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    astralis-Psoraxine das Medikament gegen Schuppenflechte - 500 Beiträge pro Seite

    eröffnet am 11.02.02 18:29:44 von
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     Ja Nein
      Avatar
      schrieb am 11.02.02 18:29:44
      Beitrag Nr. 1 ()
      Mit der Partnerschaft mit Skyepharma ist Astralis nun einen
      wichtigen Schritt vorangekommen.

      Eine Studie von Goldman Sachs sagt aus das es etwa 180 Millionen
      betroffene Patienten gibt.Das Martpotential von Psoraxine
      wird auf bis zu 6 billionen Dollar im Jahre 2007 geschätzt.
      Sensationelle Ergebnisse tun ein übriges dazu.So haben
      96% aller getesteten Patienten ein positive reaktion gezeigt.
      In der 2 Jahreshälfte sollen die Ergebnisse bestätigt werden und
      dann wird es zur Zulassung gehen.
      Avatar
      schrieb am 15.03.02 04:33:43
      Beitrag Nr. 2 ()
      Thursday March 14, 4:49 pm Eastern Time

      Press Release

      SOURCE: Astralis Ltd

      Astralis Ltd Reports 2001 Results

      FLORHAM PARK, N.J.--(BUSINESS WIRE)--March 14, 2002--Astralis Ltd (OTCBB:ASTR - news) announced today its results for the initial period ending
      December 31st, 2001.

      For the period from March 12, 2001, which was the date of inception though December 31, 2001, the Company recorded a net loss of $ 6.2 million, or $0.23 per share.
      The Company, which is in the developing stage, had no revenue during this period. Total shareholders` equity as of December 31, 2001, was $9.1 million and the
      Company had cash balances totalling $4.5 million as of December 31, 2001.

      Research and development expenses amounted to $3.2 million. This reflected spending on continued research for Psoraxine(TM), Astralis` first drug candidate for
      treatment of Psoriasis which began in early 2001, as well as payments to SkyePharma for regulatory and development services pursuant to a service agreement signed
      in December 2001. The Company anticipates that R&D expenses will increase in 2002, as Astralis and SkyePharma continue efforts relating to development of
      Psoraxine(TM) for psoriasis. It is anticipated that an Investigational New Drug (IND) application to start clinical studies will be filed with the US Food and Drug
      Administration in the second half of 2002.

      Astralis Ltd. is an emerging biotechnology company focusing on the research and development of novel treatments for immune system disorders and skin diseases.
      PSORAXINE(TM), the company`s first product candidate, is under development for the treatment of all forms of psoriasis. Astralis has completed clinical studies in
      Venezuela using PSORAXINE(TM) to treat nearly 3,000 Psoriasis patients, the majority of whom responded positively with few side effects.

      Of the nearly 3,000 treated patients, 648 achieved complete remission, while nearly half of all patients experienced a reduction in disease of between 70% and 99%, as
      measured by the Psoriasis Area and Severity Index (PASI), a validated outcomes measure. Overall, 96% of the patients had a positive response to PSORAXINE(TM),
      although these results have not yet been independently verified.

      There is no approved cure for Psoriasis. Most approved treatment protocols provide temporary or incomplete relief and may, with certain systemic treatments, cause
      serious side effects. PSORAXINE(TM) the company`s first product candidate, developed by Astralis` Chairman Dr. Jose Antonio O`Daly M.D., Ph.D., is intended to be
      a protein-based therapy that stimulates cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms.

      This press release contains forward-looking statements regarding Astralis Ltd. There can be no assurance that PSORAXINE(TM) will be successfully developed or
      manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be
      received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update
      any such forward-looking statement to reflect events or circumstances after the date of this release.

      Astralis Ltd
      (A Development Stage Entity)
      Selected Statement of Operation Information
      March 12, 2001 (Date of Inception) to December 31, 2001


      Revenues --

      Total Operating Expenses 4,084,619

      Loss from Operations 4,084,619

      Other Income

      Interest Income (9,255)

      Net Loss (4,075,364)

      Preferred Stock Dividend (2,120,000)

      Net Loss to Common Stockholder (6,195,364)

      Pro Forma Information (Unaudited)

      Net Loss (6,195,364)

      Pro forma tax provision --

      Pro forma net loss (6,195,364)

      Basic and diluted loss per common share (0.23)


      Notes to the Editor

      Astralis Ltd, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and
      skin diseases. Psoraxine(TM), the company`s first product candidate, is under development for the treatment of psoriasis, and is based on the discovery by the
      Company`s founder of a new gene sequence of proteins. To date, clinical data suggest remission of this skin condition in patient trials in Venezuela. For more
      information, visit Astralis` web site at http://www.astralisltd.com

      SkyePharma PLC, one of the world`s leading drug delivery companies, provides innovative services to major pharmaceutical partners from the point of drug discovery
      through the approval process. Its five technologies, oral, injectable, inhalation, topical, and nanoparticulate solubilisation encompass the vast majority of delivery systems
      in use by the pharmaceutical industry. For more information, visit SkyePharma`s web site at http://www.skyepharma.com

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis
      symptoms result from the overproduction of skin by blood cells associated with the immune system. These blood cells become confused and act as though the skin was
      damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like
      patches to painful pustules and massive inflammation. Most current treatments are sub-optimal and some systemic treatments can cause serious side effects.

      Additional information can be obtained from: International Federation of Psoriasis Associations at www.ifpa-pso.org US National Psoriasis Foundation at
      www.psoriasis.org The Psoriasis Association (UK) Tel: +44 (0) 1604 711129
      Avatar
      schrieb am 03.05.02 12:24:45
      Beitrag Nr. 3 ()
      Thursday May 2, 10:44 am Eastern Time

      Press Release

      SOURCE: Astralis LTD

      Astralis Receives Additional $2.5 Million Payment From SkyePharma
      Pursuant to Original Agreement

      FAIRFIELD, N.J.--(BUSINESS WIRE)--May 2, 2002--Astralis LTD (OTCBB: ASTR - news) announced today that it
      received a $2.5 million payment from SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) under the December 2001 Stock Purchase
      Agreement.

      The $2.5 million represents the second instalment of the total $10 million, due from SkyePharma. Astralis has now received a total
      of $15 million, with the remaining $5 million scheduled for payment through January 31, 2003.

      Under the terms of the original equity agreement, SkyePharma will make a total equity investment in Astralis of up to $20 million in
      convertible preferred shares, following which SkyePharma will beneficially own 18 % of Astralis. SkyePharma made an initial
      investment of $10 million on December 10, 2001, the effective date of the agreement and two subsequent investments totalling $ 5
      million.

      In addition to the original equity investment, SkyePharma and Astralis signed a technology agreement that provides Astralis with
      access to SkyePharma`s DepoFoam and other relevant drug delivery technologies, as well as a service agreement, whereby
      SkyePharma will provide all development, pre-clinical and clinical development services for PSORAXINE(TM), Astralis` novel
      injectable vaccine therapy for the treatment of all forms of Psoriasis up to the completion of Phase II clinical studies.

      Astralis Ltd. is an emerging biotechnology company focusing on the research and development of novel treatments for immune
      system disorders and skin diseases. PSORAXINE, the company`s first product, is an innovative drug under development for all
      forms of psoriasis. Astralis is currently preparing to file an IND application with the U S. FDA to start clinical trials in the U.S.

      There is no approved cure for Psoriasis. Most approved treatment protocols provide temporary or incomplete relief and may, with
      certain systemic treatments, cause serious side effects. PSORAXINE, developed by Astralis` Chairman Dr. Jose Antonio O`Daly
      M.D., Ph.D., is a protein-based therapy that stimulates cells from the patient`s immune system to reverse the inflammatory process
      responsible for psoriasis symptoms.

      This press release may contain forward-looking statements regarding Astralis LTD. Actual results may differ materially from those
      described in the press release as a result of a number of factors, including but not limited to the following: There can be no
      assurance that PSORAXINE will be successfully developed or manufactured, or that final results of human clinical trials will result
      in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at
      all, or that patient and physician acceptance of this product will be achieved. Astralis LTD undertakes no obligation to revise or
      update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Notes to the Editor

      Astralis LTD, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders
      and skin diseases. Psoraxine, the company`s first product, is an innovative drug under development for psoriasis, and is based on the company`s discovery of a new
      gene sequence of proteins. To date, preliminary clinical data suggest remission of this skin condition in patient trials in Venezuela.

      SkyePharma PLC, one of the world`s leading drug delivery companies, provides innovative services to major pharmaceutical partners from the point of drug
      discovery through the approval process. Its five technologies, oral, injectable, inhalation, topical, and nanoparticulate solubilisation encompass the vast majority of
      delivery systems in use by the pharmaceutical industry. For more information, visit SkyePharma`s web site at http://www.skyepharma.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population.
      Psoriasis symptoms result from the overproduction of skin by blood cells associated with the immune system. These blood cells become confused and act as though
      the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy
      rash like patches to painful pustules and massive inflammation. Most current treatments are sub-optimal and some systemic treatments can cause serious side effects.

      Additional information can be obtained from:

      International Federation of Psoriasis Associations at www.ifpa-pso.org

      US National Psoriasis Foundation at www.psoriasis.org

      The Psoriasis Association (UK) Tel: +44 (0) 1604 711129

      Contact:

      Astralis LTD
      Mike Ajnsztajn/Gina Tedesco, 973/227-7168
      Email: info@astralisltd.com
      Avatar
      schrieb am 17.05.02 12:30:03
      Beitrag Nr. 4 ()
      Wednesday May 15, 5:56 pm Eastern Time

      Press Release

      SOURCE: Astralis Ltd

      Astralis Ltd Reports First Quarter 2002 Results

      FAIRFIELD, N.J.--(BUSINESS WIRE)--May 15, 2002--Astralis Ltd (OTCBB: ASTR - News) announced today its results for the period ending March 31st,
      2002.

      For the period from January 1st, 2002 though March 31st, 2002, the Company recorded a net loss of $ 2.8 million, or $0.07 per share. The Company, which is in
      the development stage, had no revenue during this period. Total stockholders` equity as of March 31st, 2002, was $ 8.7 million and the Company had cash and
      marketable security balances totalling $3.8 million as of March 31st, 2002.

      Research and development expenses amounted to $2.3 million. This reflected spending on continued research for Psoraxine(TM), Astralis` first drug candidate for
      treatment of Psoriasis which began in early 2001, as well as payments to SkyePharma for regulatory and development services pursuant to a service agreement
      signed in December 2001. The Company anticipates that R&D expenses will increase during the year 2002, as Astralis and SkyePharma continue efforts relating to
      development of Psoraxine(TM) for psoriasis.

      This press release may contain forward-looking statements regarding Astralis LTD. Actual results may differ materially from those described in the press release as a
      result of a number of factors, including but not limited to the following: There can be no assurance that PSORAXINE will be successfully developed or
      manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be
      received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis will continue its research and development
      effort to the extent that we do not experience any cash shortfalls, adverse developments in our drug development or competitive or other impediments that an early
      stage company in our industry may face. Astralis LTD undertakes no obligation to revise or update any such forward-looking statement to reflect events or
      circumstances after the date of this release.

      Notes to the Editor

      Astralis Ltd, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders
      and skin diseases. Psoraxine(TM), the company`s first product candidate, is under development for the treatment of psoriasis. For more information, visit Astralis`
      web site at http://www.astralisltd.com

      SkyePharma PLC, one of the world`s leading drug delivery companies, provides innovative services to major pharmaceutical partners from the point of drug
      discovery through the approval process. Its five technologies, oral, injectable, inhalation, topical, and nanoparticulate solubilisation encompass the vast majority of
      delivery systems in use by the pharmaceutical industry. For more information, visit SkyePharma`s web site at http://www.skyepharma.com

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population.
      Psoriasis symptoms result from the overproduction of skin by blood cells associated with the immune system. These blood cells become confused and act as though
      the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy
      rash like patches to painful pustules and massive inflammation. Most current treatments are sub-optimal and some systemic treatments can cause serious side effects.

      Additional information can be obtained from:

      International Federation of Psoriasis Associations at
      www.ifpa-pso.org
      US National Psoriasis Foundation at www.psoriasis.org
      The Psoriasis Association (UK) Tel: +44 (0) 1604 711129

      Astralis Ltd
      (A Development Stage Entity)
      Selected Statement of Operation Information (Unaudited)
      January 1st, 2002 to March 31st, 2002

      Revenues --
      Total Operating Expenses $ 2,826,354
      Loss from Operations $ (2,795,929)
      Other Income
      Interest Income $ 30,425
      Net Loss to Common Stockholder $ (2,795,929)
      Basic and diluted loss per common share $ (0.07)




      Contact:

      Astralis Ltd
      Mike Ajnsztajn / Gina Tedesco, 973/227-7168
      Email: info@astralisltd.com
      Avatar
      schrieb am 14.06.02 22:14:06
      Beitrag Nr. 5 ()
      Bombenleger:
      du bist auch überall zuhause.. :-)
      Zu Psoriasis: ich kenne mich ein bisschen aus, da ich auch an dieser Krankeit leide, und das seit über 20 Jahren. Die Medikamente sind gerade in den letzten Jahren viel besser geworden, vorallem da es jetzt Medikamente ohne Kortison gibt. Doch eine Injection wäre etwas ganz Neues. Bis jetzt gab es nur Salben und Flüssigkeiten. Angeblich soll diese Injection von Psoraxine bei einigen Patienten sogar eine gänzliche Heilung von Psoriasis bewirken. Ich bin da skeptisch, aber das Ganze klingt ganz gut. Die Kooperation mit SkyePharma gefällt mir auch.

      Du sagst, dass es nächstes Jahr schon auf den Markt kommen könnte. Dies ist aber schlichtweg falsch. Selbst Astralis erwartet die Markteinführung erst in etwa 5 - 7 Jahren. Bis ein Produkt auf den Markt kommen kann, müssen Jahrelange Tests durchgeführt werden (phase I - IV). Es können sogar Jahrzehnte dauern. (Siehe Immune Response, mehr als 10 Jahre Forschung für Remune und immer noch nicht auf dem Markt!). In dieser Zeit werden Unsummen von Forschungsgeldern benötigt. zum glück hat astralis nun einen starken Partner. Aber ich warne alle vor sogenannten 1-Produkt-Firmen! Gerade in der Biotech-Branche ist es so, wenn ein Medikament bei Tests einmal nicht sehr gut abschneidet, werden die Kurse einbrechen. 50% und mehr an einem Tag ist keine Seltenheit. Falls Skye aussteigen würde, würde der Kurs sicherlich an einem Tag über 60% verlieren. Dies sind die grössten Risiken.

      Ich habe mich gerade heute als Testperson angemeldet. Doch für Europa-Testpersonen gibts die Injektion wohl erst in ein paar Jahren.

      Die Marktkapitalisierung ist jetzt auf 36 Mio. geschrumpft. Ich bin noch nicht investiert, aber bei kursen um die 0.80$ juckts mich schon. Doch ich warte noch ab. Dieser Sommer wird ein Ausverkaufssommer.

      Trading Spotlight

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      InnoCan Pharma
      0,1880EUR -1,57 %
      CEO lässt auf “X” die Bombe platzen!mehr zur Aktie »
      Avatar
      schrieb am 21.06.02 04:35:41
      Beitrag Nr. 6 ()
      Wednesday June 19, 4:31 pm Eastern Time

      Press Release

      SOURCE: Astralis LTD

      United States Patent and Trademark Office Grants Fast Track Status for
      Astralis` Psoraxine Patent Application

      FAIRFIELD, N.J.--(BUSINESS WIRE)--June 19, 2002--Astralis Ltd (OTCBB: ASTR - News) announced today that the United States Patent and Trademark Office
      (USPTO) granted its petition for special status for the patent application for Psoraxine(TM).

      The petition for special status is generally expected to expedite the USPTO patent review process. Psoraxine(TM), the company`s first product, is an innovative drug
      under development for the treatment of psoriasis, and is based on the discovery of a new gene sequence of proteins.

      The US patent filing includes various different claims from composition of matter to method of use. In addition to the filing with the USPTO, filing under the Patent
      Cooperation Treaty (PCT) was made in March 2002 to extend protection internationally.

      "This is a significant step in protecting the unique intellectual property and technology platform that can be used to further R&D efforts in other therapeutic areas as
      well" commented Dr. Jose Antonio O`Daly, Chairman of the Board of Astralis Ltd and inventor of the technology.

      This press release may contain forward-looking statements regarding Astralis LTD. Actual results may differ materially from those described in the press release as a
      result of a number of factors, including but not limited to the following: There can be no assurance that PSORAXINE(TM) will be successfully developed or
      manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be
      received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. In addition, no assurances can be given that the granting
      of the petition to for special status will, in fact, expedite the review process, of if the process is expedited, the process will issue. Astralis LTD undertakes no obligation
      to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Notes to the Editor

      Astralis Ltd, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and
      skin diseases. Psoraxine(TM), the company`s first product, is an innovative drug under development for psoriasis, and is based on the discovery of a new gene sequence
      of proteins. To date, clinical data suggest remission of this skin condition in patient trials in Venezuela. For more information, visit Astralis` web site at
      www.astralisltd.com.

      Contact:

      Astralis LTD, Fairfield
      Mike Ajnsztajn or Gina Tedesco
      +1 (973) 227-7168
      Email: info@astralisltd.com
      Avatar
      schrieb am 04.08.02 11:05:54
      Beitrag Nr. 7 ()
      Thursday August 1, 10:37 am Eastern Time

      Press Release

      SOURCE: Astralis LTD

      Astralis Receives Third $2.5 Million Payment From SkyePharma Pursuant to
      Original Agreement

      FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 1, 2002--Astralis LTD (OTCBB: ASTR - News) announced today that it received a $2.5 million payment from
      SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) under the December 2001 Stock Purchase Agreement.

