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FOR IMMEDIATE RELEASE
Contacts:
Inspire
Pharmaceuticals, Inc.
Mary Bennett
Vice President, Operations & Communications
(919) 941-9777, Extension 245 |
EURO
RSCG Life NRP
Emily Poe (212) 696-4455 x221
Allergan, Inc.
Jeff Edwards/Vince Scullin (714) 246-4636 (investors)
Suki Shattuck (714) 246-5621 (investors/media)
Christine Cassiano (714) 246-5134 (media) |
ALLERGAN
AND INSPIRE ENTER INTO A COLLABORATION FOR THE DEVELOPMENT OF TWO
NOVEL COMPOUNDS FOR THE TREATMENT OF DRY EYE
Inspire's INS365 & Allergan's RESTASIS™ in Phase III Clinical
Development
IRVINE,
California and DURHAM, North Carolina - June 27, 2001
- Allergan, Inc. (NYSE: AGN) and Inspire Pharmaceuticals, Inc. (Nasdaq:
ISPH) today announced that they have entered into a collaboration
to develop two novel therapeutic treatments for dry eye. The licensing,
development and marketing agreement includes Inspire's INS365 Ophthalmic
and Allergan's Restasis cyclosporine ophthalmic emulsion, 0.05%,
both in Phase III clinical development for dry eye.
Under
the terms of the agreement, Allergan obtains an exclusive license
to develop and commercialize INS365 Ophthalmic worldwide, with the
exception of Japan, and nine other Asian Countries covered by Inspire's
agreement with Santen Pharmaceutical Co. Ltd. In return, Inspire
will receive up to $39 million in up-front and milestone payments,
a co-promotion arrangement for INS365 Ophthalmic in the United States,
and payments based on net sales. In addition, Inspire will receive
an option to co-promote Restasis in the United States and royalties
on global net sales of Allergan's Restasis excluding the Japan,
Taiwan, Korea, Hong Kong and Peoples' Republic of China markets.
The agreement also provides for potential co-promotion by Inspire
of one or more of Allergan's other marketed and future products
in the U.S.
Dry
eye is one of the most frequent patient complaints reported to ophthalmologists
and represents a significant unmet medical need. Approximately 9
million patients in the major markets suffer from moderate-to-severe
dry eye and there is currently no FDA-approved therapeutic treatment
for dry eye disease.
"Dry
eye syndrome may lead to serious corneal damage, enhanced susceptibility
to ocular infection, and potentially, significant visual loss and
blindness," said David A. Sullivan, Ph.D., Chairman, Medical and
Scientific Advisory Board of the Sjögren's Syndrome Foundation.
"This strategic alliance between Allergan and Inspire may well lead
to the development of unique and effective therapies to treat this
currently incurable syndrome."
Restasis
and INS365 Ophthalmic are being tested in separate Phase III clinical
trials for their ability to relieve the signs and symptoms of dry
eye. It is believed that the compounds have different mechanisms
of action with Restasis decreasing the underlying inflammation
associated with dry eye and INS365 Ophthalmic increasing the lubrication
in the eye by stimulating natural tear and mucin production to restore
a healthier ocular surface.
"Allergan
is committed to being a leader in ophthalmology where the treatment
of dry eye represents a very large unmet medical need. The Inspire
technology is an excellent addition to Allergan's strong new product
pipeline," said David E.I. Pyott, Allergan's Chairman, Chief Executive
Officer and President. "Restasis and INS365 Ophthalmic are
highly complementary products. Both could be potential breakthroughs
for the treatment of dry eye, each targeted to a different patient
need."
Greg
Mossinghoff, Senior Vice President and Chief Business Officer for
Inspire, agrees, and also believes that the partnership is as complementary
as the two products. "We could not have found a better partner for
INS365 Ophthalmic," said Mr. Mossinghoff. "Allergan brings enormous
expertise to the development of ophthalmic products, and has tremendous
commercial capability in this area. Inspire plans to bolster this
effort with our own salesforce, now in development. Allergan is
clearly a longstanding leader in the understanding and treatment
of dry eye."
About
Dry Eye
Dry eye, also known as keratoconjunctivitis sicca (KCS), is a painful,
burning and irritating condition involving abnormalities and deficiencies
in the tear film due to a variety of causes. Severe dry eye due
to inflammation may result in serious damage to the ocular surface.
The incidence increases markedly with age and after menopause in
women. There are currently no FDA-approved pharmacologically active
treatments for dry eye.
Forward-looking
Statements
Any of the above statements that refer to Allergan's and/or Inspire's
estimated or anticipated future results are forward-looking and
reflect the companies' current analysis of existing trends and information.
Actual results may differ from current expectations based on a number
of factors affecting the companies' businesses, including the timing
and uncertainty of the results of both research and regulatory processes,
and including the research, development, regulatory approval, introduction
and consumer acceptance of new products. In particular, there can
be no assurance that the U.S. Food and Drug Administration will
ultimately approve cyclosporine ophthalmic emulsion, 0.05% and/or
INS365, or approve cyclosporine ophthalmic emulsion, 0.05% and/or
INS365 for the indications currently sought, or approve either on
an expedited basis. These forward-looking statements represent the
companies' judgement only as of the date of this press release.
Actual results could differ materially from those projected in this
release. Therefore, the reader is cautioned not to rely on these
forward-looking statements. The companies disclaim, however, any
intent or obligation to update these forward-looking statements.
Additional information concerning these factors can be found in
press releases as well as in Allergan's and Inspire's public periodic
filings with the Securities and Exchange Commission including Allergan's
and Inspire's 2000 Form 10-K and Form 10-Q for the quarter ended
March 30, 2001.
Copies
of Allergan press releases and additional information about Allergan
are available on the World Wide Web at www.allergan.com,
or you can contact the Allergan Investor Relations Department by
calling 714-246-4636.
Copies
of Inspire press releases and additional information about Inspire
are available on the World Wide Web at www.inspirepharm.com,
or you can contact Inspire Investor Relations by calling (919) 941-9777.
About
Allergan
Allergan, headquartered in Irvine, California, is a technology-driven,
global healthcare company, providing eye care and specialty pharmaceutical
products worldwide. Allergan develops and commercializes products
in the eye care pharmaceutical, ophthalmic surgical device, over-the-counter
contact lens care, movement disorder and dermatological markets
that deliver value to our customers, satisfy unmet medical needs
and improve patients' lives.
About
Inspire
Inspire Pharmaceuticals, Inc. discovers and develops new drugs to
treat diseases characterized by deficiencies in the body's innate
defense mechanisms of mucosal hydration and mucociliary clearance,
as well as other non-mucosal disorders. Inspire's lead product candidates
target respiratory and ophthalmic diseases with inadequate current
treatments and which represent large therapeutic market opportunities.
Inspire has five product candidates in clinical development. In
addition to this partnership with Allergan, Inspire has development
and commercialization alliances with Kissei
Pharmaceutical Co., Ltd., Santen
Pharmaceutical Co., Ltd. and Kirin
Brewery Co., Ltd. Inspire's products are based on proprietary
technology relating to P2Y receptors. Inspire is exploring other
target diseases where it believes P2Y receptors play important biological
roles.
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Editor's Note: This release is also available at:
http://www.nrp-euro.com
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Copyright
© 1999-2004 Inspire Pharmaceuticals Inc. All rights reserved
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