem Telefonat, daß Cellegy gut zu Schering passen würde und auch in den USA darüber spekuliert würde. Aber nur sehr spekulativ. Aber nach all den Infos die ich habe würde es zumindest passen.

Aber Du scheinst dich ja recht gut mit dem Wert zu befassen. Freut mich. Was hälts Du den von dem Unternehmen. Ich selbst bin vor 2 Wochen eingestiegen bei ca. 6 US$ und bin sehr optimistisch, siehe oben.

@ Vietnam-Rabbit: Ich bin fest überzeugt, daß diese Aktie noch einige Zeit sehr volatil bleiben wird. Unten werde ich weiterhin einsammeln. Kursziel ist - und dies ist begründet - bei ca. 80- 90 US $ in zwei Jahren. Dann hätte das U eine Marktkapitalisierung von 1 Milliarde und wäre marktüblich. Dies setzt aber den Erfolg wenigstens einer der Beiden Produkte in der Pipline voraus.

Soweit meine Meinung, aber bitte weiterhin um Eure Einschätzungen, da der Markt wenig an Infos hergibt. Daher sagte ich ja auch, eine noch unentdeckte Perle...

Grüße, Ciscosys

[Ciscosys]

Interessanter Kursverlauf bei Cellegy seit 1 Woche:

Nach rasanten Anstieg um 50% läuft er nun seit über eine Woche in engster Handelsspanne seitwärts. 9 Dollar +- 0,125 $. Da scheint jemand unten aufzusammeln und jemand anderes oben Gewinne mitzunehmen.

Mal sehen wer zuerst aufgibt...

Grüße, Ciscosys

[Ciscosys]

Cellegy Awarded Skin Aging Technology Patent
FRIDAY, JULY 14, 2000 7:01 AM
- PRNewswire

SOUTH SAN FRANCISCO, Jul 14, 2000 /PRNewswire via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (Nasdaq:CLGY) today announced it was granted a United States patent (number 6,071,543) covering the composition and use of certain pyridene-thiol compounds for the treatment of skin aging and wrinkling. This is the fourth patent granted to Cellegy for treatment of skin conditions. The technology was developed by Cellegy`s founder, Dr. Carl Thornfeldt.

The `543 patent is expected to provide protection for ingredients contained in several high performance skin care products developed by Cellegy. Cellegy is currently seeking additional partners, including specialty retailers and e-commerce companies, to handle the marketing of its cosmeceutical products in the U.S. and abroad. One of its products, C79 Intensive Moisturizer, is the key ingredient in a hand healing cream sold by a major specialty retailer. Cellegy`s total sales since product launch exceed $2.1 million.

Pyridene-thiols have long been used in topical products for the treatment of skin diseases. The patent covers multifunctional thiols which uniquely mitigate the signs of skin aging when topically applied. The Company has over 20 additional United States patent applications pending for first various prescription and non-prescription product candidates and related technologies.

Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the development of prescription drugs and high performance skin care products. Cellegy`s high performance cosmeceutical products have been shown in clinical tests to produce significant improvements in the appearance of photodamaged and wrinkled skin.

The Company currently has two prescription products, Anogesic(R) (nitroglycerin ointment) and Tostrex(TM) (testosterone gel) undergoing Phase III clinical trials. The Phase III clinical trial using Anogesic is designed to treat the pain associated with anal fissures; the Company is also conducting two Phase II clinical trials using Anogesic to treat hemorrhoids, a related condition which afflicts over 9 million people in the United States alone. Cellegy is also developing two unique transdermal testosterone drugs. The first product, Tostrex(TM), is for the treatment of male hypogonadism, a condition that can result in decreased energy and libido in men, generally over the age of forty. Tostrex entered Phase III clinical testing during this year`s first quarter. The second product, Tostrelle(TM), is for the treatment of decreased sexual energy in postmenopausal women. Tostrelle is currently undergoing a Phase I/II dose ranging study in the United States.

The press release contains certain forward-looking statements. Many factors could cause actual results to differ materially from those anticipated by the statements made in this press release. Among, but not limited to these, are unfavorable and/or delayed clinical trial results, inability to find commercial partners for the skin care products or lack of consumer acceptance of such products if they are commercialized.

SOURCE Cellegy Pharmaceuticals, Inc

Diese Unternehmensnachricht bestätigt mein Rating: strong buy

[RCZ]

hallo Ciscosys und Cellegy interessierte

es scheint so, das du oder dein Informant auch die FUW gelesen hat.

Ich bin ein bisschen skeptisch, ob die Firma wie es der CEO dort gesagt hat ein KUV von 10 rechtfertigen kann, da die Firma zwar 2 Phase III studien hat, leider sind aber sonst auf lange Sicht keine neuen Medikamente zu erwarten. generell gilt ja das ein KuV von 10 bei Biotechs als fair bezeichnet wird, da die erwartung besteht, daß neue Medikamente aus der Pipeline zu neuen Umsatzpotenzialen heranreifen können.


wie man am Chart sehen kann ist der Kurs immer in einer Trading Range verlaufen, sodass man Kurzfristig vorsichtig sein sollte und eventuell erst bei Ausbrauch kaufen sollte. wobei das dann natürlich auch eine Bullenfalle sein kann.

Die Aktie sollte auf einer Spekulativen Watchlist nicht fehlen, die Chancen aber auch die Risiken sind enorm groß.

mfg.
RCZ

[Ciscosys]

Guter Beitrag, seh ich ähnlich, habe auch von Anfang an gesagt, hochspekulativ. Da ich aber am unteren Ende der Trading-Range eingestiegen bin, sehe ich für mich persönlich kein Risiko.

Richtig ist aber definitiv, daß es entscheident sein wird, ob Cellegy die Range bei 9 Dollar nach oben durchbrechen kann. Dann kann es aber sehr sehr schnell gehen und man sieht nur noch die berühmten roten Lichter. Deswegen empfehle ich ein kleine Position schon jetzt aufzubauen.

Grüße, Ciscosys

[puhvogel]

Interessantes Chartverhalten, in der Tat, die letzten Tage. Spannend sind die relativ hohen Umsätze nach der Tagung.
Bin mal gespannt wie der Kampf Bullen gegen Bären ausgeht, oder soll der Kampf nur inszeniert sein?
Irgendwie fühlt man sich an den Chart von Mitte 96 erinnert, bloß da waren die Umsätze nicht so groß.
Wir werden sehen. Psychologisch wäre jedenfalls ein Überschreiten der 10 bedeutend.
Der Puhvogel

[Ciscosys]

Na, sieht doch recht gut aus...


Cellegy Pharmaceuticals Reports Second Quarter Financial Results
THURSDAY, JULY 27, 2000 6:00 AM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., Jul 27, 2000 /PRNewswire via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (Nasdaq:CLGY) reported today that for the second quarter ended June 30, 2000, revenues were $132,000, compared with $394,000 for the same period last year. For the six month period ended June 30, 2000, revenues were $662,000 including $578,000 of product sales to Gryphon Development (the product development subsidiary of a major specialty retailer), $72,000 for a Small Business Innovation Research grant, and $12,000 in revenues from Cellegy`s Australian subsidiary, which was acquired in mid-June 2000. For the same period in 1999, revenues were $754,000 consisting primarily of $712,000 in product sales to Gryphon.

For the three months ended June 30, 2000, the Company had a net loss applicable to common shareholders of $2,690,000 or $0.22 per share compared with a net loss of $2,280,000 or $0.22 per share for the same period last year. The net loss applicable to common shareholders for the six-month period ended June 30, 2000 was $4,605,000 or $0.38 per share and $4,950,000 or $0.49 per share for the same period in 1999. For both 1999 reporting periods, fewer weighted average shares were outstanding.

Operating expenses increased during the second quarter of 2000 compared with both the first quarter of 2000 and last year`s second quarter, primarily due to an increase in clinical development activities for Anogesic(R) (nitroglycerin ointment) and Tostrex(TM) (testosterone gel), which are currently undergoing several clinical studies. Operating expenses are expected to increase for the remainder of 2000 due to higher patient enrollment in various clinical trials. Cash and investments at June 30, 2000 were $11.7 million, compared with $16.7 million at December 31, 1999.

"During the second quarter, we made considerable progress in opening study sites and screening patients for entry into our clinical trials," said K. Michael Forrest, CEO. "Patient enrollment is progressing in both our Phase III clinical trial with Anogesic for the treatment of anal fissure pain, and in our Phase III trial with Tostrex for the treatment of hormone deficiency in men. Furthermore, we are encouraged by initial sales of Rectogesic(TM) (nitroglycerin ointment), a product we acquired from our Australian subsidiary. We have recently initiated marketing programs to increase market penetration through the remainder of this year."

Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the development of prescription drugs and high performance skin care products. Cellegy is currently conducting a confirmatory Phase III clinical trial using Anogesic to treat the pain associated with anal fissures, and two clinical trials using Anogesic to treat hemorrhoids, a related condition which afflicts an estimated 9 million people in the United States.

Cellegy is also developing two unique transdermal testosterone drugs. The first product, Tostrex, is for the treatment of male hypogonadism, a condition that can result in decreased energy and libido in men, generally over the age of forty. Tostrex entered Phase III clinical testing during this year`s first quarter. The second product, Tostrelle(TM), is for the treatment of decreased sexual energy in postmenopausal women. Tostrelle is currently undergoing a Phase I/II dose ranging study in the United States. Cellegy has also developed a line of high performance cosmeceutical products, which have been shown in clinical tests to produce significant improvements in the appearance of photodamaged and wrinkled skin.

This press release contains certain forward-looking statements. Actual results may differ materially from those discussed above. For more information regarding financial results, including risk factors, refer to the Company`s Annual Report on Form 10-K for the year ended December 31, 1999

[puhvogel]

Ich bin da wieder raus. Ich habe das Gefühl, da verschaukelt uns jemand, und justiert den Kurs auf 9 $. Das ganze hängt vielleicht tatsächlich mit .dem Auslaufen des Optionscheines zusammen.
Von den Präparaten her sicher interessant, da warte ich aber lieber die Versuchsergebnisse ab.
Der Puhvogel

[Ciscosys]

Interessanter erklärungsansatz, das mit dem Optionsschein. Wann läuft der aus ? Bitte dringend um Antwort. Welchen Basispreis hat der ?

