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 1934
Date of Report: June 19, 1997
INTERNEURON PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in charter)
DELAWARE
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(State of other jurisdiction of incorporation)
0-18728 043047911
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(Commission File Number) (IRS Employer Identification No.)
One Ledgemont Center, 99 Hayden Avenue, Lexington, Massachusetts 02173
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(Address of principal executive offices) (Zip Code)
Registrant's telephone no. including area code: (617) 861-8444
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ITEM 5. OTHER EVENTS
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On June 19, 1997 Interneuron Pharmaceuticals, Inc. (the "Company") and
Eli Lilly & Co. and Eli Lilly S.A. (collectively "Lilly"), entered into an
agreement relating to the licensing by Lilly from the Company of a use patent
for Lilly's antidepressant ProzacR (fluoxetine hydrochloride). Lilly licensed
from the Company a United States patent and worldwide patent application rights
covering the use of fluoxetine to treat disturbances of appetite and mood
associated with premenstrual syndrome ("PMS"). Prozac is not currently approved
to treat this indication.
The agreement requires Lilly to make certain payments to the Company,
including $1 million within 30 days of execution of the agreement and additional
future payments, which could range from an aggregate of $3 million to $4
million, contingent upon achieving regulatory related milestones, certain of
which are creditable against future royalties. The Company will also be entitled
to royalties based on Net Sales of Prozac use for PMS above a specified baseline
("Annual Excess PMS Sales") of 5% for Annual Excess PMS Sales up to $30 million,
and 20% of Annual Excess PMS Sales over $30 million, subject to maximum annual
payments of $3 million, $4 million and $5 million in the first three calendar
years, respectively, of marketing approval in the United States. Reference is
made to the related press release filed as Exhibit 99.1 hereto, which is
incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
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(c) Exhibits
99.1 Press Release dated June 19, 1997
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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 hereunto duly authorized.
INTERNEURON PHARMACEUTICALS, INC.
By: /s/ Glenn L. Cooper, M.D.
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Glenn L. Cooper, M.D.
President and Chief Executive Officer
Dated: June 20, 1997
FOR IMMEDIATE RELEASE
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CONTACT AT INTERNEURON (617)402-3410: CONTACT AT ELI LILLY (317)276-5795:
WILLIAM B. BONI JAMES P. KAPPEL
VP, CORP. COMMUNICATIONS CORPORATE SPOKESMAN
LILLY LICENSES PROZAC USE PATENT FOR THE POSSIBLE
TREATMENT OF PMS FROM INTERNEURON
LEXINGTON, MA, June 19, 1997 - Eli Lilly and Company (NYSE: LLY) and Interneuron
Pharmaceuticals, Inc. (NASDAQ: IPIC) announced today that they have entered into
an agreement regarding a use patent for Lilly's antidepressant ProzacR
(fluoxetine hydrochloride). Lilly will license from Interneuron the U.S. patent
and worldwide patent application rights covering the use of fluoxetine to treat
disturbances of appetite and mood associated with premenstrual syndrome (PMS).
Prozac currently is not approved to treat this indication.
Under the terms of the agreement, Interneuron will receive upfront fees,
milestone payments and royalties based on potential sales of Prozac in the
United States to treat premenstrual syndrome. In exchange, Lilly wi11 receive
exclusive patent rights from Interneuron.
"Consistent with our commitment to women's health, the licensing of this patent
will allow us to pursue clinical studies which evaluate the effectiveness and
safety of Prozac in treating symptoms of premenstrual syndrome, a condition that
afflicts millions of women during childbearing years," said Gary D. Tollefson,
M.D., Ph.D., a vice president of Lilly Research Laboratories. "This is an
important strategic step in our efforts to explore the potential clinical value
for Prozac in medical disorders where need exists for improved therapeutic
alternatives."
A decade after its first launch, Prozac remains the world's most widely
prescribed brand-name antidepressant. Prozac is available in more than 100
countries for the treatment of depression. It has also been cleared for
marketing in 44 countries for the treatment of obsessive-compulsive disorder and
in 40 countries for the treatment of the eating disorder bulimia nervosa.
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"The patent rights to the use of fluoxetine in treating premenstrual syndrome
are contained in Interneuron's broad patent portfolio licensed exclusively from
the Massachusetts Institute of Technology (MIT)," said Glenn L. Cooper,
president and chief executive officer of Interneuron. "They are based upon
discoveries about the fundamental relationship between brain serotonin
deficiency and unwanted weight gain and mood symptoms."
Prozac was the first medicine available in the U.S. for a class of drugs called
selective serotonin reuptake inhibitors, which increase the available levels of
the brain chemical serotonin. The use of Prozac to treat PMS was discovered by
Judith Wurtman, Ph.D., and Richard J. Wurtman, M.D., scientific founder of
Interneuron, both of MIT. This discovery was based on their earlier finding that
many individuals who gain unwanted weight and suffer from mood symptoms do so
because of an apparent deficiency in brain serotonin and that such people can be
helped by drugs which increase brain serotonin activity, such as serotonin-
reuptake blockers.
Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged
in the development and commercialization of a portfolio of products and product
candidates primarily for neurological and behavioral disorders. Interneuron is
also developing products and technologies, generally outside the central nervous
system field, through four subsidiaries: Intercardia, Inc. focused on
cardiovascular disease; Progenitor, Inc. focused on developmental genomics;
Transcell Technologies, Inc. focused on carbohydrate-based drug discovery; and
InterNutria, Inc. focused on dietary supplement products.
Lilly is a global research-based pharmaceutical corporation headquartered in
Indianapolis, Indiana that is dedicated to creating and delivering innovative
pharmaceutical-based health care solutions which enable people to live longer,
healthier and more active lives.
Except for the descriptions of historical facts contained herein, this news
release contains forward-looking statements that involve risks and uncertainties
as detailed from time to time in Interneuron's SEC filings under the Securities
Act of 1933 and the Securities Exchange Act of 1934, including, in particular,
marketing, safety and regulatory, patent, product liability, supply and other
risks, uncertainties relating to clinical trials, the early stage of products
under development, risks relating to the product launches and managing growth,
government regulation, dependence of third parties and competition.
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