      The $2.5 million represents the third instalment of the total $10 million, due from SkyePharma. Astralis has now received a total of $17.5 million, with the remaining $2.5
      million scheduled for payment on January 31, 2003.

      Under the terms of the original equity agreement, SkyePharma will make a total equity investment in Astralis of up to $20 million in convertible preferred shares,
      following which SkyePharma will beneficially own 18 % of Astralis. SkyePharma made an initial investment of $10 million on December 10, 2001, the effective date of
      the agreement, and three subsequent investments totalling $ 7.5 million.

      In addition to the original equity investment, SkyePharma and Astralis signed a technology agreement that provides Astralis with access to SkyePharma`s DepoFoam
      and other relevant drug delivery technologies, as well as a service agreement, whereby SkyePharma will provide development, pre-clinical and clinical development
      services for PSORAXINE(TM), Astralis` injectable therapy for the treatment of psoriasis.

      Astralis Ltd. is an emerging biotechnology company focusing on the research and development of novel treatments for immune system disorders and skin diseases.

      This press release may contain forward-looking statements regarding Astralis LTD. Actual results may differ materially from those described in the press release as a
      result of a number of factors, including but not limited to the following: There can be no assurance that PSORAXINE will be successfully developed or manufactured, or
      that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely
      manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis LTD undertakes no obligation to revise or update any such
      forward-looking statement to reflect events or circumstances after the date of this release.

      Contact:

      Astralis LTD
      Mike Ajnsztajn or Gina Tedesco, 973/227-7168
      info@astralisltd.com
      Avatar
      schrieb am 09.08.02 17:55:50
      Beitrag Nr. 8 ()
      Monday August 5, 5:21 pm Eastern Time

      Press Release

      SOURCE: Astralis LTD

      Astralis Completes Transfer of Scientific Team To U.S. Research Facility

      FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 5, 2002--Astralis Ltd (OTCBB: ASTR - News) announced today that it has completed the transfer of the company`s
      proprietary technology and scientific team from Venezuela to the U.S. to its recently opened corporate headquarters and U.S. based research facility located in Fairfield,
      New Jersey.

      "Astralis is now better positioned to develop its research in other therapeutic areas from our new U. S. based facility using the technology platform developed in
      Venezuela over the last 15 years" commented Mike Ajnsztajn, Astralis` Chief Executive Officer.

      In addition to research, development and manufacture of Psoraxine, a potential treatment for psoriasis, Astralis` scientific team, led by Dr. Jose Antonio O`Daly, will
      concentrate future efforts on research of treatments for other diseases and disorders including rheumatoid arthritis, severe dermatitis, papilomas, hyperkeratosis,
      melanomas, prostate enlargement, Chagas disease and leishmaniasis.

      This press release may contain forward-looking statements regarding Astralis LTD. Actual results may differ materially from those described in the press release as a
      result of a number of factors, including but not limited to the following: There can be no assurance that any products will be successfully developed or manufactured, or
      that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely
      manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis LTD undertakes no obligation to revise or update any such
      forward-looking statement to reflect events or circumstances after the date of this release.

      Notes to the Editor

      Astralis LTD, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders
      and skin diseases. For more information, visit Astralis` web site at www.astralisltd.com.

      Contact:

      Astralis LTD, Fairfield
      Mike Ajnsztajn or Gina Tedesco
      973/227-7168
      info@astralisltd.com
      Avatar
      schrieb am 13.08.02 19:12:51
      Beitrag Nr. 9 ()
      Friday August 9, 5:02 pm Eastern Time

      Press Release

      SOURCE: Astralis Ltd

      Astralis Ltd Reports First Half 2002 Results

      FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 9, 2002--Astralis Ltd (OTCBB: ASTR - News) announced today its results for the period ending June 30, 2002.

      For the period from January 1, 2002 through June 30, 2002, the Company recorded a net loss of $ 5.7 million, or
      $0.15 per share. The Company, which is in the development stage, had no revenue during this period. As of June
      30, 2002, total stockholders` equity was $ 8.6 million and the Company had cash and marketable security balances
      totalling $4.4 million.

      Research and development expenses amounted to $4.6 million. This reflected spending on continued research for
      Psoraxine(TM), the Company`s first drug candidate for treatment of psoriasis, as well as payments to SkyePharma
      for regulatory and development services pursuant to a service agreement signed in December 2001. The Company
      anticipates that research and development expenses will increase during the year 2002, as the Company continues
      efforts relating to the development of Psoraxine(TM) for psoriasis.

      This press release may contain forward-looking statements regarding Astralis LTD. Actual results may differ
      materially from those described in the press release as a result of a number of factors, including but not limited to
      the following: There can be no assurance that PSORAXINE will be successfully developed or manufactured, or
      that final results of human clinical trials will result in the regulatory approvals required to market products, or that
      final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of
      this product will be achieved. Astralis will continue its research and development effort to the extent that we do not experience any cash shortfalls, adverse
      developments in our drug development or competitive or other impediments that an early stage company in our industry may face. Astralis LTD undertakes no obligation
      to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Astralis Ltd.
      (A Development Stage Entity)
      Selected Statement of Operation Information (Unaudited)
      January 1st, 2002 to June 30th, 2002

      Revenues --
      Total Operating Expenses $ 5,494,070
      Loss from Operations $ (5,494,070)
      Investment Income $ 64,383
      Net Loss $ (5,429,687)
      Preferred Stock Dividend $ (270,000)
      Net Loss to Common Stockholder $ (5,699,687)
      Basic and diluted loss per common share $ (0.15)



      Contact:

      Astralis Ltd
      Mike Ajnsztajn
      Chief Executive Officer
      Gina Tedesco
      Chief Financial Officer
      973/227-7168
      info@astralisltd.com
      Avatar
      schrieb am 14.11.02 00:25:23
      Beitrag Nr. 10 ()
      Astralis Ltd Reports 3rd Quarter 2002 Results
      Wednesday November 13, 5:35 pm ET

      FAIRFIELD, N.J.--(BUSINESS WIRE)--Nov. 13, 2002--Astralis Ltd (OTCBB: ASTR - News)
      announced today its results for the period ending September 30th, 2002.

      For the period from January 1st, 2002 through September 30th, 2002 the Company recorded a
      net loss of $ 8.3 million, or $ 0.23 per share. The Company, which is in the development stage,
      had no revenue during this period. Total stockholders` equity as of September 30th, was $ 8.7
      million and the Company had cash and marketable security balances totalling $ 3.9 million as
      of September 30th, 2002.

      Research and development expenses amounted to $ 7.0 million. This reflected spending on
      continued research for Psoraxine(TM), Astralis` first drug candidate for treatment of Psoriasis
      which began in early 2001, as well as payments to SkyePharma for regulatory and
      development services pursuant to a service agreement signed in December 2001.

      Astralis Ltd
      (A Development Stage Entity)
      Selected Statement of Operation Information (Unaudited)
      January 1st, 2002 to September 30th, 2002

      Revenues --

      Total Operating Expenses $ 8,347,189

      Loss from Operations $ (8,347,189)

      Other Income - Interest Income $ 94,889

      Net Loss to Common Stockholder $ (8,522,300)

      Basic and diluted loss per common share $ (0.23)



      Contact:

      Astralis Ltd
      Mike Ajnsztajn
      Gina Tedesco
      973/227-7168
      Email: info@astralisltd.com



      Source: Astralis Ltd
      Avatar
      schrieb am 27.01.03 20:44:24
      Beitrag Nr. 11 ()
      ASTRALIS LTD files Form 8-K, Current Report


      Securities and Exchange Commission
      Washington, DC 20549

      Form 8-K

      CURRENT REPORT

      PURSUANT TO SECTION 13 OR 15(d) OF THE
      SECURITIES EXCHANGE ACT OF 1934

      Date of Report (Date of earliest event reported) December 16, 2002

      ASTRALIS LTD.
      (Exact Name of Registrant as Specified in its Charter)

      Delaware 000-30997 84-1508866
      --------------------------------------------------------------------------------
      (State or Other (Commission File Number) (IRS Employer
      Jurisdiction of Incorporation) Identification No.)



      75 Passaic Avenue, Fairfield, New Jersey 07004

      (Address of Principal Executive Offices) (Zip Code)

      Registrant`s telephone number, including area code (973) 227-7168


      (Former Name or Former Address, if Changed Since Last Report)




      ITEM 9. REGULATION FD DISCLOSURE.

      On December 16, 2002, the registrant mailed to its shareholders a brochure containing the following information:

      About Astralis

      Astralis Ltd, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel
      treatments for immune system disorders and skin diseases. Astralis has developed a viable technology platform, enabling the
      further development of PSORAXINE(TM) as well as other promising therapeutics.

      Versatile Research & Development Platform

      "Astralis is now better positioned to develop its research in other therapeutic areas from our new U. S. based facility using the
      technology platform developed in Venezuela over the last 15 years" commented Mike Ajnsztajn, Astralis` Chief Executive
      Officer.

      180 million people around the world suffer from Psoriasis - National Psoriasis Foundation

      Psoraxine(TM) (AS 210)

      Psoraxine(TM), the company`s first product candidate, is an innovative drug under development for the treatment of psoriasis,
      and is based on the company`s discovery of a new gene sequence of proteins. To date, clinical trial data suggests remission of
      psoriasis in approximately 3000 patients in Venezuela.

      Characteristics of Psoraxine(TM)

      Psoraxine(TM) is believed to induce a cellular response. Preliminary studies have indicated that there is no antibody creation,
      no immunosuppression, no programmed cell death, and no killing of T-cells.

      Corporate Information OTC Bulletin Board: ASTR

      Internet Address www.astralisltd.com

      Recent Share Price
      (2 December 2002)

      US $0.65

      Shares Outstanding
      (2 December 2002)

      37.5 million Common Shares

      Market Capitalization
      (2 December 2002)

      $24.4 Million

      52-week Trading Range
      $0.22 - $3.35

      Board of Directors

      Jose Antonio O`Daly, MD, PhD,
      Chairman of the Board and President of R&D

      Mike Ajnsztajn Chief Executive Officer

      Gina Tedesco Chief Financial Officer

      Gaston Liebhaber Director of International Affairs

      Michael Ashton CEO SkyePharma

      Fabien Pictet CEO Fabien Pictet & Partners Global Holdings

      Steve Fulda Fairleigh Dickenson University

      Advisory Board

      Medical Advisor
      Dr. James Leyden
      Professor
      Department of Dermatology
      University of Pennsylvania Hospital

      Marketing Advisor
      Bruce Epstein
      President Noesis Healthcare

      Contact Information:
      Gina Tedesco,
      Chief Financial Officer / Head of IR
      75 Passaic Avenue, Fairfield, N.J. 07004 U.S.A.
      Tel: 1 973 227 7168
      Fax: 1 973 227 7169
      Email: info@astralisltd.com

      Technology Transfer Update

      The transfer of the technology platform and manufacturing process to the New Jersey R&D facility was finalized in August 2002.
      The Psoraxine(TM) preliminary production process has been standardized, and continuous production has been established for
      clinical supplies.

      Psoraxine(TM) manufacturing upscaling is currently under development.

      Strong R&D Base

      With approximately $500K of capital investment in the R&D facility, Astralis has built a strong base on which to continue
      research in other therapeutic areas.

      Summary of Financial Information Astralis Ltd
      (A Development Stage Entity)

      Selected Statement of Operation Information (Unaudited) January 1st, 2002 to September 30th, 2002

      Revenues --

      Total Operating Expenses $ 8,347,189

      Loss from Operations $(8,347,189)

      Other Income - Interest Income $ 94,889

      Net Loss to Common Stockholder $(8,522,300)

      Basic and diluted loss per common share $ (0.23)

      Recent Highlights

      November 2002

      Continuing Pre-IND discussions with the FDA




      October 2002

      Manufacturing process standardized for U.S. clinical supply production for Phase I and Phase II clinical trials. Implemented
      preliminary Standard Operating Procedures and Good Manufacturing Practices

      August 2002

      Completed Transfer of Technology from Venezuela to Fairfield, New Jersey R&D Facility

      July 2002

      SkyePharma purchases an additional $2.5 million of preferred shares bringing the total capital injected to $17.5 million dollars,
      $10 million in Dec 2001, $2.5 million in Jan 2002, $2.5 million in April 2002, $2.5 million in July 2002.

      June 2002

      Initiated transfer of Venezuelan R&D Team to Fairfield, New Jersey R&D Facility. The Petition to Make Special for the
      Psoraxine(TM) Patent was granted by the United States Patent and Trademark Office, expediting the process

      May 2002

      Completed Capital Investment of approximately $500K for clean room technology and state of the art equipment for continued
      R&D into other therapeutic areas

      April 2002

      Astralis Ltd US Corporate Headquarters transferred to Fairfield, New Jersey

      February 2002

      Patent application filed under Patent Cooperation Treaty (PCT) for international protection

      December 2001

      Purchase Agreement signed with SkyePharma to purchase up to $20 million in convertible preferred shares. Service Agreement
      with SkyePharma agreed upon to provide development, pre-clinical and clinical development services. Technology Transfer
      Agreement with SkyePharma for access to drug delivery technology

      November 2001

      Raised an initial round of funding via a private placement of $3.2 million in conjunction with a merger into a public shell company
      to form Astralis Ltd.

      May 2001

      Pre Investigational New Drug Application (IND) meeting with the FDA to discuss United States IND filing

      March 2001

      Astralis filed patent with United States Patent and Trademark office for first product candidate, Psoraxine

      March 2001

      Astralis LLC founded in the US based on 15 years of work in Venezuela by Dr. Jose Antonio O`Daly

      Information or opinions in this fact sheet are presented solely for informative purposes and are not intended nor should be
      construed as investment advice. Astralis may carry a high investment risk. We encourage you to carefully review the company
      with your investment advisor and that you verify any information that is important to your investment decision. This fact sheet
      may contain forward-looking statements regarding Astralis Ltd. Actual results may differ materially from those described in the
      fact sheet as a result of a number of factors, including but not limited to the following: There can be no assurance that
      PSORAXINE(TM) will be successfully developed or manufactured, or that final results of human clinical trials will result in the
      regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or
      that patient and physician acceptance of this product will be achieved. Astralis will continue its research and development effort
      to the extent that we do not experience any cash shortfalls, adverse developments in our drug development or competitive or
      other impediments that an early stage company in our industry may face. Astralis Ltd undertakes no obligation to revise or
      update any such forward-looking statement to reflect events or circumstances after the date of this fact sheet.

      SIGNATURES

      Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
      its behalf by the undersigned hereunto duly authorized.

      ASTRALIS LTD.


      Date: December 16, 2002 By: /s/ Mike Ajnsztajn
      ---------------------------
      Mike Ajnsztajn
      Chief Executive Officer
      Avatar
      schrieb am 07.02.03 00:56:55
      Beitrag Nr. 12 ()
      Astralis Receives Final $2.5 Million Payment From
      SkyePharma Pursuant to Stock Purchase Agreement
      Monday February 3, 12:40 pm ET

      FAIRFIELD, N.J.--(BUSINESS WIRE)--Feb. 3, 2003--Astralis LTD (OTCBB: ASTR - News)
      announced today that it received a $2.5 million payment from SkyePharma PLC (Nasdaq:
      SKYE - News; LSE: SKP - News) under the December 2001 Stock Purchase Agreement.

      The $2.5 million represents the final instalment due from SkyePharma. Astralis has now
      received a total of $20 million from SkyePharma.

      Mike Ajnsztajn`s Astralis` Chief Executive Officer and Michael Ashton, SkyePharma`s Chief
      Executive Officer, jointly stated that, "SkyePharma`s continued support and equity investment
      confirms our collective commitment to introduce PsoraxineTM, Astralis` first product candidate,
      which is under development for the treatment of psoriasis."

      Astralis Ltd. is an emerging biotechnology company focusing on the research and development
      of novel treatments for immune system disorders and skin diseases.

      This press release may contain forward-looking statements regarding Astralis Ltd. Actual
      results may differ materially from those described in the press release as a result of a number
      of factors, including but not limited to the following: There can be no assurance that
      PSORAXINETM will be successfully developed or manufactured, or that final results of human
      clinical trials will result in the regulatory approvals required to market products, or that final
      regulatory approval will be received in a timely manner, if at all, or that patient and physician
      acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or
      update any such forward-looking statement to reflect events or circumstances after the date of
      this release.

      Contact:

      Astralis Ltd, Fairfield
      Mike Ajnsztajn or Gina Tedesco, 973/227-7168
      info@astralisltd.com



      Source: Astralis Ltd
      Avatar
      schrieb am 04.04.03 23:20:13
      Beitrag Nr. 13 ()
      Astralis Ltd Reports 2002 Results
      Monday March 31, 4:35 pm ET

      FAIRFIELD, N.J.--(BUSINESS WIRE)--March 31, 2003--Astralis Ltd. (OTCBB:ASTR - News)
      announced today its results for 2002. For the fiscal year ended December 31, 2002, the
      Company recorded a net loss of $ 18.4 million to common stockholders, or $0.49 per share.
      Included in this net loss is a non-cash preferred stock dividend in the amount of $9.4 million that
      was generated from the beneficial conversion feature of sales of preferred stock. The Company,
      which is a development stage entity, had no revenue during this period. Total shareholders` equity
      as of December 31, 2002, was $7.9 million and the Company had cash and marketable security
      balances totalling $1.4 million as of December 31, 2002.

