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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): MAY 14, 1999
SEPRACOR INC.
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(Exact Name of Registrant as Specified in its Charter)
DELAWARE
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(State or Other Jurisdiction of Incorporation)
0-19410 22-2536587
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(Commission File Number) (I.R.S. Employer Identification No.)
111 Locke Drive
MARLBOROUGH, MASSACHUSETTS 01757
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(Address of Principal Executive Offices) (Zip Code)
(508) 481-6700
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(Registrant's Telephone Number, Including Area Code)
NOT APPLICABLE
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(Former Name or Former Address, if Changed Since Last Report)
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ITEM 5. OTHER EVENTS.
On May 14, 1999, Sepracor Inc. issued a press release announcing that
Johnson & Johnson had elected not to exercise its option to co-promote
norastemizole. Sepracor will continue to fund clinical development and marketing
of the drug, which is currently in Phase III clinical trials. A copy of the
press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) EXHIBITS.
See Exhibit Index attached hereto.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Date: May 18,1999 SEPRACOR INC.
By: /S/ ROBERT F. SCUMACI
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Robert F. Scumaci
Senior Vice President, Finance
and Administration
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EXHIBIT INDEX
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EXHIBIT
NUMBER DESCRIPTION
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99.1 Press Release dated May 14, 1999.
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EXHIBIT 99.1
J&J ELECTS NOT TO EXERCISE OPTION TO CO-PROMOTE NORASTEMIZOLE
SEPRACOR TO COMPLETE DEVELOPMENT AND MARKET PRODUCT
MARLBOROUGH, Mass., May 14/PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news),
today announced that Johnson & Johnson (NYSE: JNJ-news) has elected not to
exercise its option to co-promote norastemizole. Sepracor will continue to fund
clinical development and marketing of the drug, which is currently in Phase III
clinical trials. Norastemizole is a third generation nonsedating antihistamine
being developed for seasonal and perennial allergic rhinitis.
Under the terms of the agreement between Sepracor and Johnson and Johnson,
Sepracor has worldwide rights to all Johnson & Johnson intellectual property
covering norastemizole, including the right to reference data from the
astemizole New Drug Application (NDA), for Sepracor's norastemizole NDA filing.
In exchange, Johnson & Johnson will receive a royalty on Sepracor's product
sales.
"We understand that Johnson & Johnson's decision not to market the product was
based primarily on the fact that the respiratory market is not expected to be a
strategic focus for J&J," said Timothy J. Barberich, President and Chief
Executive Officer. "We look forward to norastemizole complementing our
respiratory portfolio, which includes Xopenex inhalation solution and
(R,R)-formoterol."
"In conjunction with other prelaunch activities the Company expects to present
its scientific data concerning norastemizole at upcoming scientific
conferences," said Paul D. Rubin, Executive Vice President, Drug Development and
ICE Research. "Our development program is on track for NDA submission by the end
of 2000."
Sepracor's partnership with Johnson & Johnson on (+)-norcisapride remains
unchanged.
Sepracor is a specialty pharmaceutical company that develops and commercializes
potentially improved versions of widely-prescribed drugs. Referred to as
Improved Chemical Entities ("ICE"), Sepracor's ICE Pharmaceuticals are being
developed as proprietary, single-isomer or active-metabolite versions of these
leading drugs. ICE Pharmaceuticals are designed to offer meaningful improvements
in patient outcome through reduced side effects, increased therapeutic efficacy,
improved dosage forms, and in some cases the opportunity for additional
indications.
This news release contains forward-looking statements that involve risks and
uncertainties, including statements with respect to the safety, efficacy and
potential benefits of the Company's ICE Pharmaceuticals under development. Among
the factors that could cause actual results to differ materially from those
indicated by
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such forward-looking statements are: the timing of filing and approval of NDA's,
the results of the Company's clinical trials with respect to its products under
development; the scope of the Company's patent protection with respect to such
product candidates; the availability of sufficient funds to continue research
and development efforts; and certain other factors that may affect future
operating results and are detailed in the Company's periodic reports filed with
the Securities and Exchange Commission.
Xopenex is a trademark of Sepracor Inc.
To receive a copy of this release or any recent release via fax, call Sepracor's
automated news fax line at 1-800-758-5804 ext. 780960.
