SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Date of report (Date of earliest event reported) October 30, 2002
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INSPIRE PHARMACEUTICALS, INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-31135 04-3209022
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(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification No.)
4222 Emperor Boulevard, Suite 470, Durham, North Carolina 27703-8466
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (919) 941-9777
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(Former Name or Former Address, If Changed Since Last Report)
Item 5. Other Events.
On October 30, 2002, Inspire Pharmaceuticals, Inc. issued the following
press release:
"INSPIRE PHARMACEUTICALS ANNOUNCES NDA FILING PLANS FOR INS365
OPHTHALMIC BASED ON EXISTING CLINICAL DATA
-- FDA Meeting Held October 29th--
--Conference Call to be Held Today at 9:00 am EST--
"DURHAM, NC - October 30, 2002 - Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH)
today announced that it will file a New Drug Application (NDA) for INS365
Ophthalmic for dry eye based on safety and efficacy data from the
already-completed Phase II and Phase III clinical trials in approximately 1200
patients (studies 103, 104 and 105). The decision to file was based on a meeting
with the U.S. Food and Drug Administration (FDA) on October 29th. The meeting
was scheduled following the FDA's review of the data from all completed clinical
studies. The ongoing Phase III trial, study 108, will be continued as a Phase
IIIb study.
"'This is a major breakthrough for our dry eye program,' stated Christy L.
Shaffer, CEO of Inspire. `We have been pleased with the ongoing guidance we have
received from the FDA. These discussions have been helpful in defining the
pathway for the NDA filing. We are in the process of scheduling a pre-NDA
meeting, which will likely take place within the next few months. We will
provide further details on the timing of the NDA filing following the pre-NDA
meeting.'
"Dry eye is a painful, burning and irritating condition involving abnormalities
and deficiencies in the tear film due to a variety of causes. It affects
approximately 10 million Americans and is one of the most frequent patient
complaints reported to ophthalmologists. There are currently no FDA-approved,
pharmacologically active treatments for this common condition.
"Conference Call/Live Webcast
"Inspire will hold a brief conference call/webcast today at 9:00 am EST.
Participants in the United States may call 800 657-1269. Participants outside
the United States may call 973 935-2100. The live webcast can be accessed from
Inspire's website at www.inspirepharm.com or at
www.videonewswire.com/INSPIRE/103002. Call-in numbers for the replay are also
available on the website.
"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. Mucosal defense mechanisms are the natural way that the body defends
its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's
lead product candidates target ophthalmic and respiratory diseases with
inadequate current treatments and which represent large therapeutic market
opportunities. Inspire has
development and commercialization alliances with Allergan, Inc., Kissei
Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co.,
Ltd., and has a collaboration with Cystic Fibrosis Foundation Therapeutics.
Inspire's products are based on proprietary technology relating to P2Y2
receptors and to non-P2Y2 receptors that show therapeutic promise, including
P2Y12.
"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. 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 product development, revenue and earnings
expectations, intellectual property rights and litigation, competitive products,
results of clinical trials, the need for additional research and testing, delays
in manufacturing, funding and the timing and content of decisions made by
regulatory authorities, including the United States Food and Drug
Administration. Further information regarding factors that could affect
Inspire's results is included in Inspire's filings with the Securities and
Exchange Commission. 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 to reflect the occurrence
of unanticipated events."
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Inspire Pharmaceuticals, Inc.
By: /s/ Gregory J. Mossinghoff
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Gregory J. Mossinghoff
President, Treasurer and
Secretary
Dated: October 30, 2002