Newsletter

December 20, 2001

Volume IV, Issue 108

Email : info@otcjournal.com
URL : http://www.otcjournal.com

To OTC Journal Members:

Year End Update on Astralis LTD (OTC BB: ASTR)

We started covering Astralis at the end of September, prior to the completion of a merger which made Astralis a public company. At the time we were very excited about the public having the opportunity to get in on the ground floor of a potential medical breakthrough at a valuation commensurate with levels generally reserved for sophisticated investors in the biotech industry.

While the stock has been lackluster for the last two months, the company announced an Agreement on December 12th which serves to reinforce our original hypothesis.

By way of reminder, Astralis "has completed clinical studies in Venezuela using first generation Psoraxine to treat 3,000 psoriasis patients, the majority of whom responded positively with few side effects. Of the 3,000 treated patients, 638 achieved complete remission, whilst nearly half of all patients experienced a reduction in disease of between 70% and 90%, 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, although these results have not yet been independently verified." from December 12 press release.

On December 12th, Astralis revealed it had entered into several agreements with SkyePharma PLC (NASDAQ: SKYE), a British pharmaceutical company which specializes in drug delivery technologies.

The press release revealed that Astralis will pay a $5 million license fee for drug deliveries technologies. Conversely, SkyePharma will invest $20 million directly into Astralis in the form of a convertible preferred security in return for 15.3% of the company.

SkyePharma's investment of $20 million in return for 15.3% of the company implies they see upside in Astralis' technology at a $130 million valuation, a level from which they certainly hope and intend to make a substantial return on their investment.

Based on the current price of the stock, and our estimate of 38 million shares issued and outstanding, the market is currently placing a value on the company of just over $100 million.

Simply put, this means Astralis can be purchased up to about $3.40 per share before you are paying more than SkyePharma was willing to pay. They are investing $20 million.

SkyePharma's revenues were up 40% through the first six months of 2001, an explosive growth rate and the sign of a well managed company.

Look for this stock to start behaving better in 2002. Once the funding is completed, Astralis will be positioned to apply for an upgraded listing to either the NASDAQ or the American Stock Exchange.

The risk associated with an investment in Astralis is mitigated greatly by the capital they now have to fund the New Drug Application and a partnership with a successful international biotech company.

Here is the complete text of the news release for your review:

Wednesday December 12, 6:01 am Eastern Time
Press Release
SOURCE: SkyePharma PLC; Astralis LTD

SkyePharma and Astralis Enter Agreements For Promising New Psoriasis Treatment

LONDON, and FLORHAM PARK, N.J., Dec. 12 /PRNewswire -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) and Astralis LTD (OTC Bulletin Board: ASTR - news) announce several agreements concerning the formulation and development of Astralis' novel injectable vaccine therapy, Psoraxine(TM), for the treatment of all forms of psoriasis, a chronic skin disorder that affects approximately 3% of the world population.

Under the terms of a technology access agreement, SkyePharma will receive from Astralis a US$5 million license fee, which will be recognised as revenue over the lifetime of the contract, for access to DepoFoam and other relevant drug delivery technologies. In addition, through a service agreement, SkyePharma will provide all development, manufacturing, pre-clinical and clinical development services for second generation Psoraxine, up to the completion of Phase II clinical studies. On completion of Phase II studies, Astralis will offer SkyePharma the option to acquire the worldwide licensing and distribution rights to Psoraxine. If SkyePharma does not take the option, Astralis will seek a marketing partner to fund Phase III clinical studies and to provide a sales and marketing infrastructure. It is anticipated that an Investigational New Drug (IND) application to start Phase I-B clinical studies will be filed with the US Food and Drug Administration in the first half of 2002.

In a separate transaction, SkyePharma will make a total equity investment in Astralis of up to US$20 million in convertible preferred shares, on payment for which SkyePharma will own 15.3% of Astralis. SkyePharma will make an initial investment of US$10 million on signature of the agreement. The remaining US$10 million investment will be paid at times and in quantities, amongst other conditions, dependent on the date of filing the US IND, up to January 31, 2003.

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 MD, PhD, is a protein that stimulates cells from the patient's immune system to reverse the inflammatory process responsible for psoriasis symptoms.

Astralis has completed clinical studies in Venezuela using first generation Psoraxine to treat 3,000 psoriasis patients, the majority of whom responded positively with few side effects. Of the 3,000 treated patients, 638 achieved complete remission, whilst nearly half of all patients experienced a reduction in disease of between 70% and 90%, 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, although these results have not yet been independently verified.

Professor James Leyden, a Board member of the American Academy of Dermatology and past chairman of the Dermatology Foundation, said, ``I have had the opportunity to review the data generated in Venezuela, and was very encouraged by the results. I believe Psoraxine could be an exciting new treatment alternative for many of the world's psoriasis sufferers. We look forward to becoming an integral part of the ongoing clinical program.''

Michael Ashton, SkyePharma's chief executive officer commented, ``Our ability to provide Astralis with manufacturing, pre-clinical, clinical and regulatory services, as well as access to a broad drug delivery technology platform, makes SkyePharma ideally suited to their needs. We, in turn, are very excited by the opportunity to share in Astralis' promising discovery. It is rare to find a potential drug that has already shown such encouraging, early-stage clinical results in around 3,000 patients.''

