Zonagen ( Zona ) - 500 Beiträge pro Seite

[puhvogel]

Also Leute, Verkaufsempfehlungen sind ja meine Sache nicht, aber bei dieser bin ja recht sicher:
Die FDA will von Zonagen für VASOMAX noch eine zusätzliche klinische Tierstudie haben, die zwei Jahre andauern soll!!!.
Selbst wenn Zona das finanziell überleben sollten, dann existieren schon so viele moderne Behandlungsmethoden für erektile Dysfunktionen, dass die gar nicht mehr in den Markt eindringen könnten.
Die hatten mal einen gewissen Zeitvorteil , der ist jetzt aber völlig zum Nachteil geworden.
Nur meine Meinung...
Der puhvogel

[m.lynched]

Published Zonagen Data Heralds Potential for New Contraceptive Vaccine

THE WOODLANDS, Texas--(BW HealthWire)--September 18, 2000-- Zonagen, Inc. (Nasdaq:ZONA - news; PCX:ZNG)
announced that data developed by Zonagen has been published in the September 2000 issue of Journal of Reproduction and
Fertility indicating the potential of the Company`s contraceptive vaccine. The publication reported results from two primate
studies, one of which began over four years ago. These are the first studies in which a recombinant zona pellucida
immunocontraceptive vaccine consistently induced infertility compared to controls in a primate model without permanent disruption of the normal menstrual cycle.
This data was also presented on August 31, 2000 at The Molecular and Cellular Biology of the Egg and Embryo Extracellular Matrix Symposium held in Lake
Tahoe, California.

The Company has been working on a contraceptive vaccine targeting the zona pellucida since its inception as a start-up founded by Baylor College of Medicine in
1987. Since that time Zonagen has obtained 10 issued and allowed United States patents covering the science that led to the current vaccine. The technology
produces an immune response that targets the zona pellucida, the extra-cellular matrix that surrounds all mammalian eggs. This matrix is extremely complex and has
been implicated in initial sperm-egg interactions. Zonagen scientists have cloned the three genes that encode for the majority of these proteins from numerous species
including humans and the relevant proteins from two primate models, cynomolgus monkeys and baboons. The Company has found that active immunization against a
specific zona protein confers long-term infertility, presumably by blocking sperm-egg interactions. Because of the uniqueness of the zona pellucida proteins, this
infertility is not associated with any non-reproductive side effects. The most significant side effect noted in the studies is transient disruption of the normal menstrual
cycle. In order to elicit this immune response, Zonagen scientists have utilized the Company`s proprietary adjuvant Immumax(TM), also covered by an issued U.S.
patent.

Jeffrey Harris Ph.D., Director of Molecular Biology at Zonagen and named inventor on many of the Company`s zona pellucida related patents, noted, ``When we
first began this work there was some hope that a vaccine targeting the zona pellucida could actually be developed. This belief was held by several organizations
working in the field. Over time researchers encountered serious problems, such as the inability to produce consistent immune responses against the zona pellucida as
well as sorting out which zona protein to target. Adding to these issues was the concern over long-term adverse effects on the ovary. At Zonagen we have shown
that active immunization against a specific zona protein leads to consistent infertility lasting over six months without permanent disruption of the normal female
reproductive cycle.``

Michael Holland Ph.D., Senior Principal Research Scientist in the Pest Animal Control Co-operative Research Center in Australia, stated, ``Immunocontraceptive
vaccines represent an important potential addition to the options available for regulating the fertility of our own and other species. For this reason a number of groups
in America, Europe and Australia have been active in their development. The study of Harris and colleagues represents an important advance in realizing this goal.
For the first time a comprehensive study of the contraceptive potential of all three components of the human zona pellucida has been tested alone and in combination
in two primate species. This study clearly shows which is the important zona component for inducing infertility and it also shows that the contraceptive response can
be reversed given sufficient time. This implies no irreversible damage was done to the ovary as some other studies in non primates have shown. As a result of this
study we are one step closer to the goal of a human contraceptive vaccine.``

``We are pleased with the progress that our scientists have made over the years in their efforts to develop a new contraceptive approach. It certainly has not been an
easy problem to solve,`` said Joseph Podolski, President and CEO of Zonagen. He added, ``However, we are now at a point in the vaccine`s development where
involvement with a large corporate entity or multinational agency is required to advance the science.``

[m.lynched]

Meinungen?

