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: December 19, 1996
INTERNEURON PHARMACEUTICALS, INC.
---------------------------------
(Exact name of registrant as specified in charter)
DELAWARE
--------
(State of other jurisdiction of incorporation)
0-18728 043047911
------- ---------
(Commission File Number) (IRS Employer Identification No.)
One Ledgemont Center, 99 Hayden Avenue, Lexington, Massachusetts 02173
- ---------------------------------------------------------------- -----
(Address of principal executive offices) (Zip Code)
Registrant's telephone no. including area code: (617) 861-8444
Item 5. Other Events
------------
In December 1996, Intercardia, Inc., a majority-owned subsidiary of the
Registrant ("Intercardia"), CPEC, Inc., a majority-owned subsidiary of
Intercardia ("CPEC") and Knoll A.G. ("Knoll"), entered into an agreement
relating to the development and commercialization of bucindolol for the
treatment of congestive heart failure outside the United States and Japan (the
"Foreign Territory"). The agreement requires Knoll to make certain payments to
CPEC, including $2 million upon execution of the agreement and $1 million in
January 1997, as well as future payments contingent upon achieving regulatory
and net sales related milestones. Knoll and Intercardia will share the
development and marketing costs of bucindolol in the Foreign Territory and CPEC
will be entitled to 40% of net profits (and responsible for 40% of net losses)
of the product in the Foreign Territory. Knoll has the right to terminate this
agreement at any time prior to termination of the BEST Study and within 60 days
after the BEST Study's primary end-point results are reported in writing to
Knoll. Reference is made to the related press release filed as Exhibit 20.1
hereto, which is incorporated by reference herein.
In December 1996, Progenitor, Inc. ("Progenitor"), a majority-owned
subsidiary of the Registrant, entered into a license agreement with Amgen, Inc.
("Amgen") granting Amgen certain exclusive rights for the development and
commercialization of products using Progenitor's leptin receptor technology. The
agreement provides for payment of a $500,000 licensing fee to Progenitor upon
execution of the agreement, for Amgen to purchase up to $5.5 million of
Progenitor Common Stock in the event of a Progenitor initial public offering
meeting specified conditions and for development and regulatory milestone
payments to Progenitor, plus potential royalties on product sales. Reference is
made to the related press release filed as Exhibit 20.2 hereto, which is
incorporated by reference herein.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
------------------------------------------------------------------
(c) Exhibits
20.1 Press Release dated December 19, 1996
20.2 Press Release dated January 6, 1997
-2-
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
--------------------------------
Glenn L. Cooper, M.D.
President and Chief Executive Officer
Dated: January 6, 1997
Exhibit 20.1
Contact:
Intercardia:
W. Bennett Love
1-919-558-1907
Knoll AG:
Monika Enzenbach
49-621-589-2319
For Immediate Release:
Intercardia and Knoll Announce Agreement for International
Development of Heart Failure Drug
Research Triangle Park, N.C., USA, December 19, 1996 -- Intercardia,
Inc., (Nasdaq:ITRC) and BASF Pharma/Knoll, AG of Ludwigshafen, Germany,
announced today the execution of a binding Agreement for the development and
commercialization of bucindolol for the treatment of congestive heart failure
(CHF) for areas outside the United States and Japan. The Agreement sets forth
the basic terms and conditions upon which Intercardia, CPEC, Inc. and Knoll have
completed a definitive License Agreement. CPEC, which owns the rights to
bucindolol, is an 80% owned subsidiary of Intercardia.
Under the terms of the Agreement, Intercardia/CPEC and Knoll will share
development expenses and operating profits for the commercialization of
bucindolol worldwide outside of the United States, Puerto Rico and Japan.
Additionally, Knoll will make initial payments of $3 million and will make
future payments of up to $20 million upon the achievement of product approval
and sales milestones.
Bucindolol is a non-selective beta-blocker with vasodilating properties
in Phase III clinical development for the treatment of congestive heart failure.
In Phase II clinical trials, bucindolol produced improvements in left
ventricular function and in the signs and symptoms of CHF. Bucindolol is
currently being evaluated in the Beta-blocker Evaluation of Survival Trial
(BEST), a NIH/VA sponsored Phase III mortality study initiated in June 1995. The
BEST study has now enrolled approximately 1,389 CHF patients. Intercardia/CPEC
has an agreement for the development and commercialization of bucindolol in the
United States with Astra Merck, Inc.
