King Pharmaceuticals and Inyx Enter Into Strategic Alliance
September 08 2005 - 6:00PM
PR Newswire (US)
. King and Inyx Establish 10-Year Co-Marketing Collaboration for
King's Intal(R) and Tilade(R) Respiratory Products BRISTOL, Tenn.
and NEW YORK, Sept. 8 /PRNewswire-FirstCall/ -- King
Pharmaceuticals, Inc. (NYSE:KG) and Inyx, Inc. (OTC:IYXI) (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. DATASOURCE: King
Pharmaceuticals, Inc.; Inyx, Inc. 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 Web site: http://www.kingpharm.com/
http://www.inyxinc.com/ Company News On-Call:
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