[ollihat]

ZONA hat mit einem Kurssprung von über 16% wieder das bisherige Jahreshoch erreicht.

Gibt es denn Entwicklungen, die diese Spekulation auch fundamental stützen? Bisher war ZONA, wie puhvogel schon eingangs des Threads vor über einem Jahr vermerkte, ein Pleitekandidat.

[rjenzi]

Ja, es sieht tatsaechlich nicht gut fuer Zona aus. Finanziell koennten sie es zwar ueberleben, denn sie haben ca. 30.9 Millionen liquide Mittel und verkaeufliche Anlagen... Das wuerde bei der momentanen cash burn rate durchaus auch zwei Jahre reichen. Schlecht siehts aber tatsaechlich aus, bei dem Zeitvorteil bzw. Nachteil. In der Zwischenzeit duerfte der Markt mit besseren Medikamenten aufwarten und so hat Zona keine echte Chancen... Man schaue sich dabei nur mal Nastech an mit ihrem Potenzspray (ich denke es lohnt sich darauf einen Blick zu werfen).

[rjenzi]

Ja, es sieht tatsaechlich nicht gut fuer Zona aus. Finanziell koennten sie es zwar ueberleben, denn sie haben ca. 30.9 Millionen liquide Mittel und verkaeufliche Anlagen... Das wuerde bei der momentanen cash burn rate durchaus auch zwei Jahre reichen. Schlecht siehts aber tatsaechlich aus, bei dem Zeitvorteil bzw. Nachteil. In der Zwischenzeit duerfte der Markt mit besseren Medikamenten aufwarten und so hat Zona keine echte Chancen... Man schaue sich dabei nur mal Nastech an mit ihrem Potenzspray (ich denke es lohnt sich darauf einen Blick zu werfen).

[ollihat]

@rjenzi

Das war wohl nicht der passende Kommentar, auch wenn er zweimal erscheint.

ZONA ist heute nämlich wieder kräftig gestiegen, nämlich weit über 20%

Wir hätten sie besser heute morgen in Deutschland noch kaufen sollen!

Hat keiner einen besseren Kommentar?

[rjenzi]

@ollihat

Naja, da hab ich wohl Brunz rausgelassen... bzw. zum falschen Zeitpunkt. Ich hab mir das ganze nochmals angeschaut und finde Zonagen kein Investment wert. Finanziell denke ich mal, dass sie durchkommmen. Ich habe aber bedenken, ob Vasomax erfolgreich eingefuehrt werden kann (muss allerdings eingestehen, dass ich die klinischen Studien nicht allzu genau angesehen haben). Warum?

Am diesjaehrigen Urologen Kongress wurde PDE5-Hemmer als der Nachfolger von Viagra gehandelt, wegen besserem Leistung/Nebenwirkungsprofil. Bayer hat mit Vardenafil einen PDE5-Hemmer in der Entwicklung und hat jetzt die Unterlagen zu Vardenafil bei der FDA zur Pruefung eingereicht. Ich denke, dass die beiden Medikamente zur ungefaehr gleichen Zeit auf den Markt kommen werden, nur dass dabei das Medikament von Zonagen wohl zweiter machen wird...

Hier noch zwei Links dazu:

http://www.biospace.com/news_story.cfm?StoryID=7010215&full=…
http://www.universimed.com/content/urologie/2001/uro20010404…

Das ist nur meine Meinung und ich muss fairerweise erwaehnen, dass ich mir Zonagen nicht allzu genau angeschaut habe.

[puhvogel]

Etwas zur Konkurrenzsituation. Der Bericht verschweigt Uprima, die nur in europa zugelassen wurden, während es in den USA unter fast skandalösen Umständen nicht zugelassen wurde.
Von VVUS redet auch kaum noch jemand.

[puhvogel]

Text vergessen


Forbes.com
Impotence Drug Won`t Cure Bayer`s Ailment
By Matthew Herper


Something may be giving Bayer a rise, but that may not carry through to its earnings. New studies of its impotence drug, vardenafil, look good. Unfortunately, the good data is not enough to firm up Bayer`s limping drug division. Vardenafil will probably be late to market, and when it gets there it may not have significant enough advantages to get a leg up on its competition.

