Bilastine
Treatment for Allergic RhinitisInspire and FAES Farma Amend Bilastine Licensing Agreement
DURHAM, N.C.--(BUSINESS WIRE)--Jun 20, 2007 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) and FAES Farma, S.A. have amended their licensing agreement for the U.S. and Canadian development and commercialization of oral bilastine for the treatment of allergic rhinitis, based on a meeting with the Pulmonary Division of the U.S. Food and Drug Administration (FDA) in which the existing clinical data and recent QT/QTc trial results were discussed.
In consultation with Inspire, FAES has agreed to conduct additional clinical work and an expanded QT/QTc comparative trial, which will likely include an FDA-approved antihistamine. These additional trials are intended to strengthen the overall clinical package, based on feedback from the FDA.
Inspire will have no financial obligations for the oral program while FAES is conducting the additional clinical work. As a result, Inspire expects to decrease estimated cash expenditures by approximately $14 million in 2007, including an $8 million milestone payment that had been anticipated in 2007.
Inspire completed the initial licensing agreement with FAES Farma in October 2006 for the exclusive rights to develop and commercialize both the oral and ophthalmic formulations of bilastine in various territories. Inspire will continue to hold the U.S. Investigational New Drug (IND) application for oral bilastine and will work with FAES over the next year to evaluate the additional clinical data that will determine the appropriate NDA filing strategy. Beginning in December 2007, FAES has the option to discontinue the additional oral bilastine clinical work. Beginning at the same time, Inspire has the option to terminate the agreement, in whole or in part, with no further expense.
Inspire plans to continue to fund the preclinical development of an ophthalmic formulation of bilastine for the treatment of allergic conjunctivitis.
About Inspire
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. Inspire employs a U.S. sales force for the promotion of AzaSite (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is focused on the therapeutic areas of ophthalmology and respiratory/allergy, and is developing products for dry eye, cystic fibrosis, allergic rhinitis and glaucoma. Elestat and Restasis are trademarks owned by Allergan, Inc. AzaSite is a trademark owned by InSite Vision Incorporated. For more information, visit www.inspirepharm.com.
Forward-Looking Statements
The forward-looking statements in this news release relating to
management's expectations and beliefs are based on preliminary
information and management assumptions. Specifically, no assurances
can be made with respect to: the timing, structure or outcome of
FAES's additional clinical work including any QT/QTc comparative
trial, the inclusion of an FDA-approved antihistamine in such
trial, the timing of future financial obligations for the oral
bilastine program, the timing of any termination of the license
agreement, as amended, or any portion thereof, between Inspire and
FAES, actual decreases in 2007 cash expenditures, and the timing or
outcome of preclinical development of an ophthalmic formulation of
bilastine. Such forward-looking statements are subject to a wide
range of risks and uncertainties that could cause results to differ
in material respects, including those relating to the amount of net
sales of Restasis recorded by Allergan in 2007, the Company's 2007
financial results, including without limitation aggregate revenue,
aggregate expenses, research and development expenses, selling and
marketing expenses, general and administrative expenses, as well as
the impact of the anticipated AzaSite launch, including without
limitation headcount changes, related stock-based compensation
expense changes, a draw on the Company's existing debt facility,
the timing of any revised guidance, the timing and success of any
additional capital raising activities, product development,
revenue, expense and earnings expectations, the seasonality of
Elestat, intellectual property rights, adverse litigation
developments, adverse developments in the U.S. Securities and
Exchange Commission (SEC) investigation, competitive products,
results and timing of clinical trials, success of marketing
efforts, the need for additional research and testing, delays in
manufacturing, funding, and the timing and content of decisions
made by regulatory authorities, including the U.S. Food and Drug
Administration. Further information regarding factors that could
affect Inspire's results is included in Inspire's filings with the
SEC. Inspire undertakes no obligation to publicly release the
results of any revisions to these forward-looking statements that
may be made to reflect events or circumstances after the date
hereof.
Contact
Inspire Pharmaceuticals, Inc.
Investor Contact:
Jenny Kobin, 919-941-9777, ext. 219
VP, Investor Relations and Corporate Communications
or
Media Contact:
BMC Communications
Dan Budwick, 212-477-9007, ext. 14
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