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 20, 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 June 20, 2001, Inspire Pharmaceuticals, Inc. issued the following
press release:
"GENENTECH, INC. RETURNS TO INSPIRE PHARMACEUTICALS, INC. RIGHTS TO RESPIRATORY
PROGRAMS IN CHRONIC BRONCHITIS, CYSTIC FIBROSIS AND SINUSITIS
"DURHAM, NORTH CAROLINA - June 20, 2001 - Inspire Pharmaceuticals, Inc. (Nasdaq:
ISPH) announced today the reacquisition at no cost of all rights from Genentech
to P2Y2 agonist compounds for the treatment of respiratory disorders with
significant unmet medical needs including INS365 Respiratory for chronic
bronchitis and INS37217 Respiratory for cystic fibrosis and sinusitis. The
rights were originally granted by Inspire to Genentech in a December 17, 1999
license agreement. The decision to return all rights to these products to
Inspire was based on a strategic review by Genentech of its overall development
portfolio and competing priorities. Inspire has received a total of more than
$16 million in equity investments and cash payments from Genentech since the
partnership was established.
"Patient enrollment in the INS365 Respiratory Phase II program in chronic
bronchitis was suspended in late April in order to evaluate protocol design
issues. All patients enrolled in the trial were allowed to continue to receive
INS365 Respiratory or placebo through completion of the study. The study remains
blinded while patient data are being compiled. Unblinded data analysis is
expected to become available within the next several weeks. Inspire's expert
chronic bronchitis clinical advisory board will review this information.
Following this review, appropriate next steps in the program will be determined.
"An initial Phase I study of INS37217 Respiratory for the treatment of cystic
fibrosis has been successfully completed. A Phase I/II trial in adult and
pediatric CF patients has recently been initiated and the product has been
granted orphan drug designation by the FDA. In addition, it is expected that an
IND filing and initiation of a Phase I study for INS37217 Respiratory in
Sinusitis, Inspire's sixth clinical program, will occur in the third quarter of
2001.
"'Our collaboration with Genentech has been productive for both companies,' said
Christy L. Shaffer, Ph.D., President and Chief Executive Officer of Inspire.
'Though this news is unexpected and disappointing, we are very pleased to be
regaining rights to these potentially valuable and important products. Inspire
has the resources to move these programs aggressively forward to add substantial
value to the company. Not only is our development pipeline broad and deep, our
financial status is sound. Our ophthalmology clinical programs in dry eye (Phase
III) and retinal disease (Phase I/II) are progressing well, our INS316
Diagnostic program has entered Phase III development, and we have the
expectation of initiating a seventh clinical program, this one in vaginal
dryness, within the next 12 months.'
"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 five product candidates in
clinical development, and has entered into development and commercialization
alliances with 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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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: June 20, 2001