SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) or
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) August 4, 1998
INTERCARDIA, INC.
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(Exact name of registrant as specified in its charter)
Delaware
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(State of other jurisdiction of incorporation)
0-27410 56-1924222
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(Commission file number) (IRS Employer ID Number)
3200 East Highway 54, Cape Fear Building, Suite 300,
Research Triangle Park, North Carolina 27709
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (919) 558-8688
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NA
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(Former name or former address, if changed since last report).
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Item 5. Other Events.
On August 4, Intercardia, Inc., a Delaware corporation (the
"Registrant"), issued the press release attached hereto as Exhibit 99.1.
Item 7. Financial Statements and Exhibits.
(c) Exhibits.
99.1 Press release issued August 4, 1998.
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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.
INTERCARDIA, INC.
Date: August 4, 1998 /s/ Richard W. Reichow
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Richard W. Reichow
Chief Financial Officer
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INDEX TO EXHIBITS
99.1 Press release dated August 4, 1998.
[Intercardia logo appears here]
Intercardia
P.O. Box 14287
3200 East Highway 54
Cape Fear Building, Suite 300
Contact: Research Triangle Park, NC 27709-4287
Intercardia:
W. Bennett Love 919/558-8688
1-919-558-1907 919/558-8686 fax
For Immediate Release:
INTERCARDIA SEEKS RESOLUTION WITH ASTRA
PHARMACEUTICALS OF PRODUCT CONFLICT WITH BEXTRA(R)
COLLABORATION FOR USA
CONFLICT ARISES FROM CORPORATE RESTRUCTURING OF ASTRA MERCK
Research Triangle Park, N.C., USA, August 4, 1998--Intercardia, Inc.,
(Nasdaq;ITRC) has notified Astra Pharmaceuticals, L.P. that Intercardia believes
as a result of the recent restructuring of Astra Merck Inc., Astra
Pharmaceuticals, L.P. has a conflict with the terms of the Astra Merck and
Intercardia collaboration for the commercialization of BEXTRA(R) (bucindolol
HCl) for the treatment of congestive heart failure (CHF) in the United States.
BEXTRA is a non-selective beta-blocker with vasodilating properties that is in
Phase III clinical development for the treatment of congestive heart failure.
The recent restructuring of Astra Merck Inc. resulted in it being combined
with Astra USA, Inc., the U.S. subsidiary of Astra AB of Sweden, into a newly
named unit -- Astra Pharmaceuticals, L.P. Intercardia believes Astra
Pharmaceuticals has a beta-blocker from the previous Astra USA that is currently
on the market for hypertension which is also being investigated for treatment of
heart failure. Intercardia further believes participation by Astra
Pharmaceuticals in development of this product for heart failure in the U.S. is
in violation of the BEXTRA collaboration. The collaboration calls for the
parties to work exclusively with one another in the field of beta-blockers for
the treatment of CHF.
Intercardia and Astra Pharmaceuticals, L.P. are in discussions to resolve
the conflict or terminate the collaboration. Astra Pharmaceuticals has informed
Intercardia it does not believe it is in violation of the agreement. If
termination were to result, the agreement provides for return of all rights,
material and information relating to BEXTRA to Intercardia and a payment to
Intercardia.
"We have built a positive relationship with Astra Merck, but their
restructuring into Astra Pharmaceuticals could create a serious issue for us,"
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stated Clayton I. Duncan, President and CEO of Intercardia. "We want our partner
to be 100% committed to the development and commercialization of BEXTRA for
treatment of CHF and not have a separate commitment to expand the indication of
their current hypertension product to direct competition with BEXTRA in CHF."
"Because we believe Astra Merck to be a good partner, we would be
pleased to continue to work with Astra Pharmaceuticals on BEXTRA under the
current terms of the collaboration," continued Duncan. "However, if their
restructuring results in the termination of our agreement, it could provide an
unexpected opportunity for Intercardia as we would be entitled to receive back
the U.S. rights for a compound in late-stage Phase III clinical trials and a
significant payment."
"BEXTRA has advanced on multiple fronts since Intercardia first
received Astra Merck funding," stated David P. Ward, M.D., Executive Vice
President, Research and Development for Intercardia. "Use of beta blockade in
the treatment of heart failure has grown in acceptance during the past three
years. The BEST Study has progressed from 319 patients under study when we
signed the agreement with Astra Merck in December 1995, to currently over 2,400
patients under study with average follow-up exceeding 19 months. Meanwhile,
Intercardia and Astra Merck have worked 2-1/2 years performing studies and
preparing the NDA to be filed with the FDA."
BEXTRA (bucindolol HCl) is a non-selective beta-blocker with
vasodilating properties in Phase III clinical development for the treatment of
congestive heart failure. The product 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 is designed to test the
hypothesis that the addition of the beta-adrenergic blocking agent bucindolol to
standard therapy will reduce mortality in patients with moderate to severe
congestive heart failure. To date, the BEST study has enrolled over 2,400
patients in 90 medical centers throughout the U.S. and Canada.
Intercardia and BASF Pharm/Knoll AG of Ludwigshafen, Germany, have an
agreement that provides for sharing development expenses and operating profits
for the commercialization of BEXTRA outside the United States and Japan. In
Europe, in addition to being developed for CHF, BEXTRA is being evaluated in the
BEAT Study. The BEAT Study's aim is to evaluate the hypothesis that the addition
of long-term treatment with BEXTRA to best available treatment will improve
long-term survival in patients surviving a recent myocardial infarction with
left ventricular systolic dysfunction.
Congestive heart failure is a condition in which the heart
progressively loses the ability to pump sufficient quantities of blood to meet
the metabolic
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needs of the body. It is estimated that 5.0 million people in Europe and 4.7
million 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.
Intercardia, a majority-owned subsidiary of Interneuron
Pharmaceuticals, Inc. (Nasdaq:IPIC), focuses on drug discovery and clinical drug
development. 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.
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,
including risks related to dependence on collaborative partners, arbitration,
product development, funding of operations, clinical trials, regulatory
approval, competition and market acceptance. For more details 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.