[puhvogel]

Also ich sollte als erstes mal die Quelle angeben , woher ich das her habe: Vom Yahoo-Board, sollte daher auch mit größter Vorsicht genossen werden!!!
Da muß der Kurs noch so bei 8$ gestanden haben, wo jemand eben dort prognostizierte, dass der Kurs wohl in Höhe des Ausübungspreises von 9 1/8 gezogen wird.
Ende der Laufzeit war so der 13 August (bin mir nicht ganz sicher).
Man kann das natürlich auch so interpretieren, dass jemand CLGY aufkaufen und so die Aktionäre (wie mich) entnerven möchte, denn die Tradingrange war die letzten Woche ja irre eng.
Aber bei kleinen Biotechs spielt ja öfters das große Geld MM, allerdings meistens eher durch massive Käufe oder Verkäufe in der letzten Viertelstunde. Warum, wieso habe ich trotz einiger Erfahrung im Biotechbereich selbst im Nachhinein nie recht entschlüsseln können.
So ein Stillstehen des Kurses unabhängig vom Markt kenne ich bei Biotechs bisher nicht. :o
Meine ursprüngliche These, dass Privatanleger (medizinisiche Insider) nach der letztens Tagung relativ rücksichtslos kaufen, weil sie dort eine neue interessante Nachricht aufgenommen habe, habe ich bei diesem Kursverlauf und bei dem Verlauf der Umsätze aufgegeben.
Deshalb nehme ich jetzt wieder ein Warteposition ein.

PS: Keiner Tip. Schau dir mal die Nachrichten und den folgenden Kursverlauf von BLSI und SCIO an.
Wünsch Dir das Beste!
Der Puhvogel

[puhvogel]

Hilfe meine Rechtschreibung
Ich meinte natürlich : "Kleiner Tip" statt "keiner Tip"
Soll übrigens keine versteckte Kauf- oder Verkaufsempfehlung sein, sondern eher sensibilisieren, wie trickreich Biotech eigentlich ist.

[puhvogel]

Hier wird zum Beispiel davon gesprochen
http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7076685&…

[Ciscosys]

Es ist schon bemerkenswert. Die Börse kann noch so stark konsolidieren, Cellegy, auch heute wieder, trotzt allen Stürmen. Im Moment unheimlich beruhigend, daher bleib ich dabei.

Puhvogel, Danke für Deine Hinweise...

[RCZ]

HAllo puhvogel und Ciscosys,

wie würdet Ihr aktuell CLGY bewerten,
bei Yahoo Finance steht, daß noch ca. 8 Mil. $ Bargeld vorhanden ist, wenn nun dieses Jahr keine Zulassung für eines der Medikamente kommt... ?
Pleitegeier???

[RCZ]

die Angabe bei YHOO dürfte nicht stimmen da erst vor kurzem eine Privatplazierung war,
leider scheinen sich einige Leute für eine Aktie mit hohen Chancen sowie hohen Risiken nicht zu interessieren???

[puhvogel]

Wenn die mal wieder Nachrichten produzieren würden, würde ich die vielleicht mal wieder kaufen.
Was mich an diesem Wert stört, war dass der Kurs ganz offensichtlich zwei mal manipuliert wurde.
Die sich auf so etwas spezialisiert haben machen das eigentlich nur bei solchen Werten, bei denen sie ziemlich sicher sind nicht von Nachrichten gestört werden zu können.
Wie ich schon unten geschrieben habe, warte ich liebe Studienergebnisse ab und kaufe eventuell dann ...
Grüsse
Der Puhvogel

[puhvogel]

Es gab heute Nachrichten, und sogar gute :
Cellegy Pharmaceuticals to File for Anogesic(R) Approval in Canada

SOUTH SAN FRANCISCO, Calif., Feb. 8 /PRNewswire/ -- Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY - news) announced today that it intends to file a New Drug Submission (NDS) with the Therapeutic Products Programme (TPP) in Canada requesting marketing approval of its product Anogesic® (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. The decision to file in Canada, earlier than previously planned, follows a recent meeting with the TPP. Last month, the Company announced that it also intends to accelerate filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).
The Canadian NDS will include results of Cellegy`s initial Anogesic Phase III clinical trial completed in November 1999 and summary data from several trials conducted with nitroglycerin ointment by investigators around the world. Cellegy will also submit to the TPP expert reports and supportive data from the Australianregulatory package for Rectogesic(TM) (nitroglycerin ointment), which was approved by the Australian Therapeutic Goods Administration (TGA) and has beensuccessfully marketed there since early 1999.
Last month Cellegy announced the issuance of a Canadian patent covering use of Anogesic in treating anal disorders, including anal fissures and hemorrhoids. Commercial supplies of Anogesic will be produced by a Canadian manufacturer, PanGeo Pharma Inc., under a five-year supply agreement.

[puhvogel]

Es steht aktuell eine Cellegy-Diashow von einer Investmentshow im Netz:
http://www.informedinvestors.com/iif_forums/client_capsule.c…
Achtung die hauen dort ganz schön auf die Kacke, so viel Geld werden die mit Sicherheit nicht umsetzen.
Die wollen offenbar erst die Marktzulassung mit den alten Daten beantragen, dann die Ergebnisse des 2. Phase III Trial nachreichen. Ich wußte nicht dass das geht
Der Puhvogel

[puhvogel]

* Initiated coverage with BUY (highest) rating and 12-month price target of $18.

* One-year price target based on 25x P/E on $1.36 EPS in 2004, discounted back 35%.

* Believes Anogesic will receive FDA approval in 2Q 2002, with 3Q launch.

* Anogesic revenue estimates are: $7.2 million in 2H 2002; $18.8 million in 2003; $44.6 million in 2004; and $66.2 million in 2005.

* Estimates Tostrex NDA will be filed in early 2002. (WHY NOT FIRST QUARTER AS MANAGEMENT HAS PROMISED?)

* Tostrex revenue estimates are: $34.0 million in 2003; $63.3 million in 2004; and $81.2 million in 2005.
* Full year estimates are:
2002: ($1.39) on $ 11 million in revenue
2003: $0.00 on $ 59 million in revenue
2004: $1.36 on $126 million in revenue
2005: $2.07 on $189 million in revenue

* Believes company will need to do $20-30 million financing in 2002.

* Projects year-end cash balances of: $22 million in 2003; $43 million in 2004; and $85 million in 2005.

[Ciscosys]

Hi Puhvogel,

woher stammen die Daten, Quellenangabe?

Bist Du tatsächlich noch dabei ?

Vielleicht sollte ich ja mit einer kleinen Position wieder rein...


Grüße
Ciscosys

[puhvogel]

Woher ich die Daten habe, weiss ich auch nicht mehr. Sieht nach Yahoo-Board aus.
Aber so etwas denke ich mir nicht aus.
Cellegy habe ich noch, aber ich verfolge die nicht so furchtbar eng.

[tommihe]

Cellegy technisch kurz vor Ausbruch?

[LeonardoOne]

Schaut euch doch mal den Chart von Boston LifeScience an WKN:870149

[puhvogel]

Die BLSI habe ich ja auch, aber was soll mit der sein, außer das die völlig illiquide herumzappelt? Da haben einige Order den Kurs eben mal um 5% hin und hergeschaukelt.
Für Cellegy gilt im Prinzip dasselbe.

[V.Mac]

......fällt wie ein Stein !

Cellegy Pharmaceuticals Inc. (CLGY) plunged $3.70, or 56 percent, to $2.90 after it said it had withdrawn the New Drug Application for its Cellegesic pain ointment

V.Mac

[V.Mac]

Zahlen fürs erste Quartal:

Cellegy Pharmaceuticals Reports First Quarter Financial Results
THURSDAY, MAY 02, 2002 7:30 AM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., May 2, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) reported today that for the first quarter ended March 31, 2002, revenues were $267,000, compared with $41,000 for the same period last year. Revenues during this year`s first quarter consisted of $231,000 in product sales to Gryphon, the product development division of a major specialty retailer and $36,000 of Rectogesic(TM) (nitroglycerin ointment) product sales in Australia. Revenues during last year`s first quarter were $41,000 in Rectogesic product sales.

For the three months ended March 31, 2002, the company had a net loss applicable to common shareholders of $4,387,000 or $0.25 per share, compared with a net loss of $3,777,000 or $0.27 per share for the same period last year. Offsetting higher comparative revenues for this year`s first quarter, were higher operating expenses resulting primarily from certain pre-launch marketing costs for the company`s Cellegesic(TM) (nitroglycerin ointment) product candidate. Clinical trial expenses during the first quarter of 2002 were lower than during the fourth quarter of 2001 due to the completion last year of two Phase III trials. Clinical expenses are expected to remain at reduced levels during the next two quarters and marketing expenses for Cellegesic will decline for, at least, the remainder of this quarter.

Cash and investments at March 31, 2002 were $13.2 million, compared with $17.2 million at December 31, 2001. Under the marketing and sales agreement with Ventiv Health, in which Ventiv agreed to advance funding for the majority of pre-launch marketing expenses for Cellegesic, Cellegy`s repayment obligation to Ventiv at March 31, 2002 is approximately $890,000. Based on Cellegy`s withdrawal of its Cellegesic NDA previously announced on April 26, 2002, Cellegy and Ventiv will minimize marketing spending and defer marketing programs until Cellegy decides on its future strategies with respect to Cellegesic.

Commenting on the financial results, K. Michael Forrest, Chairman and CEO, said, "In light of our recent announcement to withdraw the Cellegesic NDA, we are carefully evaluating our project priorities. We intend to control spending and preserve cash, while expeditiously filing our Tostrex NDA and continuing our core product development programs."

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused on the areas of gastroenterology, sexual dysfunction in males and females, and various women`s health conditions. In June 2001, the company filed an NDA on Cellegesic for the treatment of pain associated with chronic anal fissures. On April 26, 2002, Cellegy announced the withdrawal of this NDA. The company plans to meet with the FDA before determining its strategies with regard to Cellegesic.

The company has announced positive results of a pivotal Phase III trial with its second product, Tostrex(TM) (testosterone gel) for the treatment of male hypogonadism. Cellegy plans to file an NDA on this product during the second quarter of 2002. The third product in Cellegy`s pipeline, Tostrelle(TM), a transdermal testosterone gel for the treatment of female sexual dysfunction entered into advanced clinical testing during the first quarter of 2002. Other pipeline products include nitric oxide donors for the treatment of sexual dysfunction in females, Raynaud`s Disease, Restless Leg Syndrome, and prostate cancer, as well as products for the treatment of male erectile dysfunction

V.Mac

[V.Mac]

Ist das der nächste Hoffnungsschimmer ?

Schön wärs.

Cellegy Pharmaceuticals Submits Tostrex(TM) New Drug Application
MONDAY, JUNE 03, 2002 2:45 PM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., Jun 3, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced that it has submitted a New Drug Application ("NDA") for Tostrex(TM) (testosterone gel) for treatment of male hypogonandism to the FDA.

"Following a pre-NDA meeting with FDA officials and successful completion of a pivotal Phase III trial late last year, we have now assembled and submitted the required data for our Tostrex NDA," said William L. Schary, Ph.D., Vice President, Regulatory Affairs and Quality. "We believe that the clinical trial results and all other supporting data represent an approvable NDA and we look forward to a straightforward review of this application by the FDA."

Approximately five million American men have abnormally low levels of the testosterone hormone, a condition known as hypogonadism. Hypogonadism usually results in diminished sexual function, lethargy and reduced bone and muscle mass in men. The current sales volume of products for the treatment of hypogonadism is estimated to reach $240 million this year, up sharply as a result of increasing awareness of the importance of hormone replacement therapy. Even so, only a relatively small number of men, less than 5% of the estimated number of people who are afflicted with the condition, are currently being treated. This number is expected to rise as better treatment options become available in the United States.

