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    Biodelivery Sciences Intl. - DIE NEUE FLAMEL ???- - 500 Beiträge pro Seite

    eröffnet am 12.09.03 13:33:20 von
    neuester Beitrag 11.10.04 21:17:22 von
    Beiträge: 116
    ID: 775.222
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    ISIN: US09060J1060 · WKN: 766464
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     Ja Nein
      Avatar
      schrieb am 12.09.03 13:33:20
      Beitrag Nr. 1 ()
      Diese Aktie könnte der neue Highflyer im Bereich "Drug Delivery" werden.

      Leider haben sich die guten Aussichten noch nicht in den Zahlen niedergeschlagen, doch kann in Zukunft mit regelrechten "Blockbustern" gerechnet werden (pulverisierte Omega 3 Fettsäuren).

      Ich habe mir mal eine Startposition zugelegt - was meint Ihr zu dem Wert?

      Info´s unter : www.biodeliverysciences.com !!!

      Gruß
      Falke28
      Avatar
      schrieb am 12.09.03 14:40:04
      Beitrag Nr. 2 ()
      Der Wert ist auch im Fonds vom Beckmann eine der größten Positionen... Biodelivery Sciences wird sich verXfachen!!!

      Isonics:D
      Avatar
      schrieb am 12.09.03 14:55:58
      Beitrag Nr. 3 ()
      Hallo Isionics,

      kannst Du mir sagen, welchen Fond von Beckmann Du eigentlich meinst? Ich denke, er sei nur als Berater tätig.

      Warum denkst Du wird sich dieser Wert vervielfachen?
      Kannst Du das ein wenig begründen?

      Gruß
      Falke28
      Avatar
      schrieb am 12.09.03 15:32:37
      Beitrag Nr. 4 ()
      Ist doch ein offenes Geheimnis in Frankfurt das der Beckmann jetzt den H&A Nano-Fonds managed. Ich habe deshalb schon mal nen halben tag mit Luxenburg telefoniert - in Deutschland darf von denen noch nichts darüber veröffentlicht werden weil der Vertrieb hier erst später erlaubt wird. Dann kann man das Ding ganz normal ordern!

      Über Biodelivery stand mal ein langer Artikel im Nanotechreport ich poste hier mal ein paar Stichpunkte wenn es jemanden interessiert!

      Grüße

      Isonics:D
      Avatar
      schrieb am 12.09.03 15:42:18
      Beitrag Nr. 5 ()
      @ isonics
      Immer her mit den Infos:D

      Trading Spotlight

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      Avatar
      schrieb am 14.09.03 23:26:53
      Beitrag Nr. 6 ()
      Also, Beckman hat Biodelivery in seinem Nanotechreport zum Kauf empfohlen. Er erklärt in dem zweiseitigen Bericht über das Unternehmen die Transporttechnologie, die auf kleinen Transportkapseln, den Nanocochleates beruht. Mit diesen Kapseln kann man laut Nanotechreport die unterschiedlichsten Wirkstoffe und Substanzen gezielt in den Körper bringen. Sie verfügen über viele Vorteile, sind beispielsweise hochstabil und werden aus einfachen biologischen Substanzen hergestellt.
      Das Unternehmen arbeitet laut Nanotechreport gerade an verschiedenen Anwendungen, unter anderem gegen HIV und den Nanotransport von Antibiotika. Auch im Bereich „funktionelle Nahrung“ ist das Unternehmen engagiert.

      Das Unternehmen befindet sich laut Nanotechreport am Anfang einer aussichtsreichen Entwicklung, verfügt über eine herausragende Technologie die zahlreiche Anwendungsmöglichkeiten in erfolgsversprechenden Märkten eröffnet.

      Was ich besonders spannend finde: In den US-Boards wird seit vergangenen Freitag angefangen, über diesen Wert zu diskutieren. Es handelt sich um einen reinen Nanotechwert, dessen Marketcap aktuell bei lächerlichen 26,5 Millionen liegt. Sollte das Unternehmen von den Anlegern entdeckt werden, geht es mit Sicherheit voll ab! Das kann schon in den nächsten Tagen passieren, da bisher meines Wissens nach nur im Nanotech-Reoport über die Aktie berichtet wurde und die Amis es bisher völlig verpennt haben, was man auch an den zurückligenden Handelsumsätzen sehen kann. Ich glaube Beckmann hat da einen echten weiteren Knaller entdeckt, der wirklich abgehen könnte!

      Isonics:D
      Avatar
      schrieb am 15.09.03 12:30:57
      Beitrag Nr. 7 ()
      Cashbestand bei BDSI ist aktuel noch 5 Mio-$ :rolleyes:

      Damit ist natürlich kein Blumentopf zu gewinnen, Flamel
      stand vor einem Jahr auch mal bei 20 Mio-$ Marketcap.
      Erst als sich die Kooperationen mit Big Pharma
      nach und nach eingestellt hatten, bekam die Sache eine
      Perspektive und es ging "voll ab".

      FAZIT: Solange bei BDSI keiner einsteigt, geht da garnix ab :look: !
      Avatar
      schrieb am 15.09.03 13:50:25
      Beitrag Nr. 8 ()
      Hallo Chalifmann,
      prinzipiell sehe ich das genauso. Allerdings dürfen wir nicht unterschätzen, dass BDSI aktuell den Amis gänzlich unbekannt ist. Sollten die jetzt langsam auf das Unternehmen aufmerksam werden, wird der Kurs sicher schon jetzt angangen abzuheben. Die von Dir angesprochenen unternehmerischen Erfolge (Kooperationen mit Big Pharma) müssen sich dann natürlich auch einstellen, damit der Wert eine Marketcap von FLML bekommt. Die Technologie scheint jedoch das Potenzial zu haben, das Unternehmen weiter voranzubringen!

      Isonics:D
      Avatar
      schrieb am 15.09.03 14:33:07
      Beitrag Nr. 9 ()
      Tja, der Cashbestand ist wirklich nicht das gelbe vom Ei.

      Ich wundere mich ehrlich gesagt ein wenig, dass noch keine größeren Player hier eingestiegen sind. Die Technologie kann demzufolge ja eigentlich nicht ganz so bahnbrechend sein wie z.B. die von Flamel.

      So genau kann ich die Technologien bezogen auf die Delivery - Systeme nicht unterscheiden - nur grob.
      Insofern bleibt auch mir nur, dass Unternehmen zu beobachten und bei einer signifikanten Kooperation sofort einzusteigen.

      Gruß
      Falke28
      Avatar
      schrieb am 15.09.03 16:51:08
      Beitrag Nr. 10 ()
      Man, man. Heute geht das Ding aber mächtig. Hohes Volumen!
      Das sah am Freitag Abend schon so komisch aus...

      Da scheint was durchgesickert zu sein - oder jemand hat das Papier zum Kauf empfohlen - oder wie auch immer.

      Aber da geht was Leute!:D

      Gruß
      Falke28
      Avatar
      schrieb am 16.09.03 10:36:04
      Beitrag Nr. 11 ()
      DonPenny.com has taken a position

      in Biodelivery SciencesInternational Inc. NASDAQ (BDSI) based on the recent successes of Nanotechnology companies (FLML, NANX, NVEC, TINY). BDSI is still a relatively unknown Nanotechnology company with proprietary technology,and a global partner in PPDI.

      Market Cap 24M
      Shares Outstanding: 6,985,863

      Billion dollar Internation drug company
      Pharmaceutical Product Development (NASDAQ PPDI)has equity stake in BDSI.

      BioDelivery Science International, Inc
      has a unique, patented delivery technology
      with potential applications in the pharmaceutical,
      OTC, nutraceutical, supplement, processed foods and
      beverage industries. Its nanocochleate delivery
      technology is made from all natural ingredients:
      phosphatidylserine from soy and calcium. It is a simple,
      safe, easy-to-manufacture, economical delivery technology.
      The nanocochleates work by nano-encapsulating cargo molecules.
      This is analogous to a “shrink-wrap” on a nano scale.
      Once in the nanocochleates, the cargo molecules are
      protected from heat, light, water,
      enzymes, air, and pH. BDSI (www.biodeliverysciences.com)
      is out-licensing this technology and using the
      technology to develop its own pharmaceuticals
      Avatar
      schrieb am 16.09.03 12:03:49
      Beitrag Nr. 12 ()
      Aha. Na da wollen wir doch mal sehen, ob nicht bald eine Heirat anstehen könnte - mit Big Pharma.

      Wollen wir es hoffen!

      Gruß
      Falke28
      Avatar
      schrieb am 16.09.03 12:16:23
      Beitrag Nr. 13 ()
      Avatar
      schrieb am 16.09.03 13:51:37
      Beitrag Nr. 14 ()
      Compound Partnerships

      Pharmaceutical and biotechnology companies have discovered a number of therapeutic compounds that have not yet been developed for a variety of reasons. As part of our mission to help clients maximize the return on their R&D investment, we seek opportunities to in-license select discoveries, jointly develop them with a partner and license them out again in collaborative arrangements that utilize our global development resources.

      Under this compound partnering strategy we share the risk with our clients, helping them evaluate drug candidates earlier in the development cycle when the investment risk is significantly less than during later phases. We believe these risk-sharing models provide a significant reduction in cost and time to market for clients. Our goal is to create value for our clients while optimizing the potential for long-term revenue gains for PPD through the development of intellectual property.

      Our existing pipeline of several compounds at different stages of development verifies the success of our compound partnership strategy. We expect dapoxetine, the genitourinary compound we licensed to ALZA in January 2001, to enter Phase III development in 2003. In 2002, we obtained worldwide rights from Bayer AG to undertake additional Phase I and II clinical studies on implitapide. MRL International, a division of our development subsidiary, plans to initially pursue a safe and effective dose for patients with genetic or inherited forms of high cholesterol.

      We gained the rights from BioDelivery Sciences International to a drug delivery formulation that we can apply to two products, allowing them to be taken orally instead of by injection.


      http://www.ppdi.com/PPD_2_3.htm
      Avatar
      schrieb am 16.09.03 14:16:48
      Beitrag Nr. 15 ()
      Hallo Isonics und andere,

      du sprichst davon, dass Beckman den H&A Fond betreut. Dann kannst du mir sicher die WKN von NANOBAC Pharmaceuticals Inc. nennen. Dieser Wert ist im og Fond mit über 11 % gewichtet.

      mfg Wurze16
      Avatar
      schrieb am 23.09.03 16:36:18
      Beitrag Nr. 16 ()
      Welcome [Sign In] To track stocks & more, Register
      Financial News
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      Press Release Source: BioDelivery Sciences International, Inc.


      Bioral(TM) Pharmaceutical Delivery System Improves Efficacy And Reduces Side Effects of Aspirin
      Tuesday September 23, 7:30 am ET


      NEWARK, N.J., Sept. 23 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) announced today that results of animal studies show that the patented cochleate based delivery system Bioral(TM), used with aspirin, improves efficacy at significantly lower dosage and substantially reduces gastrointestinal side effects.
      ADVERTISEMENT


      The findings were presented at the "Inflammatory Processes in Drug Delivery" meeting in Philadelphia, PA. The Bioral(TM) Pharmaceutical Delivery System is a delivery system based on cochleates, which are calcium-phospholipid structures composed of naturally occurring materials that "wrap" around the drug being introduced into the body. The company has tested cochleates as a delivery system for other drugs, as well as micronutrients, but this is the first study which demonstrates the positive effects of the Bioral(TM) system with aspirin.

      Sara Krause-Elsmore, PhD, a research scientist at BDSI who leads the Bioral Non-Steroidal Anti-Inflammatory Drug (NSAID) Cochleate Program, stated; "Taking anti-inflammatories, such as aspirin, for extended periods of time to combat chronic inflammation leads to serious problems in the digestive tract, like bleeding and ulcers. This data shows that cochleates greatly reduce GI side effects in animal models and increase efficacy of aspirin at lower doses."

      The Bioral(TM) Pharmaceutical Delivery System uses cochleates, made of naturally occurring material, to surround the aspirin molecules. The cochleate crystalline structure protects the stomach lining and delivers the aspirin more efficiently to the inflamed cells. "Because cochleates protect the GI tract from the aspirin molecules, side effects are much less than with regular aspirin. Bioral(TM) does not change the molecule itself, and therefore the ability of the medication to decrease inflammation remains," said Dr. Krause-Elsmore.

      About Bioral(TM) Pharmaceutical Delivery System

      For additional information regarding BioDelivery`s patented, Bioral(TM) Pharmaceutical Delivery System, please visit our website at http://www.biodeliverysciences.com/

      BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages.

      Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company`s results to differ. Factors that may cause such differences include, but are not limited to, the Company`s ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company`s ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company`s need for additional funding, uncertainties regarding the Company`s intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company`s filings with the Securities and Exchange Commission.

      L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.
      Avatar
      schrieb am 09.10.03 11:33:28
      Beitrag Nr. 17 ()
      Das hört sich nicht schlecht an würde ich sagen. Hier könnte sich in Zukunft ein echter Blockbuster entwickeln (bzgl. Omega-3-Fettsäuren, deren Wirkung und Nano-Delivery-Systeme). Der Newsflow ist eine feine Sache. Nur sollte auch noch ein größerer Partner her...

      Gruß
      Falke28


      New BioGeode(TM) Cochleates Could Make Healthy Nutrients More Available In Processed Foods
      Tuesday September 30, 7:00 am ET


      NEWARK, N.J., Sept. 30 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) announced today a new formulation of cochleates, BioGeode(TM) nanocochleates, which have the ability to stabilize and protect an extended range of micronutrients and the potential to increase the nutritional value of processed foods.
      ADVERTISEMENT


      The research with new BioGeode(TM) nanocochleates was presented at the annual meeting of the American Association of Cereal Chemists in Portland, Oregon by Raphael J. Mannino, PhD, Chief Scientific Officer and Executive Vice President of BioDelivery Sciences International, Inc. The nanocochleates of the BioGeode(TM) delivery system result from crystallization of soy-derived phospholipids and calcium around a nano-droplet of oil containing the micronutrients. A "geode" is defined as a nodule of stone having a cavity; thus these new types of cochleates are termed BioGeode(TM) cochleates. The crystalline structure of the nanocochleates creates a stabilizing matrix in which the micronutrients are protected from the extreme conditions of food manufacturing and storage.

      Dr. Mannino stated, "As our research shows, BioGeode(TM) nanocochleates may allow for the production of stable, convenient preparations of micronutrients in processed foods, such as fast foods. Ordinarily, potentially beneficial micronutrients such as omega fatty acids and antioxidants can be destroyed during food manufacturing and storage. The crystalline structure of the BioGeode(TM) nanocochleates has been demonstrated to protect important micronutrients, thus potentially increasing the nutritional value of food. In addition, the FDA has authorized several beneficial health claims for phosphatidylserine, one of the fundamental building blocks of BioGeode(TM) nanocochleates. This may allow potential licensees of our BioGeode(TM) technology to make these health claims in products which utilize our technology."

      BioGeode(TM) nanocochleates are an enhancement of BDSI`s licensed Bioral(TM) cochleate delivery technology. "The diversity and adaptability of cochleate delivery vehicles is becoming clearer. BioDelivery Sciences International, Inc. has successfully adapted the same basic delivery technology for very different purposes. We feel that both Bioral(TM) cochleates and BioGeodes(TM) have global market potential and represent a strong pipeline for current and future development" stated Dr. Mannino.

      The research with omega fatty acid BioGeode(TM) nanocochleates demonstrates that BDSI`s delivery system has the potential to protect micronutrients through the production process of many different foods in the human and animal food nutritional markets. Dr. Mannino stated, "Two possible applications for BioGeode(TM) nanocochleates would be for microencapsulating nutrients for use in cereals or candy bars."

      Both the BioGeode(TM) technology and BDSI`s Bioral(TM) Pharmaceutical Delivery System are based on "cochleates." Cochleates are calcium- phospholipid structures composed of naturally occurring materials that "wrap" around the drug or nutrient being introduced into the body. As previously announced, in early 2003, BDSI formed a majority-owned subsidiary, Bioral Nutrient Delivery, LLC, or BND, in order to exploit the potential of BDSI`s core licensed technologies in the delivery of fragile micronutrients into the body. Effective April 1, 2003, all applications of BDSI`s technology for the human and animal food processing opportunity were licensed to BND, and the BioGeode(TM) technology will fall under this license.

      BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the-counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages.

      Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company`s results to differ. Factors that may cause such differences include, but are not limited to, the Company`s ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company`s ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company`s need for additional funding, uncertainties regarding the Company`s intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company`s filings with the Securities and Exchange Commission.


      L.G. Zangani, LLC provides financial public relations service to the Company.
      As such L.G. Zangani, LLC and/or its officers, agents and employees, receives
      remuneration for public relations and or other services in the form of monies,
      capital stock in the Company, warrants or options to purchase capital in the

      Company.