      On January 31, 2003, SkyePharma PLC (NASDAQ:SKYE - News; LSE:SKP - News) purchased
      an additional 250,000 shares of the Company`s Series A Convertible Preferred Stock under the
      terms of a Stock Purchase Agreement dated December 10, 2001. The Company received $2.5
      million in consideration for the shares. This amount represents the final installment due from
      SkyePharma under the terms of the Stock Purchase Agreement.

      Research and development expenses for 2002 amounted to $ 7.7 million. These expenditures
      included continued research for Psoraxine(TM), the Company`s first drug candidate for the
      treatment of Psoriasis, which began in early 2001, as well as payments to SkyePharma for
      regulatory and development services pursuant to a Service Agreement signed in December 2001.

      This press release may contain forward-looking statements regarding Astralis Ltd. Actual results
      may differ materially from those described in the press release as a result of a number of factors,
      including but not limited to the following: There can be no assurance that Psoraxine(TM) will be
      successfully developed or manufactured, or that final results of human clinical trials will result in
      the regulatory approvals required to market products, or that final regulatory approval will be
      received in a timely manner, if at all, or that patient and physician acceptance of this product will
      be achieved. Astralis will continue its research and development effort to the extent that we do
      not experience any cash shortfalls, adverse developments in our drug development or competitive
      or other impediments that an early stage company in our industry may face. Astralis Ltd
      undertakes no obligation to revise or update any such forward-looking statement to reflect events
      or circumstances after the date of this release.

      -0-

      Astralis Ltd
      (A Development Stage Entity)
      Selected Statement of Operation Information
      January 1st, 2002 to December 31st, 2002


      Revenues --
      Total Operating Expenses $9,151,521
      Loss from Operations $(9,151,521)
      Investment Income $111,273
      Net Loss $(9,040,248)
      Preferred Stock Dividend $(9,348,750)
      Net Loss to Common Shareholders $(18,388,998)
      Basic and diluted loss per common share $(0.49)



      Contact:

      Astralis Ltd.
      Mike Ajnsztajn or Gina Tedesco, 973/227-7168
      info@astralisltd.com



      Source: Astralis Ltd.
      Avatar
      schrieb am 14.08.03 17:39:14
      Beitrag Nr. 14 ()
      FDA Allows Astralis to Proceed with U.S. Phase I Clinical Trials for Psoraxine for the Treatment of Psoriasis
      Monday August 4, 8:15 am ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 4, 2003--Astralis Ltd (OTCBB: ASTR - News) announced today that the U.S. Food and Drug Administration (FDA) has allowed the Company to start Phase I clinical trials in the U.S. for Psoraxine(TM) for the treatment of moderate to severe plaque psoriasis. The trial, a double-blind, placebo controlled study, will be carried out at the Texas Dermatology Research Institute by Dr. William Abramovits, Professor of Dermatology at Baylor University Medical Center, Dallas, Texas. The trial is expected to commence within the next few weeks.
      Dr. James Leyden, Chairman of Astralis` Medical Advisory Board, Professor at the Department of Dermatology at the University of Pennsylvania and past chairman of the Dermatology Foundation, commented, "We look forward to the opportunity to study Psoraxine(TM) in the U.S. If the results seen in patients in Venezuela are replicated, a very important advance in the treatment of psoriasis will clearly have been established."

      "The green light from the FDA, allowing Astralis to initiate testing on humans in the United States, marks an important milestone for the Company and Psoraxine(TM), its novel treatment for Psoriasis" said Mike Ajnsztajn, Chief Executive Officer of Astralis Ltd.

      Psoraxine, developed by Astralis` Chairman Dr. Jose Antonio O`Daly MD, PhD, is a protein that the Company believes stimulates cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms.

      Astralis has already completed clinical studies in Venezuela using a first generation version of Psoraxine(TM) to treat 2,770 psoriasis patients, the majority of whom responded positively with no serious adverse events. Of the 2770 treated patients, 28% achieved complete remission. An additional 46% of patients experienced a reduction in disease of between 70% and 99%, as measured by the Psoriasis Area and Severity Index (PASI), a validated outcomes measure. These results have not yet been independently verified.

      This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that PSORAXINE(TM) will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Notes to the Editor

      Astralis Ltd, an emerging biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine(TM), the company`s first product candidate, is an innovative drug under development for psoriasis, and is based on the discovery of a new gene sequence of proteins. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful pustules and massive inflammation.

      Additional information can be obtained from:

      International Federation of Psoriasis Associations at www.ifpa-pso.org
      US National Psoriasis Foundation at www.psoriasis.org


      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd
      Mike Ajnsztajn or Gina Tedesco, 973-227-7168
      Fax: 973-227-7169
      Email: info@astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 14.08.03 17:39:59
      Beitrag Nr. 15 ()
      Astralis Ltd Reports First Half 2003 Results
      Tuesday August 12, 4:56 pm ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 12, 2003--Astralis Ltd (OTCBB: ASTR - News) announced today its results for the period ending June 30, 2003. For the period from January 1, 2003 through June 30, 2003, the Company recorded a net loss of $2.8 million, or $0.07 per share. The Company, which is in the development stage, had no revenue during this period. Total stockholders` equity was $ 8.3 million as of June 30, 2003 and the Company had cash and marketable security balances totalling $ 2.5 million as of June 30, 2003.
      Research and development expenses amounted to $2.1 million for the period ending June 30, 2003. This includes spending on preclinical studies for PsoraxineTM, the Company`s first drug candidate for the treatment of Psoriasis.

      Astralis Ltd.
      (A Development Stage Entity)
      Selected Statement of Operation Information (Unaudited)
      January 1, 2003 to June 31 2003

      Revenues $--

      Total Operating Expenses 2,851,687

      Loss from Operations ($ 2,851,687)

      Other Income

      Investment Income $85,027

      Net Loss to Common Stockholder $(2,766,660)

      Basic and diluted loss per common share $(0.07)



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd
      Mike Ajnsztajn or Gina Tedesco, 973-227-7168
      info@astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 21.09.03 17:15:11
      Beitrag Nr. 16 ()
      Astralis Commences U.S. Phase I Clinical Trials for Psoraxine for the Treatment of Psoriasis
      Tuesday September 9, 8:55 am ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Sept. 9, 2003--Astralis Ltd (OTCBB: ASTR - News) announced today that the Phase I clinical trial for Psoraxine(TM) for the treatment of moderate plaque psoriasis has begun. The trial, a double-blind, placebo controlled study, is being carried out by Dr. William Abramovits, Professor of Dermatology at Baylor University Medical Center, Dallas, Texas.
      "It is exciting to be in the forefront of the investigation of a novel type of treatment for psoriasis, a condition that so adversely impacts the quality of life of those affected by it," commented Dr. Abramovits.

      The trial will evaluate the safety of a single dose of Psoraxine(TM) in 20 patients with stable moderate psoriasis for more than three months and covering between 3 % and 15 % of the body surface. Secondary end points to measure efficacy such as PASI (Psoriasis Area and Severity Index) and Quality of Life Improvement will be analyzed. Psoraxine(TM) is administered by intramuscular injection and the trial will encompass three dose ranges of 50, 150, and 300 micrograms in addition to a placebo control arm.

      Psoraxine(TM) is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Jose O`Daly MD, PhD, Astralis` Chairman of the Board and Head of Research and Development, stated, "It is gratifying that the culmination of my research efforts of the last fifteen years have now entered the US pipeline. I look forward to having Psoraxine(TM) tested under FDA guidelines to confirm the safety of the product. This is truly an exciting time for Psoraxine(TM), as a researcher I look towards exploring potential possibilities of this new drug class."

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin by epidermal cells induced by cells from the immune system. These blood cells over-stimulate the epidermis and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful plaques or pustules and massive inflammation.

      This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that PSORAXINE(TM) will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd
      Mike Ajnsztajn / Gina Tedesco, 973-227-7168
      Fax: 973-227-7169
      Website: www.astralisltd.com
      E-mail: info@astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 09.10.03 19:02:55
      Beitrag Nr. 17 ()
      Astralis Announces Psoraxine Patent For the Treatment of Psoriasis Allowed by the U.S. Patent and Trademark Office
      Wednesday October 8, 4:59 pm ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Oct. 8, 2003--Astralis Ltd (OTCBB:ASTR - News) today announced that a Notice of Allowance from the United States Patent and Trademark Office was granted for the patent related to Psoraxine(TM), Astralis` immunotherapeutic agent for the treatment of psoriasis.
      The patent covers Astralis` protein-based therapy and its use in the treatment of psoriasis and focuses on Psoraxine`s composition of matter, method of use and a partial gene sequence of proteins.

      Psoraxine(TM), administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine(TM) is currently being tested in U.S. Phase I clinical trials.

      This press release may contain forward-looking statements regarding Astralis Ltd. There can be no assurance that PSORAXINE(TM) will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Note to Editors

      Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine(TM), the company`s first product candidate, is an innovative drug under development for psoriasis, and is based on the discovery of a proprietary protein extract.. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful pustules and massive inflammation.

      Additional information can be obtained from:

      US National Psoriasis Foundation at www.psoriasis.org or the International Federation of Psoriasis Associations at www.ifpa-pso.org.



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd, Fairfield
      Mike Ajnsztajn or Gina Tedesco, 973-227-7168
      Fax: 973-227-7169
      E-mail: info@astralisltd.com
      Web site: www.astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 23.11.03 11:13:08
      Beitrag Nr. 18 ()
      Astralis Ltd Reports 3rd Quarter 2003 Results
      Friday November 14, 5:01 pm ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Nov. 14, 2003--Astralis Ltd (OTCBB:ASTR - News) announced today its results for the period ending September 30, 2003. For the period from January 1, 2003 through September 30, 2003, the Company recorded a net loss of $3.96 million, or $(0.11) per share. The Company, which is in the development stage, had no revenue during this period. Total stockholders` equity as of September 30th, was $7.4 million and the Company had cash and marketable security balances totalling $2.0 million as of September 30, 2003.
      Research and development expenses amounted to $3.01 million. This includes spending on preclinical studies and the Phase I clinical study for Psoraxine(TM), the Company`s first drug candidate for the treatment of Psoriasis.

      Astralis Ltd
      (A Development Stage Entity)
      Selected Statement of Operation Information (Unaudited)
      January 1st, 2003 to September 30th, 2003


      Revenues --

      Total Operating Expenses $ 4,067,642

      Loss from Operations $ (4,067,642)

      Other Income - Investment Income $ 105,107

      Net Loss to Common Stockholder $ (3,962,535)

      Basic and diluted loss per common share $ (0.11)



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd, Fairfield
      Mike Ajnsztajn or Gina Tedesco, 973/227-7168
      Email: info@astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 10.12.03 11:13:34
      Beitrag Nr. 19 ()
      Dr. Gerald Krueger Joins Astralis` Medical Advisory Board
      Monday December 1, 5:48 pm ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Dec. 1, 2003--Astralis Ltd (OTCBB: ASTR - News) is pleased to announce the appointment of Dr. Gerald Krueger to its Medical Advisory Board. Dr. Krueger, a professor of dermatology at the University of Utah School of Medicine, is a leading expert in psoriasis. Dr. Krueger has served as the principal investigator of over 90 clinical trials, mostly on psoriasis, over the past 25 years. Dr. Krueger also consults for the FDA on psoriasis. Dr. Krueger recently completed a 10-year term as chairman of the Medical Advisory Board of the National Psoriasis Foundation and continues to serve on the Executive Committee of the Dermatology Foundation. Dr. Krueger has been elected into the Alpha Omega Alpha Honor Society of Medicine. He has received the Taub International Award for psoriasis research, The American Skin Association Award for psoriasis research, and the National Psoriasis Foundation`s Lifetime Achievement Award and Founders Award.
      "It is an honor to welcome Dr. Krueger to the Astralis` Medical Advisory Board. The wealth of knowledge and clinical expertise that Dr. Krueger brings to the table enhances our abilities to continue with our clinical development plan for Psoraxine(TM)," stated Mike Ajnsztajn, Chief Executive Officer.

      This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that PSORAXINE(TM) will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Astralis Ltd
      75 Passaic Ave
      Fairfield, New Jersey, 07004
      Phone: 1 (973) 227- 7168
      Fax: 1 (973) 227- 7169
      Email: info@astralisltd.com

      Mike Ajnsztajn, Chief Executive Officer
      Gina Tedesco, Chief Financial Officer

      Notes to the Editor

      Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine(TM), the company`s first product candidate, is an innovative drug under development for psoriasis, and is based on the discovery of a proprietary protein extract. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause a range of symptoms including itchy rash like patches, painful pustules and massive inflammation.

      Additional information can be obtained from:

      US National Psoriasis Foundation at www.psoriasis.org

      International Federation of Psoriasis Associations at www.ifpa-pso.org



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd
      Mike Ajnsztajn/Gina Tedesco, 973-227-7168
      Fax: 973-227-7169
      Email: info@astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 28.02.04 10:40:12
      Beitrag Nr. 20 ()
      Astralis Receives Patent For the Treatment of Psoriasis and Certificate of Registration For The Brand Psoraxine From The U.S. Patent and Trademark Office
      Thursday January 15, 7:01 am ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Jan. 15, 2004--Astralis Ltd (OTCBB: ASTR - News) today announced that the United States Patent and Trademark Office has issued Patent 6,673,351 Titled: Composition and Methods for the Treatment and Clinical Remission of Psoriasis to Astralis Ltd, effective on January 6, 2004. The patent focuses on Psoraxine`s manufacturing and usage for the treatment and clinical remission of psoriasis, as well as a partial gene sequence of this novel protein. The patent will expire in March 2021.
      Astralis has already filed the patent in the European Union and in certain countries, including Canada, Mexico and Japan.

      In addition, a Certificate of Registration was awarded for the brand Psoraxine®, Astralis` immunotherapeutic agent for the treatment of psoriasis, currently in Phase I clinical trials.

      Jose A. O`Daly, M.D., PhD, President of Research and Development commented, "This patent is a significant milestone in establishing Astralis` technology platform to pursue the development of future products."

      Notes to the Editor

      Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine® is currently being tested in U.S. Phase I clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful pustules and massive inflammation.

      Additional information can be obtained from:
      US National Psoriasis Foundation at www.psoriasis.org
      International Federation of Psoriasis Associations at
      www.ifpa-pso.org

      This press release may contain forward-looking statements regarding Astralis Ltd. There can be no assurance that PSORAXINE® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd, Fairfield
      Mike Ajnsztajn/Gina Tedesco, 973-227-7168
      Fax: 973-227-7169
      Email: info@astralisltd.com
      Website: www.astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 28.02.04 10:40:42
      Beitrag Nr. 21 ()
      Astralis Receives $ 4.08 Million from Private Placement
      Wednesday January 21, 7:00 am ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Jan. 21, 2004--Astralis Ltd (OTCBB: ASTR - News) announced today the closing of a private placement from which it received gross proceeds of approximately $ 4.08 million. The transaction consisted of the sale to accredited investors of units consisting of 8,159,964 shares of common stock and warrants to purchase 8,159,964 shares of common stock.
      Concurrently with this transaction, SkyePharma (LSE: SKP, NASDAQ: SKYE) converted all of its outstanding shares of Series A Preferred Stock of Astralis into 25,000,000 shares of common stock at a reduced conversion price of $0.80 per share. As a result, Skyepharma, which did not otherwise participate in the transaction, will no longer generally have the rights of a preferred stockholder of Astralis. SkyePharma has agreed that 12,500,000 shares of its common stock issued upon conversion of the Series A Preferred Stock will be subject to a right of repurchase by Astralis under certain circumstances at a premium to the conversion price. Following the conversion of the preferred stock and the issuance of shares in the private placement, Astralis will have approximately 70,698,153 million shares of common stock outstanding and no longer has any shares of preferred stock outstanding. This total excludes outstanding warrants and options, and warrants issued in the private placement.

      "These funds bring our current cash-on-hand to approximately $ 5.3 million, providing us with the financial resources to fund Phase II clinical trials of Psoraxine® , for the treatment of psoriasis and continue our research & development plan," said Mike Ajnsztajn, Chief Executive Officer.

      The securities offered to accredited investors in the private placement were sold in reliance on an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The securities have not been registered under the Securities Act or any state securities laws and the securities may not be offered or sold absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. In connection with the offering, Astralis has agreed, subject to certain terms and conditions, to file a registration statement under the Securities Act covering the resale of the shares purchased and shares issuable upon exercise of the warrants. This press release does not and will not constitute an offer to sell or the solicitation of an offer to buy shares or warrants and is being issued under Rule 135c under the Securities Act.

      This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that PSORAXINE® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd
      Mike Ajnsztajn
      or
      Gina Tedesco
      973-227-7168
      Fax: 973-227-7169
      info@astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 28.02.04 10:41:29
      Beitrag Nr. 22 ()
      Astralis Announces Completion of Patient Enrollment In Phase I Clinical Trial for Psoraxine
      Thursday January 22, 7:02 am ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Jan. 22, 2004--Astralis Ltd (OTCBB: ASTR - News) announced today that the company has completed patient enrollment of its blinded Phase I clinical trial for the company`s lead product, Psoraxine®, a new biological treatment for psoriasis. Twenty patients at two clinical sites were enrolled in the trial. No clinically significant adverse effects related to Psoraxine® have been reported so far. Full analysis of the trial is expected following its completion.
      This Phase I study was designed to evaluate the safety of a single dose of Psoraxine® in patients with stable, moderate psoriasis and covering between 3 % and 15 % of the body surface. Secondary end points, to measure efficacy such as PASI (Psoriasis Area and Severity Index) and Quality of Life Improvement, will also be analyzed. Psoraxine® is administered by intramuscular injection and the trial encompasses 3 dose levels of 50, 150, and 300 micrograms in addition to a placebo control arm.