Tostrex is a clear, non-staining testosterone gel which will be administered to a small area on the thighs once a day. Tostrex is covered by an issued patent in the United States; patents are pending in all important overseas markets. Tostrex will be provided in a proprietary metered dose cannister, which allows for easy administration of precise doses required to meet individual patients` needs.

Cellegy is exploring co-promotion opportunities for Tostrex with leading pharmaceutical companies in the United States and is entertaining outlicensing possibilities for the product in overseas markets.

---------------------------------------------------

V.Mac

[V.Mac]

oder bewirkt das einen weiteren Anstieg ?


Cellegy Issued U.S. Patent Covering Use of PDE Inhibitors for Treatment of Anorectal Disorders

WEDNESDAY, JUNE 05, 2002 7:30 AM - PRNewswire

SOUTH SAN FRANCISCO, Calif., Jun 5, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that the United States Patent and Trademark Office (USPTO) has issued patent number 6,319,869 entitled "Compositions and Methods for the Treatment of Anorectal Disorders."

This patent delineates methods of treating anorectal disorders with topical phosphodiesterase (PDE) inhibitors, alone or in combination with other compounds. The methods involve topically administering therapeutically effective amounts of various types of phosphodiesterase inhibitors.

PDE inhibitors enhance and prolong smooth muscle relaxation, and thus are useful in treating various types of anorectal disorders including anal fissures and hemorrhoids. Viagra(R) is an example of a commonly used PDE inhibitor that, through a similar mechanism of action, restores penile function in men with erectile dysfunction.

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused in the areas of gastroenterology, sexual dysfunction in males and females, and various women`s health conditions.

Cellegy has a number of late stage products in its development pipeline. The company is developing Cellegesic(R) (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures and plans to meet soon with FDA officials to discuss next steps regarding requirements for approvability of the drug. The PDE inhibitor program provides Cellegy with compounds having mechanisms other than nitroglycerin for treating anal fissures and hemorrhoids.

The company recently announced that it has filed an NDA covering its product, Tostrex(TM) (testosterone gel), for the treatment of male hypogonadism. The third product in Cellegy`s pipeline, Tostrelle(TM), a transdermal testosterone gel for the treatment of female sexual dysfunction entered into Phase II/III clinical testing during the first quarter of 2002.

Other pipeline products include nitric oxide donors for the treatment of sexual dysfunction in females, Raynaud`s Disease, Restless Leg Syndrome, and prostate cancer, as well as products for the treatment of male erectile dysfunction. Cellegy is currently exploring various partnering opportunities for these product candidates in the United States and international markets.
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V.Mac

[V.Mac]

heute gehts mal wieder etwas nach oben, wohl auch wegen erfolgter Gespräche mit der FDA.

Article for Cellegy Pharmaceuticals Inc

Cellegy Reports on Meeting With the FDA regarding Cellegesic
TUESDAY, JUNE 18, 2002 7:00 AM- PRNewswire

SOUTH SAN FRANCISCO, Calif., Jun 18, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that it met last week with the U.S. Food and Drug Administration (FDA) regarding its Cellegesic(TM) (nitroglycerin ointment) product candidate for the treatment of pain associated with chronic anal fissures. On April 26, 2002, Cellegy announced that it had withdrawn its New Drug Application (NDA) for Cellegesic, and that it planned to meet again with the FDA in order to obtain greater clarity on the Agency`s requirements for marketing approval.

"We were pleased with the tenor of the dialogue which was constructive and in line with our expectation when we withdrew the NDA," commented K. Michael Forrest, Chief Executive Officer of Cellegy. "Supplemental analyses will be provided and additional meetings may need to take place. Although it is too early to predict the timing and outcome of the discussions, possible outcomes include a re-submission of the withdrawn NDA or the need for additional clinical trials. We continue to believe that Cellegesic is an effective and well tolerated product for the treatment of chronic anal fissure pain."

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused on the areas of gastroenterology, sexual dysfunction in males and females, and various women`s health conditions.

In addition to Cellegesic, Cellegy has several product candidates at various stages of clinical development in its pipeline. The company recently filed an NDA on its second product, Tostrex(TM) (testosterone gel), for the treatment of male hypogonadism. The third product in Cellegy`s pipeline, Tostrelle(TM), a transdermal testosterone gel for the treatment of female sexual dysfunction, entered into Phase II/III clinical testing during the first quarter of 2002. Other pipeline products include nitric oxide donors for the treatment of sexual dysfunction in females, Raynaud`s Disease, Restless Leg Syndrome, and prostate cancer, as well as products for the treatment of male erectile dysfunction. Cellegy is currently exploring various partnering opportunities for these product candidates in the U.S. and international markets.


V.Mac

[V.Mac]

und wieder was neues.

Cellegy Issued U.S. Patent Covering Use of Potassium Channel Openers For Treatment of Anorectal Disorders
TUESDAY, JUNE 25, 2002 7:00 AM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., Jun 25, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that the United States Patent and Trademark Office (USPTO) has issued a patent (US 6,395,736) that covers methods of treating anorectal disorders by administering certain concentrations of topical potassium channel openers to the anorectal region in order to decrease abnormally high pressure of the anal sphincter muscle. The disorders disclosed in the patent include anal fissures, hemorrhoids and constipation.

Potassium channel openers help smooth muscle relaxation and, therefore, are anticipated to provide useful medical options in treating anorectal disorders. Data obtained from in vivo experiments demonstrated effective internal anal sphincter relaxation with administration of various potassium channel openers. These agents are expected to compliment Cellegesic`s(R) (nitroglycerin ointment) effect on smooth muscle relaxation.

Dr. Vivien Mak, Vice President of Research at Cellegy, commented, "Over the past two weeks, Cellegy has been issued two important United States patents (covering the use of PDE inhibitors and potassium channel openers) that result from our ongoing efforts to develop products for the treatment of fissures and hemorrhoids. Such products are expected to deepen our Cellegesic product line through the development of new dosage forms, line extensions and product improvements in order to maximize the commercial potential of Cellegy`s investment in this greatly underserved therapeutic area. Our patent portfolio in this field has been significantly strengthened by the two recently issued patents."

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused on the areas of gastroenterology, sexual dysfunction in males and females, and various women`s health conditions.

Cellegy has a significant pipeline of late stage products. Apart from Cellegesic, which is the subject of ongoing discussions with the FDA regarding requirements for marketing approval in the United States, the company recently announced that it has filed an NDA (New Drug Application) on its patented product Tostrex(TM) (testosterone gel), for the treatment of male hypogonadism. Another product in Cellegy`s pipeline, Tostrelle(TM), a transdermal testosterone gel for the treatment of female sexual dysfunction entered into Phase II/III clinical testing during the first quarter of 2002. Additional pipeline products include nitric oxide donors for the treatment of dyspareunia (a form of sexual dysfunction) in females, Raynaud`s Disease, Restless Leg Syndrome, and prostate cancer, as well as products for the treatment of male erectile dysfunction. Cellegy is currently exploring various partnering opportunities for these patent protected product candidates in the United States and international markets.

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V.Mac

[V.Mac]

Sollten wir das ATL bei 1,50 USD gestern intraday gefunden haben ? Heute gehts zumindest mal wieder über die 2 USD-Marke. Wäre ja schön, wenns Richtung 3 USD ginge.

V.Mac

[V.Mac]

eine Meldung, was auch sonst !

Cellegy Issued U.S. Patent Covering Use of Nitric Oxide Donors And Phosphodiesterase Inhibitors for the Treatment of Female Sexual Dysfunction and Raynaud`s Disease
TUESDAY, JULY 30, 2002 7:30 AM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., Jul 30, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that the United States Patent and Trademark Office (USPTO) has issued patent number 6,423,683 entitled "Microdose Therapy."

This patent delineates methods of treating several peripheral vascular disease states, including female sexual dysfunction and Raynaud`s Disease, using a nitric oxide donor (such as nitroglycerin) or a phosphodiesterase inhibitor, such as sildenafil citrate (Viagra(R), Pfizer). Diminished levels of endogenous nitric oxide have been associated, at least in part, with these diseases.

It is estimated that the incidence of female sexual dysfunction could be almost double the incidence of male erectile dysfunction. Raynaud`s Disease, a vasoconstrictive condition causing pain and discomfort to the fingers and toes of an estimated 28 million people in the United States, can occur in both men and women. Recent data indicates that up to 75% of the patients diagnosed with this disease are female. With no currently FDA-approved products on the market, these disease states represent significant unmet medical needs in the field of women`s health.

"The issuance of this important patent continues to demonstrate Cellegy`s understanding of low dose nitric oxide as a novel approach in the treatment of female sexual dysfunction and Raynaud`s Disease," stated Dr. Vivien Mak, Vice President of Research at Cellegy. Furthermore, Dr. Mak added, "Supplementation with appropriate levels of nitric oxide donor compounds, or phosphodiesterase inhibitors, may lead to the restoration of normal levels and cellular function without causing unwanted side effects such as headaches that are commonly associated with current doses of nitric oxide donor compounds."

In a study supported by Cellegy, Dr. Jennifer Berman at UCLA Medical Center obtained positive results from an initial pilot clinical study using nitroglycerin ointment in the treatment of vulvodynia (pain experienced with sexual intercourse). Vulvodynia is considered a subset of female sexual dysfunction. Cellegy plans to move forward into formal clinical programs to develop treatments covered by this patent via a combination of internal product development efforts and external corporate partnerships.

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused in the areas of gastroenterology, sexual dysfunction in males and females, and various women`s health conditions. Cellegy has a number of late stage products in its development pipeline. The company is developing Cellegesic(R) (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures and has recently met with FDA officials to discuss the next steps regarding requirements for approvability of the product.

The company recently announced that it has filed an NDA covering its product, Tostrex(TM) (testosterone gel), for the treatment of male hypogonadism. The third product in Cellegy`s pipeline, Tostrelle(TM), a transdermal testosterone gel for the treatment of female sexual dysfunction due to testosterone deficiency entered into Phase II/III clinical testing during the first quarter of 2002. Other pipeline products include nitric oxide donors for the treatment of Restless Leg Syndrome and prostate cancer, as well as products for the treatment of male erectile dysfunction. Cellegy is currently exploring various partnering opportunities for these product candidates in the United States and international markets.

------------------------------------

wenns dem Kurs hilft !

V.Mac

[V.Mac]

Q-2 Zahlen per heute (gestern). Man müsste nur wissen, was eigentlich erwartet war. Ich werde momentan nicht so schlau draus. Auf jeden Fall sollte die Kohle bei der jetztigen Cash-burn-rate noch rund 10 MOnate langen. Wird wohl Zeit, dass die FDA endlich ne Zulasung ausspricht.

Der Kurs in USA hat auf jeden Fall nachgegeben.

Hope the best. !!