      --------------------------------------------------------------------------------
      Source: BioDelivery Sciences International, Inc.
      Avatar
      schrieb am 10.10.03 16:24:51
      Beitrag Nr. 18 ()
      Mein Gott hat diese Aktie im Moment einen enttäuschenden Kursverlauf...da ist ja wohl überhaupt kein Käufer mehr da...

      Hoffentlich kommen bald mal überdurchschnittlich gute News - sonst fallen wir wahrscheinlich bald auf Null:D


      Gruß
      Falke28
      Avatar
      schrieb am 13.10.03 17:47:06
      Beitrag Nr. 19 ()
      Hallo @ all,gibt es irgendwelche news,glaube die 4usd werden heute geknackt.drpaulo2001
      Avatar
      schrieb am 13.10.03 22:34:20
      Beitrag Nr. 20 ()
      ja, sind news rausgekommen oder was sollen diese 25%? :D
      Avatar
      schrieb am 15.10.03 14:08:09
      Beitrag Nr. 21 ()
      Hi Falke28,

      bin mit 3,21$ Einstiegskurs dabei. Wollt es dir nur mal gesagt haben, du weisst ja, unsere Diskussion von damals. Im Nahrungsmittelbereich sollte sich bald was tun. Die Tests zum Gebrauch in Tiernahrungsmitteln sollte bald beendet sein.

      Nebenbei:
      Du hast mich mal zu Natural Health Tech irgendwas gefragt. Meine Antwort: Ich würde niemals in dieses Unternehmen investieren. Kann zwar sein, dass sie zukünftig erfolgreich sind, aber ein Unternehmen, dass sich nur auf den aufkommenden Gesundheitswahn im Lebensmittelbereich setzt (ich meine damit diese fragwürdigen Beimischungen, deren Effekt nicht wirklich abschätzbar ist) ist nicht mein Ding.

      Da gefällt mir Biodelivery Sciences schon besser, da sie im Lebensmittelbereich zumindest etwas einzigartiges bieten und nebenher auch noch Medikamentenkandidaten in der Pipeline haben.

      Vor allem ist hier die HIV-Impfung zu erwähnen, die gerade auf Geheiss des NIH zur Schluckimpfung umfunktioniert wird. Wer die präklinischen Behandlungsergebnisse von bereits infizierten Personen gelesen hat, weiss was potentiell möglich ist.


      Also auf gutes gelingen, Falke
      Avatar
      schrieb am 16.10.03 08:46:59
      Beitrag Nr. 22 ()
      Hallo Neoe,

      da hast Du aber einen guten Einstiegskurs erwischt. Herzlichen Glückwunsch!
      Das es bei dieser Aktie noch mal zu wirklich guten News kommen kann glaube ich auch.

      Die NHCL.OB ist von der Produktpipeline aber gar nicht so schlecht - und die meisten Menschen leben sowieso mehr in der Phantasie als in der Realität. Aber Du hast schon recht, diese Aktie hat eine deutlich andere Risikostruktur.
      Ich bin auch sehr verwundert - da scheint was nicht zu stimmen - gestern fast 25% Minus - war das nun eine technische Reaktion da der Kurs so gestiegen ist in den letzten Monaten? Oder steckt da mehr dahinter? Auf jeden Fall ist nun das Vertrauen erst mal erschüttert.
      Mal sehen, was dort demnächst noch für News kommen...
      Aber von der Bewertung her ist diese Aktie halt verdammt billig - also muß mehr dahinter stecken (weia...).

      Tja, also weiter gutes gelingen bei Deinen Investitionen

      Gruß
      Falke28
      Avatar
      schrieb am 20.10.03 22:45:41
      Beitrag Nr. 23 ()
      hi leute, ne idee, warum es so bergab geht?
      Avatar
      schrieb am 23.10.03 09:01:33
      Beitrag Nr. 24 ()
      Ich habe wirklich keine Ahnung warum es so runter geht.

      Der Kursverlauf ist mehr als enttäuschend. Nur ist die Liquidität in diesem Wert auch sehr gering. Bei einer guten Nachricht kann dieser Wert richtig explodieren (Kooperation).
      Hier muss man einfach ausharren und auf guten newsflow spekulieren - was der Kurs bis dahin macht ist reine Nebensache (außer es kommen richtig schlechte Nachrichten).


      Gruß
      Falke28
      Avatar
      schrieb am 23.10.03 22:56:56
      Beitrag Nr. 25 ()
      Ich beobachte die ja auch schon etwas länger...aber mir ist bislang noch kein Blockbuster bekannt, mit dem die Firma Cash generieren kann. Und das ist wohl das Problem...solange Verluste anfallen kann es auch mal schräg nach unten gehen.
      Avatar
      schrieb am 23.10.03 23:51:50
      Beitrag Nr. 26 ()
      Der Tenor im yahoo-board (selbst von strong-buy-Anhängern):
      Der Laden ist am Arsch. Liquide Mittel gehen zu Ende. Hm. Stinkt mir gewaltig - hab zuviel davon...
      Avatar
      schrieb am 24.10.03 00:58:55
      Beitrag Nr. 27 ()
      Moin zusammen,
      würde mich freuen noch die eine oder andere Aktie günstig abzugreifen, meine BDSI-Position ist noch ausbaufähig ;) Natürlich darf man nicht alles auf eine Karte setzen, aber sei es bei BDSI, OBDU, TGAL oder NVEC: Das sind alles Werte mit hohem Risiko, die meiner Meinung nach aber langfrisitg durch Qualität überzeugen.

      BDSI ist doch ein gutes Beispiel: Der Cash-Bestand reicht noch bis weit über Mitte 2005. Ich verstehe nicht wie man sich da jetzt verrückt machen kann :confused:
      Natürlich ist der Wert High-Risk, aber das ist nun mal jeder Wachstumswert in der Anfangsphase. Wenn wir bei BDSI die erste große Kooperationen sehen dann ist der Kurs innerhalb fünf Minuten jenseits von 10 Dollar. Das geht dann so schnell das keiner von uns mehr günstig nachlegen kann. Und so ein jump wäre dann nur der Anfang...

      Wenn Ihr eine Aktie wollt bei der schon sämtliche Kooperationen unter Dach und Fach sind dann bezahlt ihr halt auch mal minimum 200 Millionen Marketcap. BDSI hat aktuell eine Marketcap von zwanzig, eine herausragende Technologie, beruhigend viel Cash und mit PHARMACEUTICAL PRODUCT DEVELOPMENT einen starken Big-Cap mit einer 1,5 Milliarden Marketcap im Boot.

      Immer cool bleiben :cool:

      Grüße

      Isonics :D
      Avatar
      schrieb am 27.10.03 08:21:07
      Beitrag Nr. 28 ()
      Ich habe gehört, dass diese Aktie von dem Nanotech-Investor empfohlen wurde. Ich glauge nicht, nachdem was ich über diesen Brief gehört habe, dass dort Werte empfohlen werden, welche vom Cashbestand kurz vor dem aus stehen.
      Außerdem war, und ich denke ist immer noch, der H&A Fond investiert-auch diese Jungs würden nicht in einen eindeutigen Pleitekandidat investieren.

      Bisher ging es mit hohen Volumina immer nur berauf anstatt bergab - also kaufen die Fonds immer noch (die sind ja auch winzig vom Volumen her gesehen).

      Wie gesagt, wir alle warten auf einen guten Newsflow - vor allem auf eine Kooperation zu Kommerzialisierungszwecken.


      Also hier würde ich auch mit einem hohen Risiko investiert bleiben.

      Gruß
      Falke28
      Avatar
      schrieb am 27.10.03 12:24:58
      Beitrag Nr. 29 ()
      @Isonics


      sag, hast Du ne info über deren aktuelle burn rate pro monat?


      oder wie kommst Du drauf das die noch bis ende 2005 flüssig sind?



      thx, Hack
      Avatar
      schrieb am 28.10.03 10:52:14
      Beitrag Nr. 30 ()
      Ein schon ein paar Tage altes Interview:

      The following article appeared in Drug Delivery Technology Magazine -
      October 2003 - Vol 3 - No 7 - pgs: 66-67

      Drug Delivery Executive

      BioDelivery Sciences International: Delivering Value Through
      Nanoencapsulation.

      BioDelivery Sciences International (BDSI) is a developmental-stage
      biotech company, which became publicly traded in June 2002 in an
      extremely hostile financial environment. The company was founded upon a
      unique broad-based technology formulation and delivery platform known as
      cochleate technology. Applications of this unique technology include
      drug stabilization, efficient delivery, formulation of hydrophobic
      drugs, as well as the conversion of exclusively intravenous drugs into
      oral drugs. Drug Delivery Technology recently interviewed Dr. Raphael J.
      Mannino, Executive Vice President & Chief Scientific Officer of BDSI, to
      examine his company`s unique technology, competitive advantage, and
      diversification.

      Q: What is the conceptual basis of BioDelivery Sciences International?

      A: For a company to stand out in this competitive biotechnology
      environment, it must contain three key elements: strong financial
      organization; unique, broadly applicable and cost-effective technology;
      and a deep pipeline that fills previously unmet needs. BDSI boasts an
      excellent combination of these important elements. And following its
      initial public offering, BDSI is stronger that ever. We are aggressively
      developing a focused pipeline of potential target products based on
      cochleate technology for use in the branded pharmaceutical, over the
      counter, and nutraceutical markets. These initial products are for five
      major medical indications with large worldwide markets.

      Q: What is BDSI`s technology platform?

      A: BDSI`s technology utilizes a solid, multilayer crystalline structure
      called a cochleate composed of inexpensive, naturally occurring
      food-grade material, phospholipids, and calcium. Cochleate technology is
      a formulation as well as a delivery technology. The nature of a
      cochleate provides an environment for molecules that is essentially free
      of water and protected from oxygen. When imbedded within the matrix of a
      cochleate, even fragile molecules can be stabilized so that they can
      survive processing and extend shelf life. In addition, cochleate
      technology is highly adaptable to insoluble hydrophobic molecules, which
      other technologies often find are difficult to work with.

      Q: Are there other properties of cochleate technology that provide BDSI
      with a competitive advantage?

      A: The BDSI cochleate technology can convert intravenous and injectable
      medications into oral therapeutics. Because the technology is based upon
      transporting drugs across the intestinal tract and delivering the drug
      directly to cells, cochleate-delivered drugs demonstrate decreased
      toxicity and increased efficacy. From an intellectual property position
      perspective for the cochleate technology, BDSI has exclusive world-wide
      rights to a broad range of issued US patents providing extensive
      coverage to cochleate technology formulations and applications.

      Q: As a new public company, how would you describe BDSI`s first year?

      A: Within the past year, BDSI has expanded and enhanced its
      infrastructure in terms of both personnel and technical resources. BDSI
      is now stronger and more sophisticated in our creative and developmental
      capabilities. In addition, we have expanded our intellectual property
      portfolio through the invention of a new composition of matter based
      upon cochleate technology that should extend our potential product line,
      leading to increased commercial opportunities.

      Q: What future developments do you foresee in BDSI and your pipeline?

      A: With a proprietary and broad based technology platform, BDSI plans to
      aggressively move forward with scale-up and cGMP manufacturing of our
      lead product, Bioral(tm) Amphotericin B. Our objective is to submit
      anIND early in 2004. Several other potential products are in earlier
      stages of development with partners.

      Q: What makes the business model for BDSI unique and/or competitive?

      A: BDSI intends to generate revenue in the short-term through licensing
      and milestone payments. This should be followed in the longer term by
      royalty payments for marketed products by partners utilizing our
      technology. Currently, we have entered into several evaluation
      agreements with major pharmaceutical companies. In addition, BDSI has
      signed licenses with Pharmaceutical Product Development, Inc. (PPDI) to
      apply Bioral(tm)
      delivery technology in two therapeutic areas. We also aim to keep our
      burn rate low by minimizing our involvement in paying the costs of
      long-term clinical trials.

      Q: How are you looking to further diversify the company?

      A: Unlike most other delivery technologies, cochleates are made of
      inexpensive, food-grade components. This has allowed BDSI to explore
      opportunities in the food industry, which involve stabilizing and
      delivering fragile nutrients. In January 2003, BDSI created a
      subsidiary, Bioral Nutrient Delivery, to develop our cochleate
      technology outside of the pharmaceutical industry, which has been our
      main focus. BDSI intends to grant an exclusive world-wide perpetual
      sublicense to this subsidiary for the purpose of developing our
      Bioral(tm) cochleate technology in the processed food and beverage
      industry for both human and animal consumption. With a proprietary and
      broadbased technology platform; state-of-the-art license technology; and
      a talented, creative, energetic team, BDSI is strategically poised to
      aggressively undertake and reach major milestones during this coming
      year.

      Reproduced with permission by: Drug Delivery Technology October 2003 Vol
      3 No 7

      Please Note: To be removed from our mailing lists please reply to this
      email with the subject: "REMOVE"


      "Currently, we have entered into several evaluation
      agreements with major pharmaceutical companies.":D

      Sehr interessant...mal sehen, was dabei rauskommt.


      Gruß
      Falke28
      Avatar
      schrieb am 05.11.03 13:10:42
      Beitrag Nr. 31 ()
      leute ihr werdet sehen der kurs zieht von ganz alleine wieder an. es wird früher oder später zu regelrechten kaufpaniken kommen im bereich der nanotechnologie, vgl.
      den zeiten des internethypes-bloss noch ne ganze spur heftiger.

      also was lohnt sich mehr hier einzusteigen bei einer marketcap. von 16 millionen us-dollar und einem float von 2,7 million shares?!
      Avatar
      schrieb am 06.11.03 16:19:20
      Beitrag Nr. 32 ()
      Diese Aktie hört nicht auf zu fallen. Aber wie gesagt: kommt ernstes Interesse in diesen Wert, so erleben wir einen regelrechten Hype (free float nur 2,7 Mio. Shares!!!).

      Hoffentlich kommen in nicht all zu ferner Zukunft auch mal News über Kooperationen...


      Gruß
      Falke28
      Avatar
      schrieb am 07.11.03 09:30:54
      Beitrag Nr. 33 ()
      Die neuen Zahlen sind da:

      Form 10QSB for BIODELIVERY SCIENCES INTERNATIONAL INC
      --------------------------------------------------------------------------------

      6-Nov-2003

      Quarterly Report


      ITEM 2. Management`s Discussion and Analysis of Financial Condition and Plan of Operations
      The following discussion and analysis should be read in conjunction with the Condensed Consolidated Financial Statements and Notes thereto included elsewhere in this Form 10-QSB. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company`s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Form 10-QSB.


      For the Nine Months Ended September 30, 2003 Compared to the Nine Months Ended September 30, 2002

      Sponsored Research Revenue. During the nine month period ended September 30, 2003, we reported $689,867 of sponsored research revenues. Of this amount, $623,617 was from a grant from the National Institutes of Health, and $66,250 was from a collaborative research agreement. In the prior year, all revenue aggregating $605,972 was derived from the grant.

      License Fee Revenues. During December 2002, the Company entered into a licensing agreement with a company (which is a shareholder), which included an up-front non-refundable payment of $2 million to the Company, which was received in January 2003. The Company is recognizing it over the period of the related research and development commitment ($1,800,000 for the nine months ended September 30, 2003). The agreement also provides for milestone payments.

      Research and Development. Research and development expenses of $1,986,194 and $1,428,755 were incurred during the nine month periods ended September 30, 2003 and 2002, respectively. Research and development expenses generally include: salaries for key scientific personnel, research supplies, facility rent, lab equipment depreciation, a portion of overhead operating expenses and other costs directly related to the development and application of the Bioral(TM) cochleate drug delivery technology.

      General and Administrative Expense. General and administrative expenses of $1,887,369 and $945,016 were incurred in the nine month periods ended September 30, 2003 and 2002, respectively. These expenses are principally composed of legal and professional fees, patent costs, and other costs including office supplies, conferences, travel costs, salaries, website update and development, and other business development costs. Furthermore, 2003 expenses include approximately $388,000 related to BND operating activities that commenced in 2003, approximately $150,000, of which, related to offering costs associated with a registration statement. Furthermore, on February 13, 2003, we made an unsecured loan to us in the amount of $500,000 to fund our formation expenses and working capital requirements. This loan accrues interest at a rate of 4.85% annually and will be paid back solely from 10% of any royalty revenue that may be received by BND, in preference to the holders of our Class B Shares.




      Stock-Based Compensation Expense. Stock-based compensation expense of $36,714 and $526,318 were incurred in the nine month periods ended September 30, 2003 and 2002, respectively. The reduction results principally from non-recurring items in 2002 associated with the Company`s forgiveness of employee stock subscription notes receivable and related income taxes paid on behalf of such employees.