Congestive heart failure is a condition in which the heart
progressively loses the ability to pump sufficient quantities of blood to meet
the metabolic needs of the body. It
-1-
is estimated that 4.5 million people in Europe and 3.5 million people in the
United States are afflicted. CHF is the most common reason for hospitalization
in patients over the age of 65 in the U.S. and Europe.
"We are pleased to enter into this collaboration with Knoll," stated
Clayton I. Duncan, President and CEO of Intercardia and CPEC. "Knoll has a long
and distinguished history in developing cardiovascular drugs and is a market
leader in Europe, especially with Isoptin(R) (verapamil). They are committed to
continuing this successful route into the future as evidenced by the recent
launch of the fixed combination of verapamil and the ACE inhibitor
trandolapril."
"The collaboration with Intercardia gives us access to a new and
innovative treatment of the cardiovascular disease congestive heart failure,"
states Dr. Dirk Wuppermann, Member of the Board of Directors at Knoll AG. "With
the beta-blocker bucindolol we are able to complement our existing products
portfolio for cardiology with Isoptin(R) (verapamil), Gopten(R)/Mavik(R)
(trandolapril) and Tarka(R) (verapamil + trandolapril) for hypertension.
Furthermore, with this product we will be among the first entering this new area
of non-selective, vasodilating beta-blocker therapy for congestive heart
failure. The cooperation concerning bucindolol underlines Knoll's dedication to
the cardiovascular area and its future commitment in this indication."
Intercardia, a majority-owned subsidiary of Interneuron
Pharmaceuticals, Inc. (Nasdaq:IPIC), focuses on late stage discovery and
development of therapeutics for the treatment of cardiovascular and pulmonary
disease. The Company's strategy is to develop and add value to in-licensed
products and sponsored research programs and to enter into collaborations and
licensing agreements with corporate partners for final product development,
manufacturing and marketing.
BASF Pharma researches, develops, manufactures and markets drugs. The
main research areas consist of cardiovascular disease, the central nervous
system, oncology/immunology and metabolism including antiobesity. Top BASF
Pharma sellers include the calcium channel blocker verapamil (trade name
Isoptin(R)) and the thyroid drug Synthroid(R) which is sold exclusively in the
USA and Canada. Promising future products include sibutramine, a drug to treat
obesity and diseases associated with being overweight, Tarka(R), an
antihypertensive drug and MAK 195F, a monoclonal anti- TNF antibody for
treatment of septic shock. The last of BASF Pharma's four top priority projects
is ancrod, a drug for ischemic stroke.
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's lead products include: Redux(TM) for obesity, currently marketed
by American Home Products and co-promoted by Interneuron; citicoline for stroke,
in Phase 3 clinical trials;
-2-
and bucindolol for congestive heart failure, in Phase 3 clinical trials through
Intercardia. Interneuron's other subsidiaries include: Progenitor, Inc. focused
on gene discovery through developmental biology, Transcell Technologies, Inc.
focused on carbohydrate- based drug discovery, and InterNutria, Inc. focused on
dietary supplement products.
The statements in this press release that are not purely statements of
historical fact are forward-looking statements that are subject to factors that
could cause the actual results to differ materially from those projected. For
more detail regarding these factors, see Intercardia's SEC filings. Readers are
cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. The company assumes no obligation to update
the information in this release.
-3-
Exhibit 20.2
CONTACTS:
For Amgen Media Inquiries: For Progenitor:
- -------------------------- ---------------
David Kaye Douglass B. Given, M.D., Ph.D.
Assoc. Director of Corp. Communications President and Chief Executive
Amgen, Inc. Officer
Tel: (805) 447-6692 Progenitor, Inc.
Tel: (614) 488-6688
For Amgen Investor Relations: For Interneuron:
- ----------------------------- ----------------
Ron Renaud William B. Boni
Assoc. Manager, Investor Relations Vice President, Corp.