Cellegy Pharmaceuticals Reports Second Quarter Financial Results
TUESDAY, AUGUST 06, 2002 7:31 AM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., Aug 6, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) reported today that for the second quarter ended June 30, 2002, revenues were $150,000, compared with $53,000 for the same period last year. Revenues during this year`s second quarter consisted of $55,000 in cosmeceutical product sales and $95,000 of Rectogesic(TM) (nitroglycerin ointment) product sales in Australia. Revenues during last year`s second quarter consisted of $53,000 in Rectogesic product sales. For the six months ended June 30, 2002, revenues were $417,000 consisting of $287,000 in cosmeceutical product sales, primarily sales to Gryphon, the product development division of a specialty retailer, and $130,000 in Rectogesic sales. Revenues for the first six months of last year were $94,000 consisting entirely of Rectogesic sales.

For the three months ended June 30, 2002, the Company had a net loss applicable to common shareholders of $5,624,000 or $0.32 per share, compared with a net loss of $4,156,000 or $0.29 per share for the same period last year. For the six months ended June 30, 2002, the net loss applicable to common shareholders was $10,010,000 or $0.58 per share, compared with a net loss of $7,933,000 or $0.56 per share for the same period last year. Compared with the first half of last year, higher revenues for this year were offset by higher operating expenses resulting primarily from pre-launch marketing costs for the company`s Cellegesic(TM) (nitroglycerin ointment) product candidate. Cellegy expects that clinical and marketing expenses for Cellegesic will be minimal for the remainder of the current quarter ended September 30, 2002. Expense levels for the fourth quarter will be influenced by the FDA`s recommendation regarding the next steps for Cellegesic.

Cellegy has initiated several cost reduction programs, including the elimination or deferral of non-core research programs, a salary reduction for executives and certain other employees, and a reduction in force of nine employees. These programs have reduced the monthly cash flow (burn rate) by about 40% from the second quarter rate to a current rate of about $900,000 per month. This excludes any potential income from corporate partnerships, which are actively being pursued and evaluated. The Company will continue to aggressively pursue its clinical, regulatory and development programs, as necessary, for key product candidates: Cellegesic, Tostrex and Tostrelle.

Cash and investments at June 30, 2002 were $8.4 million, compared with $17.2 million at December 31, 2002. Under the marketing and sales agreement with Ventiv Health, in which Ventiv agreed to advance funding for the majority of the pre-launch marketing expenses for Cellegesic, Cellegy`s repayment obligation to Ventiv at June 30, 2002 was approximately $1.5 million. Based on Cellegy`s withdrawal of its Cellegesic NDA, previously announced on April 26, 2002, Cellegy and Ventiv have suspended marketing expenditures until the regulatory status of Cellegesic is clarified. If the Ventiv contract is terminated, Cellegy is obliged to repay one half of the $1.5 million.

Commenting on the financial results, K. Michael Forrest, Chairman and CEO said, "In light of our withdrawal of the Cellegesic NDA and poor market conditions, we have taken steps to conserve cash resources and to focus even more sharply on our most advanced products. During the quarter, we filed our NDA on Tostrex and are pleased to report that the NDA has been accepted for review by the FDA. We are in active discussions with a number of potential partners who are interested in overseas and U.S. rights to Tostrex. During this quarter, we also held substantial discussions with the FDA regarding Cellegesic and are now awaiting a decision from the Agency as to whether they will permit us to re-file the NDA or require an additional trial before the re-submission can take place. With regard to Tostrelle, our Phase II/III trial for the treatment of female sexual dysfunction continues to progress satisfactorily."

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused on the areas of gastroenterology, sexual dysfunction in males and females, and various women`s health conditions.

In June 2001, the company filed an NDA on Cellegesic for the treatment of pain associated with chronic anal fissures. On April 26, 2002, Cellegy announced the withdrawal of this NDA. The company has subsequently met with the FDA to determine their requirements, has submitted additional information to the FDA and is awaiting the Agency`s recommendation as to the next steps with regard to considering marketing approval of Cellegesic.

The company has announced positive results of a pivotal Phase III trial with its second product, Tostrex(TM) (testosterone gel) for the treatment of male hypogonadism. Cellegy filed the Tostrex NDA during the second quarter of 2002, and that filing has been accepted for review by the FDA. The third product in Cellegy`s pipeline, Tostrelle(TM), a transdermal testosterone gel for the treatment of female sexual dysfunction entered into advanced clinical testing during the first quarter of 2002. Other pipeline products include nitric oxide donors for the treatment of sexual dysfunction in females, Raynaud`s Disease, Restless Leg Syndrome, and prostate cancer, as well as products for the treatment of male erectile dysfunction.
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V.Mac

[V.Mac]

von den Tiefstständen um 1,50 USD haben wir uns in den letzten Wochen ja deutlich erholt.
Ein weiterer Grund für einen nachaltenden Aufschwung dürfte die nachfolgend eingestellt Meldung sein.


Cellegy Pharmaceuticals Announces Positive Results Using Nitroglycerin For Female Sexual Dysfunction
WEDNESDAY, AUGUST 21, 2002 7:00 AM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., Aug 21, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that in the July/August issue of The Journal of Gender-Specific Medicine, results were reported from a study, supported by Cellegy Pharmaceuticals, regarding the use of topical nitroglycerin (NTG) for the treatment of women with vulvodynia. The paper was authored by Dr. Kathleen Walsh and her co-investigators at the University of California, Los Angeles Medical Center.

Vulvodynia is categorized by symptoms of vulvar pain, regardless of etiology. This pain is usually cyclic, occurring just before or during menses and is exacerbated by sexual intercourse. It is estimated that vulvodynia affects as many as 15% of women in the general gynecologic population. Currently, there are no approved medical treatments indicated for the treatment of vulvodynia.

This open label study included 34 women diagnosed with vulvodynia. Topical treatment with NTG was initiated in the clinic and was continued at home for four to six weeks. Patients were instructed to use topical nitroglycerin five to ten minutes before sexual relations and, as part of the study, patients completed pre and post treatment questionnaires.

An improvement in pain was reported by 91.5% of patients (31/34). Significant decreases in pain intensity (P<.0001) and frequency of overall pain (P<.006) were also reported. The most common side effect was headache.

Dr. Jennifer Berman, one of the study`s co-investigators commented, "Topical NTG is safe and effective in providing pain relief of vulvodynia. This will be a significant advance in the medical treatment of a painful condition that affects millions of women."

Cellegy has a number of issued and pending patents on the use of nitric oxide donors for the treatment of female sexual dysfunction, and intends to develop a topical NTG product for vulvodynia.

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused in the areas of gastroenterology, sexual dysfunction in males and females, and various women`s health conditions. Cellegy has a number of late stage products in its development pipeline. The company is developing Cellegesic(TM) (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures and has recently met with FDA officials to discuss the next steps regarding requirements for approvability of the product.

The company`s NDA covering Tostrex(TM) (testosterone gel), for the treatment of male hypogonadism, has recently been accepted for review by the FDA. The third product in Cellegy`s pipeline, Tostrelle(TM), a transdermal testosterone gel for the treatment of female sexual dysfunction due to testosterone deficiency entered into Phase II/III clinical testing during the first quarter of 2002. Other pipeline products include nitric oxide donors for the treatment of Restless Leg Syndrome and prostate cancer, as well as products for the treatment of male erectile dysfunction. Cellegy is currently exploring various partnering opportunities for these product candidates in the United States and international markets.

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Weiter nach oben wäre schön.

V.Mac

[V.Mac]

heute gibts wieder Meldungen. Zuerst wird die Gründung eines Beratungs-Boards bekannt gegeben und die einzelnen Personen vorgestellt. Wohl nicht so kursbeinflussend, denke ich.

Female Sexual Health Advisory Board Formed by Cellegy Pharmaceuticals
THURSDAY, SEPTEMBER 05, 2002 7:30 AM
- PRNewswire

SOUTH SAN FRANCISCO, Calif., Sep 5, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today the formation of a Female Sexual Health Advisory Board. The members of the board, prominent clinicians and scientists with extensive clinical and research experience in the treatment of female health disorders, will advise Cellegy during the development of its products for the treatment of sexual dysfunction.


Members of the Advisory Board include:

Jennifer R. Berman, M.D., Assistant Professor Urology and Gynecology, UCLA School of Medicine. Dr. Berman and her sister, Laura Berman, LCSW, Ph.D., are co-directors and founders of the Female Sexual Medical Center in the Department of Urology. Drs. Berman have published many articles on female sexual dysfunction, including results recently reported in The Journal of Gender-Specific Medicine from a study, supported by Cellegy Pharmaceuticals, regarding the use of topical nitroglycerin (NTG) for the treatment of women with vulvodynia. Dr. Berman also co-authored the New York Times best-selling book, For Women Only: A Revolutionary Guide to Overcoming Sexual Dysfunction and Reclaiming Your Sex Life.

Susan R. Davis, M.D., Ph.D., Founder and Director of Research of the Jean Hailes Foundation in Clayton, Victoria, Australia. Dr. Davis focuses her research and clinical practice on the role of androgens in women, factors affecting reproductive health in women, and menopause and its influence on women`s health. She has published numerous articles, papers and abstracts and has written two books for women: The Healthy Woman and Our Health, Our Lives. Dr. Davis is the recipient of the Robert Greenblatt Prize for Research from the International Menopause Society in 1993. In 2000, she received the Glenn Aging Award of The Endocrine Society and the International Glaxo Team Award for diabetes education.

Andre T. Guay, M.D., Clinical Assistant Professor of Medicine (Endocrinology), Harvard Medical School and Director, Center for Sexual Dysfunction, Leahy Clinic Northshore, Peabody, Massachusetts. Dr. Guay has published extensively in the areas of reproductive endocrinology and neuroendocrinology. His current areas of research are male and female sexual dysfunction, specifically male and female testosterone deficiency.

Morrie M. Gelfand, CM, M.D., Professor of Obstetrics and Gynecology, McGill University School of Medicine, Montreal, Quebec, Canada. Dr. Gelfand has been involved in the management of menopause for over 20 years and was a co-investigator in the original demonstration of the effectiveness of testosterone in female sexual dysfunction. He was past president of the Society of Obstetricians and Gynecologists of Canada and is currently president of the North American Menopause Society.

Jeanne Leventhal Alexander, M.D., Regional Director of the Northern California Kaiser Psychiatry Women`s Health Program and a regional champion/director for Best Practices on Mood and Menopause as well as Libido and Menopause. She is an Assistant Clinical Professor of Psychiatry at Stanford Medical School and is the Director of the Kaiser Women`s Wellness Psychiatry Seminar; an educational program distributed throughout the Kaiser system nationwide via videotape. She recently started a non-profit foundation, The Alexander Foundation for Women`s Health, whose goals are advancing knowledge in women`s health for physicians and patients.