      Interest Income (Expense). Interest income (expense) for the periods ended September 30, 2003 and 2002 was principally composed of earnings from invested cash offset by interest expense on the line of credit, notes payable and capital leases payable.

      Income Taxes. While net operating losses were generated during the nine month period ended September 30, 2003, we did not recognize any benefit associated with these losses, as all related deferred tax assets have been fully reserved. Financial Accounting Standards Board Statement No. 109 provides for the recognition of deferred tax assets if realization of such assets is more likely than not. Based upon available data, which includes our historical operating performance and our reported cumulative net losses in prior years, we have provided a full valuation allowance against our net deferred tax assets as the future realization of the tax benefit is not sufficiently assured.

      Other comprehensive loss Other comprehensive loss consists exclusively of unrealized losses on marketable equity securities classified as available for sale. These securities were purchased in the first quarter of 2003.

      Liquidity and Capital Resources

      Since inception, we have financed our operations primarily from the sale of our securities. From inception through September 30, 2003, we raised approximately $10,400,000 million, net of costs, through these issuances. At December 31, 2002, we had cash and cash equivalents totaling approximately $5,200,000. At September 30, 2003, we had approximately $3,600,000 in cash and short-term investments.

      The operations of BioDelivery Sciences, Inc., prior to our acquisition of a controlling interest on October 10, 2000, were financed primarily through funded research agreements. In 2001, the National Institutes of Health awarded to us a three-year Small Business Innovation Research Grant (SBIR), to be utilized in our research and development efforts.

      The NIH award consisted of 2001 and 2002 grants aggregating approximately $1,700,000, $445,000 of which has been recognized as revenue in 2003. Additionally, in July 2003 the Company was awarded $989,000 as the final year segment of the three year SBIR award. The grants are subject to provisions for monitoring set forth in NIH Guide for Grants and Contracts dated February 24, 2000, specifically, the NIAID Policy on Monitoring Grants Supporting Clinical Trials and Studies.



      In the third quarter of 2003, we obtained a $1 million bank term loan, at an interest rate of 7.5%, used to acquire laboratory and other equipment and facilities improvements in our Newark, New Jersey lab. The collateral is all equipment owned by us.

      Working capital was $3.3 million and $4.8 million at September 30, 2003 and December 31, 2002, respectively. At September 30, 2002, the working capital was $5.8 million.

      From our inception through September 30, 2003, we have incurred approximately $5.5 million of research and development expenses. Additionally, during the period March 28, 1995 (date of BioDelivery Sciences, Inc.`s incorporation, our predecessor entity), through the acquisition of a controlling interest in BioDelivery Sciences, Inc. in October 2000, we incurred approximately $6.8 million of research and development expenses.

      We have incurred significant net losses and negative cash flows from operations since our inception. As of September 30, 2003, we had an accumulated deficit of $9.5 million and total stockholders` equity of $4.1 million. At September 30, 2002, our accumulated deficit was $7.4 million and our stockholders` equity was approximately $6.5 million.

      We anticipate that cash used in operations and our investment in facilities will continue in the future as we research, develop, and, potentially, manufacture our drugs. While we believe further application of our Bioral (TM) cochleate technology to other drugs will result in license agreements with manufacturers of generic and over-the-counter drugs, our plan of operations in the next 18 months is focused on our further development of the Bioral(TM) cochleate technology itself and its use in a limited number of applications. Such plans do not include the marketing, production or sale of FDA approved products.

      We believe that our existing cash and short-term investments, together with available financing, grants and new licensing revenues will be sufficient to finance our planned operations and capital expenditures through at least the next 18 to 24 months. We may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding. Accordingly, we may be required to raise additional capital through a variety of sources, including:

      o the public equity market; o private equity financing; o collaborative arrangements; o grants and new license revenues; o public or private debt; and o redemption and exercise of warrants





      There can be no assurance that additional capital will be available on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain of our drugs, technologies or potential markets, either of which could have a material adverse effect on our business, financial condition and results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in ownership dilution to our existing stockholders.

      Critical Accounting Policies and Estimates

      The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. We believe that the following are some of the more critical judgment areas in the application of our accounting policies that affect our financial condition and results of operations. We have discussed the application of these critical accounting policies with our Board of Directors and its Audit Committee.

      Revenue recognition:

      Sponsored research amounts are recognized as revenue, when the research underlying such payments has been performed or when the funds have otherwise been utilized, such as for the purchase of operating assets. Revenue is recognized to the extent provided for under the related grant or collaborative research agreement.

      Non-refundable license fees are generally up-front payments for the initial license of and access to the Company`s technology. For nonrefundable license fees received at the initiation of license agreements for which the Company has an ongoing research and development commitment, the Company defers these fees and recognizes them ratably over the period of the related research and development. For nonrefundable license fees received under license agreements where the continued performance of future research and development services is not required, the Company recognizes revenue upon delivery of the technology. In addition to license fees, the Company may also generate revenue from time to time in the form of milestone payments. Milestone payments are only received and recognized as revenues if the specified milestone is achieved and accepted by the customer and continued performance of future research and development services related to that milestone are not required.





      Stock-based compensation:

      The Company follows Statement of Financial Accounting Standards (SFAS) No. 123, Accounting for Stock-Based Compensation (SFAS 123), which establishes a fair value based method of accounting for stock-based employee compensation plans; however, the Company has elected to account for its employee stock compensation plans using the intrinsic value method under Accounting Principles Board Opinion No. 25 with pro forma disclosures of net earnings and earnings per share, as if the fair value based method of accounting defined in SFAS 123 had been applied.

      Had compensation cost for the Company`s stock option plan been determined on the fair value at the grant dates for stock-based employee compensation arrangements consistent with the method required by SFAS 123, the Company`s net loss and net loss per common share would have been the pro forma amounts indicated in Note 2 to the financial statements.


      Gruß
      Falke28
      Avatar
      schrieb am 08.11.03 09:26:36
      Beitrag Nr. 34 ()
      und sind die nun gut oder schlecht


      danke malo
      Avatar
      schrieb am 09.11.03 10:35:51
      Beitrag Nr. 35 ()
      Fragt sich, ob wir hier noch lange über gut od. schlecht diskutieren müssen:

      We believe that our existing cash and short-term investments, together with available financing, grants and new licensing revenues will be sufficient to finance our planned operations and capital expenditures through at least the next 18 to 24 months.

      At December 31, 2002, we had cash and cash equivalents totaling approximately $5,200,000. At September 30, 2003, we had approximately $3,600,000 in cash and short-term investments.

      Wenn nicht bald jemand Kohle rüberschiebt, ists aus. Biodelivery ist praktisch ein Optionsschein. Und solange die Finanzierung nicht langfristig gesichert ist, ist Biodelivery - von der geringen Größe mal ganz abgesehen - für Fonds tabu.

      Fazit: Im Moment reines Zockerpapier.
      Avatar
      schrieb am 10.11.03 19:56:07
      Beitrag Nr. 36 ()
      @Andus



      ähm sorry, aber die haben noch geld für 18-24 monate! das sind 2 jahre das weißt Du oder? Du tust so als ob die im jänner out of cash wären. :confused:


      ich kenn einige biotech unternehmen die noch absolute start ups sind, und nur sehr sehr wenige habe mehr als 2 jahre cash im voraus. weißt Du was in 2 jahren alles passieren kann?


      ist schon ein bißchen übertrieben Deine einschätzung.



      Hack
      Avatar
      schrieb am 11.11.03 12:59:04
      Beitrag Nr. 37 ()
      ´Da muß ich Hackertom zustimmen. Ich denke auch, dass die eigentlich nicht so besonders schlecht dastehen.

      Aber das Risiko ist hoch - keine Frage.

      Sollten aber in diesen zwei Jahren mal gute News kommen - und die Chance ist sehr hoch denke ich - sehen wir da Papier schnell deutlich höher!


      Also uns allen viel Glück

      Gruß
      Falke28
      Avatar
      schrieb am 11.11.03 13:24:37
      Beitrag Nr. 38 ()
      Jetzt hätte ich fast vergessen die Neuigkeiten zu posten:

      Welcome [Sign In] To track stocks & more, Register
      Financial News
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      Press Release Source: BioDelivery Sciences International, Inc.


      BioDelivery Sciences International, Inc. to Participate in BioMilano 2003
      Tuesday November 11, 7:05 am ET
      Company Will Showcase BioGeode(TM) and Bioral(R) Drug and Micronutrient Delivery Systems In New Markets


      NEWARK, N.J., Nov. 11 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) announced today its participation in the BioMilano 2003 Italian Partnering Conference in Milan, Italy on November 21, 2003. BioMilano 2003 is a showcase for Italian financial institutions and pharmaceutical industry members. BioDelivery Sciences International was invited to present at this prestigious event through its relationship with Sigma Tau, one of Italy`s top pharmaceutical companies and a sponsor of the event.
      ADVERTISEMENT


      According to Raphael J. Mannino, PhD., Chief Scientific Officer and Executive Vice President of BioDelivery Sciences International, Inc, by presenting at this one-day intensive conference, BDSI will gain access, exposure and contacts in both the financial and pharmaceutical markets in Italy.

      BioDelivery Sciences International, Inc.`s licensed and patented Bioral® cochleate pharmaceutical delivery system and proprietary BioGeode(TM) nutrient and flavoring delivery system for food, beverage and personal care applications, have global market potential and represent a strong pipeline for current and future development.

      "Accordingly, the timing of the BioMilano 2003 presentation couldn`t be better," Dr. Mannino said, "Italy has demonstrated great potential for international exploration in the pharmaceutical industry, and BDSI is positioning itself there for potential investment and partnering opportunities."

      Bioral(TM) Amphotericin B, a cochleate preparation of a powerful anti- fungal agent, is one of BDSI`s lead pharmaceutical projects. This preparation showcases one of the many advantages of the Bioral® cochleate delivery system: Toxic drugs which were previously only available by injection have been demonstrated to be readily and effectively deliverable in a stable, safe and orally bio-available formulation.

      The new BioGeode(TM) delivery system has an enhanced protective structure that can be employed to stabilize and deliver a wide range of micronutrients and has the potential to increase the nutritional value of processed foods and beverages. It also has potential and wide-ranging applications in personal care products and for the delivery of difficult to work with water-insoluble compounds such as hydrophobic drugs, antioxidants and oils. Micronutrients formulated into BioGeodes(TM) are stabilized and protected from the potentially harsh conditions of food processing and product manufacturing and also exhibit extended shelf life. The lead product employing the BioGeode(TM) delivery system is an antioxidant preparation which has been manufactured in kilogram quantities using standard, cost-effective manufacturing protocols.

      Both the BioGeode(TM) and Bioral® Delivery Systems are manufactured from safe, naturally occurring phospholipid and calcium that form a protective barrier around the drug or nutrient being introduced into the body. In January 2003, BDSI formed a majority-owned subsidiary, Bioral Nutrient Delivery, LLC, or BND, in order to exploit the potential of BDSI`s core licensed technologies in the delivery of fragile micronutrients into the body. Effective April 1, 2003, all applications of BDSI`s technology for the human and animal food and beverage processing and personal care product opportunities were licensed to BND, and the BioGeode(TM) technology will fall under this license for these applications.

      BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the- counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages and personal care products.

      Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company`s results to differ. Factors that may cause such differences include, but are not limited to, the Company`s ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company`s ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company`s need for additional funding, uncertainties regarding the Company`s intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company`s filings with the Securities and Exchange Commission.

      L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.




      --------------------------------------------------------------------------------
      Source: BioDelivery Sciences International, Inc.


      Gruß
      Falke28
      Avatar
      schrieb am 14.11.03 18:12:16
      Beitrag Nr. 39 ()
      Die neuen Zahlen sind da. Es hat sich nicht geändert an der schon bekannten Einschätzung - die Firma wird bei der jetzigen Burnrate noch ca 6-7 Quartale durchhalten.

      Der Umsatz ist leicht gesunken - aber der große Deal soll ja erst noch kommen.

      Die Marktkapitalisierung liegt nun bei erstaunlichen 15 Mio. $. Da ist wahrlich nicht viel. Hier ist keinerlei Phantasie eingepreist.

      Also warten wir auf eine wirklich interessante Meldung.

      Wenn ein Kommerzialisierungsdurchbruch kommen sollte können wir uns wahrscheinlich über eine Verdreifachung diese Wertes freuen...Aber auf diese Meldung muß man bei diesem Wert wohl "zocken".

      Also weiterhin viel Glück

      Gruß
      Falke28

      Link: http://finance.yahoo.com/q/bs?s=BDSI
      Avatar
      schrieb am 14.11.03 19:49:26
      Beitrag Nr. 40 ()
      Hallo @ all,denke kurs wird bewußt nach unten gedrückt,um billig einzusammeln.Denke nächste Woche an bio-milano konferenz,d.wird das ding bekannt und bekommt fahrt,wetten.drpaulo2001
      Avatar
      schrieb am 22.11.03 00:58:24
      Beitrag Nr. 41 ()
      Also diese Aktie kostet mich noch den letzten Nerv... die denkt nicht dran mit dem Fallen mal aufzuhören. Hier wieder mal News...


      BDSI Announces Plans to Distribute Interests in Food Processing and Personal Care Product Subsidiary to Stockholders
      Wednesday November 19, 5:14 pm ET


      NEWARK, N.J., Nov. 19 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) announced today that it is intending to distribute to its stockholders 3,545,431 Class B Memberships Shares, or approximately 47% of the currently outstanding interests, of its subsidiary, Bioral Nutrient Delivery, LLC ("BND"). BDSI previously announced that it would distribute rights to its stockholders to purchase up to 11,277,000 of such interests from BDSI, both initially at $0.01 per interest and then quarterly over of 3 year period at the then fair market value. BDSI has decided to change the structure and distribute only 3,545,431 Class B Shares directly to BDSI stockholders of record on a pro-rata, one-time basis. Subject to compliance with applicable laws and the facts and circumstances at such time, the Company may elect to distribute additional Class B Shares in the future, although no assurances can be given that any such additional distributions will ever be undertaken. In February 2003, BND filed a registration statement on Form SB-1 with the Securities and Exchange Commission to register the rights and the underlying Class B Membership Shares. Given the change in structure, such registration statement was formally withdrawn on November 18, 2003. Instead, BND today filed a registration statement on Form 10-SB covering the proposed, one-time distribution of 3,545,431 Class B Memberships Shares by BDSI to its stockholders. BDSI stockholders will not be required to purchase Class B Shares in connection with the distribution.
      ADVERTISEMENT


      In addition, BDSI announced that BDSI and BND have amended their April 1, 2003 license agreement to included personal care products. The original license gave BND rights to BioDelivery`s licensed nano-encochleation delivery technology to develop ways to deliver nutrients for non-pharmaceutical use in the processed food and beverage industries for both human and animal consumption. As amended, the license gives BND the right to exploit such technology in the personal care products sector as well. In addition, BDSI and BND have amended their March 31, 2003 management agreement, pursuant to which BDSI provides management and administrative services to BND at no cost, to extend the initial term of such agreement from Mach 31, 2004 to December 31, 2004.

      Francis E. O`Donnell, Jr., M.D., President and CEO of BDSI and BND stated that "The distribution of Class B Shares in BND is being effected in order to separate BND, its licensed technology, and the processed food and beverage and personal care product opportunity from the rest of BDSI`s pharmaceutical, vaccine, gene delivery, OTC drug, and nutraceutical businesses. This will allow both BND and BDSI to focus on their respective businesses and provide BND and BDSI with the flexibility to pursue different strategies and react more easily and prudently to changing market environments."

      The distribution of Class B Shares in BND will commence when the Form 10-SB becomes effective pursuant to SEC rules, which is anticipated to be 60 days from the date of filing. Following the distribution, BSDI stockholders will own approximately 47% of the currently outstanding economic interests in BND, and BND will be a separate reporting company with the SEC. However, such percentage will be subject to dilution based on a number of factors, including the possibility of new equity ownership interests being issued as BND pursues its licensing opportunities. Furthermore, the interests in BND will not, nor is it anticipated that they will be, publicly-traded and holders of such interests will be severely limited in their rights to transfer such interests. More information about the distribution, the Class B Shares and BND generally can be found in the registration statement on Form 10-SB filed by BND with the SEC, including the information statement attached thereto as an exhibit.

      BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the-counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages and personal care products.

      Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company`s results to differ. Factors that may cause such differences include, but are not limited to, the Company`s ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company`s ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company`s need for additional funding, uncertainties regarding the Company`s intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company`s filings with the Securities and Exchange Commission.

      L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.




      --------------------------------------------------------------------------------
      Source: BioDelivery Sciences International, Inc.



      Gruß
      Falke28
      Avatar
      schrieb am 24.11.03 22:07:57
      Beitrag Nr. 42 ()
      Hallo falke 28 !!!!!!

