SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a - 16 OR 15d - 16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of September, 2006
SkyePharma PLC
SkyePharma PLC, 105 Piccadilly, London W1J 7NJ England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40F.
Form 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _______
For Immediate Release 6 September, 2006
SkyePharma PLC
SkyePharma and Mundipharma Announce Exclusive Licence Agreement for Marketing
and Distribution of Flutiform™ in Europe
€15 million upfront and €70 million in milestones
Double Digit Royalties
LONDON, ENGLAND, 6 September, 2006 -- SkyePharma PLC (LSE: SKP; Nasdaq: SKYE)
announces today that it has entered into an agreement with Mundipharma
International Corporation Limited ("Mundipharma") for the development, marketing
and distribution in Europe and certain other international markets of
Flutiform™, its novel combination product for asthma and chronic obstructive
pulmonary disease ("COPD").
Mundipharma will have exclusive rights to market Flutiform™ in Europe and
other territories outside North, Central and South America, with an option to
negotiate for exclusive rights in Japan. Mundipharma is a privately-owned
pharmaceutical company that is already SkyePharma's licensee for its oncology
drug DepoCyte®, in Europe and certain other markets.
SkyePharma's Chief Executive, Frank Condella, said: "I am pleased to announce
another significant step in the strategic plan that we announced to shareholders
earlier this year. We expect to reach the market with Flutiform™ in 2009, by
which time the European market for combination treatments for asthma and COPD is
expected to exceed $3 billion.
"We are delighted to build on our existing relationship with Mundipharma in
Europe with a licence for Flutiform™, our leading pipeline product.
Mundipharma has demonstrated its ability to market products effectively in the
complex European pharmaceutical market and they are well placed to introduce
Flutiform™, which will be a key product for them."
Ake Wikstrom, Regional Director, Europe, Mundipharma International Limited,
said: "This agreement is important to us for two reasons. Firstly, Flutiform™
offers the potential of an excellent therapeutic option in the management of
asthma and COPD and thus represents a major opportunity for our continued
growth. Secondly, having previously partnered with SkyePharma, this clearly
demonstrates Mundipharma's ability to commit to licensing opportunities and
really deliver on those commitments."
SkyePharma has received an upfront payment of €15 million ($19 million) on
signature and will receive additional milestone payments of up to a further €70
million ($90 million) on attainment of various development and revenue targets.
SkyePharma will receive royalties on sales by Mundipharma, with the royalty rate
in double digits and escalating on attainment of various sales targets. In
addition SkyePharma and Mundipharma's associate company, Mundipharma Medical
Company, will be entering into a manufacturing and supply agreement under which
SkyePharma will supply commercial goods and samples to Mundipharma Medical
Company at cost plus an applicable margin.
SkyePharma is currently conducting the clinical trials required for US approval
of Flutiform™ in adult asthma. Mundipharma will have access to data from these
trials, which will be used as the basis for obtaining European approval of
Flutiform™. Mundipharma will also conduct, at its own expense, an additional
clinical study needed for regulatory approval in Europe and also the studies
that will be needed to extend the indication to paediatric patients and to a
higher dose strength. The costs of these studies will be recouped from future
royalty and milestone payments to SkyePharma.
Flutiform™ consists of a unique fixed-dose combination of the long-acting
bronchodilator formoterol with the inhaled steroid fluticasone in a proprietary
metered-dose aerosol inhaler with a dose counter. The product is taken twice a
day. SkyePharma's proprietary formulation technology, designed to stabilise the
active components and thereby ensure a reproducible dose even after prolonged
storage, provides patent protection for Flutiform™ to 2019. Flutiform™ is
currently in Phase III development for the indication of asthma in adults and
adolescents and is expected to be submitted for approval in the USA in the
second half of 2007 and in Europe in 2008 and to reach these markets in 2009.
In May SkyePharma announced that it had licensed Flutiform™ to Kos
Pharmaceuticals, Inc. (NASDAQ: KOSP) for the US market, with an option on the
Canadian market. SkyePharma remains in negotiations with potential partners for
the remaining markets around the world.