Raymond C. Rosen, Ph.D., Professor of Psychiatry and Medicine at the Robert Wood Johnson Medicine School, Piscataway, New Jersey. He is also Director, Program in Human Sexuality, and Director, Sexual Pharmacology Unit. Dr. Rosen is past president of the International Academy of Sex Research and former editor of the Annual Review of Sex Research. He is Vice Chair of the 2nd International Consultation on Erectile and Sexual Dysfunction, and the recent recipient of the Masters and Johnson Award for distinguished contributions to sexuality education and research. Dr. Rosen was co-chair of the recent Princeton Consensus Conference on Androgen Insufficiency in Women. He has published nine books, 28 book chapters and more than 130 papers in aspects of sexuality and sexual dysfunction.

Daniel L. Azarnoff, M.D., Cellegy`s Senior Vice President, Clinical and Regulatory Affairs said, "We are gratified to have attracted physicians and scientists of the high caliber of our board members as advisors during development of Tostrelle(TM) (testosterone gel), Cellegesic(TM) (nitroglycerin ointment) and other nitric oxide donors for the treatment of female sexual dysfunction. Cellegy`s portfolio of products holds significant potential to improve the lives of women suffering from a variety of conditions that interfere with their sexual well-being."

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused in the areas of gastroenterology, the treatment of sexual dysfunction in males and females and the treatment of various women`s health disorders.

The Company is currently conducting an advanced clinical trial using Tostrelle(TM) (testosterone gel) for the treatment of diminished libido in menopausal women. Cellegy also plans to conduct a clinical trial using nitroglycerin ointment for the treatment of dyspareunia, a condition in which women experience pain before, during or after sexual intercourse. These two conditions are estimated to affect as many as 20 million women in the United States alone.

In addition to its products for female sexual dysfunction, the Company is developing Cellegesic(TM) (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. In April 2002, Cellegy announced that it had withdrawn its NDA for Cellegesic. After subsequent discussions with the FDA, Cellegy submitted additional information to the Agency and is now awaiting a decision regarding requirements for approvability of the product.

On the basis of positive results achieved in a pivotal Phase III trial with Tostrex(TM) (testosterone gel) for the treatment of male hypogonadism, Cellegy filed an NDA which has been accepted for review by the FDA. Other pipeline products include nitric oxide donors for the treatment of sexual dysfunction in females, Raynaud`s Disease, and prostate cancer, as well as products for the treatment of male erectile dysfunction.

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und weiter gehts: die Meldung verspricht eher mal wieder steigende Kurse, auch wenn erst mal weitere Kosten auf Cellegy zukommen. Aber langfristig........!

Cellegy to conduct additional trial of Cellegesic (CLGY) By Michael Baron
Cellegy Pharmaceuticals (CLGY) is providing an update on the regulatory status of Cellegesic nitoglycerin ointment for the treatment of pain caused by chronic anal fissures. The company said that the Food and Drug Administration will require an additional phase III clinical trial to obtain approval of Cellegesic. Cellegy withdrew its new drug application for Cellegesic in April. The company now plans to conduct the confirmatory trial, which it believes will be smaller and shorter than its previous trial, then re-file the new drug application. Cellegy believes it can complete the trial at a cost of $1.5 million to $2 million. The stock closed Friday flat at $2.40.


Wenns hilft ....?

V.Mac

[V.Mac]

Die Kursgewinne der letzten Tage (Wochen) haben sich ja schnell wieder in Luft aufgelöst. Am Donnerstag (morgen) nimmt Cellegy an einem Meeting teil. Vielleicht gibts ja "BREAKING NEWS".

Cellegy to Present at Bear Stearns Healthcare Conference
MONDAY, SEPTEMBER 16, 2002 8:00 AM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., Sep 16, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that it will present at the Bear Stearns 15th Annual Healthcare Conference being held this week at The Waldorf-Astoria in New York. Cellegy`s presentation is scheduled for 8:00 a.m. EDT on Thursday, September 19, 2002. Mr. K. Michael Forrest, Cellegy`s Chairman and CEO, will provide an update on Cellegesic and Tostrex trial results and timelines, as well as its current financial status.

Bear Stearns is a leading investment bank with a significant focus and major presence in healthcare. The conference features leading pharmaceutical and biotech companies presenting to portfolio managers and institutional investors.

We invite our stockholders and other interested parties to access the presentation through our website at www.cellegy.com.

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused in the areas of gastroenterology, the treatment of sexual dysfunction in males and females and the treatment of various women`s health disorders.

Cellegy has a number of late stage products in its development pipeline, including Tostrex(TM) (testosterone gel), for the treatment of male hypogonadism. The Company`s NDA for Tostrex has recently been accepted for review by the FDA. Cellegy`s other testosterone product, Tostrelle(TM), for the treatment of female sexual dysfunction due to testosterone deficiency, entered into Phase II/III clinical testing during the first quarter of 2002.

In addition to its testosterone products, the Company is developing Cellegesic(TM) (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. Cellegy plans to conduct an additional Phase III clinical trial which will be designed to confirm the significant pain reduction achieved by the product in two previous large, randomized Phase III trials. The new trial, expected to be a comparatively smaller study, will commence following FDA review and acceptance of the protocol. Other pipeline products include nitric oxide donors for the treatment of sexual dysfunction in females, Raynaud`s Disease, and prostate cancer, as well as products for the treatment of male erectile dysfunction. Cellegy also plans to conduct a clinical trial using nitroglycerin ointment for the treatment of dyspareunia, a condition in which women experience pain before, during or after sexual intercourse.

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Wenns hilft.

V.Mac

[V.Mac]

so richtige "Breaking News" hats bisher nicht gegeben, aber das Personal an Board wird wieder aufgestockt.

Dr. David Karlin Joins Cellegy Pharmaceuticals as Vice President, Clinical Research
FRIDAY, OCTOBER 25, 2002 8:00 AM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., Oct 25, 2002 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that it has appointed David A. Karlin, M.D., to the position of Vice President, Clinical Research. Dr. Karlin will serve as an officer of the company, reporting to K. Michael Forrest, Cellegy`s CEO. He will be responsible for worldwide clinical development of all the company`s product candidates.

Dr. Karlin has over 16 years of biopharmaceutical industry product development experience in gastroenterology, hepatology, oncology, cystic fibrosis, antiemetics, analgesics, gene therapy and DNA vaccines. Before joining Cellegy, Dr. Karlin served in senior clinical development positions at several biotechnology companies, including Genteric, Inc., Matrix Pharmaceutical and SciClone Pharmaceuticals. Dr. Karlin also held key positions at Syntex Corporation, including Director of Medical Research and Clinical Program Team Leader, Senior Clinical Research Physician for Syntex Medical Research (Europe), Associate Medical Director and Head, Gastroenterology and Anti-Ulcer Therapy for Syntex (USA).

"David`s background and experience will add measurably to Cellegy`s clinical trial expertise for both near-to-market products and those that are in Cellegy`s pipeline," said Mr. Michael Forrest. "We are particularly pleased to have additional gastroenterology and oncology experience in our clinical group as we move forward with a confirmatory trial on Cellegesic(TM) ointment and with early investigations of the effects of nitric oxide donors on metastases and chemotherapeutic drug resistance."

Before joining the biopharmaceutical industry, Dr. Karlin had a distinguished career in academic medicine as Associate Professor, Department of Medicine, Gastroenterology Section at the Temple University School of Medicine; Assistant Professor, Department of Medicine, Gastroenterology Section at the University of Texas M.D. Anderson Hospital and Tumor Institute; and Instructor, Department of Medicine, Gastroenterology Section at the University of Chicago. Dr. Karlin held the rank of Major USAF MC for the Department of Medicine Staff Gastroenterology Service and Staff Hematology Oncology Service at the Lackland Air Force Base in San Antonio, Texas.

Dr. Karlin received his medical degree from the University of Chicago, and subsequently completed his Internal Medicine residency at the University of Michigan, and Gastroenterology and Gastrointestinal Oncology training at the University of Chicago.

Cellegy Pharmaceuticals is a specialty biopharmaceutical company focused in the areas of gastroenterology, the treatment of sexual dysfunction in males and females and the treatment of various women`s health disorders.

Cellegy has a number of late stage products in its development pipeline, including Tostrex(TM) gel, for the treatment of male hypogonadism. The Company`s NDA for Tostrex has been accepted for review by the FDA. Cellegy`s other testosterone product, Tostrelle(TM) gel, for the treatment of female sexual dysfunction due to testosterone deficiency, entered into Phase II/III clinical testing during the first quarter of 2002.

In addition to its testosterone products, the Company is developing Cellegesic(TM) ointment for the treatment of pain associated with chronic anal fissures. Cellegy plans to conduct an additional Phase III clinical trial which will be designed to confirm the significant pain reduction achieved by the product in two previous large, randomized Phase III trials. The new trial, expected to be a comparatively smaller study, will commence following FDA review and acceptance of the protocol. Other pipeline products include nitric oxide donors for the treatment of sexual dysfunction in females, Raynaud`s Disease, and prostate cancer, as well as products for the treatment of male erectile dysfunction. Cellegy also plans to conduct a clinical trial using nitroglycerin ointment for the treatment of dyspareunia, a condition in which women experience pain before, during or after sexual intercourse.

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Wenns dem Kurs hilft...

V.Mac

[V.Mac]

Wir haben jetzt innerhalb von 8 bis 10 Tagen den Niedergang im Tief bis 1,28 USD oder so gesehen, um bis heute wieder bis 2,35 USD im Hoch zu steigen.

Warum ?


Meldungen hab ich keine gefunden. Aber es geht auch ohne News, wenns nur weiter nach oben geht.

V.Mac

[V.Mac]

Hallo, Leute

Ein Grund für den Anstieg der letzten 14 Tage könnte heute publik geworden sein.
Cellegy hat in einem "Private Placement" 2,2 Mio Aktien für USd 2,50 pro an einen Investor verkauft, der damit insgesamt knapp 20% an Cellegy hält.

Na, und wenn EIN Mann soviel investiert, macht der das doch nicht, um seinem Geld mal hinterherzuweinen.

Also:

Weiter nufff!

V.Mac

[V.Mac]

Heute hat sich Cellegy sogar noch mal etwas gestärkt gezeigt, was den Schlusskurs angeht.

Mir ist recht. Wenn in einem Jahr wieder der zweistellige Berich drin ist, fände ich das gut genug.

V.Mac

[V.Mac]

Q-3 Zahlen per 11.11.02, gar nicht so schlecht, wie ich finde.

Verlust wurde deutlich reduziert, allerdings fiel auch der Umsatz recht schmal aus.

Die Meldung:

Cellegy narrows loss in Q3 (CLGY) By Michael Baron
Cellegy Pharmaceuticals (CLGY) is reported a third-quarter loss of $1.6 million, or 9 cents a share, down from its year-ago loss of $3.9 million, or 23 cents a share, and narrower than the average estimate of two analysts polled by Thomson First Call for a loss of 9 cents a share. Revenue slipped to $145,000 in the latest three months from $265,000 in the same period a year earlier. Cellegy also said that it recently received orders totaling about $800,000 from Gryphon that it expects to record in the fourth quarter. The company said that it`s in active talks with potential partners interested in marketing rights to Tostrex, and it has also held discussions with the Food and Drug Administration regarding the phase III protocol for Cellegesic.