      Was sagst Du nun zu tegal ???

      Gruß
      Avatar
      schrieb am 24.11.03 22:57:18
      Beitrag Nr. 43 ()
      Hi

      Ich glaube ich schichte um in Tegal ,bevor die noch auf 0 fällt.
      Biodelivery ist nichts für mich ,seit ich die gekauft habe seh ich nur die farbe Rot.
      Grrrrrr

      Gruss
      M.B.
      Avatar
      schrieb am 25.11.03 08:54:51
      Beitrag Nr. 44 ()
      Endlich wieder mal eine sinnvolle Nachricht. Gefällt mir, dass die mit in Israel vertreten sein wollen. Gute Basis, um ihre Technologie voranzutreiben und bekannt zu machen:

      Press Release Source: BioDelivery Sciences International, Inc.


      BDSI to Establish Israeli Subsidiary to Develop Oral Enzyme Replacement For Gauchers Disease
      Monday November 24, 11:24 am ET


      NEWARK, N.J., Nov. 24 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) announced today that it has entered into an memorandum of understanding to establish an Israeli subsidiary, tentatively named Biorazyme Ltd., for the purpose of developing oral formulations of lysosomal storage enzymes, such as glucocerebrosidase for the treatment of Gauchers Disease.

      The new company will initially be majority-owned by BDSI, with the remainder being owned by BDSI`s Israeli joint venture partners who will be developing the new oral formulations in conjunction with BDSI. BDSI intends to sub-license its licensed and patented Bioral(TM) technology to assist in the creation of the new formulations. BDSI will also have the right to appoint a majority of the new company`s board of directors and will provide certain support services when requested.

      According to publicly available information, worldwide sales of enzyme replacement for Gauchers are estimated to be over $600,000,000. In addition, lysosomal storage enzyme replacement therapy is currently available only by intravenous infusion at bi-weekly intervals and at an annual cost of approximately $200,000 per patient. Accordingly, only the most severe cases in the most affluent countries can access the enzyme replacement therapy. BDSI believes that its patented and licensed Bioral(TM) nanotechnology may be able to provide an effective oral enzyme replacement therapy. Such an oral formulation could have many advantages, including reduced cost, daily dosing, greater patient acceptance and expanded market opportunities. In order to validate these potential benefits, it is anticipated that Biorazyme will conduct a multi-stage study plan aimed at evaluating the new formulations for, among other items, feasibility based on in vitro studies, the optimal formulation, stability, release profile and potency.

      Lysosomal storage disorders represent a group of more than 40 different inherited diseases, each caused by a specific lysosomal enzyme deficiency. Although considered rare, some are more common in specific ethnic groups. Enzyme replacement therapy is currently approved for three such diseases (Gauchers disease, Fabry disease and Mucopolysaccharidosis I) and is being investigated for others. The major consequences of these diseases currently are the life long dependency on intravenous infusions and the high cost.

      The Bioral(TM) delivery technology consists of nanocochleates which are nanocrystalline delivery vehicles made from all-natural components: soy-derived phospholipid and calcium. These nanocochleates wrap around the cargo pharmaceutical like a shell and allow the drug (or enzyme, in this case) to be delivered into the body safely and effectively. The Bioral(TM) delivery technology is simple, inexpensive and commercially scalable. When used in this context, BDSI`s technology will be referred to as Biorazyme(TM).

      Dr. Raphael Mannino, Executive Vice-President and Chief Scientific Officer of BDSI, said, "We are hopeful that our Bioral(TM) delivery system will be able to effectively deliver the missing enzyme in these diseases. In the case of Gauchers, for example, the ability to selectively target delivery to monocytes and macrophages is a potential advantage of our technology. Moreover, previous studies elsewhere have suggested that phosphatidylserine, the major phospholipid component of our Bioral(TM) delivery technology, stimulates the glucocerebrosidase enzyme activity in Gauchers, thus potentially enhancing the efficacy of the replaced enzyme"

      BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the-counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages and personal care products.

      Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company`s results to differ. Factors that may cause such differences include, but are not limited to, the Company`s ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company`s ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company`s need for additional funding, uncertainties regarding the Company`s intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company`s filings with the Securities and Exchange Commission.


      L.G. Zangani, LLC provides financial public relations service to the Company.
      As such L.G. Zangani, LLC and/or its officers, agents and employees, receives
      remuneration for public relations and or other services in the form of monies,
      capital stock in the Company, warrants or options to purchase capital in the

      Company.




      --------------------------------------------------------------------------------
      Source: BioDelivery Sciences International, Inc.


      @ hafenloher: Ich beobachte solche Werte ständig und Tegal läuft wirklich nicht schlecht - sowie halt alle Halbleiterwerte extrem hoch bewertet sind. Tegal ist ein Zock genau wie Biodelivery auch. Bisher ist die Tegal eben besser gelaufen. Herzlichen Glückwunsch!

      @ Brauchgeld: Geld zu brauchen ist an der Börse wohl der schlechteste Gehilfe... aber ich verstehe Dich schon - der Chart und das Bild dieser Company sehen echt mies aus. Ich könnte keinem wirklich dringend raten diese Aktie zu kaufen - aber sie jetzt noch zu verkaufen? Wenn man Geld braucht schon (Schade!) aber wenn nicht?
      Ich gehe den Zock auf jeden Fall weiter - diese Aktien will ich nun nicht mehr aus der Hand geben. Aufgrund anderer Gewinne kann ich mir das allerdings auch leisten.

      Wenn hier mal eine Meldung kommt dann sieht der Kurs ganz schnell ganz anders aus! Aber ob und wann diese Meldung kommt - keine Ahnung.

      Wenn man sich es leisten kann würde ich auf jeden Fall halten - und abwarten ;)

      Gruß
      Falke28
      Avatar
      schrieb am 25.11.03 16:56:42
      Beitrag Nr. 45 ()
      Cool. Das Ding fällt echt gleich auf Null. Ich lach mich fast tot :laugh: :laugh: :laugh:

      Das ist schon so traurig, dass es schon wieder lustig ist.

      Was für eine Negativperformance in den letzten Wochen - Wahnsinn!


      Mal sehen, was daraus jetzt noch wird...


      :laugh: :laugh: :laugh:


      Gruß
      Falke28
      Avatar
      schrieb am 25.11.03 18:42:16
      Beitrag Nr. 46 ()
      Was hier abläuft ist Schmu und ich bin leider noch dabei.

      Wenn in der letzten Meldung wenigstens der Name gefallen wäre, hätte ich vielleicht ein besseres Gefühl. Vermutlich ist das Joint Venture ein Ergebnis der Konferenz in Italien, daher denke ich das kein grosser israelitischer Name dahintersteckt, dafür ging es dann zu schnell.
      Avatar
      schrieb am 25.11.03 20:00:38
      Beitrag Nr. 47 ()
      @Fahlke



      hallo. ich bin auch noch immer drin in BDSI. läuft echt nicht wirklich gut. ich bleib aber auch drin. hast du dir mal angesehen was die für einen free float haben?


      bißchen über 2 millionen glaub ich. weißt du was da los ist wenn die ne ordentliche finanzierungsmeldung oder so bringen? dann ist die hölle los bei diesem free float.


      ansonsten haben ja die amis auf den boards die meldung mit der abspaltung und mit diesen "class B shares" nicht so gut gefunden, was hast denn du darüber für ne meinung.


      zumindest schauts jetzt so aus als ob 1.80 echt der boden nach unten ist. vorübergehend zumindest.


      gruß, Hackertom
      Avatar
      schrieb am 26.11.03 09:58:45
      Beitrag Nr. 48 ()
      Hallo Hackertom1,

      ja, dass mit dem free float war mir bekannt. Ich habe relativ kurzfristig auf einen Hype like NVE Corporation gesetzt (NVEC). Die haben auch einen recht geringen free float - aber bei denen hagelt es ständig News; und zwar gute News.

      Ja mit den Class B Shares ist das so eine Sache - die versuchen einen Teil der Firma "abzuspalten" um neue Liquidität zu bekommen. Das aber ist in zweifacher Hinsicht negativ: zum einen läßt kein auch nur etwas größerer Anleger seinen Aktienbestand unkontrolliert verwässern - und das, obwohl die Firma zwar über eine nette Pipeline verfügt, aber sich noch immer kein wirklicher Erfolg eingestellt hat!
      Zum zweiten läßt solch eine Strategie erahnen, dass das Management in einiger Zeit nicht mit bahnbrechenden Erfolgen rechnet. Laut Burnrate und Aussage des Managements hält die Liquidität noch für 18-24 Monate. Aber: warum sollte man Class B Shares anbieten, wenn ein richtiger Erfolg kurz bevor stehen könnte?

      Fazit: das Management rechnet vielleicht selbst nicht mit einem "Durchbruch" und versucht deshalb lieber primär die Liquidität der Firma noch etwas länger zu sichern...

      Aber: Spekulation bleibt das alles trotzdem. Es könnte auch anders herum sein. Aber ich habe noch mit keinem aus dieser Firma telefoniert, da ich denke, dass das eh nix bringt. Die Wahrheit bekomme ich dadurch auch nicht heraus.

      Auf jeden Fall gefällt mir der Einzug nach Israel - zweites Land nach den USA in der Biotechnologie - wo viele Kontakte zu knüpfen sind.

      Medizinische Transportsysteme und Dosierungssysteme im Nanometerbereich sind für mich die Zukunft schlechthin. In einiger Zeit wird nichts mehr verabreicht, ohne auf diese Weise optimiert worden zu sein. Aber das wird natürlich noch ein wenig dauern.

      Beurteilen kann ich die Technologie von Biodelivery Sciences nicht wirklich - dazu müßte ich vor Ort sein. Und selbst dann müßte ich ein Qentchen "Vision" beimengen um den kommerziellen Erfolg auch nur erahnen zu können.

      Fazit: Die Omega 3 Fettsäuren-Geschichte gefällt mir gut. Ein netter Anfang.
      Man muß an diese Firma "glauben" und sein Portfolio diversifizieren. Die Aktie kann schon bald bei zwanzig stehen oder aber sie läuft weiterhin asymptotisch gegen Null ;-)
      Wenn Du an die Technologie glaubst, leg Dir noch ein paar Flamel Technologies ins Depot. Von denen hab ich auch so einiges liegen. Die haben den (möglichen) Erfolg ihrer Technologie schon fast bewiesen.

      Also viel Glück an alle
      Falke28

      PS: @ Neoe: Stimmt, ein großer Name wäre besser gewesen - aber der hätte ja schon fast einen "Durchbruch" bedeutet. signalisiert.
      Avatar
      schrieb am 26.11.03 10:06:37
      Beitrag Nr. 49 ()
      Hier noch eine Meldung (etwas emotional aufgeladen) aus dem Yahooboard:

      This is either a complete waste of time and energy by the company......... or is this for the greater good of the stock holders. According to the website they have a policy for the corporate behavior. I am still trying to find the benefit of seperate companies (other than meaningless work for the executives). In light of the recent stock drop, I feel their focus should be contracts and marketing...... not killing trees with meaningless shares of stock in a second company.........when the first has yet to have any "real" success. So much potential, and yet we have no results. They better announce something of substance soon before they loose the faith of a few more larger shareholders and this goes back to its low.




      Gruß
      Falke28
      Avatar
      schrieb am 26.11.03 21:01:57
      Beitrag Nr. 50 ()
      @falke

      Danke für die Glückwünsche, aber ich sagte Dir vor Monaten , das Tegal KEIN Zock ist, meiner Meinung nach...Gruss
      Avatar
      schrieb am 01.12.03 22:13:59
      Beitrag Nr. 51 ()
      Wer weiß was hier los ist?
      ÜBER 20 %+!!!!
      Aber das Volumen ist nicht sehr hoch!?!
      Avatar
      schrieb am 03.12.03 09:34:08
      Beitrag Nr. 52 ()
      Hier eine Erklärung von jemandem, der mit der IR Abteilung gesprochen haben will:

      clarification
      by: manonash1 12/02/03 11:43 am
      Msg: 299 of 300

      I just spoke with IR. It appears that the reason for the 47% on the rights offering is that they need to keep the remainder for the warrant holders. This means that if you hold warrants, you are holding them on both companies, not just BDSI. So, contrary to a previous message, they aren`t carving out a portion of the company and taking it away from the stockholders. And....the warrants continue to apply to the full value they originally did.


      Gruß
      Falke28
      Avatar
      schrieb am 04.12.03 00:25:31
      Beitrag Nr. 53 ()
      Und wieder draussen, ist mir zuviel hickhack. Sehe an anderer Stelle bessere Chancen.
      Avatar
      schrieb am 04.12.03 12:31:52
      Beitrag Nr. 54 ()
      Hallo @ all,War gerade in lanzarote,u.sehe bdsi hat sich ein wenig erholt.Einige schreiben bdsi hat sich in israel puplik gemacht .Jetzt meine frage.Welche gesellschaft hat das meiste geld?Antwort ,,die j.... .Glaubt mir die steht in ca.3 jahren bei 300 usd.Warum ,der a.markt startet nächstes jahr eine Party ,noch schlimmer wie die letzte.Jetzt ist der dollar niedrig ,u.der a.markt läuft auf vollen touren,n.jahr startet der dollar zur aufholjagt .wetten ....gruß drpaulo2001
      Avatar
      schrieb am 04.12.03 17:06:38
      Beitrag Nr. 55 ()
      Hier eine Meldung von BDSI vom 1. Dez.
      http://www.biodeliverysciences.com/Investor_Relations/11.24.…

      Viel informatives z.B Vergleich mit anderen Konkurrenztechnologien, stehen in Lizenzverhandlungen mit zwei major pharmaceuticals und einem führenden aus dem Food-Bereich, jährlicher Millardenmarkt mit LeadproductAmB,erhalten in 6 Monaten nochmals 2 Mill. vom NIH u.s.w.

      Viel Spaß beim lesen bei dem kostenlosen 5-Seitigen Bericht. Kostet normalerweise bei TWST 75$.
      Avatar
      schrieb am 05.12.03 19:32:37
      Beitrag Nr. 56 ()
      @dr paolo


      sag, kannst du die wörter nicht ausschreiben?


      man muß bei deinem posting die ganze zeit rätseln was du denn gerade meinst. die minute kannst dir doch nehmen.


      also welche gesellschaft hat am meisten geld? die j....?


      was soll das heißen?



      Hack
      Avatar
      schrieb am 05.12.03 20:09:23
      Beitrag Nr. 57 ()
      Lass es - da tummelt sich ein Antisemit unter uns....
      Avatar
      schrieb am 05.12.03 20:25:03
      Beitrag Nr. 58 ()
      @Monsieur



      aha, jetzt hat`s bei mir auch geklingelt!


      nur warum das nicht ausschreiben wenn er davon überzeugt ist?



      Hack
      Avatar
      schrieb am 06.12.03 19:53:03
      Beitrag Nr. 59 ()
      Hallo @ all,ich meine die auf jamaika.So jetzt weißt du es.Zu Hack ,ich weiß nicht was du meinst .werde deutlicher .drpaulo2001
      Avatar
      schrieb am 08.12.03 00:00:48
      Beitrag Nr. 60 ()
      @dr paulo



      alles was ich will ist das du die wörter ausschreibst. nichts anderes weil ich nicht die hälfte von deinem posting erraten will.



      Hack
      Avatar
      schrieb am 08.12.03 17:18:21
      Beitrag Nr. 61 ()
      Sorry hackertom,kommt nicht mehr vor.Hab mal gelesen das viele israelis ihre dicken konten auf jamaika hätten.Darum denke ich das das positiv ist,wen die sich in israel breit machen.gruß drpaulo2001
      Avatar
      schrieb am 08.12.03 22:20:29
      Beitrag Nr. 62 ()
      ja hoffentlich kommt da was heraus in israel!


      mfg, Hack
      Avatar
      schrieb am 11.12.03 08:44:10
      Beitrag Nr. 63 ()
      Die Israelis sind absolute Weltklasse in Sachen Biotechnologie. Das liegt vor allem daran, dass in deren Religion dem Embryo "die Seele erst nach 40 Tagen eingehaucht wird". Demzufolge ist Stammzellenforschung und alles andere für die kein Problem (Ethik).

      Sollte Europa, und vor allem Deutschland, hier nicht bald mal den Weg frei machen ist der gesamte Zug abgefahren.

      Insofern: sehr positiv das Engagament in Israel. Hier können viele Kontakte geknüpft werden...