For further information please contact:
SkyePharma PLC +44 207 491 1777
Frank Condella, Chief Executive Officer
Peter Laing, Director of Corporate Communications +44 207 491 5124
Sandra Haughton, US Investor Relations +1 212 753 5780
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court / Rebecca Skye Dietrich
Mundipharma International Ltd
Rob Cohen, European Communications Director +44 1223 424211
Notes for editors
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
www.skyepharma.com.
About Mundipharma
Mundipharma is one of the Purdue/Mundipharma/Napp independent associated
companies - privately owned companies and joint ventures covering the world's
pharmaceutical markets. The companies worldwide are dedicated to bringing to
patients with severe and debilitating diseases the benefits of novel treatment
options in fields such as severe pain, haemato-oncology and respiratory disease.
For more information: www.mundipharma.co.uk
About the treatment of asthma
Asthma is an inflammatory condition that makes the airways in the lung (bronchi)
abnormally responsive to external stimuli such as dust, pollen or cold air,
resulting in constriction of the bronchi and difficulty in breathing. Patients
with asthma are normally treated with two types of therapy: an anti-inflammatory
drug that addresses the underlying cause of the condition and a bronchodilator
that opens the airways, relieving the symptoms and allowing patients to breathe
normally. The older short-acting bronchodilators have now largely been displaced
by long-acting bronchodilators that provide symptom relief for 12 hours
(particularly valuable overnight). Asthma drugs can be taken orally but most are
inhaled, with the active drug delivered to the inner surface of the lung by
means of an inhaler device, either a metered-dose aerosol inhaler (MDI) or a
breath-actuated dry powder inhaler (DPI). The world market for asthma drugs is
expected to exceed $20 billion by 2010, with use in COPD, another inflammatory
lung condition, expected to add a further $10 billion. The US market accounts
for approximately half of the global total.
The fastest-growing part of this market is combination treatments, which combine
a long-acting bronchodilator with an inhaled steroid in a single delivery
device. Combinations are not only more convenient for patients than carrying two
separate inhalers but also optimise the efficacy of the individual agents. Sales
of GlaxoSmithKline's combination Advair (Seretide in Europe) already exceed $6
billion, of which half is in the US, and AstraZeneca's Symbicort (which has
recently been approved by the FDA but which is not yet on the US market) add
another $1 billion. By 2010 the combination category is expected to account for
over half of the asthma/COPD market by value.
About Flutiform™
SkyePharma's product Flutiform™ consists of a unique fixed-dose combination of
the long-acting bronchodilator formoterol with the inhaled steroid fluticasone
in a proprietary non-CFC metered-dose aerosol inhaler with a dose counter.
Formoterol provides 12 hours of bronchodilation and has a rapid onset of action
(1-3 minutes). By contrast salmeterol, the bronchodilator used in
GlaxoSmithKline's Advair/Seretide, also provides 12 hours of bronchodilation but
has the drawback of needing up to 30 minutes after inhalation to take effect.
The inhaled steroid fluticasone (a component of Advair/Seretide) has low
systemic absorption and is perceived to have a better safety and efficacy
profile than budesonide, the steroid used in AstraZeneca's Symbicort, and is the
physician-preferred inhaled steroid in the US. The proprietary SkyeDry(TM)
formulation technology employed in Flutiform™, designed to stabilise the active
components and thereby ensure a reproducible dose even after prolonged storage,
provides patent protection to 2019. The product will be available in two dose
combinations with each dose delivering 10 micrograms of formoterol with either
100 or 250 micrograms of fluticasone. A version with a higher dose of
fluticasone is also being developed for the European market.
Flutiform™ completed its Phase II trial in asthma in 2005. The results
confirmed that Flutiform™ behaved exactly as if the two component drugs had
been taken separately, with rapid onset of bronchodilation that was maintained
for 12 hours, no evidence of drug-drug interactions and no safety concerns.
Following discussions with the FDA on the Phase II trial results, the Phase III
trial of Flutiform™ started on schedule in February 2006. The trial programme
is on track for SkyePharma's target of regulatory submission to the FDA in the
second half of 2007. SkyePharma believes that Flutiform™ should reach the US
market in 2009. Mundipharma expects to file in Europe by the end of 2008 and
Flutiform™ to reach the market by the end of 2009.
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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SkyePharma PLC
By: /s/ Douglas Parkhill
Name: Douglas Parkhill
Title:
Company Secretary
Date: September 6, 2006