      "This Phase I trial could provide compelling evidence for the safety and tolerability for the intramuscular administration of Psoraxine®" said Jerry Bagel M.D., Director of the Psoriasis Treatment Center of Central New Jersey and Associate Clinical Professor of Dermatology at Columbia University and principal investigator of this study.

      "We are extremely pleased with these preliminary study findings, which position Psoraxine® as a promising alternative for treating Psoriasis. We are looking forward to initiating our Phase II trial in 2004," said Mike Ajnsztajn, Astralis` CEO.

      Notes to the Editor

      Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine® is currently being tested in U.S. Phase I clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful pustules and massive inflammation.

      This press release may contain forward-looking statements regarding Astralis Ltd. There can be no assurance that PSORAXINE® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd, Fairfield
      Mike Ajnsztajn or Gina Tedesco, 1 973-227-7168
      Fax: 1 973-227-7169
      Email: info@astralisltd.com
      Website: www.astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 28.02.04 10:42:10
      Beitrag Nr. 23 ()
      Astralis Expands its Intellectual Property by Filing Two New Patents with the U.S. Patent and Trademark Office
      Tuesday February 24, 7:00 am ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--Feb. 24, 2004--Astralis Ltd (OTCBB:ASTR - News) today announced that a patent application was recently filed with the United States Patent and Trademark Office. This patent focuses on the mechanism of action of Psoraxine®, Astralis` product candidate for the treatment of Psoriasis, expanding the claims to include other medical indications such as Atopic Dermatitis, Psoriatic Arthritis and Rheumatoid Arthritis. In addition, the patent elaborates further on the mechanism of action of Leishmania extracts, which are believed to induce T-cell activation.
      A second patent was also filed this month relating to a culture medium for parasitic organisms, which is part of Astralis` technology platform.

      On January 6, 2004, the Patent Office issued U.S. Patent No. 6,673,351 B1, entitled Compositions and Methods for the Treatment and Clinical Remission of Psoriasis, to Astralis.

      "This is an important aspect of Astralis` research plan designed to expand and strengthen our intellectual property and allow us to continue our research in immunotherapeutic products," commented Jose Antonio O`Daly, MD, PhD., Chairman of the Board of Astralis and inventor of the technology.

      Notes to the Editor

      Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine® is currently being tested in U.S. Phase I clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful pustules and massive inflammation.

      This press release may contain forward-looking statements regarding Astralis Ltd. There can be no assurance that PSORAXINE® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd, Fairfield
      Mike Ajnsztajn or Gina Tedesco, 973-227-7168
      Fax: 973-227-7169
      Email: info@astralisltd.com
      Website: www.astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 04.04.04 17:42:11
      Beitrag Nr. 24 ()
      SkyePharma`s Partner Astralis Initiates US Phase II Trial for Novel Psoriasis Treatment
      Tuesday March 30, 10:37 am ET


      LONDON, March 30 /PRNewswire-FirstCall/ -- SkyePharma PLC (Nasdaq: SKYE - News; LSE: SKP - News) welcomes the recent announcement by its partner Astralis Ltd (OTC Bulletin Board: ASTR - News) that it has initiated a Phase II clinical trial in the USA for Psoraxine(TM), a novel injectable treatment for moderate psoriasis, a common chronic skin condition. This follows the successful completion of a US Phase I trial, which commenced in September 2003. A first generation version of Psoraxine(TM) was studied extensively in Venezuela, where nearly 3,000 patients participated in open-label clinical studies, the vast majority showing a positive response with few side-effects.
      ADVERTISEMENT


      Michael Ashton, SkyePharma`s Chief Executive, said, "The US Food & Drug Administration`s decision to authorize the Phase II trial for Psoraxine(TM) is an encouraging step forward. We are optimistic that this trial will replicate the very promising results seen in the previous studies in Venezuela. There is still significant unmet medical need in psoriasis and we are convinced that there is a substantial opportunity for a safe and effective new treatment."

      The randomised double-blind, placebo-controlled US study will evaluate the safety and efficacy of repeated doses of Psoraxine(TM) in 120 patients with moderate to severe plaque psoriasis. Patients at 10 US sites will receive a course of six intramuscular injections, administered every two weeks, with an 8-week follow-up period and the trial will involve three dose levels in addition to a placebo control arm. The study will also examine specific immunological changes in order to further elucidate the mode of action of Psoraxine(TM).

      Through a service agreement, SkyePharma is providing development, manufacturing, pre-clinical and clinical development services to Astralis for a second generation version of Psoraxine(TM), up to the completion of Phase II clinical studies. In the event that Phase II studies are successfully completed, Astralis will offer SkyePharma the option to acquire the worldwide licensing and distribution rights to Psoraxine(TM). SkyePharma is a substantial investor in Astralis.

      About SkyePharma

      SkyePharma PLC develops pharmaceutical products benefiting from world- leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now nine approved products incorporating three of SkyePharma`s five technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit www.skyepharma.com.

      About psoriasis

      Psoriasis is a chronic, genetically linked skin disorder that affects approximately 2-3% of the world`s population. For example, there are 7 million patients in the USA, with around 250,000 new cases diagnosed every year. The prevalence in Europe is similar. About 25% of patients are classified as moderate to severe, with over 10% of their body area affected. Psoriasis symptoms result from the overproduction of skin by epidermal cells induced by cells from the immune system. These blood cells over-stimulate the epidermis and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin cells can cause symptoms ranging from itchy rash-like patches to painful plaques or pustules, accompanied by massive inflammation.

      Psoriasis is normally episodic, with patients experiencing flares of increasing severity followed by periods of remission. Disease severity in psoriasis is measured by the PASI (Psoriasis Area and Severity Index) score, based on subjective assessment by the patient and objective measurements by the clinician. The PASI score ranks from 0-72 with zero indicating symptom- free. The FDA hurdle for demonstrating the efficacy of psoriasis treatments is a 75% reduction in PASI score.

      About Psoraxine(TM)

      Psoraxine(TM) is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Jose O`Daly MD, PhD, Chairman of the Board and Head of R&D for Astralis, is a Venezuelan parasitologist. While developing an improved vaccine for leishmaniasis, a parasitic infection transmitted by sandflies and endemic in much of South America, he noticed that vaccinated patients affected by psoriasis saw their symptoms resolve. The version of Psoraxine(TM) used in the clinical studies in Venezuela was based on a cellular extract from several species of the Leishmania parasite. Since 1992, nearly 3,000 patients have been treated with a course of injections in open- label studies. A clinically significant reduction in PASI score was reported for a great majority of the patients treated. The only significant side-effect in these studies was pain at the injection site. The second generation version of Psoraxine(TM) being used in the US trials is a purified protein fraction.

      About Astralis

      Astralis Ltd, an emerging biotechnology company based in Fairfield, New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. For further information visit www.astralisltd.com.

      Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors, which are described in SkyePharma`s 20-F and other documents on file with the SEC. These include without limitation risks in obtaining and maintaining regulatory approval for existing, new or expanded indications for its products, other regulatory risks, risks relating to SkyePharma`s ability to manufacture pharmaceutical products on a large scale, risks that customer inventory will be greater than previously thought, risks concerning SkyePharma`s ability to manage growth, market a pharmaceutical product on a large scale and integrate and manage an internal sales and marketing organization and maintain or expand sales and market share for its products, risks relating to the ability to ensure regulatory compliance, risks related to the research, development and regulatory approval of new pharmaceutical products, risks related to research and development costs and capabilities, market acceptance of and continuing demand for SkyePharma`s products and the impact of increased competition, risks associated with anticipated top and bottom line growth and the possibility that upside potential will not be achieved, competitive products and pricing, and risks associated with the ownership and use of intellectual property rights. SkyePharma undertakes no obligation to revise or update any such forward- looking statement to reflect events or circumstances after the date of this release.




      --------------------------------------------------------------------------------
      Source: SkyePharma PLC
      Avatar
      schrieb am 04.04.04 17:43:14
      Beitrag Nr. 25 ()
      Astralis Ltd Reports 2003 Results
      Tuesday March 30, 4:30 pm ET


      FAIRFIELD, N.J.--(BUSINESS WIRE)--March 30, 2004--Astralis Ltd (OTCBB:ASTR - News) announced today its results for 2003. For the fiscal year ended December 31, 2003, the Company recorded a net loss of $5.08 million to common stockholders, or $0.14 per share. The Company, which is a development stage entity, had no revenue during this period. Total shareholders` equity as of December 31, 2003, was $6.21 million and the Company had cash and marketable security balances totaling $1.38 million as of December 31, 2003.
      Research and development expenses for 2003 amounted to $4.04 million. These expenditures included costs for the preclinical and Phase I clinical trials for Psoraxine®, the Company`s first drug candidate for the treatment of Psoriasis, as well as the amortization of payments in the amount of $1.0 million to SkyePharma for regulatory and development services pursuant to a Service Agreement signed in December 2001.

      In December 2003, the Company received $221,636 in cash from the sale of a portion of its tax related net operating losses (NOLS) under the State of New Jersey`s Technology Business Tax Certificate Transfer Program. This program is an initiative passed by the New Jersey State Legislature that allows qualified technology and biotechnology businesses in New Jersey to sell unused amounts of NOLS and defined Research and Development tax credits for cash.

      On January 20, 2004, and February 19, 2004 the Company sold to accredited investors an aggregate of approximately 10.5 million shares of common stock and warrants to purchase approximately 10.5 million shares of common stock. The Company received approximately $5.23 million in consideration for the sale.

      This press release may contain forward-looking statements regarding Astralis Ltd. Actual results may differ materially from those described in the press release as a result of a number of factors, including but not limited to the following: There can be no assurance that Psoraxine® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis will continue its research and development effort to the extent that we do not experience any cash shortfalls, adverse developments in our drug development or competitive or other impediments that an early stage company in our industry may face. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Astralis Ltd
      (A Development Stage Entity)
      Selected Statement of Operation Information
      January 1, 2003 to December 31, 2003


      Revenues --
      Total Operating Expenses $5,362,081
      Loss from Operations $(5,362,081)
      Investment Income $60,018
      Net Loss Before Income Tax Benefit $(5,302,063)
      Income Tax Benefit 221,636
      Net Loss to Common Shareholders $(5,080,427)
      Basic and diluted loss per common share $(0.14)



      --------------------------------------------------------------------------------
      Contact:
      Astralis Ltd
      Mike Ajnsztajn or Gina Tedesco
      973-227-7168
      info@astralisltd.com



      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 07.05.04 19:25:41
      Beitrag Nr. 26 ()
      Astralis Ltd. Selects Allen & Caron for Corporate Communications, Investor and Media Relations
      Monday May 3, 5:36 am ET


      FAIRFIELD, N.J., May 3 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) a biotechnology company engaged in the research and development of novel treatments for immune system disorders and skin diseases, announced that it has selected Irvine, CA-based Allen & Caron Inc as its corporate communications, investor relations and media relations agency.
      ADVERTISEMENT


      Astralis currently has one product in clinical development, Psoraxine®, now in Phase II clinical trials, for the treatment of psoriasis. A proprietary protein extract, Psoraxine represents an innovative approach to the treatment of the disease, as it appears to act through a mechanism of immuno-stimulation, as opposed to the immuno-suppression techniques used by some existing biologic therapies. The Company also has pre-clinical focus in other areas including eczema, seborrheic dermatitis, psoriatic arthritis, rheumatoid arthritis and leishmaniasis.

      Astralis CEO Mike Ajnsztajn commented, "We have arrived at the place in our strategic plan that calls for increased communication with professional investment audiences, both in the US and abroad, and we have selected Allen & Caron due to their experience and ability in assisting companies wishing to position themselves properly within the investment community. We believe that Allen & Caron should be able to help us with the dissemination of our corporate information to the Street, as well as to industry and financial media."

      Allen & Caron Chairman and CEO, Joe Allen, said, "Astralis`s proprietary technology platform, and resulting therapy, Psoraxine, position the Company in front of some very large potential market opportunities. According to the National Psoriasis Foundation, psoriasis affects more than 4.5 million people in the US alone. We believe that Astralis presents an interesting and compelling story to Wall Street and we look forward to working with them to broaden their audience, by increasing overall awareness among US institutional investors and the international media."

      About Allen & Caron Inc

      Allen & Caron is a full service corporate, investor and marketing communications agency serving the needs of public companies. The Allen & Caron international client base includes emerging growth companies in a range of industry segments. The firm maintains offices in Irvine, CA, New York City and London. For more information, please visit www.allencaron.com.

      About Astralis Ltd.

      Fairfield, NJ-based Astralis is a development-stage biotechnology company engaged in the research and development of novel treatments for immune system disorders and skin diseases. The Company`s current activities focus on the development of a product candidate named Psoraxine® -- now in Phase II clinical trials -- for the treatment of psoriasis. Psoraxine is a proprietary protein extract with a mechanism of action that is believed to be based on immuno-stimulation. Astralis is also engaged in research on the possible development of the technology underling Psoraxine for the treatment of other indications, such as eczema, seborrheic dermatitis, psoriatic arthritis, rheumatoid arthritis and leishmaniasis.

      In January 2004, Astralis received its first patent from the United States Patent Office. For more information, please visit www.astralisltd.com.

      This press release may contain "forward-looking statements", as defined by the Private Securities Litigation Reform Act of 1995, regarding Astralis Ltd., including with respect to the objectives, intentions, and expectations relating to clinical studies. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that Psoraxine® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Other factors that could cause actual results to differ materially from anticipated results include, but are not limited to, those risks and uncertainties detailed in the Company`s annual report on Form 10-KSB and other reports filed from time to time with the Securities and Exchange Commission. Astralis Ltd. undertakes no obligation to revise or update any forward-looking statement herein to reflect events or circumstances after the date of this release.

      For further information, please contact: Investors, Jay F. McKeage, jay@allencaron.com, or Media, Brian Kennedy, brian@allencaron.com, both of Allen & Caron Inc, +1-212-691-8087, for Astralis Ltd.; or Mike Ajnsztajn, Chief Executive Officer, or Gina Tedesco, Chief Financial Officer, both of Astralis Ltd., +1-973-227-7168, info@astralisltd.com.




      --------------------------------------------------------------------------------
      Source: Allen & Caron Inc
      Avatar
      schrieb am 10.06.04 20:48:05
      Beitrag Nr. 27 ()
      Astralis Ltd. Reports First Quarter 2004 Results
      Friday May 14, 5:03 pm ET


      FAIRFIELD, N.J., May 14 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) announced today, its results for the first quarter of 2004. For the quarter ended March 31, 2004, the Company recorded a net loss of $12.5 million to common stockholders, or $0.19 per share. A one-time preferred stock dividend, related to the conversion into common stock of our Series A Preferred Stock, owned by SkyePharma PLC, accounts for $10.75 million of the net loss. The Company, which is a development stage entity, had no revenue during this period. Total shareholders` equity as of March 31, 2004, was $9.5 million and the Company had total cash and marketable securities of $5.4 million as of March 31, 2004.
      Research and development expenses for the period amounted to $1.3 million. These amounts included costs incurred in connection with the Phase I and Phase II clinical trials for Psoraxine®, the Company`s first drug candidate, as well as the amortization expense of $0.43 million for previous payments to SkyePharma for regulatory and development services pursuant to a Service Agreement signed in December 2001 and licenses of drug delivery systems.

      Psoraxine® is a protein-based therapy that is believed to act as an immunostimulator, rather than an immunosuppressor. The Company is currently conducting Phase II clinical trials in patients with moderate to severe psoriasis in 10 sites throughout the United States.

      This press release may contain forward-looking statements regarding Astralis Ltd. Actual results may differ materially from those described in the press release as a result of a number of factors, including but not limited to the following: There can be no assurance that Psoraxine® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis will continue its research and development effort to the extent that we do not experience any cash shortfalls, adverse developments in our drug development or competitive or other impediments that an early stage company in our industry may face. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Astralis Ltd.
      (A Development Stage Entity)
      Selected Statement of Operation Information
      January 1, 2004 of March 31, 2004

      Revenues --

      Total Operating Expenses $1,760,549

      Loss from Operations $(1,760,549)

      Investment Income $12,576

      Net Loss $(1,747,973)

      Preferred Stock Dividends $(10,750,000)

      Net Loss to Common Shareholders $(12,497,973)

      Basic and diluted loss per common share $(0.19)




      Fairfield, NJ-based Astralis is a development-stage biotechnology company engaged in the research and development of novel treatments for immune system disorders and skin diseases. The Company`s current activities focus on the development of a product candidate named Psoraxine® -- now in Phase II clinical trials -- for the treatment of psoriasis. Psoraxine is a proprietary protein extract with a mechanism of action that is believed to be based on immuno-stimulation. Astralis is also engaged in research on the possible development of the technology underling Psoraxine for the treatment of other indications, such as eczema, seborrheic dermatitis, psoriatic arthritis, rheumatoid arthritis and leishmaniasis. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis. Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful pustules and massive inflammation.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
      Avatar
      schrieb am 10.06.04 20:49:42
      Beitrag Nr. 28 ()
      Form 10QSB for ASTRALIS LTD


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

      17-May-2004

      Quarterly Report


      ITEM 2. MANAGEMENT`S DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS
      The following discussion of our financial condition and plan of operationshould be read in conjunction with our financial statements and the relatednotes included elsewhere in this quarterly report on Form 10-QSB. This quarterlyreport contains certain statements of a forward-looking nature relating tofuture events or our future financial performance. We caution prospectiveinvestors that such statements involve risks and uncertainties, and that actualevents or results may differ materially. In evaluating such statements,prospective investors should specifically consider the various factorsidentified in this quarterly report, including the matters set forth under thecaption "Risk Factors" which could cause actual results to differ materiallyfrom those indicated by such forward-looking statements. We disclaim anyobligation to update information contained in any forward-looking statement.