      Gruß
      Falke28
      Avatar
      schrieb am 21.12.03 20:46:10
      Beitrag Nr. 64 ()
      Hallo hackertom,weißt du was in berlin los ist,kurs bei comdirect bei 3,32 ,stimmt das ?Wenn ja,warum auf einmal so ein sprung.drpaulo2001
      Avatar
      schrieb am 23.12.03 20:12:28
      Beitrag Nr. 65 ()
      @Dr Paolo


      ich hab keine ahnung. ich seh im moment einen kurs von 2.15 in berlin. das problem bei Biodelivery ist das in deutschland praktisch kein umsatz stattfindet, deswegen ist das was du gesehen hast wahrscheinlich nur eine "ASK Quote" gewesen, sprich jemand hat als ASK3 3.32 reingestellt, um eben bei 3.32 zu verkaufen. das machen manche nur weil sich manchmal eben immer wieder irre finden lassen die bei solchen werten unlimitiert in den markt in deutschland gehen. passiert natürlich ganz selten.


      es war bei 3.32 sicher kein umsatz schätze ich mal.



      Hack
      Avatar
      schrieb am 02.01.04 01:30:43
      Beitrag Nr. 66 ()
      Hi alle.
      Ich bin jetzt erst auf diesen Wert aufmerksam geworden und denke da ich schon einiges Interessantes dran. Habe im Internet ein bisschen geforscht und dachte dies wäre noch interessant. Die Uni hat das ganze Projekt also unterstützt und ist an der Firma auch beteiligt. Leider ist BioDelivery Sciences Int. die erste Firma von einigen Startups von dieser Uni die an die Börse geht, dh es fehlt ein Track record. Ang. einen Partner sieht es eher so aus, als würden die demnächst keinen Partner bekannt geben, suchen sich wohl erst dann einen Partner, wenn die ein für Phase II clinical trials fertiges Produkt haben. Wie lange das noch dauert weiss evtl keiner.

      June 2002 marked a milestone in the University of Medicine and Dentistry of New Jersey’s technology transfer office’s history. On June 24, 2002, BioDelivery Sciences International went public using stock ticker BDSI. BioDelivery Sciences International is the first UMDNJ spin off company to go public and represents over 15 years of research and patience. Dr. Raphael Mannino and Dr. Susan Gould-Fogerite are founders of BioDelivery Sciences International.

      Dr. Mannino has served as a member of the Board of Directors since the incorporation of BioDelivery Sciences International in 1995, is a world leader in Cochleate Technology and an internationally recognized expert in applying artificial lipid-based delivery systems to problems in biotechnology, including drug delivery, vaccine design and gene therapy applications. Dr. Mannino has held faculty positions at UMDNJ, New Jersey Medical School and The Albany Medical College. Dr. Susan Gould-Fogerite has been a codeveloper of Cochleate Technology. Dr. Gould-Folgerite is Executive Vice President of Business Development (Vaccines and Gene Therapy). She received her Ph.D. from Albany Medical College and is currently an Associate Professor at UMDNJ. New Jersey Medical School provided the necessary leadership and guidance to ensure the success of BioDelivery Sciences International.

      The groundbreaking technology was developed by Drs. Mannino and Gould-Fogerite while faculty members at the University of Medicine and Dentistry of New Jersey and The Albany Medical College and licensed exclusively to BioDelivery Sciences International. Cochleate delivery vehicles (Bioral™) are a broad-based enabling technology for the delivery of a wide range of therapeutic products. Cochleate delivery vehicles are stable phospholipid-cation precipitates composed of simple, naturally occurring materials, for example, phosphatidylserine and calcium. They consist of alternating layers of phospholipid and multivalent cations existing as stacked sheets, or continuous, solid, lipid bilayer sheets rolled up in a spiral configuration, with little or no internal aqueous space.

      This unique structure provides protection from degradation for associated, or “enchochleated,” molecules. Since the entire cochleate structure is a series of solid layers, components within the interior of the cochleate structure remain intact, even though the outer layers of the cochleate may be exposed to harsh environmental conditions or enzymes. This includes protection from digestion in the stomach.

      In exchange for the exclusive licenses the universities received equity positions in the new company, milestones and a royalty stream on new products. BioDelivery Sciences International is just one of over 10 spin off companies from the University of Medicine and Dentistry of New Jersey and represents the University’s contribution to the economy of New Jersey with new jobs and investment capital.
      Avatar
      schrieb am 02.01.04 01:32:26
      Beitrag Nr. 67 ()
      Und hier auch noch was Interessantes, obwohl schon 6 Jahre alt, also 1997 geschrieben.

      In Good Company

      In the fall 1995 issue of HealthState, we profiled two scientists who were in a precarious position. Drs. Raphael J. Mannino and Susan Gould-Fogerite at UMDNJ-New Jersey Medical School had developed a novel system for delivering therapies - drugs, vaccines, genes - and were ready to begin testing it in human trials.

      Although this work had been funded by the National Institutes of Health for more than 10 years, studies directed toward human trials are not sponsored by traditional NIH basic research grants. The scientists needed to form a company and get financial backing in order to keep their core group together and take the next step. And they did.

      For business expertise, they turned to Irving A. Berstein, PhD, who had started up three medical technology companies that were eventually acquired by major corporations. For 14 years he was associated with M.I.T. and Harvard Medical School`s joint division of health sciences and technology. Berstein was impressed with the scientists` innovation - a jelly roll-shaped cochleate whose outer lipid coating protects the inner layers of therapies from being degraded by stomach acids. BioDelivery Sciences, Inc. (BDS) was formed in March 1995, with Berstein as chairman of the board, Mannino as president and chief scientific officer, and Gould-Fogerite as vice president.

      She says the company`s licensing and research agreements have made it profitable from the start. One signed in June 1996 with Wyeth-Lederle Vaccines and Pediatrics, a division of American Home Products, provides BDS with up to $15 million for research and development over several years. In return, Wyeth-Lederle gets exclusive licensing rights for the technology used for human vaccines.

      This is a good deal for the University, too. Besides having equity in the company, it shares in income from licensing agreements, royalties on products and gets overhead from grants awarded to the researchers.

      "The last time we talked to HealthState we were on the edge," says Gould-Fogerite. "`Staying Alive` was an appropriate title for the article. Now it`s a matter of where we concentrate our efforts. We have a lot of work in vaccines and we`re investigating drug delivery and gene therapy. The preliminary data is encouraging."

      Their cochleate system allows for oral, nasal and - in some cases - ocular delivery of vaccine formulations. The DNA vaccines encode for specific proteins. Once they are expressed, the immune system makes antibodies and cell-mediated responses to them. Using DNA rather than killed or attenuated virus to produce immunity is particularly advantageous in people who are immune compromised. Mannino and Gould-Fogerite hold two patents on their delivery systems, two are about to issue and several are pending.

      Two members of the research group are alumni of the UMDNJ-Graduate School of Biomedical Sciences. Alan Mautone, who is director of delivery technologies research, has a doctorate in physiology and has worked on aerosolized lipid-based drug delivery systems for 10 years. Dan Brois, the company`s assistant director of gene therapy applications, earned his PhD in pathology and has expertise in both molecular and cellular biology.

      BDS has offices in Lexington, Mass., where Berstein is located, and in France, but the research facility is still at UMDNJ. Mannino and Gould-Fogerite are setting up shop in those "eternal" interims - the blue buildings on Bergen Street that housed New Jersey Medical School when it relocated to Newark in 1967.

      top
      Avatar
      schrieb am 02.01.04 01:40:07
      Beitrag Nr. 68 ()
      Und noch eins. Diese Firma ist auch ein Spin-off der selben Uni. Hört sich auch gut an, leider noch nicht börsnotiert.

      PTC Therapeutics, Inc. discovers and develops small molecule drugs by applying its integrated RNA biology and chemistry platforms. PTC`s compounds modulate gene expression by selectively binding to either RNA targets or to proteins that interact with RNA. This approach has advanced the Company`s drug discovery programs rapidly from targets to pre-clinical drug candidates. PTC`s pipeline includes programs in infectious diseases, oncology and genetic disorders.

      PTC was established in 1998 based on research conducted at the Robert Wood Johnson Medical School in New Jersey and at the University of Massachusetts Medical School by the Company`s scientific founders, Dr. Stuart Peltz and Dr. Allan Jacobson. PTC obtained its seed investments from Tularik, the late Dr. Robert Swanson (Founder and former Chairman and CEO of Genentech), and Peter Svennilson of Three Crowns Capital. PTC has raised over $56 million to date. The Company currently has 86 employees and occupies a 30,000 sq.ft. facility in South Plainfield, NJ
      Avatar
      schrieb am 02.01.04 01:47:26
      Beitrag Nr. 69 ()
      Ok das letzte jetzt. Also schon einiges in der Pipeline, aber alles erst in Phase I wie es aussieht.

      Clinical Trial for HIV Vaccine

      A new autologous vaccine tested by researchers at UMDNJ-New Jersey Medical School (NJMS) appears to be a safe and effective therapy for controlling HIV infection. The treatment, which is based on the person’s own virus and cells, is designed to stimulate a different and stronger immune response to the specific virus subtypes with which they are infected.

      The clinical trial involved 10 HIV-infected individuals, nine children and one adult. They were treated over a six-year period with an innovative therapy developed by BioDelivery Sciences International, Inc. (BDSI), a New Jersey-based bio-tech company whose founders include two NJMS faculty members, Raphael Mannino, PhD, and Susan Gould-Fogerite, PhD. After 44 total study doses, no adverse reactions were observed in the patients. Most subsequently received combination anti-retroviral drug therapy, and since then have maintained stable low viral levels. At last evaluation (August 2001) all patients had no progression of disease and reported subjective improvement, especially with regard to quality of life. The principal investigator of the study was James M. Oleske, MD, François-Xavier Bagnoud Professor of Pediatrics and director of the Division of Allergy, Immunology, Infectious and Pulmonary Diseases at NJMS.

      During the trial, the number and percentage of CD4+ cells increased, or the rate of decline decreased, in nine of the patients. This change is significant because these cells, crucial to the functioning of a healthy immune system, are typically destroyed during HIV infection.

      In addition, gamma interferon ELISPOT assays recently were performed on cells that had been frozen at various time points prior to and during the trial. "Encouragingly, these studies indicated that five of the patients developed HIV-specific cytolytic T cell activity during the trial," Oleske says. "This type of killer cell plays a very important role in killing infected cells and controlling the HIV virus infection."

      The researchers believe the treatment is the first autologous therapeutic HIV vaccine as well as the only therapeutic vaccine candidate with a follow-up of more than six years.

      BDSI is developing a patented delivery technology designed for a broad base of pharmaceuticals, vaccines, over-the-counter drugs, and other products. The first publicly traded company to be based on intellectual property developed at UMDNJ, it utilizes a structure called a cochleate which is a spiral, "jelly-roll" shape. The cochleate facilitates the delivery of therapeutics that normally require injection. As the next step in testing the new HIV therapy, BDSI is applying to the FDA to conduct a phase one clinical trial involving a larger number of patients.
      Avatar
      schrieb am 05.01.04 17:10:13
      Beitrag Nr. 70 ()
      Ich habe mir heute eine erste kleine Portion ins Depot gelegt.
      Avatar
      schrieb am 05.01.04 20:07:11
      Beitrag Nr. 71 ()
      Hier mal was zu den heutigen Partnern. Wie es aus einem Interview des TWST zu lesen ist sind 2 Grosse Partner bei dem IPO eingestiegen. Einerseits PPDI und dann auch noch Sigma-Tau.

      Compound Partnerships

      Pharmaceutical and biotechnology companies have discovered a number of therapeutic compounds that have not yet been developed for a variety of reasons. As part of our mission to help clients maximize the return on their R&D investment, we seek opportunities to in-license select discoveries, jointly develop them with a partner and license them out again in collaborative arrangements that utilize our global development resources.

      Under this compound partnering strategy we share the risk with our clients, helping them evaluate drug candidates earlier in the development cycle when the investment risk is significantly less than during later phases. We believe these risk-sharing models provide a significant reduction in cost and time to market for clients. Our goal is to create value for our clients while optimizing the potential for long-term revenue gains for PPD through the development of intellectual property.

      Our existing pipeline of several compounds at different stages of development verifies the success of our compound partnership strategy. We expect dapoxetine, the genitourinary compound we licensed to ALZA in January 2001, to enter Phase III development in 2003. In 2002, we obtained worldwide rights from Bayer AG to undertake additional Phase I and II clinical studies on implitapide. MRL International, a division of our development subsidiary, plans to initially pursue a safe and effective dose for patients with genetic or inherited forms of high cholesterol.

      We gained the rights from BioDelivery Sciences International to a drug delivery formulation that we can apply to two products, allowing them to be taken orally instead of by injection.


      Last modified: July 10, 2003
      © 2004 Pharmaceutical Product Development, Inc.
      All rights reserved.
      Avatar
      schrieb am 06.01.04 00:17:38
      Beitrag Nr. 72 ()
      @Pegau


      interessant. danke für die vielen infos.


      Hack
      Avatar
      schrieb am 06.01.04 14:43:41
      Beitrag Nr. 73 ()
      Ich weiss nicht ob das Interview des www.twst.com schon allgemein bekannt ist. Hier der Link.

      http://www.biodeliverysciences.com/Investor_Relations/11.24.…

      Viel Spass beim Lesen.
      Avatar
      schrieb am 08.01.04 16:49:41
      Beitrag Nr. 74 ()
      Also, eins ist wohl klar. Hält die Nachfrage in Sachen Nanotechnologie an und davon gehen wir ja alle aus dann ist es nur eine Frage der Zeit bis Biodelivery auch damit in Verbindung gebracht wird und sich das Volumen rasant erhöht. Eine Meldung reicht und das Volumen bzw. der Kurs explodieren. Noch ist es zum einsteigen nicht zu spät!!!:D :D :D

      Grüße Joe
      Avatar
      schrieb am 09.01.04 22:56:56
      Beitrag Nr. 75 ()
      Immer nur ein paar tausend Stück umgesetzt, aber immer hin deutlich im Plus heute...
      Avatar
      schrieb am 13.01.04 08:54:02
      Beitrag Nr. 76 ()
      Jetzt wurden mal ein paar mehr tausend Stück umgesetzt! Un der Kurs ist auch explodiert.

      Sieht gut aus finde ich. Wie schon mehrfach erwähnt: Sollte hier eine (sehr) positive Meldung kommen, so sind wir auch oder vor allem wegen der Marktenge ganz schnell ganz viel weiter oben (Vergleiche NVEC).


      :D

      Gruß
      Falke28
      Avatar
      schrieb am 15.01.04 20:58:50
      Beitrag Nr. 77 ()
      tja, jetzt hat BDSI auch noch das gap des letzten anstiegs geschlossen, könnte also wieder nach oben gehen.

      ich hab jedenfalls ein sehr gutes gefühl bei dem wert seit ich das interview mit dem CEO gelesen hab.

      was BDSI bräuchte, ist irgendne wahnsinnskooperation wie damals Flamel gebracht hat, dann sind wir sehr schnell sehr sehr weit oben!


      good luck, Hack
      Avatar
      schrieb am 15.01.04 23:51:58
      Beitrag Nr. 78 ()
      freue mich dass wir mehr werden, hier fehlt total eine Diskussion.
      Avatar
      schrieb am 16.01.04 00:31:23
      Beitrag Nr. 79 ()
      Avatar
      schrieb am 17.01.04 09:59:30
      Beitrag Nr. 80 ()
      Hallo @ all,bdsi hat gut angezogen.Glaubt mir bdsi ist besser flamel,warum ?1.eine us firma u.da wird bush irgendwann so viel geld reinpumpen in die forschung,schaut doch die machen was mit omega3 fettsäuren die sind für übergewichtige ,das sie nicht so zunehmen.Und in den usa ist jedes 3 .kind scon über 100kilo .wartet ab auf jahre gesehen ist diese aktie der renner im nanosektor.grußdrpaulo2001
      Avatar
      schrieb am 17.01.04 13:26:14
      Beitrag Nr. 81 ()
      @Pegau


      stimmt, mehr diskussion wäre gut.

      was mir aber gefällt ist das der wert mehr oder weniger unbekannt ist. in solche sachen investier ich extrem gerne. sollte BDSI ihre pläne umsetzen können, dann schreien hier auf W.O. irgendwann alle das man die aktie kaufen soll. dann steht sie aber schon auf 10 dollar.

      hoffen wir mal.

      ich hab grad heute ne ganz interessante aktie gesehen auf yahoo finanzen, die hat mich total an BDSI erinnert. der name ist Taser Technologies. ist so ne firma die ne spezielle waffentechnik hat und die ist in den letzten 52 wochen von ein bißchen über 3 dollar auf jetzt im moment 120 gelaufen. der grund warum sie mich so an BDSI erinnert hat, ist das sie mit 2.2 millionen aktien im float nur unwesentlich weniger hat als BDSI. wenn Biodelivery mal ordentlich was an news bringt, leute die wird auch so abgehen, weil einfach keine aktien im umlauf sind die man kaufen kann. ich will jetzt hiermit nicht sagen das die auf 120 steigt, sondern will nur das potenzial mal kurz ansprechen. allerdings wird das alles noch ein bißchen dauern.


      ist ne riesen chance. mich ärgert nur das ich vor ein paar monaten als die unter 2 dollar waren, nichts dazu gekauft habe. ob die nochmal auf die 2 gehen?


