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) May 20, 2003
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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 May 20, 2003, Inspire Pharmaceuticals, Inc. issued the following press
release:
"INSPIRE PHARMACEUTICALS ANNOUNCES RESULTS IN PERENNIAL ALLERGIC
RHINITIS TRIAL
"DURHAM, NC - May 20, 2003 - Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) today
announced results of a large, multicenter trial of INS37217 Intranasal in
patients with perennial allergic rhinitis (PAR). The trial was a randomized,
parallel-group, double-blind, placebo-controlled study designed to assess the
safety and efficacy of INS37217 Intranasal in a 10mg/mL non-preserved nasal
spray formulation. The 28-day study was conducted in 630 patients at 24 centers
across the United States.
"In this study, INS37217 Intranasal was well tolerated but did not meet the
primary endpoint of significantly reducing the total nasal symptom score over
the 28-day treatment period versus placebo. The total nasal symptom score was a
composite of four symptoms: rhinorrhea (runny nose), nasal congestion, nasal
itching and post-nasal drip. The reduction in symptoms for INS37217 Intranasal
was less than that seen in the previously reported Phase I and II studies in PAR
and common cold.
"Although the primary endpoint was not met, patients receiving INS37217
Intranasal had a decreased incidence of respiratory-related infection as
compared to patients on placebo. This finding will require further evaluation.
The Company is conducting various secondary analyses and is planning an experts'
meeting to review the study data in detail and determine potential next steps
for the program.
"`While INS37217 Intranasal continued to demonstrate a strong safety profile, it
did not perform as expected in this PAR trial, compared to consistent positive
results seen in previous Phase I and II trials,' stated Christy L. Shaffer,
Ph.D., Inspire CEO. `We will continue to conduct secondary analyses to determine
future plans for the intranasal program.'
"Inspire will host a conference call today at 10:00 am EDT. Participants in the
United States can access the call by dialing 800-657-1269. Participants outside
the United States may call 973-935-2100. The call will be webcast from Inspire's
website at www.inspirepharm.com.
"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., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd., and
has a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc. Inspire's
products are based on proprietary technology relating to P2Y\\2\\ receptors and
to non-P2Y\\2\\ receptors that show therapeutic promise, including P2Y\\12\\.
"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."
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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, Secretary and Treasurer
Dated: May 20, 2003