SkyePharma Receives FDA Approval For Triglide(TM) A Novel Formulation Of Fenofibrate
09 May 2005 - 10:00PM
PR Newswire (US)
SkyePharma Receives FDA Approval For Triglide(TM) A Novel
Formulation Of Fenofibrate LONDON, May 9 /PRNewswire-FirstCall/ --
SkyePharma PLC (NASDAQ:SKYE)(LSE: SKP) announces today that the US
Food and Drug Administration ("FDA") has approved Triglide(TM), its
novel formulation of fenofibrate. This approval will trigger a $15
million milestone payment from our partner First Horizon
Pharmaceutical Corporation ("First Horizon", Nasdaq: FHRX). In May
2004, SkyePharma announced that it had granted First Horizon
exclusive U.S. marketing and distribution rights for a
cardiovascular product (now identified as fenofibrate IDD(R)-P).
Under this agreement, SkyePharma will receive up to $50 million in
milestone payments, $30 million of which are sales-based milestone
payments. In addition SkyePharma will receive 25% of First
Horizon's net sales of the product. $5 million was paid to
SkyePharma upon signature of the agreement. SkyePharma will
manufacture and supply the product from its Lyon manufacturing
facility. SkyePharma will also make a contribution of up to $5
million to First Horizon's initial marketing expenses to establish
the product. Michael Ashton, SkyePharma's Chief Executive Officer,
said: 'We are delighted with the approval of Triglide(TM). This
approval further reinforces our strategy to improve quality of
earnings via increased royalties. We are confident that First
Horizon's 400-strong representative force with their focus on
cardiovascular physicians and high-prescribing primary care
practitioners will be able to successfully create a substantial
franchise in this therapeutic area." Fenofibrate is an oral
treatment for lipid disorders such as elevated cholesterol and
triglycerides. The main drawback of fenofibrate is insolubility in
water, resulting in variable uptake from the stomach and requiring
the patient to take the tablets with food. Triglide(TM) the new
formulation developed by SkyePharma, has a comparable absorption
under fed and fasting conditions and therefore allows patients to
take the drug at any time, improving compliance and simplicity for
both patients and prescribers. This represents the first approval
for a product utilizing SkyePharma's solubilization IDD(R)-P
technology. 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 ten approved products incorporating SkyePharma's
technologies in the areas of oral, injectable, inhaled and topical
delivery, supported by advanced solubilisation capabilities. For
more information, visit http://www.skyepharma.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, SkyePharma's marketing partners' ability to market a
pharmaceutical product on a large scale and manage their sales and
marketing organisation 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. DATASOURCE:
SkyePharma PLC CONTACT: SkyePharma PLC, +44-207-491-1777, or
Michael Ashton, Chief Executive Officer, or Peter Laing, Director
of Corporate Communications, +44-205-491-5124, or Sandra Haughton,
US Investor Relations, +1-212-753-5780, all of SkyePharma PLC, Tim
Anderson or Mark Court of Buchanan Communications, +44-207-466-5000
Web site: http://www.skyepharma.com/
Copyright