      Hack
      Avatar
      schrieb am 17.01.04 23:12:58
      Beitrag Nr. 82 ()
      Wie bewärtet ihr die news von gestern?
      Avatar
      schrieb am 18.01.04 01:04:28
      Beitrag Nr. 83 ()
      @pegau


      ehrlich gesagt weiß ich nicht genau wie ich diese news bewerten soll. schon damals als die nachricht von der abspaltung gekommen ist, war ich erstmal geschockt und hab meine aktien verkauft. hab dann aber bald gesehen das alles nicht so schlimm ist wie gedacht.

      also ich versteh das so. die spalten den teil der firma der sich dem food and beverage business (die haben da ja auch irgendne anwendung im delivery bereich glaub ich) widmet, ab. was das jetzt aber für uns investoren bedeutet weiß ich nicht. bekommen wir günstig aktien für den anderen bereich, oder haben wir dadurch weniger wert in unserer eigentlichen aktie BDSI, ist immer noch ein bißchen undurchsichtig. muß doch nochmal nachfragen in amerika.


      Hack
      Avatar
      schrieb am 18.01.04 01:22:41
      Beitrag Nr. 84 ()
      Ja ich finde es auch immer noch recht undurchsichtig, oder ich habe die news evtl nicht richtig verstanden. Ich verstehe es so als ob man damals geplant hatte den BDSI aktionären die 3,5 mill aktien zu geben, nun aber diesen plan geändert hat...aber was nun kommen soll verstehe ich nicht ganz...evtl muss da noch das neue filing erst kommen. Ich sehe es auch für BDSI in dem sinne negativ, als ich es so verstanden habe, dass dieser bereich, der nun abgespalten werden soll, der bereich sein soll der das erste einkommen geben soll-also noch eine umsatzverzögerung für BDSI.
      Avatar
      schrieb am 18.01.04 01:24:18
      Beitrag Nr. 85 ()
      @ hackertom1
      ich habe auf Ragingbull einen BDSI thread aufgemacht, du kannst ja auch dort gerne weiter nachfragen, die Amis scheinen sich für diesen Wert noch gar nicht zu interessieren.
      Avatar
      schrieb am 18.01.04 01:47:22
      Beitrag Nr. 86 ()
      @pegau


      ich sehe du bist auch noch auf. :kiss:

      wir sollten auch auf dem yahoo finanzen board nachfragen, das gefällt mir persönlich viel besser von den leuten und ist auch viel frequentierter.

      werde dort mal fragen ob sie mir mal kurz sagen können was das alles zu bedeuten hat.


      Hack
      Avatar
      schrieb am 18.01.04 09:31:28
      Beitrag Nr. 87 ()
      Kommentar vom Yahoo-Board:

      OK guys, I just spent another 4 hours doing DD on nano-technology in general, and also BDSI`s role in nano drug delivery. I have also poured through the BDSI website (pretty enlightening). Without boring you with all of the details, here are my conclusions:

      1) Either I am crazy for not understanding BDSI`s poor vision, or the investment community is crazy for overlooking BDSI. The paddywagon hasn`t arrived yet, so I`m inclined to believe the latter.

      2) BDSI has the exclusive rights to the nano-technology that they`re trying to implement, even though they don`t own the patents themselves.

      3) The other drug delivery companies that are interested in nano aren`t looking to the organic nano-cochleate as a solution; they`re creating synthetic compounds that are much more expensive and difficult to manufacture.

      4) I wasn`t able to find any other companies that are as focused on the nutraceutical potential.

      5) BDSI has open requisitions for PHD`s, so that`s a good sign.

      6) Nanomedicine funding (diagnostics, *therapeutics*, and regenerative medicine) is in the top 5 priorities for the National Institute of Health. BDSI covers the therapeutic aspect.

      7) I read an interview w/ Dr. Ferrari, who is serving as a nanotechnology expert at the National Cancer Institute. The area which most excites him is drug delivery, because it has been addressed in such a limited fashion.

      8) There is a private Israeli drug-delivery company called Solubest, who has backing from some pharmas. I wonder if it`s a coincidence that BDSI established their nutraceutical center in Israel.

      9) I think I`ll stop here...it`s getting late.

      All BDSI has to do now is deliver the goods. The pieces are in place, and their technology and patents seem strong. I laugh at BDSI`s market cap compared to all other nano`s.

      good luck,
      -net
      Avatar
      schrieb am 21.01.04 19:25:28
      Beitrag Nr. 88 ()
      Hallo @ all,coller Bericht im aktioner,haben erste erfolge ,aber was mich zur vorsicht mahnt ,ist die marktk.von 23 millionen haben die ein2004 umsatz von gerade mal 3millionen .Was meint ihr soll man zukaufen ?oder finger davon?grußdrpaulo2001
      Avatar
      schrieb am 21.01.04 19:28:39
      Beitrag Nr. 89 ()
      denke auch bdsi wird vom hype bald erfasst! kaufen!!!
      Avatar
      schrieb am 25.01.04 12:51:04
      Beitrag Nr. 90 ()
      Hallo Weltklasse,kaufe Morgen zum 3 .malCa.1000stück ,weil die in einem oder 2,3 Jahren das 10fache kosten.Wenn die in einem milliardenmarkt tätig sind,denkst du eine firma läßt sich das durch die lappen gehen.Wir werder Recht haben und die chance ist jetzt da die unter 3 euro zu kriegen.drpaulo2001
      Avatar
      schrieb am 26.01.04 21:13:02
      Beitrag Nr. 91 ()
      geht ja schön rauf heute :D :D :D
      Avatar
      schrieb am 26.01.04 22:21:01
      Beitrag Nr. 92 ()
      das wird schon...aber das ist meiner Meinung nach eine Langfristanlage
      Avatar
      schrieb am 01.02.04 12:19:58
      Beitrag Nr. 93 ()
      Hier ein sehr interessanter Artikel zu der Technologie dieser Firma:

      http://biodeliverysciences.com/BDSI-DrugDeliveryTechnologyAr…

      Unbedingt anschauen!


      Gruß
      Falke28
      :D
      Avatar
      schrieb am 11.02.04 18:13:56
      Beitrag Nr. 94 ()
      BioDelivery Sciences International, Inc. in Exclusive Negotiations With Affiliate of Italy`s Sigma-Tau to Formulate New Type of Aspirin
      Wednesday February 11, 11:46 am ET


      NEWARK, N.J., Feb. 11 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) announced today that it has entered into exclusive negotiations with Defiante Farmaceutica LDA, a wholly-owned subsidiary of Sigma-Tau Finanziaria S.p.A. of Rome, Italy, one of Italy`s leading pharmaceutical groups, regarding a potential intellectual property license. It is the intention of the parties that such license would allow Defiante Farmaceutica to incorporate BDSI`s Biroal(TM) drug delivery technology into a new formulation of aspirin for use in humans. Sigma-Tau group, through Defiante, is currently a stockholder of BDSI.
      ADVERTISEMENT


      Dr. Raphael Mannino, Executive Vice-President and Chief Scientific Officer of BDSI, said, "Aspirin is certainly a widely used pharmaceutical, and a potential license with a well established pharmaceutical group like Sigma-Tau gives us evidence to back up our belief that aspirin cochleates represent a potentially important advance with significant market potential, both in the U.S. and abroad." The potential benefits of aspirin cochleates, including data showing substantially reduced gastrointestinal side effects and significantly improved efficacy, were presented in September 2003 at the "Inflammatory Processes in Drug Delivery" meeting in Philadelphia.

      The Bioral(TM) delivery technology consists of cochleates, which are crystalline delivery vehicles made from all-natural components: soy-derived phospholipid and calcium. The cochleates wrap around the cargo pharmaceutical (in this case aspirin) like a shell and have been demonstrated in an established animal model of acute inflammation to allow the cargo pharmaceutical to be delivered into the body safely and more effectively than without the cochleate coating. The Bioral(TM) delivery technology is potentially simple, inexpensive and commercially scalable.

      Pursuant to their understanding, BDSI and Defiante Farmaceutica will negotiate exclusively towards entering into a license agreement (either for an exclusive or non exclusive world wide license, depending upon the terms negotiated between the parties) to develop, manufacture, promote, distribute, sell and sublicense products containing the aspirin cochleates for all applications. The term of the exclusivity period ends on July 31, 2004. In the event the parties fail to reach a mutually satisfactory license agreement by such date, BDSI will be able to negotiate with other potential licensees for the aspirin application of its technology. As part of the agreement, Defiante has agreed to bear all expenses of evaluating BDSI`s technology for the proposed application.

      BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the-counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages and personal care products.

      Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company`s results to differ. Factors that may cause such differences include, but are not limited to, the Company`s ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company`s ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company`s need for additional funding, uncertainties regarding the Company`s intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company`s filings with the Securities and Exchange Commission.

      L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.
      Avatar
      schrieb am 12.02.04 23:13:22
      Beitrag Nr. 95 ()
      Die Entwicklung ist echt klasse...

      Weiter so! Ist erst mal eine "richtige" Meldung raus, dann geht es richtig ab!


      Gruß
      Falke28
      Avatar
      schrieb am 04.04.04 18:05:59
      Beitrag Nr. 96 ()
      So heimlich still und leise steigen nun die Kurse auch bei BDSI wieder. Die Umsätze sind zwar äußerst gering, aber der Kursverlauf errinnert mich an die NHLC.OB.
      Danach kam dann der Große Knall.


      Form 10KSB for BIODELIVERY SCIENCES INTERNATIONAL INC


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

      30-Mar-2004

      Annual Report


      Item 6. Management`s Discussion and Analysis or Plan of Operation.



      The following discussion and analysis of our financial condition and plan of operations should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this




      Report. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited to, those which are not within our control.



      Limited Operating History; Background of Our Company



      Until 2002, we were a development stage company. In late December 2002, we signed our first license agreement, which was funded in 2003. We expect to continue research and development of our drug delivery technology, and while we are seeking additional license agreements, which may include up-front payments, we do not anticipate any revenues from the sale or commercialization of our products under development (other than license fees) during 2004. The funding will come primarily from the sale of securities, exercise of warrants, collaborative research agreements, including pharmaceutical companies, and grants from public service entities and government entities.



      In 2001, the National Institutes of Health awarded us a three-year Small Business Innovation Research Grant, which is being utilized in our research and development efforts. NIH awarded to us and fully funded a 2001 grant of $884,000, a 2002 grant of $814,000, and a 2003 grant of $989,000, of which we have received $330,000 through December 31, 2003 and expect to receive the remainder through June 2004. The final year grant of approximately $989,000 is anticipated to be fully funded. This grant is more fully discussed below under Liquidity and Capital Resources. Although there can be no assurance that the full grant will be realized, we expect to receive a total of approximately $2.7 million related to our initial application for the grant through June 2004, assuming that we continue to achieve positive results from the research. The grant is subject to provisions for monitoring set forth in NIH Guide for Grants and Contracts dated February 24, 2000, specifically, the NIAID Policy on Monitoring Grants Supporting Clinical Trials and Studies. If NIH believes that satisfactory progress is not achieved by us in its subjective opinion, the total future expected funding amounts noted above may be reduced or eliminated.



      We have a limited history of operations, and while we received in December 2002 an initial payment for licensing our technology, we anticipate that our quarterly results of operations will fluctuate significantly for the foreseeable future. Prior to our October 2000 acquisition of a majority interest in BioDelivery Sciences, Inc., we had no operations. We believe period-to-period comparisons of our operating results should not be relied upon as predictive of future performance. Our prospects must be considered in light of the risks, expenses and difficulties encountered by companies maturing in commercialization of their technologies, particularly companies in new and rapidly evolving markets such as pharmaceuticals, drug delivery and biotechnology. For the foreseeable future, we must, among other things, seek regulatory approval for and commercialize our proposed drugs, which may not occur. We may not be able to appropriately address these risks and difficulties. We may require additional funds to complete the development of our technology and to fund expected operations in the next several years.



      For the Year Ended December 31, 2003 Compared to the Year Ended December 31,



      Sponsored Research Revenue. During the year ended December 31, 2003, we recognized sponsored research revenue of $913,000. Of this amount, $790,000 was from a grant from the National Institutes of Health, and $89,000 was from collaborative research agreements. In 2002, all revenue aggregating $828,000 was derived from the grant. While no assurances can be made, assuming positive results are achieved through our sponsored research activities, we expect to receive a total of approximately $2.7 million through 2004 related to our initial application for the grant.




      License Fee Revenues. During December 2002, the Company entered into a licensing agreement with a company (which is a shareholder), which included an up-front non-refundable payment of $2 million. The Company recognized it over the period of the related research and development commitment, with the entire $2,000,000 having been recognized by December 31, 2003.



      Research and Development Expenses. During the years ended December 31, 2003 and 2002, research and development expenses totaled $2.6 million and $1.5 million, respectively. The scientific staff continued to work toward increased development and application of Bioral ™ cochleate technology and other drug-related areas. Funding of this research was obtained through sponsored research revenue, common stock issuance, initial public offering funding in June 2002 and line of credit borrowings through the offering period. Research and development expenses generally include salaries for key scientific personnel, research supplies, facility rent, lab equipment depreciation and a portion of overhead operating expenses and other costs directly related to the development and application of the Bioral ™ cochleate drug delivery technology.



      General and Administrative Expenses. During the years ended December 31, 2003 and 2002, general and administrative expenses totaled $2.6 million and $1.7 million, respectively. The increase in 2003 is primarily due to increased staffing following receipt of our initial licensing revenues (received in late 2002, and recognized in 2003), and administrative costs associated with additional projects. Also included in general and administrative costs are legal settlement costs, legal and professional fees, and other costs including office supplies, conferences, travel costs, executive personnel costs, consulting fees, website update and development and business development costs. Furthermore, 2003 expenses include approximately $440,000 related to BND operating activities that commenced in 2003, approximately $215,000 of which related to offering costs associated with a registration statement.



      Stock-Based Compensation Expense. Stock- based compensation expenses of $200,000 and $689,000 were incurred during the year ended December 31, 2003 and 2002, respectively. The charge in 2002 results principally from non-recurring items in 2002 associated with the Company`s forgiveness of employee stock subscription notes receivable and related income taxes paid on behalf of such employees. In 2003, the amounts are for stock options granted for services rendered by our underwriter and legal counsel.



      Interest Income (Expense), Net. During the years ended December 31, 2003 and 2002, interest income (expense), net totaled $69,000 and $17,000, respectively. The increase in net interest income is primarily due to the public offering, and investment of liquid funds. In addition, the company borrowed funds to purchase laboratory equipment and to make leasehold improvements in 2003. The bank note terms called for interest-only through October 2003, and amortization of principal over 48 months beginning in November 2003.



      Income Tax Benefit. We recognized an income tax benefit of $55,000 in 2002 due to the carryback of net operating losses allowed as a result of the enacted tax law changes. While net operating losses were generated during both years presented, we did not recognize any benefit associated with these losses. We had federal and state net operating loss carryforwards of $8.4 million at December 31, 2003. The federal net operating loss carryforwards will expire beginning in 2020, if not utilized. The state operating loss carryforwards will expire beginning in 2007, if not utilized. Financial Accounting Standards Board Statement No. 109 provides for the recognition of deferred tax assets if realization is more likely than not. Based upon available data, which includes our historical operating performance and our reported cumulative net losses in prior years, we have provided a full valuation allowance against our net deferred tax assets as the future realization of the tax benefit is not sufficiently assured.




      Liquidity and Capital Resources



      Since inception, we financed our operations primarily from the sale of our convertible preferred stock and common stock, until the initial public offering in June 2002. From inception through March 31, 2002, we raised approximately $1.8 million, net of issuance costs, through private placements or convertible preferred stock and common stock financings. On April 1, 2001, we issued 137,300 shares of common stock in consideration for payment in full of the approximate $500,000 payable to the University of Medicine and Dentistry of New Jersey due through March, 2001. Our June, 2002 public offering, net of offering costs of $2.4 million, and including the underwriter`s over-allotment (the "green shoe"), raised approximately $8.6 million. At December 31, 2003, we had cash and cash equivalents, including investments (certificates of deposit, and corporate bonds) totaling approximately $2.6 million. At December 31, 2002 we had cash and cash equivalents totaling approximately $5.2 million. The adequacy of cash for our operations in continued research is dependent on, among other things, licensing opportunities we are able to negotiate in the coming year.



