SkyePharma PLC (Nasdaq: SKYE;
LSE: SKP) announces that its partner Critical Therapeutics Inc ("CTI",
Nasdaq: CRTX) has submitted a New Drug Application to the US Food & Drug
Administration for a controlled-release formulation of the oral anti-
inflammatory drug zileuton for asthma in adults and children aged 12 years
or older. The new formulation only needs to be taken twice a day whereas
Zyflo(R), the currently marketed version of zileuton, has the drawback of
requiring dosing four times a day.
A four times a day immediate-release version of zileuton was marketed
by Abbott Laboratories ("Abbott") as Zyflo(R) Filmtab(R) (zileuton
tablets). SkyePharma developed a controlled-release formulation of
zileuton, using its Geomatrix(TM) technology, for Abbott, which completed
Phase III development in asthma with this product. CTI acquired the rights
to zileuton from Abbott and since December 2003 SkyePharma has collaborated
with CTI on the further development of this formulation. SkyePharma will
receive a single-digit royalty on CTI's sales of the controlled-release
formulation of zileuton and will also manufacture the product for CTI at
its plant in Lyon, France.
Frank Condella, Chief Executive of SkyePharma, said: "We are pleased
that this successful collaboration with CTI has now culminated in the
filing of this version of zileuton, another example of the power of our
Geomatrix(TM) technology. Our partner expects this product to reach the
market in the second half of next year when it will become another source
of royalty and manufacturing income for SkyePharma."
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 twelve 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 skyepharma.
About Critical Therapeutics
Critical Therapeutics, Inc. is a biopharmaceutical company focused on
critical care medicine. CTI's mission is the discovery, development and
commercialization of novel therapies for the treatment of acute trauma,
cardiopulmonary disease and infectious and inflammatory illness. The
Company is headquartered in Cambridge, Massachusetts. More information
about CTI is available at crtx.
About zileuton
Zileuton is a highly potent oral anti-inflammatory drug. It works by
inhibiting the enzyme 5-lipoxygenase. This enzyme, which is involved in the
formation of leukotrienes, is a key part of the inflammatory cascade that
follows allergic challenge. Inhibition of this enzyme therefore helps
minimise bronchoconstriction and mucus secretion in asthma. In its pivotal
trials in adult asthma, zileuton was shown to bring the greatest benefit to
those with the most severe disease. Zileuton is not intended for acute
relief of asthma symptoms but chronic treatment with zileuton allows
reduction of other therapies such as oral steroids which have undesirable
side-effects.
Certain statements in this news release are forward-looking statements
and are made in reliance on the safe harbour provisions of the U.S. Private
Securities Litigation Act of 1995. Although SkyePharma believes that the
expectations reflected in these forward-looking statements are reasonable,
it can give no assurance that these expectations will materialize. Because
the expectations are subject to risks and uncertainties, actual results may
vary significantly from those expressed or implied by the forward-looking
statements based upon a number of factors, which are described in
SkyePharma's 20-F and other documents on file with the SEC. Factors that
could cause differences between actual results and those implied by the
forward-looking statements contained in this news release include, without
limitation, risks related to the development of new products, risks related
to obtaining and maintaining regulatory approval for existing, new or
expanded indications of existing and new products, risks related to
SkyePharma's ability to manufacture products on a large scale or at all,
risks related to SkyePharma's and its marketing partners' ability to market
products on a large scale to maintain or expand market share in the face of
changes in customer requirements, competition and technological change,
risks related to regulatory compliance, the risk of product liability
claims, risks related to the ownership and use of intellectual property,
and risks related to SkyePharma's ability to manage growth. SkyePharma
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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