SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_______________________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
_____________________________
Date of report (Date of earliest event reported) November 6, 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 November 6, 2002, Inspire Pharmaceuticals, Inc. issued the following press
release:
"INSPIRE PHARMACEUTICALS ANNOUNCES RESULTS OF PHASE II TRIAL OF INS37217
INTRANASAL FOR TREATMENT OF COMMON COLD
--Third Positive Trial in Intranasal Program--
"DURHAM, NC - November 6, 2002 - Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH)
today announced results from a Phase II clinical trial for INS37217 Intranasal
in patients with upper respiratory infection, i.e., common cold. Results from
the study were positive, demonstrating statistically significant improvement
(p-value * 0.05) compared to placebo in post-nasal drip and malaise at multiple
doses and on multiple days over the 14-day study period. In addition, positive
and consistent trends were demonstrated across multiple other symptoms as
compared to placebo, including improvements in rhinorrhea (runny nose), nasal
congestion, cough, facial pain and pressure and sleep disturbance. INS37217
Intranasal was well tolerated in patients, with no serious drug-related adverse
events reported. Importantly, these results are consistent with the results seen
with INS37217 Intranasal in Phase I/II and Phase II studies of patients with
perennial allergic rhinitis (PAR). INS37217 Intranasal demonstrated activity at
multiple doses; however, the 10mg/ml dose delivered twice daily has consistently
demonstrated the greatest improvement as compared to placebo in three
consecutive studies, and is the dose that will be taken forward for the first
Phase III study of INS37217 Intranasal in patients with PAR, which is targeted
for initiation by the end of 2002.
"'This is the third study of INS37127 Intranasal in which we have seen
statistically significant and clinically meaningful improvement in key upper
respiratory symptoms,' stated Christy L. Shaffer, Ph.D., CEO of Inspire. 'These
results provide strong rationale for progressing this innovative product
candidate rapidly. While the priority planned indication will be for allergic
rhinitis, these results support the potential use of INS37217 Intranasal for a
broad range of upper respiratory disorders that are characterized by congestion,
rhinorrhea, post-nasal drip, facial pain and pressure and other nasal symptoms.'
"The multi-center Phase II study of INS37217 Intranasal in patients with common
cold was a double-blind, placebo-controlled, dose-ranging trial conducted in 101
patients. Patients were dosed for 6 days and symptom scores were recorded for a
total of 14 days.
"Birgit Winther, M.D., D.Sc., Assistant Professor of Otolaryngology at the
University of Virginia and an investigator in the study, stated, 'This nasal
spray is novel in that it appears to improve a variety of nasal symptoms by
enhancing the clearance of nasal secretions. The effects appear most striking in
improving lingering symptoms. This product candidate may have the potential to
reduce the inappropriate use of antibiotics in treating common cold.'
"About Common Cold
"Common cold is caused by a variety of viral pathogens, most commonly rhinovirus
or coronavirus, and is characterized by multiple nasal symptoms including
congestion, rhinorrhea, malaise and sneezing. Colds are the leading reason for
physician visits in the United States resulting in over 60 million visits by
adults and children annually. The duration of cold symptoms is typically 7-11
days, with 25% of patients having symptoms that continue for 2 weeks.
* means less than
"About INS37217 Intranasal
"INS37217 Intranasal is a P2Y\\2\\ agonist designed to enhance mucosal hydration
and mucociliary clearance in airway tissues by activating receptors on the
mucosal surface. It is believed to be potentially useful across a wide variety
of upper respiratory disorders involving impaired nasal clearance, including
rhinosinusitis, allergic rhinitis (both seasonal and perennial) and common cold.
This approach could provide significant benefit to patients without the
potential side effects associated with antihistamines and corticosteroids.
Results from the Phase I/II study of INS37217 Intranasal were announced in March
and will be presented in an oral presentation at the American College of
Allergy, Asthma and Immunology in San Antonio on November 17/th/ at 2:00 pm.
"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 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 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: November 6, 2002