That`s bad news for Bayer, which is relying on vardenafil to buoy its limping $6 billion pharmaceutical business. This summer, it had to recall its cholesterol treatment, Baycol, after the drug was linked to dozens of deaths. The recall not only sliced $1 billion from Bayer`s top line but also exposed it to a bevy of lawsuits. Even before the Baycol fiasco, the company had a big problem: its drug pipeline has been anemic at best.

Bayer hopes vardenafil, which it will co-market with GlaxoSmithKline , will be a big hit with peak sales of $900 million. That seems optimistic given that Viagra, the only treatment on the market for erectile dysfunction, had 2000 sales of $1.3 billion. The market is growing, and it will grow faster once other drugs enter the market, but Leverkusen, Germany-based Bayer will have plenty of competition. Not only must it deal with Viagra-maker Pfizer , the world`s biggest drug company, but also with Eli Lilly and ICOS .

Lilly and ICOS have already filed their impotence drug, Cialis, with the U.S. Food and Drug Administration. That means Cialis will probably hit the U.S. market before vardenafil: Lilly and ICOS are predicting a launch in the second half of 2002. Banc of America Securities analyst Leonard Yaffe expects Cialis to rack up sales of $200 million in 2002 and $600 million in 2003--and would then keep rising. Lilly and ICOS will split the profits from the drug evenly.

All of these erectile dysfunction drugs work by blocking an enzyme called phosphodiesterase-5, and each seems to be effective more than 80% of the time. However, Cialis boasts some significant advantages over Viagra. It may have fewer side effects, and can be taken with or without food.

Best of all for Lilly, Cialis can start working up to 30 minutes after it is taken and continues to be effective for 24 hours. This could be a significant marketing advantage, says Mark Barbato, executive director and product team leader at Lilly. "Instead of taking the pill, looking at the watch, and saying `Am I ready?`" Barbato says, "it provides them freedom, allows them to choose, and takes away the clock-watching aspect, if you will."

Bayer will present its clinical data Dec. 8 at the Annual Meeting of the Sexual Medicine Society of North America in Charleston, S.C. Dr. Wayne J.G. Hellstrom, the study`s lead author and a professor at Tulane University School of Medicine, has already issued the following statement: "The Phase III Pivotal data show vardenafil works across the spectrum--consistently achieving highly positive results across a broad range of men with erectile dysfunction, regardless of the cause or severity of the condition."

That`s great news for patients and doctors, who will get another treatment option with vardenafil. The bad news is that drugs can take a year to get through the FDA. When vardenafil finally gets to the market, there may be no reason for patients already happy with Viagra or Cialis to switch to Bayer`s big hope.

[DerStaatsanwalt]

Hatte nicht mal Macrochem das beste Produkt gegen erektile Dysfunktionen???

Keine Spritze sondern eine hochwirksamen Stoff, der über die Haut zum Zielort gelangt??

Über Meinungen wäre ich sehr dankbar

[puhvogel]

Ja stimmt, die haben auch ein solches Produkt.
Das Produkt funktioniert wohl ganz gut (wenn ich mich korrekt zurückerinnere), aber die Compliance war wohl unter aller Kanone. Kein Wunder bei dieser Indikation, da wird das Blut woanders als im Hirn gebraucht.

[puhvogel]

