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Skyepharma PLC 4 January 2001 Press Announcement |
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This is a direct paste of some of the press announcements made by Skyepharma since January 2001. I have highlighted and selected certain sections for emphasis, but the text remains the same, save for one correction. Events are moving so rapidly that I can't keep up with them! You may be better served by adding a link for direct access! Should there be any errors, please advise me by e. mail.
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IMHO |
The company is in a better state than last time it traded at 50p or so. A rise could be dramatic! |
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Skyepharma PLC 4 January 2001 Press Announcement |
THURSDAY 4 JANUARY 2001 SOLARAZE |
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Announcement today and uplead statements |
In October 2000 SkyePharma announced that it had received final approval from the US Food and Drug Administration to market Solaraze in the U.S. for actinic keratosis.
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What Is Solaraze? |
Solaraze Solaraze is a topical gel for actinic keratosis, a pre-cancerous skin condition caused by over exposure to the sun. Solaraze utilises SkyePharma's Hyaluronan Induced Targeting transdermal delivery technology. Age, sun exposure and fair skin are risk factors for the development of actinic keratosis. In the US, prevalence of the condition is estimated at 25% for all adult males and 11% for adult females. Current treatment is by surgical means, which can produce scarring. However, most patients with actinic keratosis at present do not seek treatment. Increasing awareness of skin cancer is expected to lead to significant growth in the number of patients seeking treatment. |
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RNS Number:8096W Skyepharma PLC 8 January 2001 |
MONDAY 8 JANUARY 2001 SKYEPHARMA LICENSES DERMATOLOGY TECHNOLOGY - TECHNOLOGY BROADENS SKYEPHARMA'S TOPICAL DRUG DELIVERY CAPABILITIES |
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8th Jan Announcement today |
LONDON, England, January 8, 2001, - SkyePharma PLC (LSE: SKP / Nasdaq SKYE) announced today that it has licensed rights to three topical drug delivery technologies, Crystalip, DermaStick and the ES-Gel system, from Bioglan Pharma PLC (LSE: BGP ). Under the terms of the agreement SkyePharma has paid $9 million in cash and will obtain certain exclusive development and commercial rights in relation to new products from the Crystalip and DermaStick technologies and also the right to develop with Bioglan 2 new products in the ES-Gel system. SkyePharma will be entitled to retain the first $9 million of all new income generated by SkyePharma from the three technologies. After receipt of the first $9 million, all other revenues received will be split equally between SkyePharma and Bioglan. Bioglan will retain rights to use the patents and know-how related to the technologies for existing marketed products utilising the technologies, products in development and projects for companies with whom Bioglan already has such agreements. This gives SkyePharma access to three important topical technologies: Crystalip- which enhances stability of drugs by embedding them in lipid crystals. Suitable for hydrophilic or hydrophobic drugs, the drug is released as the lipid melts at skin temperature. DermaStick-presents the active ingredient in a wax stick, which facilitates controlled application to affected skin. ES Gel - a semi-solid formulation producing enhanced solubility of drugs and providing substantially increased bioavailability by the transdermal route.
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Michael Ashton, Chief Executive Officer of SkyePharma, stated: The addition of these topical drug delivery technologies to our Hyaluronan portfolio significantly strengthens our position in this important pharmaceutical sector. As we have recently demonstrated with the development and licensing of Solaraze, we will be able to accelerate the commercial opportunities for these unique technologies. The deal further demonstrates our commitment to obtain a greater share of the commercial value of our developed products.
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Terry Sadler, Chairman & Chief Executive of Bioglan stated: This licensing agreement with SkyePharma will enhance Bioglan's future revenues from these three drug delivery systems. The collaboration will also complement our own business development activities and will enable us to accelerate further the development of our dermatological drug delivery systems.
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SkyePharma PLC SkyePharma PLC, one of the world's leading drug delivery companies, develops and manufactures advanced drug delivery solutions. Its technologies include oral controlled release, injectable, inhalation, topical and nano-particulate systems. For company information, visit SkyePharma on the World Wide Web at http://www.skyepharma.com
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Bioglan Pharma Plc Bioglan is a well-established, fully integrated, profitable pharmaceutical company with a proven track record. It is based in the UK and has sales, manufacturing and R&D there and in several other countries in the EU as well as a sales and marketing organisation in the USA. Bioglan's focus is on areas where it believes there is scope for strong growth: it is active in dermatology, pain control, generics and drug delivery. Bioglan's product portfolio is predominantly in prescription pharmaceuticals. Bioglan has a number of partnerships with major multinational pharmaceutical companies in the areas of both drug delivery and product licensing. Bioglan is a member of the FTSE mid-cap 250 and of techMARK 100. For further information, including copies of previous announcements, please see Bioglan's website www.bioglan.com.
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Important disclaimer information. Applies to later articles too. |
This press release may contain forward-looking statements regarding SkyePharma PLC. 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: (Refer to underlined text) There can be no assurance that any product in the SkyePharma product pipeline 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 these products will be achieved. The Company undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release. |
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For further information please contact:
In the United States: (212) 753-5780----Lisa Carlton-Wilson ----U.S. Investor Relations Buchanan 0207 466 5000---Communications Tim Anderson/Nicola How/Isabel Petre |
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SKYEPHARMA ANNOUNCES START OF DEPOMORPHINE PHASE III TRIALS & AGREEMENT TO FUND DEPOMORPHINE |
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RNS Number:9662W Skyepharma PLC 10 January 2001 FOR IMMEDIATE RELEASE January 10 2001 |
LONDON, England, January 10, 2001, - SkyePharma PLC (LSE: SKP / Nasdaq: SKYE) announced today that it has started its Phase III clinical trials for DepoMorphine and that it has entered into an Agreement with the Paul Capital Royalty Acquisition Fund, L.P. to develop DepoMorphine. The Phase III clinical trials will involve approximately 750 patients in the U.S. and Europe, in a variety of surgical procedures, over the next 18 months. DepoMorphine, a sustained release morphine formulation using SkyePharma's DepoFoam injection technology is designed for moderate to acute post-operative pain relief. The Phase II trials established a significant and dose dependent decrease in the demand for additional pain medication over 48 hours post surgery.