      In 2001, the National Institutes of Health awarded us a three-year Small Business Innovation Research Grant, which is being utilized in our research and development efforts. NIH awarded us and fully funded 2001 and 2002 grants of $884,000 and $814,000, and a 2003 grant of $989,000, of which we have received approximately $330,000 through December 31, 2003 and expect to receive the remainder through June 2004. Therefore, we expect to receive a total of approximately $2.7 million related to our initial application for the grant through June 2004, assuming that we continue to achieve positive results from the research. The grant is subject to provisions for monitoring set forth in NIH Guide for Grants and Contracts dated February 24, 2000. If NIH believes that satisfactory progress is not achieved in its opinion, the future funding noted above may be reduced or eliminated in its sole discretion.



      We used $2.5 million of cash for operations in each of years 2003 and 2002. Until the offering in June 2002, we paid limited compensation to certain executive employees, including the CEO and chairman of the board. While members of the board of directors and other executive officers have received compensation in the form of stock options, we expect that increases in their compensation will occur in future periods commensurate with the level of services rendered.



      In the first quarter of 2003, we received a commitment for a $1 million bank line of credit, to be converted to a four year term loan, with a 75% loan to value ratio, at an interest rate of 7.5%, to be used in the purchase of laboratory and other equipment and facilities improvements in our Newark, New Jersey lab. The collateral is all equipment owned by us. We drew 100% of these funds during 2003, all of which was utilized for our Newark laboratory needs.



      We have incurred significant net losses and negative cash flows from operations since our inception. The initial public offering allowed us to pay all of our outstanding debts, including all bank debt, and outstanding obligations resulting from a dispute with a former shareholder and officer. As of December 31, 2003, we had stockholders` equity of $3.1 million, versus $5.8 million at December 31, 2002.



      During the second quarter of 2003, we, as authorized by the Board of Directors, repurchased 100,000 shares of our common stock with a per share price between $2.80 and $3.20 for a total cost of $303,894.



      We anticipate that cash used in operations and our investment in facilities will increase significantly in the future as we research, develop, and, potentially, manufacture our proposed drugs. While we believe further application of our Bioral™ cochleate technology to other drugs will result in license agreements with manufacturers of generic and over-the-counter drugs, our plan of operations in the next 18 months is focused on our further development of the Bioral™ cochleate technology itself and its use in a limited number of applications, and not on the marketing, production or sale of FDA approved products.




      We formed a majority-owned Delaware limited liability company subsidiary in January 2003, Bioral Nutrient Delivery, LLC, and signed an exclusive sub-license to BND for the purpose of exploiting our cochleate technology in the processed food and beverage industry, as opposed to the pharmaceutical industry that is our focus. The minority members are Class B founder shareholders with no cost basis and no obligation to fund deficits. As part of the business plan for BND, our shareholders will receive a dividend of approximately 50% interest in BND directly from us at nominal fair-market value, based on independent third-party appraisal. This dividend will be distributed upon SEC approval of our pending registration statement for BND. Over time we may further reduce our ownership in BND to approximately 10%, with the balance owned by our stockholders, who may receive additional dividends of interests in BND. We will be the managing member of BND, and will exercise complete management activity and control of BND. We will receive no funds as a result of the distribution of the interests to our shareholders, but we will receive reimbursement of funds expended in the organization of BND. Our business plan calls for BND to pay 8% royalties to BDSI, as BND transacts its business in the food and beverage industry. In February, 2003, we made an unsecured loan to BND in the amount of $500,000 to cover organization expenses and initial working capital requirements. The loan accrues interest at a rate of 4.85% annually, with the principal to be paid back solely from 10% of any royalty revenue that may be received by BND, with payments first applied to interest, then to principal. We are under no obligation to make any capital contributions or any additional loan funds to BND beyond the initial $500,000. We entered into a management services and administrative agreement with BND, pursuant to which certain of our officers and employees will provide services and office space to BND. This agreement provides that through 2004, we will not require repayment for allocated officer and employee salaries or certain other general and administrative costs. (Note that all of the transactions between BDSI and BND eliminate in consolidation.)



      We believe that our existing cash and cash equivalents, together with available financing, grants and new license revenue will be sufficient to finance our planned operations and capital expenditures through at least the next 18 to 24 months. We may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding. Accordingly, we may be required to raise additional capital through a variety of sources, including:



      • the public equity market,




      • private equity financing;




      • collaborative arrangements;




      • grants and new license revenues;




      • bank loans;




      • public or private debt; and




      • redemption and exercise of warrants




      There can be no assurance that additional capital will be available on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain of our technologies, drugs or potential markets, either of which could have a material adverse effect on our business, financial condition and results of operations. To the extent that additional capital is raised




      through the sale of equity or convertible debt securities, the issuance of such securities would result in ownership dilution to our existing stockholders.



      New Accounting Pronouncements



      In December 2003, the FASB issued FASB Interpretation No. 46, Consolidation of Valuable Interest Entities. This interpretation clarifies rules relating to consolidation where entities are controlled by means other than a majority voting interest and instances in which equity investors do not bear the residual economic risks. This interpretation was originally effective immediately for variable interest entities created after January 31, 2003 and for interim periods beginning after June 15, 2003 for interests acquired prior to February 1, 2003. However, the FASB is reviewing certain provisions of the standard and has deferred the effective date for public companies to periods ending after December 15, 2003. The Company currently has no ownership in variable interest entities and therefore adoption of this standard currently has no financial reporting implications.



      In April 2003, the FASB issued SFAS No. 149, Amendment of Statement 133 on Derivative Instruments and Hedging Activities. The statement amends and clarifies accounting and reporting for derivative instruments, including certain derivative instruments embedded in other contracts, and hedging activities. This statement is designed to improve financial reporting such that contracts with comparable characteristics are accounted for similarly. The statement, which is generally effective for contracts entered into or modified after June 30, 2003, did not have impact on The Company`s financial position or results of operations.



      In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity. This statement establishes standards for how an issuer classifies and measures certain financial instruments with characteristics of both liabilities and equity. This statement is effective for financial instruments entered into or modified after May 31, 2003, and is otherwise effective at the beginning of the first interim period beginning after June 15, 2003. At December 31, 2003, The Company had no such financial instruments outstanding and therefore adoption of this standard had no financial reporting implications.



      Critical Accounting Policies and Estimates



      The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. We believe that the following are some of the more critical judgment areas in the application of our accounting policies that affect our financial condition and results of operations. We have discussed the application of these critical accounting policies with our Board of Directors and its Audit Committee.



      Revenue Recognition and Research and Development Expenses



      Sponsored research amounts are recognized as revenue, when the research underlying such payments has been performed or when the funds have otherwise been utilized, such as for the purchase of operating assets. Revenue is recognized to the extent provided for under the related grant or collaborative research agreement. Research and development expenses are charged to operations as incurred.



      Revenues may also include nonrefundable technology license fees and milestone payments. The non-refundable license fees are generally up-front payments for the initial license of and access to our technology. For nonrefundable license fees received at the initiation of license agreements for which the




      Company has an ongoing research and development commitment, we defer these fees and recognize them ratably over the period of the related research and development. For nonrefundable license fees received under license agreements where the continued performance of future research and development services is not required, we recognize revenue upon delivery of the technology. In addition to license fees, we may also generate revenue from time to time in the form of milestone payments. Milestone payments are only received and recognized as revenues if the specified milestone is achieved and accepted by the customer and continued performance of future research and development services related to that milestone are not required.



      Stock Compensation



      We have historically compensated certain employees, directors and consultants with common stock, common stock options or warrants as a portion of their total compensation. The valuation of the underlying award or the related service generally requires estimates and judgment with regard to assumptions applicable to the award. Those assumptions include management`s estimates of the fair value of the services received and assumptions underlying the valuation of equity securities, such as stock volatility and estimated lives of the stock based award.



      Income Taxes



      Based on estimates of future taxable losses, management determined that a valuation allowance of $2.8 million was required for our deferred tax assets as of December 31, 2003. If this estimate proves inaccurate, a change in the valuation allowance could be required in the future. This valuation allowance was determined based on the uncertainty regarding our ability to generate adequate future taxable income during the loss carryforward period.



      Asset Impairment



      We review long-lived assets and licenses for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. If indicators of impairment were present, we would evaluate the carrying value of property and equipment and licenses in relation to estimates of future undiscounted cash flows. These undiscounted cash flows and fair values are based on judgment and assumptions.



      Contractual obligations



      At December 31, 2003, the Company`s contractual cash obligations, with initial or remaining terms in excess of one year, were as follows:




      Amount of Commitment ($)
      Expired by Year Ended December 31,
      -----------------------------------------
      Long-term Operating Annual
      Debt Leases Total
      ----------- ---------- -----------
      Less than 1 year $ 225,979 $ 56,590 $ 282,559
      2 – 3 years 505,951 62,580 568,531
      3 – 5 years 226,403 — 226,403
      -- -------- -- ------- - ---------
      Total $ 958,333 $ 119,160 $ 1,077,493
      -- -------- -- ------- - ---------

      Weiter dranbleiben!!! Bei Schwäche akkumulieren!

      Gruß
      Falke28
      Avatar
      schrieb am 06.04.04 20:55:03
      Beitrag Nr. 97 ()
      Zu Ihrer Information und zum Verbleib in Ihren Unterlagen ;) :

      "BioDelivery Sciences International, Inc. Announces Participation at the NanoBioTech Conference in San Francisco


      NEWARK, N.J., Apr 6, 2004 /PRNewswire-FirstCall via COMTEX/ -- BioDelivery
      Sciences International, Inc. (Nasdaq: BDSI) announced today their participation
      in the NanoBioTech Conference in San Francisco, CA on April 15th & 16th, 2004.
      Dr. Raphael Mannino, Chief Science Officer of BDSI, will be a guest speaker
      Friday the 16th.

      "Nanocochleates are the most advanced oral delivery technology using
      nanoparticles yet developed for human and animal usage. Uniquely, they are made
      from all-natural food components consisting of inexpensive soy- phospholipid and
      calcium. They enable targeted-delivery to specific cell types within the body.
      Smart Pharmaceuticals(TM) using the nanocochleate delivery technology have the
      potential to play a significant role in biodefense programs," said Dr Raphael
      Mannino. "Additional commercial opportunities include enhanced antimicrobials to
      deal with drug resistant infections, delivery of fragile micronutrients in
      processed foods, and applications to siRNA, a promising new class of
      oligonucleotides that is extremely susceptible to enzymatic degradation."

      With the signing of the 21st Century Nanotechnology Research and Development
      Act, guaranteeing $3.7 billion in funding for research and training, the
      Nanotech industry is poised for explosive growth in the next decade.
      Biotechnology and medicine are areas where nanotech has already begun to have an
      effect; and an even larger impact is expected as the emerging science is
      developed into commercial products.

      BioDelivery Sciences International, Inc. is a biotechnology company that is
      developing and seeking to commercialize a patented delivery technology designed
      for a potentially broad base of pharmaceuticals, vaccines, over-the- counter
      drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery,
      LLC, micronutrients in processed foods and beverages and personal care products.

      Note: Except for the historical information contained herein, this press release
      contains forward-looking statements that involve risks and uncertainties. Such
      statements are subject to certain factors, which may cause the Company`s results
      to differ. Factors that may cause such differences include, but are not limited
      to, the Company`s ability to accurately forecast the demand for each of its
      licensed technology and products associated therewith, the gross margins
      achieved from the sale of those products and the expenses and other cash needs
      for the upcoming periods, the Company`s ability to obtain raw materials from its
      contract manufacturers on a timely basis if at all, the Company`s need for
      additional funding, uncertainties regarding the Company`s intellectual property
      and other research, development, marketing and regulatory risks and certain
      other factors that may affect future operating results and are detailed in the
      company`s filings with the Securities and Exchange Commission.

      L.G. Zangani, LLC provides financial public relations service to the Company. As
      such L.G. Zangani, LLC and/or its officers, agents and employees, receives
      remuneration for public relations and or other services in the form of monies,
      capital stock in the Company, warrants or options to purchase capital in the
      Company.

      SOURCE BioDelivery Sciences International, Inc.



      CONTACT: Francis E. O`Donnell, Jr., M.D, President and CEO of

      BioDelivery Sciences International, Inc., +1-973-972-0015, or Dawn Moore of

      L.G. Zangani, LLC, +1-908-788-9660



      URL: http://www.bdsinternational.com

      http://www.prnewswire.com


      Copyright (C) 2004 PR Newswire. All rights reserved."
      Avatar
      schrieb am 07.04.04 10:02:35
      Beitrag Nr. 98 ()
      Und da war er schon der erste "kleine Knall" !!!:D


      Gruß
      Falke28
      Avatar
      schrieb am 13.04.04 15:14:07
      Beitrag Nr. 99 ()
      In dieser Aktie gehen zur Zeit nette Bewegungen vor sich. Für einen nachhaltigen Aufstieg sieht doch alles ehr gut aus...:D


      Noch ein interessanter Bericht:

      from an analyst report: ANDA vs NDA
      by: mh00034
      Long-Term Sentiment: Strong Buy 04/12/04 02:36 pm
      Msg: 560 of 560

      Delivery Systems Are Valuable Intellectual Property
      Competitive pressure on major pharmaceutical companies is helping drive collaborations
      with drug delivery companies. Shorter life cycles of branded prescription drugs, in part due
      to an energetic generic drug industry, is contributing to this trend. Companies face an estimated
      average cost of several hundreds of millions of dollars in order to take a laboratory concept
      to market. This calculation takes into account the many failures for each success that takes
      place in the development process. As a result, there has been a reluctance to divert significant
      resources to esoteric technology that may have application for a limited number of products.
      Instead, collaborations are made with specialized providers for their expertise and formulation
      technology. The partnerships often lead to better pharmaceuticals than would otherwise
      occur with more conventional formulations. Drug delivery providers offer the potential to
      enhance therapeutic value of old and new pharmaceuticals and improve competitive advantage.
      Conventionally formulated pharmaceuticals can face significant price competition from generic
      versions following patent expiration. Following the patent expiration of Bristol-Myers Squibb
      Company.s (NYSE: BMY; Neutral) billion-dollar selling antihypertension drug, Capoten
      (captopril), in 1996, the first generic entry on the market was priced at a 90% discount to
      the brand. The drastic price cut was intended to quickly seize sales from the brand and stave
      off generic competitors that planned to enter the market by making the profit opportunity
      less attractive. As a consequence of the 1984 Hatch-Waxman Act, generic drugs enter the
      market through an Abbreviated New Drug Application (ANDA) process instead of the New
      Drug Application (NDA) route for new drug formulations. Bioequivalence is validated primarily
      by analytical instrumentation instead of clinical trials. Most are rated A-B equivalent, meaning
      that they are therapeutically equivalent and interchangeable. The degree of difficulty in obtaining
      the active ingredient and manufacturing the final dosage form influences the numbers of
      generic offerings. The number of competitors dictates the degree of pricing pressure on the
      brand. Following U.S. adoption of the 1995 General Agreement on Tariffs and Trade, patent
      terms were extended from 17 years starting on the day the patent is issued to 20 years after
      a patent application is filed. However, the effective patent life of pharmaceuticals is roughly
      10-12 years. While the generic drug law has significantly reduced the cost of drugs to
      consumers in the United States, it has significantly shortened the economic lives of
      pharmaceutical innovations.




      Gruß
      Falke28
      Avatar
      schrieb am 13.04.04 18:46:21
      Beitrag Nr. 100 ()
      Was für ein starker Deal!!! Das wichtigste daran ist natürlich, dass nun einigermaßen bekannt ist, dass die Technik von Biodelivery Sciences wirklich was kann.

      Somit kommt hier weitere Phantasie rein...

      Ich habe noch einmal ordentlich nachgelegt nun da endlich gute Nachrichten draußen sind...:D :D :D

      Press Release Source: BioDelivery Sciences International, Inc.