      Overview

      We are a development stage biotechnology company engaged primarily in theresearch and development of treatments for immune system disorders and skindiseases. Our initial product candidate, Psoraxine, is a protein extract usedfor the treatment of the skin disease psoriasis.

      Currently, we are engaged in the following activities to further ourdevelopment efforts of our initial product candidate:

      o Ongoing research and development of Psoraxine, including conducting Phase II clinical trials in the U.S.; and

      o Development of the technology underlying Psoraxine for the treatment of indications other that psoriasis, such as eczema, seborrheic dermatitis and psoriatic arthritis.

      Three months ended March 31, 2004 compared to three months ended March 31, 2003

      For three months ended March 31, 2004:

      On January 20, 2004 we completed the first closing of a private placementof our securities from which we received gross proceeds of approximately $4.08million. The transaction consisted of the sale to accredited investors of unitsconsisting of 8,159,964 shares of common stock and warrants to purchase8,159,964 shares of common stock. Concurrently with this transaction, SkyePharmaPLC ("SkyePharma") converted all of its outstanding shares of our Series APreferred Stock into 25,000,000 shares of common stock at a reduced conversionprice of $0.80 per share. SkyePharma has agreed that 12,500,000 shares of thecommon stock issued upon conversion of the Series A Preferred Stock will besubject to a right of repurchase by us under certain



      circumstances at a premium to the conversion price. In connection with thistransaction and in accordance with Statement of Financial Auditing Standard 84,"Induced Conversions of Convertible Debt, an Amendment of APB Opinion No. 26" wehave recorded a non-cash preferred stock dividend in January 2004 amounting to$10,750,000.

      On February 19, 2004, we held a second closing for the private placementfrom which we received gross proceeds of approximately $1.15 million. Thetransaction consisted of the sale to accredited investors of units consisting of2,299,902 shares of common stock and warrants to purchase 2,299,902 shares ofcommon stock.

      For the three months ended March 31, 2004, we had no revenue fromoperations and incurred operating expenses of $1,760,549 which consistedprimarily of:


      o Research and development costs of $1,331,141, including $430,447 that we incurred in connection with services provided by SkyePharma under our Service Agreement with them and amortization of approximately $178,572 under our technology option license which is being amortized over a seven year period.
      o General and administrative costs of approximately $421,898, including professional fees and our general corporate expenditures.
      As a result, during the three months ended March 31, 2004, we incurred anet loss of $12,497,973.
      For the three months ended March 31, 2003:

      On January 31, 2003, we sold to SkyePharma pursuant to a PurchaseAgreement dated December 10, 2001, 250,000 shares of our Series A PreferredStock for an aggregate purchase price of $2,500,000. We received net proceeds ofapproximately $2,480,000 after we netted out from the proceeds $20,000 due toSkyePharma for services they provided under our Service Agreement with themwhich was treated as an expense at the time of payment.

      For the three months ended March 31, 2003, we had no revenue and incurredoperating expenses of $1,511,823 which consisted primarily of:


      o Research and development costs of $1,161,505, including $430,447 that was paid to SkyePharma for services provided under our Service Agreement with them and amortization of approximately $178,572 under our technology option license which is being amortized over a seven year period.
      o General and administrative costs of approximately $318,769, including professional fees and our general corporate expenditures.
      As a result, during the three months ended March 31, 2003, we incurred anet loss of $1,474,714.
      The Next Twelve Months

      At March 31, 2004 we had cash balances of $708,223 and marketablesecurities of $4,709,681.

      Based on our current operating plan, we anticipate conducting thefollowing activities and using our cash over the course of the next twelvemonths as follows:

      o Our primary focus is to further our development efforts of our initial product candidate, Psoraxine. We expect to spend $2,753,000 on research and development, of which we expect to pay approximately $1,645,000 to third parties in connection with our Phase II clinical trials.

      o We intend to implement our business plan and facilitate the operations of our company. We will spend approximately $945,000 to pay management salaries and salaries of employees, a portion of which is treated as research and development expense.



      o We also expect to expend approximately $960,000 for our general administrative and working capital requirements.

      We will need to raise additional funds to continue our operations for theperiod following the second quarter of 2005. Furthermore, substantial additionalfunds will be needed in order to fund our continued efforts to attempt to obtainFDA approval for the marketing of Psoraxine. No assurance can be given that wewill be able to obtain financing, or successfully sell assets or stock, or, evenif such transactions are possible, that they will be on terms reasonable to usor that they will enable us to satisfy our cash requirements. In addition,raising additional funds by selling additional shares of our capital stock willdilute the ownership interest of our stockholders. If we do not obtainadditional funds, we will likely be required to eliminate programs, delaydevelopment of our products, or in the extreme situation, cease operations.
      Avatar
      schrieb am 31.07.04 21:57:04
      Beitrag Nr. 29 ()
      Press Release Source: Astralis Ltd.


      Astralis Registration Statement Declared Effective by the SEC
      Tuesday July 6, 4:49 pm ET


      FAIRFIELD, N.J., July 6 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) today announced that the Securities and Exchange Commission has declared effective its Registration Statement on Form SB-2 covering 47,056,520 shares of common stock (of which 11,446,654 are issuable upon exercise of warrants) for the resale of such shares from time to time by selling stockholders.
      The Company will not receive any proceeds from the resales of shares by the selling stockholders. However, if the warrants are exercised for cash, the Company would receive the exercise proceeds.

      This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

      Notes to the Editor

      Astralis Ltd., a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine® is currently being tested in U.S. Phase II clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      Astralis Ltd
      75 Passaic Ave
      Fairfield, New Jersey, 07004
      Fax: 1 (973) 227- 7169
      Phone: 1 (973) 227- 7168
      Email:info@astralisltd.com

      Mike Ajnsztajn, Chief Executive Officer
      Gina Tedesco, Chief Financial Officer


      This news release contains forward-looking statements based on information available to Astralis as of the date hereof. Astralis` actual results could differ materially from the results stated or implied by such forward-looking statements due to a number of risks and uncertainties. These risks and uncertainties include, but are not limited to, general economic and business conditions, changes in governmental laws and regulations relating to the development and commercialization of pharmaceutical products, and competition in our industry. There can be no assurance that our product development efforts will succeed, that Psoraxine® will receive required regulatory clearance or that, even if such regulatory clearance were received, that Psoraxine will ultimately achieve commercial success. Astralis disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
      Avatar
      schrieb am 31.07.04 21:57:45
      Beitrag Nr. 30 ()
      Press Release Source: Astralis Ltd.


      Dr. Sam Barnett and Dr. Philippe Magistretti Join Astralis` Board as Independent Directors
      Wednesday July 7, 7:30 am ET


      Fairfield, N.J., July 7 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) is pleased to announce the election of Sam Barnett and Philippe Magistretti, M.D. to its Board of Directors. Dr. Barnett, a well-known pharmaceutical industry expert, will serve as an independent director and member of the audit and compensation committees. Dr. Magistretti brings his extensive expertise in both finance and medical science to the board, and will also serve as an independent director.
      "It is a pleasure to welcome both Dr. Barnett and Dr. Magistretti to the Astralis Board of Directors. Dr. Barnett`s accomplishments in the pharmaceutical field, as well as broad managerial experience, paired with Dr. Magistretti`s ideal background of financial and scientific achievements will complement the Astralis team. We plan to leverage these strengths, expecting that both new members will act as advantageous liaisons across our industry and markets," stated Mike Ajnsztajn, Chief Executive Officer.

      Sam Barnett, Ed.D

      Mr. Barnett has focused his consulting activities exclusively in the pharmaceutical industry. In his 30 years as a management consultant, he has worked with almost every major Pharmaceutical Company in both the United States and Europe. In 1979 he founded Barnett International, a leading industry-focused consulting firm, where he was Chief Consultant. Mr. Barnett later went on to lead the Americas Pharmaceutical Practice for PricewaterhouseCoopers Consulting and subsequently led the Americas Life Sciences Consulting practice for IBM, Business Consulting Services. Mr. Barnett received his Bachelor`s degree from Wesleyan University, and both his Masters and Doctorate degrees from Temple University.

      Philippe Magistretti, M.D.

      Dr. Magistretti, a member of the Board of Fellows of the Harvard Medical School, sits on the Scientific Advisory Council of the Department of Genetics, at the Harvard Medical School. He has served as president of Bank AIG, and most recently as CEO of Credit Agricole Lazard Financial Products Bank as managing director at Lazard & Co, Ltd. He is currently the CEO of Translion Inc, a start up which focuses its activities in technology transfer in the Life Sciences sector. He has previously served as an associate in the corporate finance division of Salamon Brothers in New York, and as vice-president in the Capital Markets sector of Credit Suisse First Boston in London. Dr. Magistretti received his Medical Doctors Degree and his Doctorate in Nuclear Medicine from the University of Geneva, in 1981. He received his MBA from IMEDE in Lausanne, in 1985.

      Notes to the Editor

      Astralis Ltd., a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine® is currently being tested in U.S. Phase II clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      Astralis Ltd.
      75 Passaic Ave
      Fairfield, New Jersey, 07004
      Phone: 1 (973) 227-7168
      Fax: 1 (973) 227-7169
      Email: info@astralisltd.com

      Mike Ajnsztajn, Chief Executive Officer
      Gina Tedesco, Chief Financial Officer


      This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that PSORAXINE® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd. undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
      Avatar
      schrieb am 31.07.04 21:58:27
      Beitrag Nr. 31 ()
      Press Release Source: Astralis Ltd.


      Astralis Announces Resignation of Chief Executive Officer and Chief Financial Officer
      Wednesday July 28, 8:48 am ET


      FAIRFIELD, N.J., July 28 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) today announced that Chief Executive Officer Mike Ajnsztajn and Chief Financial Officer Gina Tedesco have submitted their resignations effective immediately with respect to their positions as members of the Company`s Board of Directors and effective as of August 26, 2004 with respect to their positions as Chief Executive Officer and Chief Financial Officer, respectively. Dr. Jose O`Daly, Chairman of the Board of Directors and President of Research and Development, will serve as the Company`s interim Chief Executive Officer.
      ADVERTISEMENT


      Dr. O`Daly commented, "We are grateful for the contributions made by Mike and Gina to our Company. We intend to continue with our development efforts and the Board is committed to identifying new members for our management team on an expedited basis. With our excellent group, we expect no interruption in our current programs."

      Notes to the Editor

      Astralis Ltd., a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine® is currently being tested in U.S. Phase II clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      This news release contains forward-looking statements based on information available to Astralis as of the date hereof. Astralis` actual results could differ materially from the results stated or implied by such forward-looking statements due to a number of risks and uncertainties. These risks and uncertainties include, but are not limited to, general economic and business conditions, changes in governmental laws and regulations relating to the development and commercialization of pharmaceutical products, and competition in our industry. There can be no assurance that our product development efforts will succeed, that Psoraxine will receive required regulatory clearance or that, even if such regulatory clearance were received, that Psoraxine will ultimately achieve commercial success. Astralis disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
      Avatar
      schrieb am 31.07.04 21:59:03
      Beitrag Nr. 32 ()
      Form 8-K for ASTRALIS LTD


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

      29-Jul-2004

      Other Events, Financial Statements and Exhibits



      ITEM 5. OTHER EVENTS AND REQUIRED FD DISCLOSURE.
      On July 28, 2004, the Registrant issued a press release announcing theresignation of Mike Ajnsztajn, the Registrant`s Chief Executive Officer and GinaTedesco, the Registrant`s Chief Financial Officer. The resignations areeffective immediately with respect to Mr. Ajnsztajn`s and Ms. Tedesco`spositions as members of the Registrant`s Board of Directors and effective as ofAugust 26, 2004 with respect to their positions as Chief Executive Officer andChief Financial Officer, respectively. A copy of the press release issued by theRegistrant is included herewith as Exhibit 99.1 and is incorporated by referenceherein.





      ITEM 7. EXHIBITS.
      The following exhibits are filed with this Current Report on Form 8-K:


      ExhibitNumber Description------ --------------------------------------------------------------------99.1 Press Release, dated July 28, 2004, announcing the resignation of the Registrant`s Chief Executive Officer and Chief Financial Officer SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the


      registrant has duly caused this report to be signed on its behalf by theundersigned hereunto duly authorized.

      ASTRALIS LTD.
      Date: July 29, 2004 By: /s/ Dr. Jose Antonio O`DalyDr. Jose Antonio O`DalyChairman of the Board &President of Research andDevelopment
      Avatar
      schrieb am 08.08.04 22:10:06
      Beitrag Nr. 33 ()
      SkyePharma`s Partner Astralis Presents US Phase I Results for Novel Psoriasis Treatment
      Friday August 6, 10:00 am ET


      LONDON, Aug. 6 /PRNewswire-FirstCall/ -- SkyePharma PLC (Nasdaq: SKYE - News; LSE: SKP - News) welcomes the recent announcement by its partner Astralis Ltd (OTC Bulletin Board: ASTR - News) that Dr Jose O`Daly, the Chairman and Chief Executive of Astralis, is presenting the results of a Phase I clinical trial of Psoraxine® at the 2004 National Conference of the US National Psoriasis Foundation, being held on August 6-8 in San Diego, California. Psoraxine® is a novel injectable treatment for moderate psoriasis, a common chronic skin condition.
      The US Phase I trial commenced in September 2003. The study, conducted in Princeton, New Jersey and Dallas, Texas, was a Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study to evaluate the safety of Psoraxine®. Administered via a single intramuscular injection, Psoraxine® was given to 21 patients (5 or 6 patients per treatment arm) with moderate and clinically stable plaque psoriasis. Psoraxine® was generally well tolerated in patients with active but stable plaque psoriasis, with similar safety profiles among patients who received single doses of placebo or Psoraxine® at doses of 50 mg, 150 mg, or 300 mg. None of the patients evaluated developed skin anergy to standard recall antigens during the study. Therefore the study provided preliminary evidence of a specific response to the Psoraxine® antigen, without the suppression of normal immunologic response to other common antigens.

      The Phase I trial was primarily a safety study using a sub-optimal treatment regimen, and was not intended or expected to demonstrate efficacy. However efficacy trends were observed. The number of patients in the Psoraxine® groups that exhibited improvements in the total and partial PASI scores at Day 14 was greater than the number of patients in the placebo group. A decrease from baseline mean severity was observed in the Psoraxine® groups at Day 14 and an increase in severity observed in the placebo group. The score for itching also showed an improvement in the Psoraxine® groups as compared to the placebo group.

      Michael Ashton, SkyePharma`s Chief Executive, said: "The Phase I trial results are encouraging. Although we must caution that this was not an efficacy trial, we now look forward to the outcome of the ongoing Phase II trial for Psoraxine®, which will provide the first efficacy data using a practical dosing schedule. We hope that this trial will replicate the very promising results seen in the previous studies of the first generation version in Venezuela. There is still significant unmet medical need in psoriasis and we are convinced that there is a substantial opportunity for a safe and effective new treatment."

      A Phase II clinical trial of Psoraxine® commenced in April 2004. The primary objective of this trial is to evaluate the safety and efficacy of multiple administrations of Psoraxine® at three alternative dose levels, compared with placebo. The trial is also designed to detect and evaluate any specific immunological changes that may be induced by repeated exposure to Psoraxine® and to generate data towards a better understanding of the mechanism of action. A total of 120 patients at twelve clinical sites in the US will participate in the study. Under the trial protocol, each patient will receive a series of six intramuscular injections, once every two weeks for a total of 3 months, and subsequently will undergo evaluation for an additional two months without treatment. Patient enrolment is expected to be completed by the end of this month.

      Through a service agreement, SkyePharma is providing development, manufacturing, pre-clinical and clinical development services to Astralis for the second generation version of Psoraxine®, up to the completion of Phase II clinical studies. In the event that Phase II studies are successfully completed, Astralis will offer SkyePharma the option to acquire the worldwide licensing and distribution rights to Psoraxine®. SkyePharma is a substantial investor in Astralis.

      For further information please contact:
      SkyePharma PLC +44 207 491 1777
      Michael Ashton, Chief Executive Officer
      Peter Laing, Director of Corporate Communications +44 207 491 5124
      Sandra Haughton, US Investor Relations +1 212 753 5780

      Buchanan Communications +44 207 466 5000
      Tim Anderson / Mark Court

      Notes for editors


      About SkyePharma

      SkyePharma PLC develops pharmaceutical products benefiting from world- leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now nine approved products incorporating three of SkyePharma`s five technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit http://www.skyepharma.com.