Communications
FOR IMMEDIATE RELEASE
AMGEN AND PROGENITOR SIGN LEPTIN RECEPTOR AGREEMENT
Thousand Oaks, CA and Columbus, OH January 6, 1997 -- Amgen Inc. (NASDAQ: AMGN)
and Progenitor, Inc., a majority-owned subsidiary of Interneuron
Pharmaceuticals, Inc. (NASDAQ: IPIC), announced today that they have entered
into a license agreement granting Amgen certain exclusive rights for the
development and commercialization of products using Progenitor's leptin receptor
technology.
The agreement provides for payment of a $500,000 licensing fee to Progenitor,
and also for Amgen to purchase $5.5 million of Progenitor Common Stock in the
event of a Progenitor public offering. In addition, the agreement provides for
development and regulatory milestone payments to Progenitor, which could total
$22 million with the successful development and worldwide launch of a first
product, plus potential royalties on product sales. Additional milestone and
royalty payments could be made to Progenitor related to the development and
commercialization of a subsequent product.
Under the terms of the agreement, Amgen gains an exclusive worldwide license to
develop and commercialize Progenitor's leptin receptor technology for human
therapeutic, diagnostic and prophylactic uses. Progenitor retains exclusive
rights to the leptin receptor technology for ex vivo ligand screening, small
molecule screening and cell sorting. Progenitor also retains exclusive rights
for all human uses of leptin receptor DNA anti-sense molecules, and in vivo
human uses of leptin receptor-specific antibodies, plus certain other
co-exclusive rights to the licensed leptin receptor technology.
- MORE -
- 2 -
"This agreement confirms Amgen's commitment to develop effective treatments for
severe obesity, based on a thorough understanding of its biology. We are
extremely pleased to have the opportunity to explore the potential role of the
leptin receptor in the treatment of this disease, and we are happy that
Progenitor has selected Amgen to be its licensee," said Gordon Binder, Amgen's
chairman and chief executive officer.
"We are pleased to have Amgen's commitment to the evaluation and development of
the therapeutic potential of our leptin receptor technology, a lead discovery
from our developmental biology approach to functional genomics," remarked
Douglass B. Given, MD, PhD, president and chief executive officer of Progenitor.
"Amgen enjoys unparalleled success in development and commercialization of
recombinant proteins, and has taken a leadership role in leptin research. We see
this agreement with Amgen as the ideal vehicle for development of initial
pharmaceutical applications of this important genomics achievement, as we
explore additional product development opportunities in our retained fields,"
Dr. Given added.
Leptin is a naturally-occurring hormone produced by fat cells. It is thought
that leptin helps control the amount of body fat, and overall body weight, by
regulating appetite and metabolism. In May 1996, Amgen began the initial human
clinical trial of leptin to evaluate the safety and tolerability of the hormone
across a variety of weight categories.
Recently, Progenitor scientists, led by H. Ralph Snodgrass, Ph.D., vice
president, research and chief scientific officer, reported additional effects of
leptin, including receptor-mediated roles for leptin in the formation of blood
and immune cells from bone marrow. Their data suggest that leptin receptors
potentially may be used to sort immature blood cells and create sub-populations
of cells with desired characteristics for therapeutic applications.
Amgen is a global biotechnology company that discovers, develops, manufactures
and markets human therapeutics based on advances in cellular and molecular
biology.
Progenitor is a functional genomics company engaged in the discovery,
characterization and validation of novel genes, receptors and related proteins
as therapeutic leads and targets for the treatment of major diseases. The
company's functional genomics approach combines expertise in developmental
biology with molecular biology techniques and bioinformatics to accelerate the
discovery process.
Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged
in the development and commercialization of a portfolio of products and product
candidates
- MORE -
-3-
primarily for neurological and behavioral disorders. Interneuron's lead products
include: Redux(TM) for obesity, currently marketed by American Home Products and
co-promoted by Interneuron; citicoline for stroke, in Phase 3 clinical trials;
and bucindolol for congestive heart failure, in Phase 3 clinical trials through
Intercardia, an Interneuron subsidiary focused on cardiovascular disease.
Interneuron's other subsidiaries include Transcell Technologies, Inc., focused
on carbohydrate- based drug discovery; and InterNutria, Inc., focused on dietary
supplement products.
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 Amgen's and in Interneuron's SEC filings under
the Securities Act of 1933 and the Securities Exchange Act of 1934, including
the early stage of development of Progenitor's technology; need for additional
funds; patent, regulatory, and competitive risks; dependence on third parties;
product liability; and other risks.
###