V.Mac

[V.Mac]

Diese Woche Schlusskurs auf 6 Monatshoch, seit dem Crash im Mai 2002. Sollte es jetzt wieder bis auf die 6 USD hochgehen ? Würde mich sehr freuen, wenn wir das in den nächsten 6 Monaten sehen würden.

V.Mac

[V.Mac]

Also, zur Zeit macht mir Cellegy am meisten Freude von meinen Aktien.

Schon wieder Schlusskurs auf 6 Monatshoch.

Weiter so..

V.Mac

[V.Mac]

Also langsam wirds mir richtig unheimlich. Das geht nun schon drei Wochen so, dass meistens auf Tageshoch geschlossen wird. Heute wars USD 3,80.

Das geht mir fast schon zu schnell. Bin mal gespannt wann es zu ersten Gewinnmitnahmen kommt. Und was auch ganz schön ist, ist das dovch etwas überddurchschnittliche Handelsvolumen (in den USA, bei uns so gut wie kein HAndel)). Spricht doch eigentlich für weiter steigende Kurse.


V.Mac

[V.Mac]

Mal ne andere Frage: Bin ich eigentlich jetzt hier der einzige, der sich noch für Cellegy interessiert ?

Komisch, seit ich mein erstes Posting hier rein geschrieben habe, gibts keine anderen Meinungen/Stimmungen mehr ?!?

Naja, vielleicht schreibt ja doch noch mal jemand seine Einschätzung dazu.

V.Mac

[V.Mac]

Cellegy hält die in letzter Zeit erzielten Gewinne momentan ganz gut, heute wieder in der Range von ca 3,70 USD bis 3,88 USD.

Schön so.

V.Mac

[V.Mac]

Nachdem Cellegy in den letzte 6 Wochen hervorragend gelaufen war, habe ich mich (so kurz vor Weihnachten..) entschlossen, mal die Gewinne mitzunehmen und bin aus der Aktie raus.

Aber ich beobachte da mal weiter und wenn das Niveau wieder etwa in die Range von 2,50 USD zurückkommt, na warum nicht ein zweites mal ?

Aber die ganzen News werde ich momentan nicht mehr einstellen, hat ja eh kaum jemanden interessiert.

V.Mac

[V.Mac]

tja......vielleicht bin doch zu früh raus ?
ging immerhin schon bis USD 4,50 in den letzten Tagen.

Guten Rutsch euch allen !

V.Mac

[V.Mac]

Vielleicht bietet sich jetzt hier die weiter oben genannte 2. Chance.

Die FDA hat ein Medikament nicht zugelassen, na und da ging es kräftig abwärts.

Aber: Cellegy macht ja weiter. Meine Hoffnung steigt, dass man da noch mal einen Aufschwung mitmachen kann.

Werde mal wieder näher am Ball bleiben.

V.Mac

[Heinerle2]

Ich habe mir unmittelbar nach dem ersten Schreck ein paar gekauft - wie sich heute herausstellt, zu früh, but we will see

Greetinxx Heinerle2

[V.Mac]

also ich beabsichtige auch, für knapp unter 2 € mein Glück ein zweites Mal mit der Aktie zu versuchen. Werde mal am Montag sehen, ob ein paar Stücke für mich abfallen.

Was ich allerdings noch nicht geprüft habe, ist, wie weit die Kapitaldecke noch langt, bevor der Laden vielleicht zumachen muß. Aber bekanntlich stirbt ja die Hoffnung zuletzt.

V.Mac

[V.Mac]

vielleicht kann mir mal noch jemand sagen, ob ich das so richtig sehe.

Per 31.3.03 weist Cellegy ein operating loss von knapp 2,7 Mio USD aus. Dazu kommen noch Zinsen und damit ergibt sich ein "net loss" von rund 3,2 Mio USD

Auf der anderen Seite wird "cash u. investments" und "other assets" mit rund 24,7 Mio § ausgewiesen. Die "liabilities" (= Schulden, oder ?) betragen inkl. einer Lizenzzahlung von PDI rund 16,8 Mio USD.

Bleibt unterm Strich ein "shareholder´s equity" von rund 7,9 Mio $.

Heisst das jetzt, dass nur noch rund 7,9 Mio verfügbar sind, bevor das Geld ausgeht? Dann würde ja gerade mal noch drei Quartale Luft sein.


Bitte schaut mal unter :
http://www.cellegy.com/investors/summary.html


Hilfe/Meinungen wären nicht schlecht.

V.Mac

[Heinerle2]

Die Daten sollten so korrekt sein, siehe auch
http://biz.yahoo.com/fin/l/c/clgy_qb.html

Greetinxx Heinerle2

[Heinerle2]

News von heute.....

Cellegy Reports on Progress of Cellegesic Phase 3 Trial
For the Treatment of Anal Fissure Pain
Special Protocol Assessment Approved by FDA
New Clinical Team in Place to Monitor Progress
SOUTH SAN FRANCISCO, Calif., Aug. 6 /PRNewswire-FirstCall/ --
Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY) announced today that it has made
considerable progress with a new 150-patient Phase 3 clinical trial with
Cellegesic(TM) (nitroglycerin ointment) for the treatment of pain associated
with chronic anal fissures. There are currently no United States Food and Drug
Administration (FDA) approved drug therapies for this condition, which
afflicts approximately 700,000 people in the United States.
This new study is intended to confirm the statistically significant pain
reduction seen in the previous two Phase 3 studies. This trial`s protocol and
logistics are designed to expedite completion of the study and address FDA
requirements agreed to in several meetings and discussions during the past
several months. Highlights include:
-- The FDA has agreed to a "Special Protocol Assessment" which is intended
to provide assurance that if pre-specified trial results are achieved,
the FDA will approve the NDA. The protocol includes agreement on the
statistical methodology to be used for the analysis of results, a point
of contention in the earlier trial.
-- David A. Karlin, M.D., who joined Cellegy late last year as
Vice President, Clinical Research, has hired a new team of clinical
research associates and outside advisors to complement the Company`s
extensive clinical experience with Cellegesic. This new clinical team
will monitor 20 domestic clinical sites, whereas the previous study
used a Contract Research Organization (CRO) for recruiting, thereby
providing greater control over the domestic management of the trial.
-- Cellegy has retained a new CRO with a track record of success in
Central and Eastern Europe to monitor an additional 20 sites. Because
patients in these countries typically do not have easy access to
pharmacy compounded nitroglycerin, enrollment is predicted to be brisk.
-- Since the start of the pivotal study in June 2003, 40 clinical sites
have been recruited in the United States and Europe and 25 of
150 patients at just 7 sites have already been enrolled in the trial.
Dr. Karlin commented, "Having a medical background and clinical experience
in gastroenterology, I am particularly interested in the potential of
Cellegesic. Since coming to Cellegy I have hired a new clinical team and
outside advisors with extensive experience in Cellegy`s therapeutic areas. The
new trial selects patients with the greatest need for pain relief, those who
are most likely to benefit from Cellegesic. Based on initial recruitment, we
are optimistic that the study can be conducted expeditiously and provide the
confirmatory data required by the FDA for approval."
In April 2002, Cellegy withdrew its NDA for Cellegesic after the FDA
concluded that Cellegy had not adequately pre-specified the statistical method
used to analyze the trial results. Cellegy believes these concerns have now
been fully addressed through the new mutually agreed upon trial protocol. In
addition, the following operational changes and improvements in trial design
have been implemented:
-- The current trial will enroll 150 subjects in up to 40 sites, compared
with the previous study`s 229 subjects in 18 sites, thereby aiding in
rapid patient accrual.
-- One active dose versus placebo will be evaluated, compared with two
active doses and placebo in the previous study, thereby simplifying
trial design and data analysis.
-- The primary endpoint is the reduction in pain over a 21 day period,
compared with 56 days for the previous study. In previous trials the
most pronounced pain reduction was observed during the first three
weeks of treatment.
-- To be eligible, subjects must have a higher level of pain compared with
the previous trial or have physical signs of a chronic anal fissure,
thereby ensuring that only the most appropriate patients are included
in the trial.
Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged
in the development and marketing of prescription drugs for the treatment of
gastroenterology disorders, sexual dysfunction, and the use of nitric oxide
donors for the treatment of certain cancers. In addition to the fissure pain
indication, the Company is also developing Cellegesic for the treatment of
hemorrhoids and a painful condition called dyspareunia, which affects normal
sexual functioning in more than 5 million women in the United States. Other
nitric oxide donor products being developed by Cellegy researchers address a
number of conditions including Raynaud`s Disease and Restless Leg Syndrome.
Cellegy is also developing two transdermal testosterone gel products. The
Company recently announced results of an interim analysis of a Phase 2 study
using Tostrelle(TM) (testosterone gel) for the treatment of female sexual
dysfunction showing a favorable response rate of 71% versus a placebo response
of 13% and is currently progressing an amended Phase 2 protocol. Fortigel(TM),
for the treatment of male hypogonadism, was the subject of a Not Approvable
letter by the FDA earlier this month. The Company is now in discussions, along
with its marketing partner PDI, Inc., with the FDA to determine what
additional information will be required to gain marketing approval of Fortigel
in the United States.
This press release contains forward-looking statements. Investors are
cautioned that these forward-looking statements are subject to numerous risks
and uncertainties, known and unknown, which could cause actual results and
developments to differ materially from those expressed or implied in such
statements. Such risks and uncertainties relate to, among other factors: the
completion and outcome of clinical trials, the outcome and timing of
discussions with the FDA, particularly with regard to additional requirements
for marketing approval of Fortigel; and our need and ability to complete
corporate partnerships and financings. For more information regarding risk
factors, refer to the Company`s Annual Report on Form 10-K for the year ended
December 31, 2002.
SOURCE Cellegy Pharmaceuticals, Inc.
-0- 08/06/2003

/CONTACT: Richard Juelis, Vice President, Finance & CFO, [phone],
or K. Michael Forrest, Chairman, President & CEO, [phone], both of
Cellegy Pharmaceuticals; or Bruce Voss, [e-mail], or Ina McGuinness,
[e-mail], both of Lippert/Heilshorn & Associates, [phone],
for Cellegy Pharmaceuticals/
/Web site:



Greetinxx Heinerle2

[V.Mac]

Zahlen per heute:

Cellegy Pharmaceuticals Reports Second Quarter Financial Results
TUESDAY, AUGUST 12, 2003 7:30 AM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., Aug 12, 2003 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) reported today that for the second quarter ended June 30, 2003, revenues were $263,000, compared with $150,000 for the same period last year. Revenues during this year`s second quarter consisted of $55,000 of Rectogesic(TM) (nitroglycerin ointment) product sales in Australia and $208,000 in licensing revenue from PDI, Inc., Cellegy`s licensee for Fortigel(TM) (testosterone gel) 2%. Revenues for last year`s second quarter were comprised of $95,000 in Australian Rectogesic sales and $55,000 in skin care product sales to Gryphon Development, the product development division of a major specialty retailer.

