First Horizon Pharmaceutical (NASDAQ:FHRX)
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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/