      About psoriasis

      Psoriasis is a chronic, genetically linked skin disorder that affects approximately 2-3% of the world`s population. For example, there are 7 million patients in the USA, with around 250,000 new cases diagnosed every year. The prevalence in Europe is similar. About 25% of patients are classified as moderate to severe, with over 10% of their body area affected. Psoriasis symptoms result from the overproduction of skin by epidermal cells induced by cells from the immune system. These blood cells over-stimulate the epidermis and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin cells can cause symptoms ranging from itchy rash-like patches to painful plaques or pustules, accompanied by massive inflammation.

      Psoriasis is normally episodic, with patients experiencing flares of increasing severity followed by periods of remission. Disease severity in psoriasis is measured by the PASI (Psoriasis Area and Severity Index) score, based on subjective assessment by the patient and objective measurements by the clinician. The PASI score ranks from 0-72 with zero indicating symptom- free. The FDA hurdle for demonstrating the efficacy of psoriasis treatments is a 75% reduction in PASI score.

      About Psoraxine®

      Psoraxine® is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Jose O`Daly MD, PhD, Chairman of the Board and Chief Executive of Astralis, is a Venezuelan parasitologist. While developing an improved vaccine for leishmaniasis, a parasitic infection transmitted by sandflies and endemic in much of South America, he noticed that vaccinated patients affected by psoriasis saw their symptoms resolve. The version of Psoraxine® used in the clinical studies in Venezuela was based on a cellular extract from several species of the Leishmania parasite. Since 1992, nearly 3,000 patients have been treated with a course of injections in open-label studies. A clinically significant reduction in PASI score was reported for a great majority of the patients treated. The only significant side-effect in these studies was pain at the injection site. The second generation version of Psoraxine® being used in the US trials is a purified protein fraction.

      About Astralis

      Astralis Ltd, an emerging biotechnology company based in Fairfield, New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. For further information visit http://www.astralisltd.com.

      Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors, which are described in SkyePharma`s 20-F and other documents on file with the SEC. These include without limitation risks in obtaining and maintaining regulatory approval for existing, new or expanded indications for its products, other regulatory risks, risks relating to SkyePharma`s ability to manufacture pharmaceutical products on a large scale, risks that customer inventory will be greater than previously thought, risks concerning SkyePharma`s ability to manage growth, market a pharmaceutical product on a large scale and integrate and manage an internal sales and marketing organization and maintain or expand sales and market share for its products, risks relating to the ability to ensure regulatory compliance, risks related to the research, development and regulatory approval of new pharmaceutical products, risks related to research and development costs and capabilities, market acceptance of and continuing demand for SkyePharma`s products and the impact of increased competition, risks associated with anticipated top and bottom line growth and the possibility that upside potential will not be achieved, competitive products and pricing, and risks associated with the ownership and use of intellectual property rights. SkyePharma undertakes no obligation to revise or update any such forward- looking statement to reflect events or circumstances after the date of this release.




      --------------------------------------------------------------------------------
      Source: SkyePharma PLC
      Avatar
      schrieb am 18.08.04 11:55:06
      Beitrag Nr. 34 ()
      Astralis Ltd Reports First Half 2004 Results
      Monday August 16, 5:16 pm ET


      FAIRFIELD, N.J., Aug. 16 /PRNewswire-FirstCall/ -- Astralis Ltd (OTC Bulletin Board: ASTR - News) announced today its results for the period ending June 30, 2004. For the period from January 1, 2004 through June 30, 2004, the Company recorded a net loss of $14.4 million, or $ 0.21 per share, which includes a non-cash Preferred Stock Dividend of $10.7 million. The Company had no revenue during this period. Total stockholders` equity was $7.9 million as of June 30, 2004 and the Company had cash and marketable security balances totaling $3.98 million as of June 30, 2004.
      Research and development expenses amounted to $2.4 million for the period ending June 30, 2004. This includes spending on Phase II clinical trails for Psoraxine®, the Company`s first drug candidate for the treatment of Psoriasis.

      Astralis Ltd.
      (A Development Stage Entity)
      Selected Statement of Operation Information (Unaudited)
      January 1, 2004 to June 30, 2004

      Revenues $--

      Total Operating Expenses 3,650,643

      Loss from Operations ($3,650,643)

      Other Income

      Investment Income $27,925

      Net Loss (3,622,718)

      Preferred Stock Dividends (10,750,000)

      Net Loss to Common Stockholder $(14,372,718)




      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 24.09.04 22:52:31
      Beitrag Nr. 35 ()
      Astralis Completes Enrollment of Patients in U.S. Phase II Clinical Trial for Psoraxine(R) for Treatment of Psoriasis
      Tuesday September 21, 7:30 am ET


      FAIRFIELD, N.J., Sept. 21 /PRNewswire-FirstCall/ -- Astralis, Ltd. (OTC Bulletin Board: ASTR - News), a development-stage biotechnology company engaged in the research and development of novel treatments for immune system disorders and skin diseases, announced today that it has completed enrollment of all 120 patients required for its Phase II clinical trial for Psoraxine®. Currently on schedule, the trial, a randomized, double blind, placebo- controlled study, is evaluating the safety and efficacy of repeated administrations of Psoraxine for patients with moderate to severe plaque psoriasis.
      ADVERTISEMENT


      Dr. Jose O`Daly, President of Research and Development and interim Chief Executive Officer of Astralis, commented, "We are very pleased to have reached this important clinical milestone. The high level of interest among the investigational sites physicians and patients participating in the trial has been exceptionally gratifying. We look forward to working diligently with our sites towards reaching our goals in the most expeditious manner possible."

      Patients participating in the study have been enrolled at eleven clinical sites in locations throughout the US. Under the test protocol, each patient is receiving a series of six intramuscular injections, once every two weeks, for a total of three months, and subsequently will undergo evaluation for two months without treatment.

      The primary objective of the clinical trial is to evaluate the safety and efficacy of multiple administrations of Psoraxine at three alternative dose levels, compared to a placebo. Astralis will also seek through the study to detect and to evaluate any specific humoral or cellular immunological changes, which may be induced by repeated exposure to Psoraxine, and to generate data towards a better understanding of the drug`s mechanism of action.

      In February 2004, Astralis completed a Phase I clinical trial for Psoraxine in patients with moderate psoriasis wherein no adverse events related to Psoraxine were reported.

      About Astralis, Ltd.

      Fairfield, NJ-based Astralis is a development-stage biotechnology company engaged in the research and development of novel treatments for immune system disorders and skin diseases. Astralis` current activities focus on the development of a product candidate named Psoraxine® -- now in Phase II clinical trials -- for the treatment of psoriasis. Psoraxine is a proprietary protein extract with a mechanism of action that is believed to be based on immuno-stimulation. Astralis is also engaged in research on the possible development of the technology underling Psoraxine for the treatment of other indications, such as eczema, seborrheic dermatitis, psoriatic arthritis, rheumatoid arthritis and leishmaniasis.

      About Psoriasis

      Psoriasis is a chronic, genetically-based remitting and relapsing scaly and inflammatory skin disorder that affects approximately three percent of the world`s population. Psoriasis symptoms result from the overproduction of keratinocytes in the skin epidermis induced by activated lymphocytes and blood cells associated with the immune system. These keratinocytes move to the surface of the skin leading to plaque formation, a build-up of skin cells in the epidermal layer. For reasons still unknown, such blood cells become over-stimulated and act as though the skin was damaged, inducing proliferation and division of skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause a number of adverse symptoms, from itchy rash-like patches to raised skin with silvery white build-up on top, or acutely painful widespread areas of skin with non-infectious pustules and massive inflammation.

      This press release may contain "forward-looking statements," as defined by the Private Securities Litigation Reform Act of 1995, regarding Astralis Ltd., including with respect to the objectives, intentions, and expectations relating to clinical studies. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that Psoraxine® will be successfully developed or manufactured, that final results of human clinical trials will result in the regulatory approvals required to market products, that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Other factors that could cause actual results to differ materially from anticipated results include, but are not limited to, those risks and uncertainties detailed in the Company`s` annual report on Form 10-KSB and other reports filed from time to time with the Securities and Exchange Commission. Astralis, Ltd. undertakes no obligation to revise or update any forward-looking statement herein to reflect events or circumstances after the date of this release.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
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      schrieb am 28.10.04 12:04:00
      Beitrag Nr. 36 ()
      28-Sep-2004

      Change in Directors or Principal Officers



      ITEM 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
      On September 22, 2004, Gaston Liebhaber resigned from the Registrant`s board of directors. Mr. Liebhaber stated in his resignation letter that he is resigning because he is retiring and relocating.
      Avatar
      schrieb am 09.11.04 10:46:00
      Beitrag Nr. 37 ()
      3-Nov-2004

      Entry Material Agreement, Change in Directors or Principal Officers



      ITEM 1.01 Entry into a Material Definitive Agreement.
      In connection with the appointment of Peter Golikov as interim Chief Executive Officer and Michael Garone as interim Chief Financial Officer, as further discussed in Item 5.02 below, on October 27, 2004, the Registrant entered into agreements with Mr. Golikov and Mr. Garone pursuant to which each of Mr. Golikov and Mr. Garone will receive a salary of $11,520 per month. The agreements terminate on February 18, 2005.





      ITEM 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
      On October 13, 2004, the Registrant retained Peter Golikov as its interim Chief Executive Officer and Michael Garone as its interim Chief Financial Officer.

      Mr. Golikov, age 47, currently provides business consulting services to emerging life science companies and academia and has done so since 2003. From 1998 to 2002, Mr. Golikov served as President and Chief Operating Officer of EpiCept Corporation, a private development stage specialty pharmaceutical company. From 1997 to 1998, Mr. Golikov was the President of Virologix Corporation, a private biotechnology company developing novel antiviral treatments and vaccines. Mr. Golikov holds an M.S. and an M.B.A. from Rutgers University and a B.A. in Biology from Cornell University.

      Mr. Garone, age 46, served from 1983 to 2003 in varying positions of increasing responsibility at AT&T, including Chief Financial Officer of AT&T Alascom and Financial Planning Vice President, Broadband and Internet Services. Mr. Garone holds an M.B.A. from Columbia University and a B.A. in Mathematics from Colgate University.
      Avatar
      schrieb am 19.11.04 19:25:10
      Beitrag Nr. 38 ()
      Astralis Ltd Reports Third Quarter And Nine Month 2004 Results
      Monday November 15, 5:04 pm ET


      FAIRFIELD, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) a development-stage biotechnology company engaged primarily in the R&D of treatments for immune system disorders and skin diseases announced results today for the third quarter and nine months of 2004. For the three months ended September 30, 2004, the Company recorded a net loss of $1.6 million to common stockholders, or $0.02 per share. For the nine months ended September 30, 2004, the Company recorded a net loss of $16.0 million to common stockholders, or $0.23 per share. A one-time preferred stock dividend, related to the conversion into common stock of our Series A Preferred Stock, owned by SkyePharma PLC, accounts for $10.75 million of the net loss for the nine month period. The Company, which is a development stage entity, had no revenue during this period. Total shareholders` equity as of September 30, 2004, was $6.4 million and the Company had total cash and marketable securities of $2.9 million as of March 31, 2004.
      Research and development expenses were $1.3 million and $3.8 million for the third quarter and nine month period, respectively. These amounts included costs incurred in connection with the Phase I and Phase II clinical trials for Psoraxine®, the Company`s first drug candidate, as well as the amortization expense of $0.43 million for previous payments to a related third party for regulatory and development services pursuant to a Service Agreement signed in December 2001. Psoraxine® is a protein-based therapy that is believed to act as an immunostimulator, rather than an immunosuppressor. The Company is currently conducting Phase II clinical trials in patients with moderate to severe psoriasis in 10 sites throughout the United States.

      This press release may contain forward-looking statements regarding Astralis Ltd. Actual results may differ materially from those described in the press release as a result of a number of factors, including but not limited to the following: There can be no assurance that Psoraxine® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis will continue its research and development effort to the extent that we do not experience any cash shortfalls, adverse developments in our drug development or competitive or other impediments that an early stage company in our industry may face. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Astralis Ltd.
      (A Development Stage Entity)
      Selected Statement of Operation Information (Unaudited)
      January 1, 2004 to September 30, 2004

      Revenues $--

      Total Operating Expenses 5,282,199

      Loss from Operations $(5,282,199)

      Other Income

      Investment Income $28,454

      Net Loss to Common Stockholder $(16,003,745)

      Basic and diluted loss per common share $(0.23)



      Fairfield, NJ-based Astralis is a development-stage biotechnology company engaged in the research and development of novel treatments for immune system disorders and skin diseases. The Company`s current activities focus on the development of a product candidate named Psoraxine® -- now in Phase II clinical trials -- for the treatment of psoriasis. Psoraxine is a proprietary protein biologic with a mechanism of action that is believed to be based on immuno-stimulation. Astralis is also engaged in research on the possible development of the technology underling Psoraxine for the treatment of other indications, such as psoriatic arthritis, leishmaniasis, papilloma, eczema, seborrheic dermatitis, and rheumatoid arthritis. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis. Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause everything from itchy rash like patches to painful pustules and massive inflammation.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
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      schrieb am 18.12.04 20:22:21
      Beitrag Nr. 39 ()
      Form 8-K for ASTRALIS LTD


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

      29-Nov-2004

      Change in Directors or Principal Officers



      ITEM 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
      On November 24, 2004, Peter Golikov ceased serving as the Registrant`s interim Chief Executive Officer.
      Avatar
      schrieb am 05.01.05 12:35:53
      Beitrag Nr. 40 ()
      Statement of Astralis Re: SkyePharma PLC Recent Filings
      Wednesday December 22, 5:02 pm ET


      FAIRFIELD, N.J., Dec. 22 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) On December 13, 2004, SkyePharma PLC issued a filing stating its intention to acquire 11,160,000 shares of Astralis Ltd. from two former Directors of the Company, which would give it a 49.8% interest, and its intention to seek the right to appoint two additional directors to the Board of the Company. It also stated that in its filing that it may use this additional board representation, "so as to influence the future strategic direction of the Issuer..[and]..may consider taking further action to increase its influence over the Issuer including possibly ... seeking amendments to agreements in place between SkyePharma and the Issuer and/or other shareholders, ... or seeking to influence the selection of candidates for election to the Board or appointment of officers, any of which could involve SkyePharma obtaining further influence or control over the Issuer ... "
      Representatives of the Board and Management met Mr. Ashton, CEO of SkyePharma and a member of the Company`s Board, on December 17 to seek further clarification as to SkyePharma`s position and to express their concerns as to the implications of these actions on the Company, its actual and perceived independence and the position of all other stockholders.

      The Board of Astralis met today and authorized the issuance of this release and wishes to state formally its position on the intended purchase of these additional shares. The Board opposes SkyePharma`s attempt to seek control and/or undue influence following such a selective purchase of stock, and will seek to ensure appropriate protection of the interests of both the Company as a whole and the other stockholders of Astralis. The Board will also oppose any attempt by SkyePharma to seek to have any more of its representatives or nominees appointed to the Board.

      The Board has today also put in place changes to the Bylaws of the Company, which require any commercial transactions or agreements with persons or entities that are significant stockholders of the Company to be approved by the majority of the independent directors of the Company.

      The Board of Astralis is committed to protecting the independence of the Company and protecting the best interests of all of its stockholders.

      About Astralis Ltd.

      Astralis Ltd., a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine® is currently being tested in U.S. Phase II clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      This press release may contain "forward-looking statements," as defined by the Private Securities Litigation Reform Act of 1995, regarding Astralis Ltd., including with respect to the objectives, intentions, and expectations relating to clinical studies. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that Psoraxine® will be successfully developed or manufactured, that final results of human clinical trials will result in the regulatory approvals required to market products, that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Other factors that could cause actual results to differ materially from anticipated results include, but are not limited to, those risks and uncertainties detailed in the Company`s` annual report on Form 10-KSB and other reports filed from time to time with the Securities and Exchange Commission. Astralis, Ltd. undertakes no obligation to revise or update any forward-looking statement herein to reflect events or circumstances after the date of this release.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
      Avatar
      schrieb am 15.03.05 12:55:15
      Beitrag Nr. 41 ()
      Astralis Ltd. Appoints Mr. James Sharpe as CEO
      Tuesday February 15, 4:25 pm ET


      FAIRFIELD, N.J., Feb. 15 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) today announced the appointment of Mr. James Sharpe as Chief Executive Officer.
      "Mr. Sharpe has significant experience in managing drug development companies. His expertise in the areas of finance, emerging biotechnology, and healthcare will facilitate Astralis` financial and clinical goals," noted Dr. Jose O`Daly, Chairman and principal founder of Astralis.

      Prior to joining Astralis, from 1999 to 2005, Mr. Sharpe served as President and founder of Ankyr Consulting, L.L.C, an independent consulting company focused on strategy, business development, finance, mergers, acquisitions and operations for healthcare and biotechnology companies. From 1991 to 2005, he founded or served as President or executive management of several biotechnology companies involved in drug discovery, drug delivery, vaccines and gene therapy.

      Mr. Sharpe stated, "Astralis has a unique technology platform which stems from a fascinating discovery in the area of immune system disorders and skin diseases. Our continued goal at Astralis is to bring our first product candidate, Psoraxine(R) for the treatment of Psoriasis, to market, as well as to continue our research and product development efforts in our other target areas."

      Mr. Sharpe has a B.S. in Chemistry from Union College, and a MBA in Marketing and Finance from the University of Rochester. He was a founding member of the Pennsylvania Biotechnology Association, where he served as President for two years (1990-1992) and was a member of the Board of Directors for eight years (1989-1997). He also served for three years (1993 to 1996) as a member of the Board of Governors of the Emerging Company Section of the Biotechnology Industry Association (BIO).

