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) June 18, 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 June 18, 2002, Inspire Pharmaceuticals, Inc. issued the following
press release:
"INSPIRE PHARMACEUTICALS ANNOUNCES RESULTS OF SECOND
PHASE III TRIAL OF INS365 OPHTHALMIC FOR THE TREATMENT OF DRY EYE
Highly statistically significant result achieved on primary objective endpoint
Strong and consistent results demonstrated on multiple subjective endpoints
"DURHAM, NORTH CAROLINA - June 18, 2002 - Inspire Pharmaceuticals, Inc. (Nasdaq:
ISPH) today announced results of the second Phase III clinical trial for INS365
Ophthalmic for the treatment of dry eye.
"Inspire will be holding a conference call/webcast at 9:00 am EDT. Participants
in the United States may call 888-785-8522. Participants outside the United
States may call 706-679-3437. The conference call webcast can be accessed from
Inspire's website (www.inspirepharm.com).
"This six-month study was a double-masked comparison of the safety and efficacy
of INS365 Ophthalmic 1.0% and 2.0% eye drops to placebo. This study enrolled 527
patients at 34 sites across the United States. In this trial, 03-105, INS365
Ophthalmic 2.0% eye drops demonstrated a highly statistically significant
improvement (p-value (0.001) over placebo for the primary objective endpoint,
corneal staining. As well as achieving statistically significant results at the
primary 6-week endpoint, statistical significance was achieved as early as 2
weeks and was consistently observed throughout the 24-week study. This result is
strongly supported by statistically significant results in other secondary
objective endpoints such as conjunctival staining. These results are consistent
with the results observed in the Phase II trial, 03-103.
"The primary subjective endpoint for the study, clearing of the ocular symptom
of foreign body sensation at six weeks, did not meet but approached statistical
significance. The number of patients who cleared foreign body sensation was
consistently higher on treatment compared to placebo throughout the study
period. Moreover, there was a statistically significant improvement on this
endpoint in favor of INS365 Ophthalmic at other time points for the greater than
80% of patients who complied with the protocol. In addition, INS365 Ophthalmic
showed statistically significant improvements compared to placebo on various
other ocular symptoms at multiple time-points.
"INS365 Ophthalmic continues to demonstrate an excellent safety profile. Results
from the safety analysis show a safety profile comparable to placebo. Of the 527
patients enrolled, 458 completed the study through 6 months. There were no
serious drug-related adverse events reported in the study. There were more
patient withdrawals due to adverse events in the placebo group than in either
treatment group.
"Importantly, Inspire also announced today that enrollment in the third Phase
III pivotal trial, 03-108, is over one-third complete. This trial which compares
placebo to INS365 Ophthalmic 2.0% was launched in April 2002 and is being
conducted in a controlled adverse environment (CAE) that
controls for factors such as humidity and involves precise measurements of
patients' signs and symptoms of dry eye. As planned, to ensure that seasonal
fluctuations in humidity do not impact the study, enrollment was halted for the
summer months and will resume in the fall of this year. Top-line results from
this trial are expected in the first quarter of 2003.
" 'We are extremely pleased with the results of this study. The corneal staining
results, an important measure of the drug's efficacy, are overwhelmingly
positive throughout the entire study,' stated Christy L. Shaffer, Ph.D., Chief
Executive Officer of Inspire. 'The Food and Drug Administration has been helpful
in providing clear guidance in this important program, and we look forward to
discussing these results with the Agency to determine the requirements for a New
Drug Application filing, so that we can continue aggressively moving this
program through the clinical and regulatory paths to market.'
"Dry eye is a painful, burning and irritating condition involving abnormalities
and deficiencies in the tear film due to a variety of causes. It is one of the
most frequent patient complaints reported to ophthalmologists, and there are
currently no FDA-approved, pharmacologically active treatments for this common
condition.
"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. 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.
"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: June 18, 2002