Astralis' Chief Executive Officer, Mike Ajnsztajn, said, ``We are excited to enter into this agreement with SkyePharma, because they have a proven track record in achieving FDA approval for novel products as evidenced by the dermatological product, Solaraze, indicated for actinic keratosis. This relationship will enable us to validate the results from our prior clinical studies and to move aggressively toward gathering the necessary data for US regulatory and marketing approval. SkyePharma's equity investment confirms our collective commitment to introduce this promising product.''

This press release may contain forward-looking statements regarding SkyePharma PLC or 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. SkyePharma PLC and Astralis LTD undertake no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

Notes

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, clinical data suggest remission of this skin condition in patient trials in Venezuela.

SkyePharma PLC, an established drug delivery company, based in the UK, 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
http://www.ifpa-pso.org
US National Psoriasis Foundation at http://www.psoriasis.org
The Psoriasis Association (UK) Tel: +44 (0) 1604 711129
SOURCE: SkyePharma PLC; Astralis LTD

Charts Provided Courtesy Of TradePortal.com

The OTC Journal is a proud partner of the SwingWire.com Online Investment Community. A next generation Online Analyst Exchange providing Members the ability to search, review, track and monitor some of the Internet's best Online CAs (CyberAnalysts). Members have the opportunity to potentially achieve higher returns by viewing top performing portfolios and receiving real-time alerts from favorite CAs.

SwingWire.com also has a lucrative incentive model for experienced investors and traders who consistently outperform the market. Share market ideas with other like-minded investors, establish a proven track record, provide insightful commentary, attract followers and ultimately become one of the Internet's highest paid and most sought after CyberAnalysts!

Click here to receive your FREE 30-Day Trial Membership with no further obligation. Sign Up Today!

Disclaimer

The OTCjournal.com Newsletter is an independent electronic publication committed to providing our readers with factual information on selected publicly traded companies. All companies are chosen on the basis of certain financial analysis and other pertinent criteria with a view toward maximizing the upside potential for investors while minimizing the downside risk, whenever possible. Moreover, as detailed below, this publication accepts compensation from certain of the companies which it features. Likewise, this newsletter is owned by MarketByte, LLC. To the degrees enumerated herein, this newsletter should not be regarded as an independent publication.

Click Here to view our compensation on every company we have ever covered, or visit the following web address: http://www.otcjournal.com/disclaimer.html for our full profiles and http://www.otcjournal.com/trading-alerts/disclaimer.html for Trading Alerts.

On November 1, 2001, MarketByte LLC entered into a modified agreement regarding coverage of Astralis LLC rendering the previously published compensation disclaimer null and void. MarketByte LLC has been paid a fee of $100,000 in cash and 20,000 options, exercisable at $2 for previously published coverage of Astralis by Investor Relations Group. By mutual agreement, MarketByte LLC and Investor Relations Group terminated the obligation effective November 1, 2001. Therefore, any ongoing or future coverage subsequent to November 1, 2001 of Astralis LLC by the OTC Journal is voluntary. There is no current contractual obligation. MarketByte LLC now has no direct or indirect relationship of any kind with the management of Astralis LLC or Investor Relations Group as it pertains to Astralis LLC.

All statements and expressions are the sole opinions of the editors and are subject to change without notice. A profile, description, or other mention of a company in the newsletter is neither an offer nor solicitation to buy or sell any securities mentioned. While we believe all sources of information to be factual and reliable, in no way do we represent or guarantee the accuracy thereof, nor the statements made herein.

The editor, members of the editor's family, and/or entities with which they are affiliated, are forbidden by company policy to own, buy, sell or otherwise trade stock for their own benefit in the companies who appear in the publication unless specifically disclosed in the newsletter.

The profiles, critiques, and other editorial content of the OTCjournal.com may contain forward-looking statements relating to the expected capabilities of the companies mentioned herein.

THE READER SHOULD VERIFY ALL CLAIMS AND DO THEIR OWN DUE DILIGENCE BEFORE INVESTING IN ANY SECURITIES MENTIONED. INVESTING IN SECURITIES IS SPECULATIVE AND CARRIES A HIGH DEGREE OF RISK. THE INFORMATION FOUND IN THIS PROFILE IS PROTECTED BY THE COPYRIGHT LAWS OF THE UNITED STATES AND MAY NOT BE COPIED, OR REPRODUCED IN ANY WAY WITHOUT THE EXPRESSED, WRITTEN CONSENT OF THE EDITORS OF OTCjournal.com.

We encourage our readers to invest carefully and read the investor information available at the web sites of the Securities and Exchange Commission ("SEC") at http://www.sec.govand/or the National Association of Securities Dealers ("NASD") at http://www.nasd.com. We also strongly recommend that you read the SEC advisory to investors concerning Internet Stock Fraud, which can be found at http://www.sec.gov/consumer/cyberfr.htm. Readers can review all public filings by companies at the SEC's EDGAR page. The NASD has published information on how to invest carefully at its web site.

You can unsubscribe from this list at any time by Clicking Here and HITTING SEND. If you are having difficulty removing yourself or wish to change your address please go to http://listserv.otcjournal.com/opt.cgi?.