      Notes to the Editor

      Astralis Ltd., a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine(R), administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms. Psoraxine(R) is currently being tested in U.S. Phase II clinical trials. For more information, visit Astralis` web site at www.astralisltd.com.

      Astralis Ltd.
      75 Passaic Ave
      Fairfield, New Jersey, 07004
      Fax: 1 (973) 227- 7169
      Phone: 1 (973) 227- 7168
      Email: info@astralisltd.com


      This news release contains forward-looking statements based on information available to Astralis as of the date hereof. Astralis` actual results could differ materially from the results stated or implied by such forward-looking statements due to a number of risks and uncertainties. These risks and uncertainties include, but are not limited to, general economic and business conditions, changes in governmental laws and regulations relating to the development and commercialization of pharmaceutical products, and competition in our industry. There can be no assurance that our product development efforts will succeed, that Psoraxine will receive required regulatory clearance or that, even if such regulatory clearance were received, that Psoraxine will ultimately achieve commercial success. Astralis disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
      Avatar
      schrieb am 15.03.05 12:55:46
      Beitrag Nr. 42 ()
      18-Feb-2005

      Entry Material Agreement, Change in Directors or Principal Officers



      ITEM 1.01 Entry into a Material Definitive Agreement.
      The Registrant entered into an employment agreement with Mr. Jose Antonio O`Daly, the Chairman of the Board of Directors and the Chief Science Officer, until December 31, 2007. Under the terms of his employment agreement, Mr. O`Daly is entitled to an annual base salary of $231,000 payable in arrears in bi-monthly installments, less statutory deductions (the "Base Salary") and an annual bonus of up to 25% of his Base Salary and based upon achievement of such goals and subject to such additional terms as may be determined by the Board of Directors. As a member of the Registrant`s senior management team, Mr. O`Daly has been granted the option to purchase 728,000 shares of common stock of the Registrant with an initial exercise price of $0.70 per share. The options are fully vested and have a term of ten years.

      In the event of a voluntary termination for Good Reason or if Mr. O`Daly is terminated following a change in control or without Cause, he generally will receive, among other things, the following severance benefits: (a) an amount equal to two times his annual Base Salary established for the fiscal year in which the date of termination occurs and (b) an amount equal to two times his annual bonus award established for the fiscal year in which his date of termination occurs. In the event of a voluntary termination without Good Reason or if Mr. O`Daly is terminated with Cause, he will receive the following severance benefits: (a) an amount equal to his Base Salary for one year and (b) an amount equal to his one times his annual bonus award established for the fiscal year in which his date of termination occurs. The employment agreement includes certain non-competition and confidentiality provisions.





      ITEM 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
      The Registrant retained Mr. James Sharpe as its President and Chief Executive Officer and elected Mr. Sharpe as a member of the Board of Directors.

      Mr. Sharpe, prior to joining Astralis, served from 1999 to 2005 as President and founder of Ankyr Consulting, L.L.C, an independent consulting company focused on strategy, business development, finance, mergers, acquisitions and operations for healthcare and biotechnology companies. In early 1999, he served as President of Small Molecule Therapeutics, a privately owned drug discovery company. From 1997 to 1998, Mr. Sharpe served as Chief Operating Officer of FEI Technologies, Inc., a privately owned drug delivery company. From 1991 to 1996, Mr. Sharpe served as President and co-founder of GX BioSystems A/S, a privately owned biotechnology company focused on vaccines and biopesticides. Mr. Sharpe recently founded Metacine, Inc., a cancer vaccine company, based on dendritic cell technology, and co-founded Optigenix, Inc., a directed evolution company. Mr. Sharpe was also a participant in the founding of AthenaBio Technologies, Inc., which involved the merger of four companies including Optigenix. Mr. Sharpe has a B.S. in Chemistry from Union College, and a MBA in Marketing and Finance from the University of Rochester. He was a founding member of the Pennsylvania Biotechnology Association, where he served as President for two years and was a member of its Board of Directors for eight years. He also served for three years as a member of the Board of Governors of the Emerging Company Section of the Biotechnology Industry Association (BIO).

      As of February 15, 2005, the Registrant entered into an employment agreement with Mr. James Sharpe to serve as the Chief Executive Officer of the Registrant until January 15, 2007. Under the terms of his employment agreement, Mr. Sharpe is entitled to an annual base salary of $231,000 payable in arrears in bi-monthly installments, less statutory deductions (the "Base Salary") and an annual bonus of up to 25% of his Base Salary and based upon achievement of such goals and subject to such additional terms as may be determined by the Board of Directors. As a member of the Registrant`s senior management team, Mr. Sharpe has been granted the option to purchase 728,000 shares of common stock of the Registrant, which will vest to the extent of 182,000 immediately and then an additional 182,000 shares per year on a cumulative basis until all options have vested. The options have an initial exercise price of $0.70 per share and have a term of ten years. In addition, on the first date of employment, Mr. Sharpe shall be issued 100,000 shares of common stock and on the date that is one year following the first date of employment, an additional 100,000 shares, which will be fully vested and fully paid on the date of issuance. Also, the Registrant will make the following payments to Mr. Sharpe: (a) $35,000, no later than January 15, 2006 and (b) an additional amount of not less than $35,000 and not more than $65,000 no later than January 15, 2007, provided however, that if prior to January 15, 2007, the cash balance of the Registrant falls below $350,000, the Registrant will immediately pay the minimum remaining amount to Mr. Sharpe.

      In the event that Mr. Sharpe is terminated after a change of control, he generally will receive, among other things, the following severance benefits:
      (a) an amount equal to two times his annual Base Salary established for the fiscal year in which the date of termination occurs and (b) an amount equal to two times his annual bonus award established for the fiscal year in which his date of termination occurs. In the event Mr. Sharpe is terminated for Good Reason, without Cause, or non-renewal, he will generally receive the following severance benefits: (a) an amount equal to one times his annual Base Salary established for the fiscal year in which the date of termination occurs and (b) an amount equal to one times his annual bonus award established for the fiscal year in which the date of termination occurs. The employment agreement includes certain non-competition and confidentiality provisions.
      Avatar
      schrieb am 15.03.05 12:56:37
      Beitrag Nr. 43 ()
      Astralis Phase II Study of Psoraxine for Psoriasis Does Not Meet Primary Study Endpoint
      Monday March 14, 7:30 am ET


      FAIRFIELD, N.J., March 14 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) today announced that the Phase II study of its novel immuno-stimulatory product for the treatment of Psoriasis did not meet the primary study endpoint upon completion of the treatment phase of the study. In the study, Psoraxine was found to be safe and well tolerated.
      ADVERTISEMENT


      The Phase II randomized, double-blind, placebo-controlled study involved 120 patients with moderate to severe psoriasis who received intramuscular injections of Psoraxine. The primary endpoint of the study was a specified level of improvement of symptoms as measured in accordance with the Psoriasis Area and Severity Index (PASI), a measurement scale that ranks the severity of symptoms of patients suffering from psoriasis. Initial analysis of the preliminary data showed no statistically significant clinical improvement compared to placebo following six injections over twelve weeks of treatment.

      "We are currently analyzing the data to understand why this study differs from the long-term improvement of the more than 2700 patients who were treated previously in Venezuela," said Jose O`Daly, M.D., Ph.D., Chief Scientific Officer and Chairman of the Board of Astralis. "We are committed to understanding whether a different approach, including evaluating a longer course of therapy and/or modifications to the formulation may yield an outcome that is more consistent with the results we have seen with patients treated in Venezuela."

      CEO, James Sharpe noted that, "Although we are disappointed by our preliminary results, we remain committed to Psoraxine and its future clinical development. We also remain committed to the use of our technology platform in other dermatological diseases, as well as in other therapeutic areas including arthritis."

      Further details about the trial will be available when all data analyses are complete.

      This press release may contain "forward-looking statements," as defined by the Private Securities Litigation Reform Act of 1995, regarding Astralis Ltd., including with respect to the objectives, intentions, and expectations relating to clinical studies. There can be no assurance that Psoraxine® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Other factors that could cause actual results to differ materially from anticipated results include, but are not limited to, those risks and uncertainties detailed in the Company`s` annual report on Form 10-KSB and other reports filed from time to time with the Securities and Exchange Commission. Astralis Ltd. undertakes no obligation to revise or update any forward-looking statement herein to reflect events or circumstances after the date of this release.

      Notes to the Editor

      Astralis Ltd., a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, administered by intramuscular injection, is a protein-based therapy that is believed to stimulate cells from the patient`s immune system to reverse the inflammatory process responsible for psoriasis symptoms.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
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      schrieb am 25.04.05 10:43:58
      Beitrag Nr. 44 ()
      Form 10KSB for ASTRALIS LTD


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

      31-Mar-2005

      Annual Report



      Item 6. Management`s Discussion and Analysis or Plan of Operation
      The following discussion of our financial condition and plan of operation should be read in conjunction with our financial statements and the related notes included elsewhere in this annual report on Form 10-KSB. This annual report contains certain statements of a forward-looking nature relating to future events or our future financial performance. We caution prospective investors that such statements involve risks and uncertainties, and that actual events or results may differ materially. In evaluating such statements, prospective investors should specifically consider the various factors identified in this annual report, including the matters set forth under the caption "Risk Factors" which could cause actual results to differ materially from those indicated by such forward-looking statements. We disclaim any obligation to update information contained in any forward-looking statement.

      Overview

      We are a development stage biotechnology company engaged primarily in the research and development of treatments for immune system disorders and skin diseases. Our initial product candidate, Psoraxine(R), is a protein extract used for the treatment of the skin disease psoriasis.

      Currently, we are engaged in the following activities to further our development efforts of our initial product candidate:

      o Ongoing research and development of Psoraxine(R);

      o Conducting clinical trials to obtain the approval of the United States Food and Drug Administration for the marketing of Psoraxine(R); and

      o Development of the technology underlying Psoraxine(R) for the treatment of indications other that psoriasis, such as eczema, seborrheic dermatitis and leishmaniasis.

      Fiscal year ended December 31, 2004 compared to fiscal year ended December 31, 2003

      For fiscal year ended December 31, 2004:

      On January 20, 2004 we closed a private placement from which we received gross proceeds of approximately $4.08 million. The transaction consisted of the sale to accredited investors of units consisting of 8,159,964 shares of common stock and warrants to purchase 8,159,964 shares of common stock. Concurrently with this transaction, SkyePharma converted all of its outstanding shares of Series A Preferred Stock into 25,000,000 shares of common stock at a reduced conversion price of $0.80 per share. In accordance with Statement of Financial Auditing Standard 84, "Induced Conversions of Convertible Debt, an Amendment of APB Opinion No. 26," we recorded this conversion transaction as a non-cash preferred stock dividend in January 2004 in the amount of $10,750,000.

      On February 19, 2004, we held a second closing for our private placement from which we received gross proceeds of approximately $1.15 million. The transaction consisted of the sale to accredited investors of units consisting of 2,299,902 shares of common stock and warrants to purchase 2,299,902 shares of common stock. In connection with our private placements and the conversion of SkyePharma`s Series A Preferred Stock, SkyePharma agreed that 12,500,000 shares of the common stock issued upon conversion will be subject to a right of repurchase by us under certain circumstances at a premium to the conversion price. We assigned the right to purchase 1,250,000 of these shares to FPP Capital Advisors as consideration for services it provided to us in negotiating the Series A Preferred Stock conversion by SkyePharma. Accordingly, we recorded a non-cash charge of $376,508 in June 2004 in connection with this assignment.

      In February 2004, in connection with the private placement, FPP Capital Advisors received a consulting fee of $261,496, warrants to purchase 418,394 shares of our common stock at $0.50 per share and warrants to purchase 418,394 shares of our common stock. In June 2004, we issued units consisting of 150,000 shares of common stock and warrants to purchase 150,000 shares of common stock to FPP Capital Advisors in consideration for services rendered to us in negotiating our right to repurchase 12,500,000 shares of common stock from SkyePharma.

      For the fiscal year ended December 31, 2004, we had no revenue from operations and incurred operating expenses of $9,580,307 which consisted primarily of:

      o Research and development costs of $7,689,060, including $2,360,000 that we incurred to conduct our Phase I and Phase II clinical studies, $1,007,500 for services provided by SkyePharma under our Service Agreement with them, amortization of approximately $714,288 of the technology option license under our Technology Access Option Agreement with SkyePharma as an intangible asset over its seven-year life, and a charge of $2,797,612 to record an impairment of the technology option license.

      o General and administrative costs of approximately $1,860,844, including professional fees and our general corporate expenditures.

      1 As a result, during the fiscal year ended December 31, 2004, we incurred a net loss of $20,037,568, which also included a non-cash preferred stock dividend of $10,750,000.

      In December 2004, we received $293,461 in cash from the sale of a portion of our tax related net operating losses ("NOLS") under the State of New Jersey`s Technology Business Tax Certificate Transfer Program. The program is an initiative adopted by the New Jersey State legislature that allows qualified technology and biotechnology businesses in New Jersey to sell unused amounts of NOLS and defined research and development tax credits for cash.

      For fiscal year ended December 31, 2003:

      In January 2003, pursuant to a Purchase Agreement dated as of December 10, 2001, we sold 250,000 shares of our Series A Convertible Preferred Stock to SkyePharma for an aggregate purchase price of $2,500,000. We received proceeds of $2,480,000 after we netted out from the proceeds $20,000 due to SkyePharma in connection with the Service Agreement.

      During the fiscal year ended December 31, 2003, we received $825,000 outstanding under subscription notes. In April 2003, we entered into an Amended Investor Relation Agreement with a stockholder who had outstanding subscription notes. In exchange for services rendered, we reduced the outstanding amount by $36,000. In 2004, the stockholder will provide services valued at $24,000 in lieu of payment of the outstanding subscription receivable balance.

      For the fiscal year ended December 31, 2003, we had no revenue from operations and incurred operating expenses of $5,362,081 which consisted primarily of:

      o Research and development costs of $4,045,673, including $1,007,500 that we incurred in connection with services provided by SkyePharma under our Service Agreement with them and amortization of approximately $714,288 under our technology option license which is being amortized over a seven year period.

      o General and administrative costs of approximately $1,290,346, including professional fees and our general corporate expenditures.

      As a result, during the fiscal year ended December 31, 2003, we incurred a net loss of $5,080,427.

      In December 2003, we received $221,636 in cash from the sale of a portion of our tax related net operating losses ("NOLS") under the State of New Jersey`s Technology Business Tax Certificate Transfer Program. The program is an initiative adopted by the New Jersey State legislature that allows qualified technology and biotechnology businesses in New Jersey to sell unused amounts of NOLS and defined research and development tax credits for cash.

      The Next Twelve Months

      At December 31, 2004 we had cash balances of $2,312,401, which we estimate will last us through approximately the second quarter of 2005, and no marketable securities.

      Based on our current operating plan, we anticipate conducting the following activities and using our cash over the course of the next twelve months as follows:

      o Our primary focus is to further our development efforts of our initial product candidate, Psoraxine(R). In March 2005, the Company announced that the Phase II study of its novel immuno-stimulatory product for the treatment of Psoriasis did not meet the primary study endpoint upon completion of the treatment phase of the study. In the study, Psoraxine(R) was found to be safe and well-tolerated. Accordingly, we are currently analyzing the data to understand why we received these unexpected results. In this regard, we are implementing cost containment measures and realigning development activities to focus on such things as formulation, manufacturing, analytical protocols and potency. We remain committed to Psoraxine(R) and its future development, and hope to see it return to Phase II clinical trials in 2006. We also remain committed to exploring applications of our technology platform in other dermatological diseases, as well as in other therapeutic areas including arthritis. We expect that we would be required to incur expenses of approximately $2,500,000 to third parties in connection with continuing development of Psoraxine(R) and exploration of other applications of the technology.

      o We intend to implement our business plan and facilitate the operations of our company. We will spend approximately $1,250,000 to pay management salaries and salaries of employees, a portion of which is treated as research and development expense.

      o We also expect to expend approximately $1,100,000 for our general administrative and working capital requirements.

      We will need to raise additional funds immediately to continue our operations for the period following the second quarter of 2005 and to fund any of the activities described above. Furthermore, substantial additional funds will be needed in order to fund our continued efforts to obtain FDA approval of Psoraxine(R). No assurance can be given that we will be able to obtain financing on terms that we find acceptable, or that they will enable us to satisfy our cash requirements. In addition, raising additional funds by selling additional shares of our capital stock will dilute the ownership interest of our stockholders. If we do not obtain additional funds, we will likely be required to eliminate programs, delay development of our products, or in the extreme situation, cease operations.
      Avatar
      schrieb am 25.04.05 10:44:28
      Beitrag Nr. 45 ()
      Astralis Ltd. Reports 2004 Results
      Friday April 1, 12:28 pm ET


      FAIRFIELD, N.J., April 1 /PRNewswire-FirstCall/ -- Astralis Ltd. (OTC Bulletin Board: ASTR - News) today announced its results for 2004. For the fiscal year ended December 31, 2004, the Company recorded a net loss of $20.04 million to common stockholders, or $0.28 per share, which included a non-cash preferred stock dividend of $10.75 million. The Company, which is a development stage entity, had no revenue during this period. Total shareholders` equity as of December 31, 2004, was $2.40 million and the Company had a cash balance totaling $ 2.31 million as of December 31, 2004.
      Research and development expenses for 2004 amounted to $7.68 million. These expenditures included $2.36 million incurred to conduct Phase I and Phase II clinical studies for Psoraxine®; $1,007,500 for services provided by SkyePharma under our Service Agreement with them; amortization of approximately $714,288 under our technology option license which was being amortized over a seven year period; and a one time charge of $2,797,612 to record the impairment of the technology option license.