10 Millionen $ weg für.... nix

Zonagen, Inc. and Lavipharm Corp. Sign Definitive Merger Agreement

THE WOODLANDS, Texas & EAST WINDSOR, N.J.--(BUSINESS WIRE)--Oct. 30, 2002--Zonagen, Inc. (Nasdaq:ZONA)(PCX:ZNG) and Lavipharm Corp. announced today that they have entered into a definitive agreement to merge in a tax-free, stock-for-stock transaction. Upon completion of the merger, Dr. Athanase Lavidas, Chairman of Lavipharm Corp., will
become the Chairman of the Board of Directors of this merged entity.
Lavipharm`s executive management team will become the executive management team of the merged company, which will be renamed, "Lavipharm Corporation." Lavipharm Corp.`s major shareholder is Lavipharm S.A., a Greek corporation with shares traded on the Athens Stock Exchange.
Under the terms of the merger agreement, which has been approved by the boards of directors of Zonagen and Lavipharm, the holders of Lavipharm common stock and Series A preferred stock together will receive an amount of shares of Zonagen common stock that would provide them with 40% of the total shares of Zonagen common stock outstanding
following the merger. In addition, Lavipharm S.A., the holder of Lavipharm Corp.`s Series B preferred stock, will receive 2,000,000 shares of Zonagen common stock in connection with the repayment of $10,000,000 of Lavipharm indebtedness.
Certain holders of Lavipharm common stock and Series A preferred stock will be entitled to receive additional shares of Zonagen common stock upon the achievement of certain earn-out milestones. Based upon the number of shares of Zonagen common stock outstanding as of
yesterday, Zonagen would issue approximately 7.7 million shares at the closing of the merger and up to approximately 9.6 million additional shares if all of the earn-out milestones are achieved, which amount would result in existing Lavipharm stockholders owning 60% of the
total shares of Zonagen common stock outstanding, excluding the 2,000,000 shares described above. Zonagen`s obligation to i due earn-out shares expires on December 31, 2003.
Zonagen`s board of directors has received a fairness opinion from CIBC World Markets Corp. in connection with the merger. The consummation of the merger is conditioned upon customary closing conditions, including the approval of Zonagen`s stockholders. It is anticipated that after the merger Lavipharm will focus ondevelopment of its drug formulation and drug delivery technologies.
About Zonagen

Zonagen is engaged in the development of pharmaceutical products for the reproductive system, including sexual dysfunction, vaccine adjuvants, products for fertility and female health as well as urological applications, specifically prostate cancer. For more information, visit Zonagen`s web site at http://www.zonagen.com.

About Lavipharm

Lavipharm is an innovative drug formulation and drug delivery company. Lavipharm combines proprietary particle engineering, solubilization and formulation technologies with its expertise in drug delivery to improve pharmaceutical and OTC products and drug candidates developed by other companies. Lavipharm applies its
technologies to drugs in the early stage of development including small molecules, peptides and proteins, and to drugs that are currently marketed but have not performed to their full market potential. Lavipharm`s technologies can further enhance the value of currently marketed drugs by attempting to improve their pharmaco-kinetic profile, and thereby potentially improving patient compliance and/or extending patent protection. By developing creative
solutions to enhance delivery of drug molecules, Lavipharm also assists its customer base in differentiating their products from those of the competition. By improving existing products in less time, at a potentially lower risk of failure, and at potentially lower costs than
required to develop new chemical entities, Lavipharm believes it can add scientific and commercial value to pharmaceutical company products, both in the short and longer term. For more information, visit Lavipharm`s web site at http://www.lavipharm.com.

[puhvogel]

Dow Jones Business News
FDA Notifies Zonagen Another 2-Yr Animal Study Required
Tuesday November 19, 9:11 am ET


THE WOODLANDS, Texas -(Dow Jones)- Zonagen Inc. (NasdaqNM:ZONA - News) received notice from the Division of Reproductive and Urologic Drug Products of the Food and Drug Administration that an additional two-year rodent study will be required in order to lift the clinical hold on Vasomax, or phentolamine.

Zonagen`s Vasomax is an oral drug for the treatment of erectile dysfunction.

"We are disappointed in the committee`s decision," said Joseph Podolski, president and chief executive of Zonagen. "We remain convinced that Vasomax does not pose a safety risk to humans. Nevertheless, we do not presently plan to conduct another two-year study."

In a press release Tuesday, the company said the FDA came to the conclusion following a meeting between Zonagen and the full Cancer Assessment Committee of the FDA on Oct. 21.

Zonagen presented data at the meeting that suggests phentolamine neither initiates nor promotes brown fat proliferations, or hibernomas, in the rat.

The FDA asserted that the study did not demonstrate a clear positive response in young animals without a response in older animals or provide any explanation for the hibernomas seen in an earlier study.

Zonagen has been trying to resolve the FDA`s concerns regarding the appearance of brown fat proliferations in a prior two-year rat study.

The FDA summarized its position by stating that in order to remove the clinical hold, results showing no drug related hibernoma formation in a two-year carcinogenicity study in mice or rats should be submitted.