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: July 3, 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 July 3, 1997 Interneuron Pharmaceuticals, Inc. ("Interneuron"),
Transcell Technologies, Inc., a majority-owned subsidiary of Interneuron
("Transcell") and Merck and Co., Inc. ("Merck") entered into a Research
Collaboration and License Agreement effective as of June 30, 1997 (the "Merck
Agreement") relating to the discovery, development and commercialization of
novel antibacterial agents. The Merck Agreement contemplates research programs
for the synthesis and biological evaluation of antibacterial compounds selected
from two distinct structural classes and the license to Merck of products
arising from either program. The Merck Agreement provides for payments to
Transcell of $1,500,000 in connection with the execution of the agreement,
$1,000,000 for an option to expand the field of the license to include all
antibacterial agents, $750,000 per year for two years research support, and
additional payments based upon the achievement of defined, mostly late-stage
clinical development and regulatory milestones for compounds and products
generated from the research programs. While there is no assurance these
milestones will be reached, these additional payments could total $45,000,000 if
a product from each of the two research programs receives approval for marketing
from the Food and Drug Administration.
Transcell will also be entitled to royalties on Net Sales, as defined in
the Merck Agreement, ranging from 6% to 10% of Net Sales of Licensed Products
covered by Valid Patent Claims, and from 3% to 5% of Net Sales of other
products. Fifty percent (50%) of certain milestone payments are creditable
against royalties.
Certain of the rights licensed to Merck are based on exclusive licenses or
rights held by Transcell and Interneuron from Princeton University and
Interneuron is currently sponsoring research at Princeton relating to one of the
research programs. To the extent products developed and milestones achieved
under the Merck Agreement are based on these rights, Princeton will be entitled
to varying percentages of the payments and/or royalties received from Merck.
Merck has the right to terminate the Merck Agreement at any time with 90 days
notice.
Statements in this Form 8-K that are not descriptions of historical facts
are forward-looking statements that are subject to risks and uncertainties.
Actual results could differ materially from those currently anticipated due to a
number of factors, including those set forth in Interneuron's filings under the
Securities Act of 1933 and under the Securities Exchange Act of 1934 under "Risk
Factors" and elsewhere, including, in particular, risks relating to product
development and commercialization; the early stage of products under
development; marketing risks, revenue fluctuations, safety, regulatory,
competition, patent, product liability, supply and other risks; uncertainties
relating to clinical trials; manufacturing and supply risks; dependence on third
parties and risks related to contractual agreements.
Reference is made to Interneuron's press release dated July 7, 1997 filed
as Exhibit 99.1 hereto and incorporated by reference herein.
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ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
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(c) Exhibits
99.1 Press Release dated July 7, 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
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Glenn L. Cooper, M.D.
President and Chief Executive Officer
Dated: July 7, 1997
FOR IMMEDIATE RELEASE
CONTACT AT INTERNEURON, (617)-402-3410:
WILLIAM B. BONI
VP, CORP. COMMUNICATIONS
CONTACT AT TRANSCELL, (609)-655-6900:
VINCENT L. FABIANO
EXECUTIVE VP AND COO
TRANSCELL AND MERCK ENTER INTO
ANTI-BACTERIAL RESEARCH COLLABORATION
LEXINGTON, MA and PRINCETON, NJ, July 7, 1997 - Transcell Technologies, Inc., a
majority-owned subsidiary of Interneuron Pharmaceuticals, Inc. (NASDAQ: IPIC)
and Interneuron today announced that they have entered into a collaborative
research and licensing agreement with Merck & Co., Inc. (NYSE: MRK) to discover
and commercialize novel antibacterial agents.
The initial focus of this collaboration will be the discovery and biological
evaluation of analogues of anti-bacterial compounds selected from two distinct
structural classes and the license to Merck of any products arising out of the
two research programs. Transcell will utilize its combinatorial technologies to
prepare libraries of carbohydrate derivative compounds for biological evaluation
and further development. Additionally, Merck has an option to extend the field
of the collaboration and license to include all antibacterial pharmaceutical
products.
Under this agreement, Transcell receives from Merck an initial licensing payment
and research support over two years. In addition, Transcell will receive
additional payments based upon the achievement of defined milestones for each
program. While there is no assurance these milestones will be reached, these
additional payments, combined with the initial licensing payment and research
support, could total approximately $48,000,000 if products from both programs
were approved by the FDA. In addition, Transcell would receive royalty payments
on sales of any products that may be developed based on the research programs.
Certain of the rights licensed to Merck are based on exclusive licenses or
rights held by Transcell and Interneuron from Princeton University, which will
be entitled to varying percentages of certain payments and royalties received
from Merck. Transcell's combinatorial
carbohydrate technology is based upon the research of its scientific founders,
Dr. Daniel Kahne and Dr. Suzanne Walker of Princeton University.
"Merck's recognition that Transcell's platform of synthetic chemistries and
combinatorial technologies can add significant value to its antibacterial drug
discovery programs is a very important step in our development of the technology
for drug discovery in several therapeutic areas," said Vincent L. Fabiano,
executive vice president and chief operating officer of Transcell. "We are
pleased to have Merck as our first drug discovery partner. Our partnership,
which initially will provide Merck access to libraries of new analogues of two
antibiotics, has the potential for expansion into the broad field of
antibacterial drug discovery."
Transcell Technologies, a majority-owned subsidiary of Interneuron
Pharmaceuticals, is exploiting the molecular diversity of carbohydrates to
discover novel small molecule pharmaceutical products.
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 three other subsidiaries: Intercardia, Inc. focused on
cardiovascular disease, Progenitor, Inc. focused on developmental genomics, and
InterNutria, Inc. focused on dietary supplement products.
Except for the descriptions of historical facts contained herein, this 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 under "Risk Factors" that could
cause Interneuron's actual results to differ significantly from those discussed
in the forward-looking statements, including the early stage of development of
Transcell's technology, uncertainties related to pre- clinical development,
corporate collaborations, clinical trials, patent risks, government regulation,
and dependence on third parties for manufacturing and marketing.
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