Licensing Agreement
19 Mayo 2003 - 2:30AM
UK Regulatory
RNS Number:2423L
Skyepharma PLC
19 May 2003
Immediate Release 19 May 2003
KING PHARMACEUTICALS AND SKYEPHARMA ANNOUNCE
LICENSING AGREEMENT TO DEVELOP
MODIFIED-RELEASE FORMULATION OF ALTACE
BRISTOL, TENNESSEE & LONDON, UK, May 19, 2003 - King Pharmaceuticals, Inc.
(NYSE:KG) and SkyePharma PLC (NASDAQ: SKYE; LSE:SKP) announced today that they
have entered into a licensing agreement for the purpose of developing and
commercializing a modified-release formulation of King's product Altace
(ramipril) utilizing SkyePharma's patented oral drug delivery technology
Geomatrix. Altace is a patented angiotensin converting enzyme ("ACE") inhibitor
with net sales in the United States and Puerto Rico totalling $534.7 million for
the last twelve months ending March 31, 2003.
SkyePharma's Geomatrix range of technologies involves a fully-developed,
multi-layered tablet technology that controls the release of a product's active
ingredient for the purpose of optimizing a drug's pharmacokinetic behavior. The
specific Geomatrix technology planned for use in the development of a
modified-release formulation of Altace should provide the product with extended
duration of action and improved bioavailability. SkyePharma has various issued
patents covering the Geomatrix drug delivery technologies, with patent
protection in the U.S. extending to 2017. Also, SkyePharma has patent
applications for additional patents under review covering its Geomatrix drug
delivery technologies.
Jefferson J. Gregory, Chairman and Chief Executive Officer of King, stated, "We
are very pleased to collaborate with SkyePharma in the development and potential
commercialization of a modified-release formulation of our leading product
Altace. SkyePharma's patented Geomatrix delivery platform and proven
formulation expertise should result in the improved bioavailability of Altace."
Mr. Gregory added, "We continue to work diligently on additional product
life-cycle strategies intended to enhance the value of our Altace franchise."
Michael R. D. Ashton, SkyePharma's Chief Executive Officer, said, "We are
delighted that King has chosen SkyePharma to help develop an improved
formulation of their lead product, Altace. This development project, involving a
unique delivery formulation within our Geomatrix range of technologies,
highlights the importance to SkyePharma of our oral delivery franchise, which
can improve both new and currently marketed products. Strategically this deal is
another example of our growing number of relationships with pharmaceutical
companies where our delivery technologies help to expand the commercial
potential of their product portfolios. Additionally it may potentially provide
another manufacturing opportunity for our Lyon plant."
Altace was first approved by the U.S. Food and Drug Administration ("FDA") in
1991 for use in the treatment of hypertension and subsequently approved by the
FDA for the treatment of congestive heart failure after a patient suffers a
heart attack. Additionally, based on evidence from the landmark HOPE trial,
Altace remains the only differentiated ACE inhibitor because it has received FDA
approval to reduce the risk of stroke, myocardial infarction and death from
cardiovascular causes in patients 55 and older either with a history of coronary
artery disease, stroke, or peripheral vascular disease or with diabetes and one
other cardiovascular risk factor (e.g., elevated cholesterol levels, cigarette
smoking, etc.).
Under the Development, Commercialization and Licensing Agreement, King has
agreed to pay SkyePharma $1 million on signing and will pay potential additional
future payments of up to $6.5 million for certain milestones that may occur up
to and including FDA approval of an Altace product utilizing SkyePharma's drug
delivery technologies. King has also agreed to reimburse SkyePharma for direct
expenses associated with SkyePharma's development of a modified-release
formulation of Altace. Furthermore, King will have sole responsibility for all
clinical studies and costs associated with any such modified-release formulation
of Altace and all the necessary regulatory submissions leading to potential
approval of such a product. King will pay SkyePharma a royalty on net sales of
any FDA-approved formulation of Altace utilizing SkyePharma's patented drug
delivery technology during the term of King's license.