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Under the Agreement with Paul Capital, SkyePharma will receive $30 million over the next two years to fund the clinical development and regulatory submission of DepoMorphine, in return for the sale of a portion of future royalty and revenue streams from DepoMorphine and certain SkyePharma products. Between January 2003 and December 2014, Paul Capital stand to receive 15% of the annual royalties and revenues from DepoMorphine and three other SkyePharma products, namely Xatral OD, Solaraze and DepoCyt up to an agreed ceiling. Once the predetermined ceiling is reached the percentage participation will fall to 3% for the remainder of the period until December 31, 2014.
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Michael Ashton, Chief Executive Officer of SkyePharma, stated, 'The start of Phase III clinical trials for DepoMorphine is an important milestone for SkyePharma and we look forward to updating you on progress in due course. Additionally, our agreement with Paul Capital will enable SkyePharma to continue the clinical development of DepoMorphine without its significant Research and Development cost impacting our reported profits in the development phase. This is important as SkyePharma moves towards profitability, yet maintains investment for the long term.'
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RNS Number: 3373X Skyepharma PLC 17 January 2001
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MEDITECH SIGNS AGREEMENT WITH SKYEPHARMA PLC LONDON, England, January 17, 2001 - SkyePharma PLC (LSE SKP; Nasdaq: SKYE) announced today that it has signed an Agreement with Meditech Research Limited including the terms of a license to commercialise Solaraze in Australia, New Zealand, Malaysia and Singapore. SkyePharma will receive a 15% share of all monies Meditech receives from either commercialising or licensing Solaraze and associated products in the above territories. After Australian regulatory approval is obtained, Solaraze will be marketed by Meditech or its sub-licensee, Faulding Limited. SkyePharma has agreed to work with Meditech to expedite approval. Independently Meditech has obtained a non-exclusive licence over the HIT Technology to exclusively exploit its anti-cancer HyACTTM project world-wide. Meditech will pay SkyePharma 10% of all net revenue it receives from the HyACTTM project. However, the first A$5 million Meditech receives by way of reimbursement of development expenses will not be subject to the 10% royalty. SkyePharma has no obligation to fund the ongoing research. |
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Michael Ashton, Chief Executive Officer of SkyePharma, stated: "Following the acquisition of Hyal's assets and intellectual property, we are delighted to help get this important product on the Australian market, where the prevalence of actinic keratosis is reported at 40-50% of people aged over 40 years. I am also enthusiastic about the licensing of HIT technology in a separate area, namely for Meditech's anti-cancer product HyACTTM." |
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Usual Disclaimer applies |
Meditech Research Limited, (formerly Hyal Pharmaceuticals Australia Limited) is an Australian Biotechnology company. Its lead project HyACTTM is focused towards improving the affectivity of anti-cancer drugs in the treatment of a wide range of human cancers. For company information, visit Meditech on the World Wide Web at http://www.mrl.com.au |
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Skyepharma PLC 22 January 2001
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XATRAL(R) OD FILED FOR U.S. MARKETING APPROVAL LONDON, England, January 22nd, 2001 - SkyePharma PLC (LSE: SKP / Nasdaq: SKYE) and Sanofi-Synthelabo announced today that a New Drug Application (NDA) was filed with the U.S. Food & Drug Administration in December 2000 for Xatral OD, a sustained release once-daily formulation of alfuzosin 10mg. The formulation utilises SkyePharma's proprietary oral drug delivery technology, GEOMATRIX(R). Xatral is used for the treatment of the functional symptoms of benign prostatic hyperplasia (BPH), a common disorder in men over the age of 50. Xatral is available in more than 80 countries world-wide as a two or three times a day formulation. The GEOMATRIX formulation allows the drug to be taken once-a-day and will be Xatral's first introduction in the U.S.A. |
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Michael Ashton, SkyePharma's Chief Executive Officer commented, "We are excited about the future revenue and earnings potential for Xatral OD in the U.S. following the successful launch of the product in Europe. The once-a-day formulation utilising Geomatrix should increase convenience and compliance, resulting in a better outcome for patients." |
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Usual Disclaimer applies |
Xatral OD was launched in Europe in February 2000 and is now available in six European countries and French overseas territories. In those countries, the once-daily formulation has already gained a significant proportion of Xatral sales. It is expected that other European launches of Xatral OD will follow in the near future. |
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Additional RNS items on Shares in issue etc. see the company news archive or RNS archive. |
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Ordinaries (UK) ADRs (US) Pricing links |
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UK Ordinaries |
The Basic UK shares. [SKP] |
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ADR |
Valued at 10 times the UK Ordinary shares. Traded on the US Nasdaq exchange. [SKYE] |
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Warrants |
To buy the Ordinary shares in the ratio 10 warrants plus 40p for 1 Ordinary. Expired. |
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SCHEDULE A SECURITY: SKYEPHARMA PLC Announced 6th. August 2001 |
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SHARES MANAGEMENT HELD COMPANY NOMINEE/REGISTERED NAME (Ordinary Shares) |
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The following shares are based on the assumed conversion of
4,000,000 convertible securities
Total Ordinary Shares: 16,246,613
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Page set up Jan 4th. 2001 Edits July 4th. 2002 Price links March 29. 2003 |