. King and Inyx Establish 10-Year Co-Marketing Collaboration
for King's Intal(R) and Tilade(R) Respiratory Products
. Inyx Receives 10-Year Manufacturing and Supply Contract
Relating to Intal(R) and Tilade(R)
BRISTOL, Tenn. and NEW YORK, Sept. 8 /PRNewswire-FirstCall/ -- King
Pharmaceuticals, Inc. (NYSE: KG) and Inyx, Inc. (OTC Bulletin Board: IYXI)
announced today that they have entered into a strategic collaboration relating
to Intal(R) (cromolyn sodium) and Tilade(R) (nedocromil sodium), which
includes the continued development of a new formulation of Intal(R) utilizing
hydrofluoroalkane (HFA), an environmentally friendly propellant. Intal(R) and
Tilade(R) are King's currently marketed inhaled anti-inflammatory agents for
the management of asthma.
Brian A. Markison, President and Chief Executive Officer of King, stated,
"Inyx's focus on respiratory products and technical expertise with aerosol
delivery provide King with a good strategic partner for enhancing the
development and growth of our lead respiratory products, Intal(R) and
Tilade(R). These capabilities should prove particularly valuable as we
collaborate with Inyx to continue the development of an HFA formulation of
Intal(R)." Mr. Markison added, "Inyx will have many of the manufacturing
responsibilities related to the production of our Intal(R) and Tilade(R)
product lines. We believe that Inyx's manufacturing capabilities should
provide a high quality continuous supply of these products."
"We are extremely pleased to enter into this strategic alliance with King
Pharmaceuticals. The contractual relationship with King is expected to
generate significant revenues and income for Inyx starting in 2006, and
building in coming years," said Jack Kachkar, M.D., Chairman and Chief
Executive Officer of Inyx.
The strategic alliance includes several 10-year agreements, with renewal
options, and the formation of an Alliance Management Committee comprised of
three senior executives from each company. Pursuant to the agreements, King
and Inyx will co-market Intal(R) and Tilade(R) and each have a share in net
revenues. King will continue marketing to hospitals and primary-care
physicians, while Inyx will pursue direct sales to the specialist markets,
including pediatricians, allergists and pulmonologists. Inyx also plans to
supervise the distribution of Intal(R) HFA in Canada, following the receipt of
necessary Canadian regulatory approval.
"This is Inyx's first revenue-sharing deal with a client, and it is the
single most material agreement that Inyx has signed to date," said Inyx CEO
Dr. Kachkar. Inyx's co-marketing of Intal(R) and Tilade(R) will be conducted
by a newly established wholly owned Inyx subsidiary, Exaeris, Inc., which will
be independent of the company's contract development and manufacturing
operations.
About Intal(R) and Tilade(R)
Intal(R) and Tilade(R) are the only mast-cell stabilizers (non-steroidal
anti-inflammatory, non-beta-2 agonist agents) currently available for the
treatment of asthma. Intal(R) is administered with either an inhaler or a
nebulizer and is indicated for the long-term management of bronchial asthma in
adults and children five years of age or older. Intal(R) is not indicated for
the treatment of acute asthma attacks. Intal(R) is contraindicated in
patients with known hypersensitivities to cromolyn sodium. Tilade(R) is
administered with an inhaler and is indicated for the long-term treatment of
bronchial asthma and associated chronic cough in adults. Tilade(R) is not a
bronchodilator and, therefore, should not be used for the reversal of acute
bronchospasm. A new Intal(R) inhaler formulation utilizing hydrofluoroalkane,
an environmentally friendly propellant, is currently under review by the U.S.
Food and Drug Administration. The HFA formulation of Intal(R) is patented in
the United States until September 2017.
About King Pharmaceuticals
King Pharmaceuticals, Inc., headquartered in Bristol, Tennessee, is a
vertically integrated branded pharmaceutical company. King, an S&P 500 index
company, seeks to capitalize on the opportunities in the pharmaceuticals
industry through the development, including through in-licensing arrangements
and acquisitions, of novel branded prescription pharmaceutical products in
attractive markets and the strategic acquisition of branded products that can
benefit from focused promotion and marketing and product life-cycle
management. For more information, please visit: http://www.kingpharm.com.
About Inyx
Inyx, Inc. is a specialty pharmaceutical company with aerosol drug
delivery technologies and products for the treatment of respiratory, allergy,
dermatological, topical and cardiovascular conditions. Inyx focuses its
expertise on both prescription and over-the-counter pharmaceutical products,
and provides specialty pharmaceutical development and production consulting
services. In addition, Inyx is developing its own proprietary products to be
marketed by selected clients and strategic partners. The company's operations
are conducted through several wholly owned subsidiaries, including: Inyx USA,
Ltd., based in Manati, Puerto Rico; Inyx Pharma Limited, near Manchester,
England; Inyx Europe Limited, also near Manchester; and Inyx Canada, Inc. in
Toronto. Inyx, Inc.'s corporate offices are in New York City. For more
information, please visit: http://www.inyxinc.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements reflect
managements' current views of future events and operations, including, but not
limited to, statements pertaining to the potential development and
commercialization of Intal(R) HFA; statements pertaining to the future
marketing and supply of the Intal(R) and Tilade(R) product lines; and
statements pertaining to Inyx's future financial growth. Some important
factors which may cause results to differ materially from such forward-looking
statements include dependence on the companies' abilities to carry out their
respective business plans; dependence on the successful development and
commercial acceptance of Intal(R) HFA in the United States and Canada;
dependence on the companies' ability to successfully market the Intal(R) and
Tilade(R) product lines; dependence on Inyx's ability to successfully transfer
to its facility in Manati, Puerto Rico and obtain related regulatory approval
for certain portions of the manufacture process for the Intal(R) and Tilade(R)
product lines; dependence on the ability of Inyx to successfully manufacture
Intal(R) HFA after obtaining the necessary regulatory approval; dependence on
the availability and cost of raw materials; dependence on the unpredictability
of the duration and results of the U.S. Food and Drug Administration's ("FDA")
review of Investigational New Drug Applications ("IND"), New Drug Applications
("NDA"), and supplemental New Drug Applications, ("sNDAs") and/or the review
of other regulatory agencies worldwide; dependence on compliance with FDA and
other government regulations that relate to King's and Inyx's respective
businesses; and dependence on changes in general economic and business
conditions; changes in current pricing levels; changes in federal and state
laws and regulations; changes in competition; unexpected changes in
technologies and technological advances; and manufacturing capacity
constraints. 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 10-K for the year ended
December 31, 2004 and Form 10-Q for the second quarter ended June 30, 2005,
and Inyx's Form 10-K for the year ended December 31, 2004 and Form 10-Q for
the second quarter ended June 30, 2005, which are on file with the U.S.
Securities and Exchange Commission. The companies 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.
SOURCE King Pharmaceuticals, Inc.; Inyx, Inc.
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Related links:
http://www.kingpharm.com
http://www.inyxinc.com
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green, Executive VP Corporate
Affairs of King Pharmaceuticals, Inc., +1-423-989-8125; or Jay M.
Green, Executive VP of Inyx, Inc., +1-212-838-1111, or
jgreen@inyxinc.com
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