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) January 16, 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 January 16, 2002, Inspire Pharmaceuticals, Inc. issued the following
press release:
"INSPIRE ANNOUNCES PRELIMINARY RESULTS IN FIRST PHASE III CLINICAL TRIAL OF
INS365 OPHTHALMIC FOR THE TREATMENT OF DRY EYE
"DURHAM, NORTH CAROLINA - January 16, 2002 - Inspire Pharmaceuticals, Inc.
(Nasdaq: ISPH) announced today top line preliminary efficacy results from the
first of two Phase III clinical trials for INS365 Ophthalmic eye drops for the
treatment of dry eye. These preliminary results indicate that INS365 Ophthalmic
did not meet the primary efficacy objectives of the study. While patient
improvement on INS365 Ophthalmic was clearly observed, and was similar to that
observed in the Phase II study, there was an improvement of similar magnitude
observed in the placebo group. The trial was a placebo-controlled, double-masked
comparison of the safety and efficacy of INS365 Ophthalmic to placebo, at
concentrations of 1% and 2%. This first of two Phase III studies enrolled 558
patients in 35 sites across the United States. The second Phase III study is
ongoing, and efficacy results are expected in the second quarter of this year.
The company will make a decision on whether or not to continue the program when
the results of the second Phase III trial are available.
" `We are clearly disappointed by the results of this first Phase III trial,'
stated Christy L. Shaffer, President and CEO of Inspire. `The placebo effect in
this trial was greater than in our Phase II trial, and we will be continuing to
analyze these preliminary data in the coming weeks to determine whether there
are factors that influenced these preliminary results.'
"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 six product candidates in clinical development, and
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
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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."
A live webcast of our conference call on January 16th at 9:15 am Eastern and a
replay for 14 days after will be available at
http://www.videonewswire.com/Inspire/011602/.
* * * * *
During the January 16, 2002 conference call, Inspire indicated that it will
continue to review the data from the first Phase III clinical trial for INS365
Ophthalmic eye drops, while the safety extension portion of the study continues;
that the safety extension may also include additional efficacy data; that it
intends to review the results of the second Phase III clinical trial with its
partner, Allergan Inc., prior to making any decisions about the future of the
dry eye program; that the company does not currently have any financing plans;
and that it does not intend to make any changes in staffing levels at this time.
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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,
Senior Vice President and
Chief Business Officer
Dated: January 16, 2002