Exhibit 20.1
Contact:
Intercardia:
X. Xxxxxxx Love
0-000-000-0000
Xxxxx XX:
Xxxxxx Xxxxxxxxx
00-000-000-0000
For Immediate Release:
Intercardia and Xxxxx 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/Xxxxx, XX 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 Xxxxx 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 Xxxxx will share
development expenses and operating profits for the commercialization of
bucindolol worldwide outside of the United States, Puerto Rico and Japan.
Additionally, Xxxxx 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
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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 Xxxxx," stated
Xxxxxxx X. Xxxxxx, President and CEO of Intercardia and CPEC. "Xxxxx 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 Xx. Xxxx Xxxxxxxxxx, Member of the Board of Directors at Xxxxx XX. "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 Xxxxx'x 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;
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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.
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