      In December 2004, the Company received $293,461 in cash from the sale of a portion of its tax related net operating losses (NOLS) under the State of New Jersey`s Technology Business Tax Certificate Transfer Program. This program is an initiative passed by the New Jersey State Legislature that allows qualified technology and biotechnology businesses in New Jersey to sell unused amounts of NOLS and defined Research and Development tax credits for cash.




      ASTRALIS LTD
      (A DEVELOPMENT STAGE ENTITY)
      SELECTED STATEMENT OF OPERATION INFORMATION
      JANUARY 1, 2004 OF DECEMBER 31, 2004


      Revenues --

      Total Operating Expenses $9,580,307

      Loss from Operations $(9,580,307)

      Investment Income $(722)

      Net Loss Before Income Tax Benefit $(9,581,029)

      Income Tax Benefit $293,461

      Preferred Stock Dividend $(10,750,000)

      Net Loss to Common Shareholders $(20,037,568)

      Basic and diluted loss per common share $(0.28)


      This press release may contain forward-looking statements regarding Astralis Ltd. Actual results may differ materially from those described in the press release as a result of a number of factors, including but not limited to the following: There can be no assurance that Psoraxine® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis will continue its research and development effort to the extent that we do not experience any cash shortfalls, adverse developments in our drug development or competitive or other impediments that an early stage company in our industry may face. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.




      --------------------------------------------------------------------------------
      Source: Astralis Ltd.
      Avatar
      schrieb am 07.05.05 10:25:12
      Beitrag Nr. 46 ()
      Gordon Schooley Joins Astralis` Board of Directors
      Tuesday April 26, 7:00 am ET


      FAIRFIELD, N.J., April 26 /PRNewswire-FirstCall/ -- Astralis Ltd (OTC Bulletin Board: ASTR - News) announced the appointment of Gordon Schooley, Ph.D. to its Board of Directors. Dr. Schooley will also serve as a member of Astralis` Medical Advisory Board. Schooley, a recognized scientist and clinical expert, is currently the Chief Scientific Officer of SkyePharma, PLC.
      "It is a pleasure to welcome Dr. Schooley to the Astralis Board of Directors. His accomplished background over a period of 33 years in the pharmaceutical field, including his extensive clinical and product development experience will provide valuable expertise to Astralis, and will complement the Astralis team nicely," stated James Sharpe, Chief Executive Officer. "The addition of Dr. Schooley to the Board also signifies the resurgence of the cooperation between Astralis and SkyePharma. We are pleased to have him on our Board, and look forward to his contributions."

      Jose O`Daly, M.D., Ph.D., Chief Scientific Officer and Chairman of the Board of Astralis, said, "We are very pleased to see the addition of Dr. Schooley, whom I have known since 2001, to our Board of Directors. His appointment demonstrates the commitment of both Astralis and SkyePharma to continuing the development of Psoraxine, our product for the treatment of Psoriasis. We also welcome Dr. Schooley`s advice and guidance as we work to develop the other products in our pipeline."

      Dr. Schooley received his BS and MS degrees in Business and Statistics from Brigham Young University and his Doctorate degree in Biostatistics from The University of Michigan School of Public Health.

      This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that Psoraxine® will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Notes to the Editor

      Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine®, the company`s first product candidate, is an innovative drug under development for psoriasis, and is based on the discovery of a proprietary protein extract. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over-stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause a range of symptoms including itchy rash like patches, painful pustules and massive inflammation.


      Additional information can be obtained from:

      US National Psoriasis Foundation at www.psoriasis.org

      International Federation of Psoriasis Associations at www.ifpa-pso.org




      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 07.05.05 10:25:48
      Beitrag Nr. 47 ()
      Astralis Announces Presentation of Phase II Results at 66th Society for Investigative Dermatology Meeting
      Friday May 6, 4:59 pm ET


      FAIRFIELD, N.J., May 6 /PRNewswire-FirstCall/ -- Astralis Ltd (OTC Bulletin Board: ASTR - News) announced today that the results of its 120 patient, 11 site, multi-dose Phase II clinical trial of Psoraxine®, its product for the treatment of psoriasis, was presented at the Society of Investigational Dermatology meeting in St. Louis, MO, on Friday, May 6, 2005. The report authored by Dr. James Kreuger, Professor and Medical Director of Investigative Dermatology at Rockefeller University, and Dr. Bruce Miller, MD at Oregon Medical Research Center, presents both PASI (Psoriasis Area Severity Index) and patient biopsy results, respectively the primary and secondary endpoints of the trial.
      ADVERTISEMENT


      Although the six injection, twenty week trial of Psoraxine® did not demonstrate a statistically significant clinical improvement in PASI scores compared to placebo, the trial again confirmed the safety of the product for human use. Upon more detailed analysis of both PASI and biopsy results, the Company has observed specific data that has led it to conclude that the product is active, although not at the level it expected.

      Following analysis of the clinical trial design, manufacturing process and product formulation data, Astralis has identified several factors including the limited number of injections used and the formulation of the active components of the product that may have contributed to the unexpected results of the Phase II trial. Based on these analyses, the Company remains committed to the development of Psoraxine®, and is embarking on a program to improve the performance of its treatment for psoriasis.

      "We continue to be encouraged by the safety profile demonstrated by the product", remarked Dr. Jose O`Daly, Chairman and CSO of Astralis. "In 140 patients in two clinical trials in the United States no serious adverse events related to the product were reported. The demonstrated lack of significant side-effects in the United States trials and in prior Venezuelan trials suggests we can continue clinical testing of our current product, AS210, while we also work on improving its efficacy". The most commonly reported adverse events were headache, and injection site pain and tenderness.

      With respect to the trial`s overall results, Dr. Gordon Schooley, Chief Scientific Officer of SkyePharma and a member of Astralis` Board of Directors, said "Despite the lack of statistically significant differences in PASI scores, the primary endpoint, the performance of a 300 microgram dose of AS210 appeared more active than either of the other two doses of AS210. We are hopeful that changes in the protocol such as optimizing the administration technique and dosing regimen can improve product efficacy in the treatment of psoriasis."

      James Sharpe, President & CEO of Astralis said that "Astralis continues to believe that the results seen previously in Venezuela can be reproduced in the United States, and feels that the Phase II data provides important information about the active components, formulation, dosing frequency and other variables necessary to optimize the product`s performance".

      This press release may contain forward-looking statements regarding Astralis Ltd. Clinical results may differ materially from those described in the press release as a result of a number of factors. There can be no assurance that PSORAXINE(TM) will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of this product will be achieved. Astralis Ltd undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

      Notes to the Editor

      Astralis Ltd, a biotechnology company based in New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. Psoraxine(TM), the company`s first product candidate, is an innovative drug under development for psoriasis, and is based on the discovery of a proprietary protein extract. For more information, visit Astralis` web site at www.astralisltd.com.

      Psoriasis

      Psoriasis is a chronic, genetically based remitting and relapsing scaly and inflammatory skin disorder that affects approximately 3% of the world`s population. Psoriasis symptoms result from the overproduction of skin induced by blood cells associated with the immune system. These blood cells are over- stimulated and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin can cause a range of symptoms including itchy rash like patches, painful pustules and massive inflammation.


      Additional information can be obtained from:

      US National Psoriasis Foundation at www.psoriasis.org

      International Federation of Psoriasis Associations at www.ifpa-pso.org




      --------------------------------------------------------------------------------
      Source: Astralis Ltd
      Avatar
      schrieb am 16.05.05 23:50:31
      Beitrag Nr. 48 ()
      Form 10QSB for ASTRALIS LTD


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

      16-May-2005

      Quarterly Report



      ITEM 2. MANAGEMENT`S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
      The following discussion of our financial condition and plan of operation should be read in conjunction with our financial statements and the related notes included elsewhere in this quarterly report on Form 10-QSB. This quarterly report contains certain statements of a forward-looking nature relating to future events or our future financial performance. We caution prospective investors that such statements involve risks and uncertainties, and that actual events or results may differ materially. In evaluating such statements, prospective investors should specifically consider the various factors identified in this quarterly report, including the matters set forth under the caption "Risk Factors" which could cause actual results to differ materially from those indicated by such forward-looking statements. We disclaim any obligation to update information contained in any forward-looking statement.


      Overview
      General

      We are a development stage biotechnology company engaged primarily in the research and development of treatments for immune system disorders and skin diseases, such as psoriasis and psoriatic and rheumatoid arthritis. Our initial product candidate, Psoraxine(R), is a protein extract used for the treatment of the skin disease psoriasis.

      Currently, we are engaged in the following activities to further our development efforts of our initial product candidate:

      o Ongoing research and development of Psoraxine(R);

      o Conducting clinical trials to obtain the approval of the United States Food and Drug Administration for the marketing of Psoraxine(R); and

      o Development of the technology underlying Psoraxine(R) for the treatment of indications other than psoriasis, such as eczema, seborrheic dermatitis and leishmaniasis.

      Recent Developments


      Deferral of 10% of Salary by Executive Officers.
      Based on our current plans, we believe that we have sufficient funds to meet our operating expenses and capital requirements through approximately July 2005. We will need to raise additional funds to continue our operations following that period. Substantial additional funds will also be needed in order to fund our continued efforts to obtain approval from the Food and Drug Administration for the marketing of Psoraxine(R), especially given the failure of our Phase II clinical study for Psoraxine(R) to meet its primary endpoint. In

      response to our limited working capital and our substantial need for funds to continue testing Psoraxine(R) to obtain FDA approval, our executive officers have agreed to defer 10% of their salaries until such time as appropriate funding can be raised. As a result, the annual salary of Dr. Jose Antonio O`Daly, our Chairman of the Board and Chief Scientific Officer, will be reduced from $231,000 to $207,900, the annual salary of James Sharpe, our President and Chief Executive Officer, will be reduced from $231,000 to $207,900 and the minimum monthly salary of Michael Garone, our Chief Financial Officer, will be reduced from $15,600 to $14,040.

      Astralis Phase II Study of Psoraxine(R) for Psoriasis Did Not Meet Primary Study Endpoint.

      On March 14, 2005, we issued a press release to disclose the results of our Phase II study for Psoraxine(R). The Phase II study of our novel immuno-stimulatory product for the treatment of Psoriasis did not meet the primary study endpoint upon completion of the treatment phase of the study. In the study, Psoraxine(R) was found to be safe and well-tolerated. The Phase II randomized, double-blind, placebo-controlled study involved 120 patients with moderate to severe psoriasis who received intramuscular injections of Psoraxine(R). The primary endpoint of the study was a specified level of improvement of symptoms as measured in accordance with the Psoriasis Area and Severity Index (PASI), a measurement scale that ranks the severity of symptoms of patients suffering from psoriasis. Initial analysis of the preliminary data showed no statistically significant clinical improvement compared to placebo following six injections over twelve weeks of treatment.

      We entered into an Employment Agreement with our new Chief Executive Officer.

      In January 2005, pursuant to the terms of the Employment Agreement we entered into with James Sharpe, our President and Chief Executive Officer, and a member of Board of Directors, we granted Mr. Sharpe options to purchase 728,000 shares of our common stock, which vested to the extent of 182,000 immediately and thereafter an additional 182,000 shares will vest each year on a cumulative basis until all options have vested. The options have an initial exercise price of $0.70 per share and have a term of ten years. In addition, Mr. Sharpe was issued 100,000 shares of our common stock, which were fully vested and considered fully paid when issued.


      Plan of Operation
      Three months ended March 31, 2005 compared to three months ended March 31, 2004

      For three months ended March 31, 2005:

      For the three months ended March 31, 2005, we had no revenue from operations and incurred operating expenses of $1,691,095 which consisted primarily of:

      o Research and development costs of $1,086,664, including $861,526 of costs relating to the Phase II study for Psoraxine(R). Research and development costs did not include any allocation of costs under our Services Agreement with SkyePharma, which expired in December 2004.

      o General and administrative costs of approximately $596,509, including professional fees, rents, salaries for management and our general corporate expenditures.

      As a result, during the three months ended March 31, 2005, we incurred a net loss of $1,680,197.

      For the three months ended March 31, 2004:

      On January 20, 2004 we completed the first closing of a private placement of our securities from which we received gross proceeds of approximately $4.08 million. The transaction consisted of the sale to accredited investors of units consisting of 8,159,964 shares of common stock and warrants to purchase 8,159,964 shares of common stock. Concurrently with this transaction, SkyePharma PLC ("SkyePharma") converted all of its outstanding shares of our Series A Preferred Stock into 25,000,000 shares of common stock at a reduced conversion price of $0.80 per share. SkyePharma has agreed that 12,500,000 shares of the common stock issued upon conversion of the Series A Preferred Stock will be subject to a right of repurchase by us under certain circumstances at a premium to the conversion price. In connection with this transaction and in accordance with Statement of Financial Auditing Standard 84, "Induced Conversions of Convertible Debt, an Amendment of APB Opinion No. 26" we have recorded a non-cash preferred stock dividend in January 2004 amounting to $10,750,000.

      On February 19, 2004, we held a second closing for the private placement from which we received gross proceeds of approximately $1.15 million. The transaction consisted of the sale to accredited investors of units consisting of 2,299,902 shares of common stock and warrants to purchase 2,299,902 shares of common stock.

      For the three months ended March 31, 2004, we had no revenue from operations and incurred operating expenses of $1,760,549 which consisted primarily of:

      o Research and development costs of $1,331,141, including $430,447 that we incurred in connection with services provided by SkyePharma under our Service Agreement with them and amortization of approximately $178,572 under our technology option license which is being amortized over a seven year period.

      o General and administrative costs of approximately $421,898, including professional fees and our general corporate expenditures.

      As a result, during the three months ended March 31, 2004, we incurred a net loss of $12,497,973.

      Comparison

      Although our research and development expenses declined from $1,331,141 during the three months ended March 31, 2004 to $1,086,664 during the three months ended March 31, 2005, the 2004 period included $251,875 of costs related to our Services Agreement with SkyePharma and $178,572 of costs related to our Technology Access Option Agreement with SkyePharma. In fact, because of the increased costs relating to the Phase II trials for Psoraxine(R) during the period, the Company`s expenses without giving effect to the SkyePharma Services Agreement and/or Technology Access Option Agreement increased during the period ended March 31, 2005 by $185,970.

      General and administrative costs increased by $174,611, reflecting increased professional fees and increased management salaries as a result of our need to retain a new Chief Executive Officer and Chief Financial Officer.

      Net loss for the three months ended March 31, 2004 was $12,497,973, which included $10,750,000 of costs relating to a non-cash preferred stock dividend resulting from our preferred stock conversion to common stock completed during such three-month period. Without giving effect to such transactions, we would have had losses of $1,747,973 during the three months ended March 31, 2004, which included $430,447 of costs associated with our Services Agreement and Technology Access Option Agreement with SkyePharma. As a result, due to the costs relating to our Phase II trials for Psoraxine(R), during the period ended March 31, 2005, although we had losses of $1,680,197 for such period, our losses, excluding the non-cash preferred stock dividend, Services Agreement and Technology Access Option expenses, actually increased by $362,670 for the period ended March 31, 2005 compared to the same period ended March 31, 2004.

      The Next Twelve Months

      At March 31, 2005 we had cash balances of $1,014,876, which we estimate will last us through approximately July 2005, and no marketable securities.

      Based on our current operating plan and subject to raising more capital as discussed below, we anticipate conducting the following activities and using our cash over the course of the next twelve months as follows:

      o Our primary focus is to further our development efforts of our initial product candidate, Psoraxine(R). In March 2005, the Company announced that the Phase II study of its novel immuno-stimulatory product for the treatment of Psoriasis did not meet the primary study endpoint upon completion of the treatment phase of the study. In the study, Psoraxine(R) was found to be safe and well-tolerated. In this regard, we are implementing cost containment measures and realigning development activities to focus on such things as formulation, manufacturing, analytical protocols and potency. We remain committed to Psoraxine(R) and its future development, and expect to redesign and recommence Phase II clinical trials in 2006. We also remain committed to exploring applications of our technology platform in other dermatological diseases, as well as in other therapeutic areas including arthritis. We expect that we would be required to incur expenses of no less than $1,930,000 to third parties in connection with continuing development of Psoraxine(R) and exploration of other applications of the technology.

      o We intend to implement our business plan and facilitate the continuing operations of our company. We will spend approximately $1,690,000 to pay management salaries and salaries of employees, a portion of which is treated as research and development expense.

      o We also expect to expend approximately $1,280,000 for our general administrative and working capital requirements.

      We will need to raise additional funds immediately to continue our operations for the period following July 2005 and to fund any of the activities described above. If we are able to identify additional capital to fund its operating and capital expenditures for 2005, such funds will be required to cover the cost to evaluate the results from our Phase II clinical studies for Psoraxine(R), to continue clinical trials for Psoraxine(R) and to initiate development of products for arthritis and leishmaniasis. Substantial additional funds will be needed in future years in order to fund our efforts to obtain FDA approval to market these products. No assurance can be given that we will be able to obtain financing on terms that we find acceptable, or that they will enable us to satisfy our cash requirements. In addition, raising additional funds by selling additional shares of our capital stock will dilute the ownership interest of our stockholders. If we do not obtain additional funds, we will likely be required to eliminate programs, delay development of our products, or in the extreme situation, cease operations.


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      astralis-Psoraxine das Medikament gegen Schuppenflechte