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) April 24, 2001
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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 April 24, 2001, Inspire Pharmaceuticals, Inc. issued the following press
release:
"INSPIRE PHARMACEUTICALS, INC. PROVIDES UPDATE ON PHASE II TRIAL OF
INS365 RESPIRATORY FOR CHRONIC BRONCHITIS
"DURHAM, NORTH CAROLINA - April 24, 2001- Inspire Pharmaceuticals, Inc. (Nasdaq:
ISPH) announced today a decision to temporarily suspend enrollment of new
patients in the double-blind, placebo-controlled, multicenter Phase II trial of
INS365 Respiratory for chronic bronchitis, in order to further evaluate the
protocol design. All patients currently enrolled in the trial will continue to
receive INS365 Respiratory or placebo through completion of the study.
"'We are working closely with Genentech to analyze and review the protocol
design and data from patients currently enrolled in the trial. This analysis is
intended to provide information that will ensure optimal design and conduct of
the remainder of the Phase II program. We are keeping the FDA well informed,'
said Don Kellerman, Pharm.D., Senior Vice President of Development at Inspire.
"Inspire and Genentech have an ongoing collaboration to develop treatments for
respiratory disorders with significant unmet medical need, including chronic
bronchitis, cystic fibrosis and sinusitis. In addition to the chronic bronchitis
clinical program, an initial Phase I study of INS37217 Respiratory for the
treatment of cystic fibrosis has been completed.
"Chronic bronchitis is a serious and potentially life-threatening lung disease
caused primarily by environmental factors such as smoking and pollution. It
involves excessive retention of mucus as well as inflamed airways leading to
impaired mucociliary clearance causing patients to experience frequent
respiratory infections. In the United States there are approximately 13 million
patients diagnosed with chronic bronchitis. If left untreated, these patients
experience progressive deterioration in lung function that can eventually result
in respiratory failure and death. It is the fourth leading cause of death in the
United States with increasing rates of morbidity and mortality.
"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 respiratory and ophthalmic diseases with
inadequate current treatments and which represent large therapeutic market
opportunities. Inspire has four product candidates in clinical development, and
has entered into development and commercialization alliances with Genentech,
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 U.S. Food and Drug Administration. Further
information regarding factors that could affect the Company's results is
included in the Company's filings with the Securities and Exchange Commission.
The Company 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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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,
Senior Vice President and
Chief Business Officer
Dated: April 24, 2001