For the six months ended June 30, 2003, revenues were $655,000 comprised of $171,000 (a 30% plus increase over last year`s first half) in Rectogesic sales in Australia, $416,000 in licensing revenue from PDI, $55,000 in skin care product sales and $13,000 in Canadian government grants. Revenues for the first six months of last year were $417,000 consisting of $131,000 in Rectogesic sales in Australia and $286,000 in skin care product sales, primarily to Gryphon.

For the three months ended June 30, 2003, the Company had a net loss of $4,582,000 or $0.23 per share, compared with a net loss of $5,624,000 or $0.32 per share for the same period last year. For the six months ended June 30, 2003, the net loss was $7,714,000 or $0.39 per share, compared with a net loss of $10,010,000 or $0.58 per share for the same period last year. Cash and investments at June 30, 2003 were $17.6 million, compared with $ 20.9 million at March 31, 2003 and $23.9 million at December 31, 2002. Net cash used in operations during the second half of this year is expected to average about $1.0 million per month.

Commenting on the first half results, K. Michael Forrest, Chairman and CEO, said, "We are making good progress with patient enrollment in our Cellegesic and Tostrelle clinical trials and with our nitric oxide donor-based development programs. Management changes in our clinical department are contributing to the expeditious completion of these key clinical studies. We will continue to control spending and preserve cash, focusing on our core product development projects."

A Conference Call, to discuss second quarter financial results and provide a business update, will be held on Thursday, August 14, 2003 beginning at 12:30 p.m. EDT (9:30 a.m. PDT). Please dial 888-803-8269 from the United States. Those interested in listening to the conference call live via the Internet may do so by visiting the Company`s Web site at www.cellegy.com. To listen to the call live, please go to the Web site 15 minutes prior to its start to register; a replay will be available on the Web site for 14 days.

Additional Financial Information

In December 2002, Cellegy received $15 million from PDI for exclusive commercial rights to Fortigel in North American markets. To date, Cellegy has recorded licensing revenue of $208,000 from PDI in each of the first two quarters of 2003 reflecting the amortization of this payment over the expected commercial life of Fortigel. The balance will continue to be recorded as licensing revenue in subsequent quarters over the life of the product. Gryphon has not yet determined their skin care product requirements for the remainder of 2003.

Lower operating expenses in the first two quarters of this year, compared with the same period last year resulted primarily from pre-launch marketing costs for the Company`s Cellegesic(TM) (nitroglycerin ointment) 0.4% product candidate last year, as well as, the costs of completing two Phase III clinical trials last year. No additional Cellegesic marketing costs are anticipated for 2003. Operating expenses in this year`s second quarter included non-cash compensation charges, totaling approximately $935,000, associated with the cancellation of certain Cellegy stock options, a payment made in stock to acquire certain patent rights and bonus payments made in stock.

Clinical expenses are expected to increase during the next two quarters as enrollment in the Cellegesic and Tostrelle clinical trials accelerate. In the first quarter ended March 31, 2003, Cellegy incurred a non-cash, non-operating expense of $542,000 associated with the reassessment of Cellegy`s South San Francisco facility sub-lease arrangement, primarily related to the write down of capitalized tenant improvements. We do not expect any further adjustments to these assets in the foreseeable future.


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Die Aktie dankt es heute mit einem kräftigen Plus (jedenfalls zur Zeit)

Übrigens werden cash und investments mit 17,6 Mio USD per 30.6.03 ausgewiesen, stimmt also mit meinen oben gemachten Recherchen überein, allerdings muss man wohl die "Investments" mit zur Kapitaldecke zählen. Und da ca. 1 Mio USD mtl. verbrannt werden, langt die Kohle wohl doch noch länger.

Nur schade, dass der Kurs bei knapp unter 2 € stehen blieb und nicht noch etwas weiter gefallen ist. So ist mir tatsächlich nur eine kleine erste Position bei 1,95 € "zugelaufen". Wollte tiefer noch mehr nehmen, aber was solls.....

V.Mac

[V.Mac]

Gute Neuigkeiten!

Cellegy Pharmaceuticals (CLGY: news, chart, profile) gained more than 18 percent after the San Francisco firm received a patent for its microdose therapy, a female sexual dysfunction product. The company said the patent covers methods of treating urogenital disorders in females using a nitric oxide or phosphodiesterase inhibitor.



So muss es sein.

V.Mac

[Heinerle2]

Bei 3 USD deckelt heute jemand gewaltig. Wenn diese fallen, geht es ab. Um 3.50 USD denke ich mal nach - (Teil-) Verkauf?

Greetinxx Heinerle2

[Heinerle2]

Close 3.14 - GO !

Greetinxx Heinerle2

[V.Mac]

Die Meldung von gestern noch mal ausführlich.

Cellegy Issued Patent for Treatment of Female Sexual Dysfunction
THURSDAY, AUGUST 28, 2003 7:30 AM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., Aug 28, 2003 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that the United States Patent and Trademark Office (USPTO) has issued patent number 6,610,652 entitled "Microdose Therapy."

This patent delineates methods of treating urogenital disorders in females, using a nitric oxide (NO) donor or a phosphodiesterase (PDE) inhibitor. Such urogenital disorders include pain during intercourse (dyspareunia), decreased vaginal lubrication, and decreased vaginal engorgement. Commonly known NO donor compounds include nitroglycerin and sodium nitroprusside; PDE inhibitors include sildenafil (Viagra(TM), Pfizer), vardenafil (Levitra(TM), Bayer) and tadalafil (Cialis(TM), Lilly/ICOS). This patent increases the Company`s intellectual property portfolio to 5 issued United States patents and over 20 pending United States and foreign patent applications for the treatment of urogenital disorders and female sexual dysfunctions using NO donors and related compounds.

Dyspareunia is characterized by difficult or painful sexual intercourse afflicting approximately 5 million women in the United States. Treating dyspareunia with a nitric oxide donor could potentially provide significant benefits to patients who are poorly served by currently available treatments, such as lubricants. The utility of nitroglycerin ointment in the treatment of vaginal pain was previously demonstrated in a pilot study conducted by Dr. Jennifer Berman at UCLA Medical Center.

"Cellegy is pleased to add this issued patent to the Company`s expanding intellectual property portfolio for the treatment of urogenital disorders and female sexual dysfunctions using nitric oxide donor compounds," said David A. Karlin, M.D., Cellegy`s Vice President, Clinical Development. "We plan to initiate a confirmatory dose ranging clinical study using nitroglycerin for the treatment of dyspareunia before the end of this year."

Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the development and marketing of prescription drugs for the treatment of gastroenterology disorders, sexual dysfunction in men and women, and the use of nitric oxide donors for the treatment of certain cancers. The Company is progressing a Phase 3 clinical study for Cellegesic(TM)(nitroglycerin ointment) for the treatment of chronic anal fissure pain. It is also developing Cellegesic for hemorrhoids and dyspareunia. Tostrelle(TM)(testosterone gel) 0.5%, is undergoing a Phase 2 clinical trial for the treatment of sexual dysfunction (decline in libido) in women. Cellegy currently is assessing what additional data will be required by the FDA in order to gain approval of Fortigel(TM)(testosterone gel) 2.0 for the treatment of male hypogonadism. Other nitric oxide donor products in early stage development include treatments for prostate cancer, Raynaud`s Disease, Restless Leg Syndrome and erectile dysfunction

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V.Mac

[Heinerle2]

Nächster Anlauf, die 3 USD endlich nachhaltig rauszunehmen, könnte heute angelaufen sein, Volume up!

Greetinxx Heinerle2

[V.Mac]

Scheinbar scheint die Meldung von heute den Kurs ganz gut zu beflügeln. Auf jeden Fall haben wir in den letzten Tagen die 3 USD-Marke wohl nachhaltig geknackt. Heute ging es bis 3,95 USD rauf, um dann wieder etwas zu konsolidieren.

Patient Testing in Cellegesic Phase 3 Trial Complete
THURSDAY, JANUARY 08, 2004 7:35 AM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., Jan 08, 2004 /PRNewswire-FirstCall via Comtex/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that it completed patient testing late last year in its Phase 3 clinical trial with Cellegesic(TM) (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. One hundred percent of the data has already been collected from clinical sites in the United States and Europe. Preparation for data entry and analysis is ahead of schedule, and Cellegy now anticipates that study results will be available and announced during February 2004. The trial, which began at the end of June 2003, is being conducted under a "Special Protocol Assessment" which is intended to provide assurance that, if pre-specified trial results are achieved, the United States Food and Drug Administration (FDA) will approve the New Drug Application (NDA).

The primary endpoint of the Phase 3 study is the reduction in pain over a 21-day period. In previous Cellegesic studies submitted to the FDA by Cellegy, the most pronounced pain reduction was observed during the first three weeks of treatment.

K. Michael Forrest, Cellegy`s CEO said, "I am pleased that this study continues to proceed well ahead of schedule, with 193 subjects having completed testing versus the 150 originally targeted. Assuming a favorable trial outcome, we are now in a position to be able to prepare and resubmit the NDA to the FDA during the second quarter of this year."

About Chronic Anal Fissures

An anal fissure is a painful tear in the lining of the anal mucosa. Chronic fissures are often treated with a surgical procedure that involves cutting the internal anal sphincter muscle to decrease anal pressure. While effective, the procedure is painful, costly and often leaves patients incontinent. Cellegesic works by gently relaxing the sphincter muscle, alleviating the pain without causing incontinence.

There currently are no FDA approved drug therapies for this debilitating condition, which, according to latest Verispan audits, afflicts approximately 750,000 Americans, resulting in over one million physician visits per year. The most recent audit data also shows about 100,000 uses of pharmacy-compounded nitroglycerin for the treatment of anal fissures over the last 12 months. Cellegy believes that, due to the extensive off-label use of nitroglycerin by the medical community, there will be rapid uptake of Cellegesic once approved.

--------------------------------------------------------------------------

Sollte wirklich im zweiten Halbjahr die Zulassung erfolgen, ist wohl noch einiges an Musik im Kurs drin.

V.Mac

[Heinerle2]

Ich habe heute bei 4 USD glatt verkauft . Bei einem Rücksetzer denke ich evtl wieder darüber nach.

Greetinxx Heinerle2

[V.Mac]

heute Schluß immerhin auf Tageshoch bei 4,17 USD. Na und der Dollar wird zur Zeit auch wieder stärker gegenüber dem Euro,da sind Kursgewinne ja fast vorprogrammiert.

V.Mac

[V.Mac]

Momentan macht mir Cellegy viel Freude, geht schon wieder deutlich rauf seit letzter Woche, rund 10% auf aktuell USD 4,60.

Möglicherweise hat die nachfolgende Meldung was damit zu tun, so wie ich das verstehe, wird dadurch die Kapitaldecke dicker....