About Altace
When used in pregnancy during the second and third trimesters, ACE inhibitors
can cause injury and even death to the developing fetus. When pregnancy is
detected, use of Altace should be immediately discontinued. Common adverse
events associated with Altace include persistent dry cough, dizziness, and
symptomatic hypotension. Hypoglycemia has been reported rarely in concomitant
therapy with oral hypoglycemics or insulin, and therefore patients should be
closely monitored for symptoms of hypoglycemic reactions. Rare cases of
angioedema, including intestinal angioedema, have been reported. Altace is
contraindicated in patients who are hypersensitive to the product or have a
history of angioedema related to previous treatment with an ACE inhibitor.
King Pharmaceuticals, Inc., headquartered in Bristol, Tennessee, is a vertically
integrated pharmaceutical company that develops, manufactures, markets, and
sells branded prescription pharmaceutical products. King, an S&P 500 Index
company, seeks to capitalize on opportunities in the pharmaceutical industry
created by cost containment initiatives and consolidation among large global
pharmaceutical companies. King's strategy is to acquire branded pharmaceutical
products and to increase their sales by focused promotion and marketing and
through product life cycle management.
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 nine approved products incorporating three of
SkyePharma's five delivery technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation capabilities.
SkyePharma has two FDA- and EMEA-approved manufacturing plants in San Diego,
USA, and Lyon, France. For more information, visit www.skyepharma.com.
This release contains forward-looking statements which reflect management's
current views of future events and operations, including, but not limited to,
statements pertaining to the development and potential commercialization of a
modified-release formulation of Altace by SkyePharma and King, statements
pertaining to existing U.S. patent protection through 2017 covering the specific
Geomatrix technology planned for use in the development of a modified-release
formulation of Altace, and a potential manufacturing opportunity for
SkyePharma's Lyon plant. These forward-looking statements involve certain
significant risks and uncertainties, and actual results may differ materially
from the forward-looking statements. Some important factors which may cause
results to differ include: dependence on King's and Wyeth Pharmaceuticals'
ability to successfully market Altace under the co-promotion agreement between
King and Wyeth, dependence on the development and implementation of successful
marketing strategies for Altace by King and Wyeth, dependence on King's ability
to maintain effective patent protection for Altace through October 2008, and
successfully defend against any attempt to challenge the enforceability of
patents relating to the product, dependence on SkyePharma's and King's ability
to successfully develop a modified release formulation of Altace with extended
duration of action and improved bioavailability, dependence on SkyePharma's and
King's ability to maintain effective patent protection for a modified release
formulation for Altace through 2017, dependence on SkyePharma's and King's
ability to obtain the issuance of additional U.S. patents covering the specific
Geomatrix technology used in the development of a modified-release formulation
of Altace, dependence on the development and implementation of successful launch
and marketing strategies for a modified-release formulation of Altace, once
approved, dependence on sales of King's currently marketed products, including,
in particular, but not limited to, Altace, Levoxyl (levothyroxine sodium
tablets, USP), and Thrombin-JMI (thrombin, topical, bovine, USP), dependence on
whether King chooses to utilize SkyePharma's manufacturing facilities in Lyon,
France for the purpose of manufacturing any modified-release formulation of
Altace that may be successfully developed by King and SkyePharma, dependence on
King's ability to continue to successfully execute the Company's proven growth
strategies, management of King's growth and integration of its acquisitions, and
the high cost and uncertainty of research, clinical trials, and other
development activities involving pharmaceutical products, including, but not
limited to, a modified release formulation of Altace. Other important factors
that may cause actual results to differ materially from the forward-looking
statements are discussed in the "Risk Factors" section and other sections of
King's Form 8-K dated April 15, 2003, previously submitted to the Securities and
Exchange Commission (SEC), and of SkyePharma's SEC filings. Both King &
SkyePharma do not undertake to publicly update or revise any of their
forward-looking statements even if experience or future changes show that the
indicated results or events will not be realized.
For further information please contact:
King Pharmaceuticals, Inc.
James E. Green, Executive Vice President, Corporate Affairs + 1 423 989 8125
SkyePharma PLC
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications + 44 207 491 1777
Sandra Haughton, US Investor Relations + 1 212 753 5780
Buchanan Communications
Tim Anderson / Nicola How + 44 207 466 5000
EXECUTIVE OFFICES
KING PHARMACEUTICALS * 501 FIFTH STREET, BRISTOL, TENNESSEE 37620
SKYEPHARMA PLC * 105 PICCADILLY, LONDON, W1J 7NJ, UNITED KINGDOM
This information is provided by RNS
The company news service from the London Stock Exchange
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