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
December 7, 1998
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Date of Report (Date of Earliest Event Reported)
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)
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INFORMATION TO BE INCLUDED IN THE REPORT
Item 5. Other Events.
On December 7, 1998, Sepracor Inc. (the "Company") and Eli Lilly and
Company ("Lilly") announced that they had entered into a licensing agreement
relating to R-fluoxetine. A copy of the press release relating to this
announcement is attached hereto as Exhibit 99.1.
The Agreement will become effective on the next business day following the
expiration or earlier termination of any notice and waiting period under the
Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits.
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See Exhibit Index attached hereto.
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SIGNATURES
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 thereunto duly authorized.
Date: December 10, 1998 SEPRACOR INC.
By: /s/ Robert F. Scumaci
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Robert F. Scumaci
Senior Vice President of Finance
and Administration
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EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit
Number Description
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<S> <C>
99.1 Press Release dated December 7, 1998.
</TABLE>
Exhibit 99.1
Lilly and Sepracor Announce Agreement on Next-Generation Antidepressant
INDIANAPOLIS, Dec. 7 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY -
news) and Sepracor Inc. (Nasdaq: SEPR - news), announced today that they have
entered into a license agreement that will enable Lilly to exclusively develop
and globally commercialize R-fluoxetine. R-fluoxetine, a new chemical entity
patented by Sepracor, is a modified form of an active ingredient found in
Prozac. Prozac was the first selective serotonin reuptake inhibitor (SSRI) to
enter the U.S. market more than 10 years ago. It is the world's most widely
prescribed brand-name antidepressant, having been prescribed to more than 35
million people in more than 100 countries with worldwide sales of approximately
$2.6 billion in 1997. R-fluoxetine is currently in Phase I clinical development
in the United States.
"R-fluoxetine is an exciting molecule with a good chance of becoming an
important new advance in treating depression. Despite recent advances in
diagnosing and treating clinical depression, this illness remains a vastly
underdiagnosed and therefore undertreated disease affecting more than 18 million
adults in the U.S. alone," said Sidney Taurel, Lilly president and chief
executive officer. "This licensing agreement with Sepracor, coupled with our
internal progress in developing new antidepressants, will enable Lilly to
introduce new and advanced treatments for this debilitating illness and to build
upon our leadership position in neuroscience products."
R-fluoxetine has been shown in preclinical studies to have the potential to
offer greater flexibility in treating depression compared to currently marketed
antidepressants. In addition, preclinical 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.
Under the terms of the agreement, 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. In addition, 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 all subsequent development work on
R-fluoxetine, regulatory submissions, product manufacturing, marketing and
sales.
"R-fluoxetine represents another significant opportunity to provide important
therapeutic advances through the development of single-isomer and metabolite
versions of existing pharmaceutical products," said Timothy J. Barberich,
Sepracor's president and chief executive officer.
"We believe Sepracor has undertaken some very insightful research toward the
development of a single-isomer version of fluoxetine that may have significant
clinical and commercial potential," said August M. Watanabe, M.D., Lilly
executive vice president, science and technology. "Our success in developing and
marketing Prozac, as well as our overall approach to discovering novel
antidepressants, uniquely qualifies us to take the development of R-fluoxetine
forward."
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 methods of treatment, 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.
Lilly is a global research-based pharmaceutical corporation headquartered in
Indianapolis, Ind., that is dedicated to creating and delivering innovative
pharmaceutical-based health care solutions that enable people to live longer,
healthier and more active lives.
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. As a product in the
earliest 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)
