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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
Date of Report (Date of earliest event reported): April 13, 2000
SEPRACOR INC.
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(Exact name of registrant as specified in its charter)
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DELAWARE 0-19410 22-2536587
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(State or other jurisdiction (Commission File Number) (IRS Employer Identification No.)
of incorporation)
111 Locke Drive
Marlborough, MA 01752
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(Address of principal (Zip Code)
executive offices)
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Registrant's telephone number, including area code: (508) 481-6700
N/A
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(Former name or former address, if changed since last report)
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Item 5. Other Events.
On April 13, 2000, Sepracor Inc., a Delaware corporation (the
"Company"), issued a press release announcing that the Federal Trade Commission
closed its investigation under the Hart-Scott-Rodino Antitrust Improvements Act
of 1976, as amended, of a license agreement (the "Lilly Agreement") with Eli
Lilly and Company ("Lilly") under which the Company granted to Lilly exclusive
worldwide rights to the Company's patent covering (R)-fluoxetine. A copy of the
press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
The Lilly Agreement became effective on April 14, 2000.
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: April 20, 2000 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
NO. DESCRIPTION
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99.1 Press Release dated April 13, 2000.
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EXHIBIT 99.1
LILLY AND SEPRACOR ANNOUNCE COMPLETION OF FTC REVIEW;
(R)-FLUOXETINE LICENSE AGREEMENT TO BECOME EFFECTIVE
MARLBOROUGH, Mass., April 13 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news)
announced today that the Federal Trade Commission (FTC) has closed its
investigation, under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, of
the license agreement that allows Eli Lilly and Company to exclusively develop
and globally commercialize (R)-fluoxetine. (R)-Fluoxetine, a new chemical
entity, is a modified form of an active ingredient found in Prozac(R).
"We are pleased that the FTC has concluded its HSR review of the agreement with
Lilly for (R)-fluoxetine. Upon closing of the transaction, Sepracor will receive
an up-front milestone payment and license fee of $20 million. The Company will
also receive up to $70 million in additional milestone payments based on the
progression of (R)-fluoxetine through development," said Timothy J. Barberich,
Sepracor's Chairman and Chief Executive Officer. "We believe that (R)-fluoxetine
represents a significant opportunity to provide an important therapeutic advance
over existing therapies through applying the single-isomer strategy."
In addition to the up-front milestone payment and license fee and additional
milestone payments, Sepracor will receive royalties on (R)-fluoxetine worldwide
sales beginning at product launch. In exchange, Lilly will receive exclusive,
worldwide rights to (R)-fluoxetine for all indications and uses. Lilly will be
responsible for developmental work on (R)-fluoxetine, regulatory submissions,
product manufacturing, marketing and sales.
- (R)-Fluoxetine has been shown in preclinical and clinical studies to
have the potential to offer greater flexibility in treating depression
compared to currently marketed antidepressants. In addition, clinical
data suggest that (R)-fluoxetine has the potential to provide
treatment benefits in a broader range of patients and for a broader
range of indications than most currently available antidepressants,
including Prozac.
Based on current regulatory guidelines, Lilly hopes to complete the clinical
studies needed to thoroughly evaluate (R)-fluoxetine by 2001 with regulatory
submissions taking place at that time. Sepracor's patent portfolio for
(R)-fluoxetine includes a U.S. method-of-use patent covering (R)-fluoxetine as
an antidepressant that expires in 2015 and several other patent filings covering
unique formulations and manufacturing processes.
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 leading
drugs. ICE pharmaceuticals are designed to offer meaningful improvements in
patient outcomes through reduced side effects, increased therapeutic efficacy,
improved dosage forms and, in some cases, the opportunity for additional
indications.
This release contains forward-looking statements that reflect management's
current views of the scientific and commercial potential of the (R)-fluoxetine
molecule. The information is based on management's current expectations but
actual results may differ materially due to various factors.
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As a product in the early stages of clinical development, its success is subject
to a number of risks and uncertainties, including the successful outcome of
clinical trials; the timely receipt of regulatory approvals; the clinical
profile and pricing of competitive products; market conditions; and those
outlined in Lilly and Sepracor filings with the SEC.
Prozac(R) (fluoxetine hydrochloride, Dista)
To receive a copy of this release or recent releases via fax, call Sepracor's
automated new fax line at 1-800-758-5804 ext. 780960.