      BioDelivery Sciences International, Inc. Announces Licensing of Its Topical BioNasal (TM) Amphotericin B for Chronic Sinusitis
      Tuesday April 13, 11:00 am ET


      NEWARK, N.J., April 13 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI; BDSIW) today announced it has licensed a topical formulation of its lead product, encochleated amphotericin B to Accentia, Inc. Accentia, Inc., a Hopkins Capital Group company, is a privately-held, vertically-integrated specialty biopharmaceutical company that provides comprehensive biopharmaceutical services, including product commercialization, clinical manufacturing, contract sales and product distribution. Accentia is commercializing technology licensed from Mayo Foundation for Medical Education and Research for the treatment of chronic sinusitis (rhinosinusitis) in the US and European Union (EU). Chronic rhinosinusitis (CRS) is the largest market opportunities lacking an approved pharmaceutical in the US. CRS affects an estimated 37 million patients in the US and a comparable number in the EU. For purposes of market-size comparison, the hypercholesterolemic market in the US accounts for the top-selling pharmaceuticals in the industry and the market is estimated to be approximately 36 million patients. The technology consists of using low-dose topical antifungals to control the debilitating symptoms of chronic rhinosinusitis. According to the terms of the license, Accentia will pay BDSI a running royalty of 12-14% on net sales in the US. Accentia estimates that annual prescription cost will be approximately $1000/patient. Accentia is responsible for all expenses related to the development of an encochleated BioNasal (TM) amphotericin B for the indication of CRS in the US and EU including the filing of an IND and clinical trials. BDSI retains world-wide rights to the oral and intravenous formulations of encochleated amphotericin B and non-US and non-EU rights to a topical formulation of BioNasal (TM) encochleated amphotericin B.
      "We are delighted to be able to commercialize the unique, patented BDSI nanocochleate delivery technology using amphotericin B for the indication of chronic rhinosinusitis. We believe that amphotericin B is the most promising topical antifungal for this indication because it is an extremely powerful fungicidal and its use in CRS is very unlikely to lead to acquired resistance. Because amphotericin B in solution has a limited shelf life of just a few weeks, and because it normally requires refrigeration, we believe that the encochleated formulation is the only practical way to develop a commercially viable topical amphotericin B with extended stability at room temperature", said Martin Baum, President of New Business Development for Accentia. "CRS is a very important chronic disease based on a frustrating inability to identify its causation. Investigators at the Mayo Clinic have published clinical studies reporting a new disease paradigm wherein ubiquitous saprophytic mold elicits an immune-mediated response in affected patients, but not in unaffected patients. By using low-dose topical amphotericin B, it was possible to target the origin of this disease in these clinical studies, which provides many patients with symptomatic improvement."

      Accentia is in the business of commercializing targeted therapeutics in patent-protected drug delivery technologies in the respiratory, oncology and critical care areas. A rapidly growing market, targeted therapeutics focus their action to specific cellular targets, reducing undesirable collateral damage while boosting efficacy. Accentia, through its majority-owned subsidiary Biovest International, Inc. (see www.biovest.com) is working to accelerate the development of an autologous vaccine for non-Hodgkins lymphoma produced from a hybridoma using the Biovest proprietary bioreactor. Accentia and its subsidiaries collectively provide vertically integrated capabilities that include pre-market research and outcomes analyses; marketing and selling branded pharmaceuticals by licensing or acquiring under-promoted products and late stage development compounds; and a proprietary bioreactor technology to perform contract production of custom-designed biologics, including vaccines. For more information about Accentia, go to www.Accentia.net.

      BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the- counter drugs, nutraceuticals and micronutrients in processed foods and beverages. The Hopkins Capital Group owns approximately 40% of the issued common stock of BDSI. Additional details relating to BDSI`s financial and operational results for 2003 may be found in its Annual Report on Form 10-K for 2003, filed with the Securities and Exchange Commission on March 30, 2004. Such Report is available free of charge via EDGAR at the SEC`s website, www.sec.gov. and at BDSI`s website, www.bdsinternational.com.

      Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company`s results to differ. Factors that may cause such differences include, but are not limited to, the Company`s ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company`s ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company`s need for additional funding, uncertainties regarding the Company`s intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company`s filings with the Securities and Exchange Commission.

      L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.




      --------------------------------------------------------------------------------
      Source: BioDelivery Sciences International, Inc.


      Gruß
      Falke28
      Avatar
      schrieb am 13.04.04 23:48:37
      Beitrag Nr. 101 ()
      Hi Falke, stimme ich Dir zu, scheint ein guter Deal zu sein. Was mich ein bisschen Sorgen macht ist die Tatsache dass beide Firmen der gleichen Capital Group gehören...ist das evtl mehr nur eine Werbung für beide Firmen?
      Aus der Press Release ist auch zu lesen dass ... Accentia is responsible for all expenses related to the development of an encochleated BioNasal (TM) amphotericin B for the indication of CRS in the US and EU including the filing of an IND and clinical trials. Was bedeutet dies? Wie lange dauert das noch, und wir wissen noch nicht ob das ganze zugelassen wird, oder?
      Das beste ist doch dass ... Accentia will pay BDSI a running royalty of 12-14% on net sales in the US with annual prescription cost $1000/patient and estimated 37 million patients in the US and a comparable number in the EU. Was bedeutet dass auch wenn nur 1% dieser Patienten die Medizin benutzt, würde BDSI 88 Millionen $ an Royalties einkassieren! Und BDSI ist ja momentan nur 30 Millionen $ wert.
      Avatar
      schrieb am 14.04.04 10:23:24
      Beitrag Nr. 102 ()
      Also, sicher ein Rechenfehler...die $1000/Patient sind sicherlich die Gesamtkosten für die Krankenkasse/Patient...ich weiss nicht wie hoch die "net sale" ist aber wenn diese 10% der Gesamtkosten ist wäre die royalty für BDSI immerhin $8,8 Millionen/Jahr/1% der geschätzten Patientmengde. Können wir nur hoffen dass die Medizin wirklich gebraucht wird...
      Avatar
      schrieb am 15.04.04 00:29:19
      Beitrag Nr. 103 ()
      @Pegau


      hi.


      ich hab die news jetzt mehrere tage mit jemandem besprochen der aus dem business kommt. die geschichte ist die folgende.

      die möglichen royalties einnahmen sind angsteinflößend was den marktbedarf angeht. bei 5% marktdurchdringung wären es ca. 240 mille für bdsi pro jahr. wohlgemerkt, es steht NICHT das bdsi auch außerhalb von den usa royalties bekommt!!

      ich versteh auch nicht ganz warum du denkst das die net sales nur 10% von den 1000 dollar sein würden. welchen anteil die krankenkasse davon zahlt kann bdsi ja egal sein. insgesamt kostet das zeug 1000 dollar pro jahr, punkt. oder auf was wollen die mit dem "net sales" hinaus?

      das problem ist natürlich das scheinbar noch 2-3 jahre vergehen werden bis das zeug am markt ist, schätzt mein kontaktmann. also wenn du mich frägst, ist das der grund warum die aktie so ne erbärmliche kursvorstellung nach so einer news gibt. das ist alles noch viel zu weit weg. wie ich immer gesagt hab, kann echt sein das wir hier ne 2. flamel oder mehr in der hand haben vorausgesetzt diese technik funktioniert so wie sie sich das denken. aber leider wird das alles noch dauern.


      Hack
      Avatar
      schrieb am 15.04.04 00:52:04
      Beitrag Nr. 104 ()
      Hi Hacker, ist mir schon klar das es BDSI egal ist wie gross der Anteil der Krankenkasse am Preis ist. Was ich aber dachte, ist dass mit "net sales" die Gesamtverkaufsumme der Accentia/BDSI gemeint ist, bevor Händleraufschlag etc dazukommt. Und da kenne ich mich nicht aus. Wenn Accentia das Produkt für $10 auf den Markt bringt, könnte es in meinen Augen leicht bis zu $100 in der Apothek verkauft werden. Die $1000 per Patient sind ja schliesslich "annual prescription cost", was ich als die Kosten für die Krankenkasse+Patient verstehe und nicht das Geld was Accentia einkassiert. Die grosse Frage ist aber sicherlich: wenn wir schon mal 2-3 Zeit vor uns haben, soll mann noch einsammeln wobei es nun langsam recht interessant aussieht...Ich denke ich werde es tun wenn mehrere solcher PR kommen.
      Avatar
      schrieb am 15.04.04 01:01:30
      Beitrag Nr. 105 ()
      Also nochmals eine Rechnung von mir...wie Du richtig sagst steht nichts von Royalties in der EU, also lasse ich diese aus...

      37.000.000 Patienten in den USA
      Estimated prescription cost $1000/Patient
      10% Marginal für Accentia/BDSI ergibt $100 net sales/Patient
      Gesamt "net sales" 37.000.000*$100 = $3.700.000.000
      Bei 5% Marktdurchdringung sind das $185.000.000 "net sales"/Jahr
      Bei 12-14% Royalties ergibt das $22.200.000-25.900.000 für BDSI/Jahr. Hört sich doch immer noch sehr gut an...meiner Meinung nach.
      Avatar
      schrieb am 15.04.04 01:07:03
      Beitrag Nr. 106 ()
      Es steht auch einiges Wissenschaftliches zum Thema ... z.B. dieser Abstrakt...

      J Allergy Clin Immunol. 2002 Dec;110(6):862-6.

      Intranasal antifungal treatment in 51 patients with chronic rhinosinusitis.

      Ponikau JU, Sherris DA, Kita H, Kern EB.

      Department of Otorhinolaryngology-Head and Neck Surgery, Mayo Clinic Rochester, Rochester, MN 55905, USA.

      BACKGROUND: Chronic rhinosinusitis (CRS) is the most common chronic disease that is frequently refractory to treatment. OBJECTIVE: We sought to establish the safety and demonstrate the clinical efficacy of intranasal antifungal drug therapy in patients with CRS in a pilot trial. METHODS: A prospective open-label trial used amphotericin B as a medical treatment in 51 randomly selected patients with CRS. The antifungal agent was applied intranasally as 20 mL of a 100 microg/mL solution twice daily. The outcome was measured by using their symptoms and by using an endoscopic scoring system in all patients. In addition, pretreatment and posttreatment coronal computed tomographic scans of the nose and sinuses were available for evaluation in 13 patients. RESULTS: By using amphotericin B, improvement of sinusitis symptoms was observed in 38 (75%) of 51 patients. Endoscopically, 18 (35%) of 51 patients became disease free, and an additional 20 (39%) of 51 had improvement of at least one stage (P <.001). No effect was seen in 13 (25%) of 51 patients. The available computed tomographic scans before and after treatment demonstrated a significant reduction in the inflammatory mucosa thickening that had occluded the paranasal sinuses (P <.0001 in maxillary sinus). CONCLUSION: This open-label pilot trial demonstrates that direct mucoadministration of an antifungal drug appears to be both safe and effective in the treatment of patients with CRS. Therefore controlled and blinded trials are indicated to clarify the novel role of intranasal antifungal drugs in the treatment of CRS.
      Avatar
      schrieb am 15.04.04 11:02:21
      Beitrag Nr. 107 ()
      Hallo Zusammen,

      nette Diskussion... Ich denke entscheidend ist der Aspekt, dass die Technologie von BDSI wirklich funktioniert.

      Aber stimmt, wenn beide Unternehmen zur gleichen Capital Group gehören kann einem das wirklich zu denken geben.

      Allerdings glaube ich, dass "Delivery Systeme" zur medizinischen Zukunft gehören. Diese Technik wirk die Medikation so sehr auf eine neue Ebene heben, dass in späterer Zukunft kaum ein Medikament mehr ohne eine solche Technologie auskommt. Zur Zeit ist es ja so, dass der ganze Körper mit "dem Medikament" geflutet werden muß, um ein Resultat zu erreichen. Was für eine Effizienzverschwendung. Außerdem gibt es viel Stoffe, welche toxisch wirken - außer an dem Krankheitsherd!!!
      Man stelle sich die Möglichkeiten vor!

      Kurzum: Flamel und vor allem BDSI gehören auf jeden Fall in mein Depot. Aber: bei BDSI sind die Risiken schon noch sehr hoch. Ob diese Meldung nun Werbung war ober nicht - für mich ist diese Aktie eine große Summe und das damit verbundenen Risiko wert!! :D :D :D

      Gruß
      Falke28
      Avatar
      schrieb am 20.04.04 10:58:05
      Beitrag Nr. 108 ()
      Ich muss zugeben, dass mich die Performance dieser Aktie immer wieder enttäuscht. Vor allem das Volumen in den USA ist wirklich zum weinen!

      Trotzdem halte ich langfristig eine große Position dieses Papieres.

      Gruß
      Falke28

      PS: Die Technologie dieser Firma scheint nach wie vor super zu sein.
      Avatar
      schrieb am 28.04.04 14:03:42
      Beitrag Nr. 109 ()
      Also ich muss aber auch sagen, dass mich das Handelsvolumen dieser Aktie immer wieder von neuem enttäuscht.:rolleyes:

      Gruß
      Falke28
      Avatar
      schrieb am 30.04.04 15:11:03
      Beitrag Nr. 110 ()
      Es gibt halt kein Volumen...

      Gruß
      Falke28
      Avatar
      schrieb am 10.08.04 09:16:59
      Beitrag Nr. 111 ()
      Sehr enttäuschende Entwicklung...

      Kann aufgrund fraglicher Finanzen nicht mehr zum Kauf raten. Hier würde ich erst auf wirklich gute News warten.

      Hoffentlich wird mit dem 4 Millionen Kredit bedacht umgegangen und bald mal eine gute Perspektive an Land gezogen...

      Gruß
      Falke28
      Avatar
      schrieb am 15.08.04 18:15:24
      Beitrag Nr. 112 ()
      Hallo Falke28,

      dieser Verfall ist doch nicht gerechtfertigt!?
      Was hast Du für New´s

      Gruß
      M.;)
      Avatar
      schrieb am 15.09.04 15:17:38
      Beitrag Nr. 113 ()
      Naja, dieser Verfall war schon gerechtfertigt - die Firma stand immerhin kutz vor der Insolvenz. Nun hält si sich allerdings erstaunlich gut auf diesem Level. Ich hoffe, wir können uns demnächst über 3 Dollar vorerst stabilisieren.

      Liquidität ist nun ja erst mal wieder vorhanden - nur fehlt es wirklich mal an durchschlagenden Erfolgen. Die Phantasie ist durch den Asset-Verkauf ja nun auch ein wenig geschröpft.

      Dieser Wert bleibt ein sehr hohes Risiko - Tötalverlust ist leider durchaus noch drin. Die Technologie sollte sich erst mal in der Praxis beweisen können.

      Für risikobereite kann zum halten - allerdings nicht zum kaufen meinerseits geraten werden.
      Wir warten alle auf eine sinnvolle praktische Anwendung der Technologie.

      Zeigt uns doch mal was richtiges Leute!

      Gruß
      Falke28
      Avatar
      schrieb am 21.09.04 21:00:11
      Beitrag Nr. 114 ()
      es lohnt sich bei biodelivery zu bleiben und beobachten.
      leider kann es im herbst rasant nach unten gehen...

      bin bei bio sante ... 2000 ST
      bei acacia combimatrix ... 3000 ST
      bei nanometrics ... 2000 ST
      bei tegal ... 3000 ST
      bei nanobac ( probe ) ... 1000 ST
      bei nanopierce ... 5000 ST
      usw.

      gute prognosen :
      BEI 2700%
      OMG 6600%
      Avatar
      schrieb am 08.10.04 13:45:16
      Beitrag Nr. 115 ()
      Diese Meldung hier war ausschlaggebend für den klasse Move:


      SECURED DIGITAL APPLICATIONS, INC. PREANNOUNCES REVENUE AND EARNINGS ESTIMATES FOR THIRD QUARTER 2004

      NEW YORK--(BUSINESS WIRE)--Oct. 7, 2004--Secured Digital Applications, Inc. (OTCBB:SDGL) www.digitalapps.net today announced that it anticipates revenue for the three months ended September 30, 2004 to be approximately $5 million, 17% higher than the corresponding period ended September 30, 2003. This would be the second consecutive quarter that the company is expected to achieve revenue in excess of $5 million. Total revenue for the nine months ended September 30, 2004 is estimated to reach $14.6 million, 25% higher than the corresponding period in 2003.
      The Company also estimates its gross profit to be approximately $525,000 for the three months ended September 30, 2004, compared to a gross profit of $668,000 for the three months ended September 30, 2003. Gross profit for the nine months ended September 30, 2004 is estimated to be approximately $1.5 million, about 10% higher than the corresponding period in 2003.

      Secured Digital anticipates net income of approximately $104,000 and $448,000 for the three and nine months ended September 30, 2004; compared to a net income of $413,000 and $693,000, respectively, for the three and nine months ended September 30, 2003. The Company expects an increase in administrative expenses for the three months ended September 30, 2004 as a result of higher consulting and professional charges relating to the Company`s expansion activities.

      The information contained herein does not include the financial results of the Gallant IT group of companies, a 56% controlling interest in which were acquired by the Company on September 29, 2004. Secured Digital cautions that its anticipated results are preliminary, based on the best information currently available to it, and are subject to customary quarter-end review and adjustments.



      Nun muß nur noch wirklich etwas dahinterstecken...
      Es könnte sich hier rein theoretisch auch um "manipulative Käufe und Newspolitik" handeln, damit ein Listing an der Nasdaq bestehen bleibt.

      Meine alte Einschätzung gilt nach wie vor: vorsicht bei Käufen! Erstmal auf richtige Nachrichten warten...


      Gruß
      Falke28
      Avatar
      schrieb am 11.10.04 21:17:22
      Beitrag Nr. 116 ()
      @Falke


      was hat SDGL bitte mit BDSI zu tun??


      thx, Tommy


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