Cellegy Secures Innovative Equity Financing Facility with Current Value of $15 Million
FRIDAY, JANUARY 16, 2004 4:27 PM
- PR Newswire CLGY 4.60 +0.21

SOUTH SAN FRANCISCO, Calif., Jan 16, 2004 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today the Company has entered into a Structured Secondary Offering Facility agreement, (SSO), with Kingsbridge Capital Limited. The facility requires Kingsbridge to purchase up to 3.74 million shares of newly issued common stock at times and in amounts selected by Cellegy over a period of up to two years, subject to certain restrictions. At the current market price of Cellegy stock, the value of the facility is approximately $15 million. Cellegy may begin to draw down funds after the effectiveness of a registration statement that the Company will file with the Securities and Exchange Commission. The value of the financing facility will be adjusted by the price of the Company`s stock at the time of the filing of the registration statement.

Cellegy has put this contingent financing facility in place to allow it to raise capital as required, in amounts and at the times of its choosing. The agreement does not prohibit Cellegy from conducting additional debt or equity financings, including PIPEs, shelf offerings, secondary offerings or any other non-fixed or future priced securities.

The timing and amount of any draw downs are at Cellegy`s sole discretion, subject to certain conditions. Individual draw downs must be at least 3 trading days apart and are limited to certain maximum amounts depending on the then current market capitalization of the Company. The purchase price of the common stock will be at discounts ranging from 8% to 12% of the average market price of the common stock prior to each future draw down. The lower discount applies to higher stock prices. In connection with the agreement, Cellegy issued warrants to Kingsbridge to purchase 260,000 shares at an exercise price of $5.27 per share. Cellegy can, at it`s discretion and based on its cash needs, determine how much, if any, of the equity line it will draw down in the future, subject to the other conditions in the agreement.

K. Michael Forrest, Cellegy`s CEO said, "We are very pleased to have put this contingent financing facility with Kingsbridge in place. The facility allows us to raise capital as required, at favorable economic terms and at our discretion. Kingsbridge Capital is a highly respected private equity fund. We look forward to adding them to our current investor group."

Adam Gurney, Managing Director of Kingsbridge, stated, "We are excited by Cellegy`s near-to-market pipeline, which we believe is of great medical potential and is a significant value-creating opportunity for Cellegy and its investors. Kingsbridge is very pleased to be helping the Company during its transition to commercialization."

------------------------------------------------------------------------------------------------

und dann gibts mal wieder neues Personal an Board.....

Cellegy Appoints Robert Rothermel to Its Board of Directors
WEDNESDAY, JANUARY 21, 2004 3:43 PM
- PR Newswire
CLGY 4.60 +0.21

SOUTH SAN FRANCISCO, Calif., Jan 21, 2004 /PRNewswire-FirstCall via COMTEX/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that Mr. Robert B. Rothermel has been elected to the Board of Directors. Mr. Rothermel is currently a partner of CroBern Management Partnership, a healthcare management and venture capital firm. Mr. Rothermel recently retired after 37 years in client service and leadership responsibilities with Deloitte & Touche; he had been a partner since 1973. His most recent position was the global leader of the firm`s Enterprise Risk Services practice, that focuses on helping clients manage risk and control throughout the organization. Under his leadership the Practice grew to 5,000 dedicated professionals in 25 countries.

Previous to this position he served a broad range of clients in a variety of industries. He was the lead client service partner for major corporations including Sears Roebuck & Co., American Hospital Supply Corporation and Molex Incorporated. He has led additional professional services in a number of specialty areas such as IPOs, acquisitions, divestitures, and restructurings. During his career at Deloitte & Touche, Mr. Rothermel served as a member of the firm`s Global Assurance and Advisory Management Committee, Board of Directors, US Management Committee and has chaired the firm`s Partner Compensation Committee).

Richard C. Williams, Chairman, stated, "We are pleased to have Bob Rothermel joining the Board of Cellegy. His distinguished career with Deloitte & Touche gave him a varied and board based background. His strengths in finance, accounting and general business matters within industry and specifically in healthcare will be beneficial to our company."

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Also, mein Wunsch wäre bald mal Richtung 6 USD und dann noch die erfolgreiche Präsentation der Testergebnisse von Cellestic im Februar 2004......oder auch erst andersrum......

V.Mac

[V.Mac]

Cellegy auf Tageshoch bei USD 5,02 und dann mit 5,01 geschlossen, da geht noch mehr!

Immerhin 25% in der letzten Woche, und das für einen Wert der in Deutschland (vielleicht zum Glück!?) noch nicht diskutiert wird.

Ich bleibe mal dabei.

V.Mac

[V.Mac]

Cellegy wieder auf dem Niveau von vor dem Juli-Einbruch!!

Heute bis 5,60 USD im Hoch. Was ist im Busch ? Weiss man in USA vielleicht schon was über den Antrag Mitte Februar? Auf jeden Fall gibts massig Vorschusslorbeeren (auf den Kurs bezogen)im Vorfeld.

Es droht natürlich auf diesem Niveau auch wieder ein heftiger Verfall, wenn die Ergebnisse nicht den Erwartungen entsprechen.

Auf jeden Fall ist das Handelsvolumen in den Staaten seit Wochen über dem langen Durchschnitt.

Ich bin immer mehr am Überlegen, ob ich nicht doch raus sollte und die Februar-Meldung abwarte.

Cellegy war für mich der Traum eines jeden Anlegers, ich habs wirklich geschafft, im absoluten Tief bei 1,95 € zu kaufen.

Gibt es noch andere Meinungen zu dem Wert ?

V.Mac

[V.Mac]

heute ist es raus und ich habe mich vorerst verabschiedet, bei über 100% vertretbar, wie ich meine. Vielleicht wars ja noch zu früh....aber wenn...... usw.

Ich bleibe auf jedem Fall bei Cellegy am Ball und wenn es mir wieder mal interessant erscheint, warum nicht ein drittes Mal investieren?

Cellegy Announces Positive Results of Phase 3 Study Using Cellegesic(TM) To Treat Chronic Anal Fissure Pain
TUESDAY, JANUARY 27, 2004 8:08 AM
- PR Newswire

CLGY 5.93 +0.639

SOUTH SAN FRANCISCO, Calif., Jan 27, 2004 /PRNewswire-FirstCall via Comtex/ -- Cellegy Pharmaceuticals, Inc. (CLGY) announced today that a preliminary analysis of a recently completed Phase 3 clinical trial shows that its lead product candidate, Cellegesic(TM) (nitroglycerin ointment, 0.4%), produced a statistically significant (p<0.05) reduction in anal fissure pain in comparison to a placebo control during the first three weeks of the trial, the primary efficacy endpoint of the study. As observed in earlier trials, the most common side effect was mild to moderate headache.

The double blind, placebo controlled trial was conducted according to a "Special Protocol Assessment" ("SPA"), that was agreed upon by the Company and the U.S. Food and Drug Administration ("FDA"). An SPA is intended to provide assurance that if the pre-specified primary endpoint is achieved and no unexpected, untoward effects are seen, the FDA will approve the product for commercial sale.

The SPA specified how dropouts due to headache would be treated. For patients who dropped out due to nitroglycerin-induced headache before day 21, the protocol required that their last daily pain intensity score be carried forward to day 21. In the Phase 3 trial, such scores were carried forward for three subjects who dropped out due to nitroglycerin-induced headaches, as defined in the protocol. Two other subjects dropped out for headache not due to nitroglycerin and, per the protocol, rather than carrying forward the last observation, all of their available pain data prior to dropout were used to estimate their pain score through day 21. The company believes that it has achieved the results specified in the SPA, although the FDA will conduct its own analysis.

David Karlin, M.D., Cellegy`s Vice President, Clinical Research, said, "We are pleased with the positive outcome of this third trial and the confirmation of the statistically significant pain relief observed in our two previous Phase 3 studies. There were no unusual or unexpected adverse events seen in the trial and the side effects that did occur were similar to those observed in the first two studies."

K. Michael Forrest, Cellegy`s CEO, said, "Based on the outcome of this trial, we intend to submit a New Drug Application ("NDA") to the FDA during the second quarter of 2004. While the results of the FDA`s analysis are always subject to uncertainty and no assurances are possible regarding the outcome of the FDA`s review process, we expect that they will approve the drug for marketing in accordance with the provisions of the Special Protocol Assessment. I would like to acknowledge our hardworking clinical, R&D, and regulatory personnel for their fine efforts in getting us to this point."

About the Cellegesic Phase 3 Clinical Trial

Subjects who met the enrollment criteria for a chronic anal fissure were randomized to receive either the placebo ointment or 0.4% nitroglycerin ointment. The daily records of average pain intensity from 187 intent-to-treat subjects (89 Cellegesic-treated and 98 placebo-treated) were analyzed for statistical evidence of efficacy during the first 21 days of treatment as the primary efficacy endpoint. The primary endpoint was achieved (p<0.05).

A secondary endpoint and several tertiary endpoints were also analyzed. The secondary endpoint was time to 50% pain reduction. On average the time to 50% pain reduction produced by Cellegesic was about a week sooner than the reduction produced by the placebo, although the difference was not statistically significant. Tertiary endpoints included reduction of average pain over the eight-week (56 days) treatment period, reduction of pain upon defecation through days 21 and 56, and healing. Average pain reduction over 56 days was significant (p<0.05) and defecation pain reduction was significant over 56 days (p<0.05). However, the significance achieved in these two tertiary endpoints did not remain statistically significant after applying adjustment to the p-values for the analysis of multiple endpoints. These results were numerically superior to placebo and demonstrate an important positive trend. There was no significant difference in fissure healing between Cellegesic and the placebo control, as in earlier trials.

Side effects seen in the trial were consistent with those observed in the previous two Phase 3 studies. The most common side effect was headache. Only 3 subjects (3.4% of subjects receiving active drug) withdrew from the study due to nitroglycerin induced headache.

About Chronic Anal Fissures

An anal fissure is a painful tear in the lining of the anal canal; the condition is associated with increased pressure in the anal canal and an associated decrease in blood supply. Chronic fissures are often treated with a surgical procedure that involves cutting the internal anal sphincter to decrease pressure in the anal canal. While effective, the procedure is painful, costly and often leaves patients (up to 35%) either gas or fecally incontinent. Cellegesic may help to avoid the risk of surgery by gently relaxing the sphincter muscle. Some patients using Cellegesic have reported mild, reversible gas incontinence. Fecal incontinence has not been reported in association with Cellegesic.

There are currently no FDA approved drug therapies for this debilitating condition, which according to Verispan audits, afflicts an estimated 750,000 Americans, resulting in over one million visits to physicians each year. The most recent audit data show about 100,000 uses of pharmacy-compounded nitroglycerin for the treatment of anal fissures over the past 12 months. Cellegy believes that if Cellegesic is approved, the extensive compounding of nitroglycerin by community pharmacies will decline as physicians begin to prescribe Cellegesic. Cellegesic will provide a stable formulation that is produced to FDA standards and is consistent from batch to batch.
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V.Mac