[Intercardia logo appears here]
Intercardia
P.O. Box 00000
0000 Xxxx Xxxxxxx 00
Xxxx Xxxx Xxxxxxxx, Xxxxx 000
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000-4287
919/558-8688
919/000-0000 fax
Contact:
Intercardia:
X. Xxxxxxx Love
000-000-0000
Astra Pharmaceuticals
Xxxx X. Xxxxxx
000-000-0000
For Immediate Release:
INTERCARDIA AND ASTRA PHARMACEUTICALS END AGREEMENT FOR COLLABORATION ON
BEXTRA(R)
Competing product arises from corporate restructuring of Astra Merck
Research Triangle Park, N.C., USA, and Xxxxx, PA. September 30, 1998
-- Intercardia, Inc. (Nasdaq:ITRC) and Astra Pharmaceuticals, L.P. (formerly
Astra Merck, Inc.) announced today termination of an agreement for the U.S.
development and commercialization of BEXTRA(R) (bucindolol HCl), a
cardiovascular drug presently under investigation for the treatment of
congestive heart failure. Due to a non-compete clause in the original
agreement between the two companies, Intercardia will now assume
responsibility for the U.S. development and commercialization for BEXTRA.
On July 1, 1998, Astra AB and Merck & Co., Inc. signed an agreement to
restructure Astra Merck's business and combine it with Astra's wholly-owned
subsidiary, Astra USA, Inc., in a new limited partnership in which Astra has
management control as the general partner. The new company, Astra
Pharmaceuticals, L.P. now has an expanded product line which includes the
once-daily beta blocker Toprol-XL(R) (metoprolol succinate) which is indicated
for treating hypertension and angina and is also being investigated for
treatment of heart failure. Since metoprolol and bucindolol are both beta
blockers being investigated for heart failure, Astra Pharmaceuticals and
Intercardia agreed to terminate the collaboration in light of a non-compete
clause in their original agreement. Xxxxx will be returning to Intercardia all
rights, material and information relating to bucindolol as well as a termination
fee.
"Xxxxx Xxxxx has been a good partner and very professional throughout our
relationship. Nevertheless, we believe termination of the BEXTRA Collaboration
presents an unexpected opportunity for Intercardia," stated Xxxxxxx X. Xxxxxx,
President and CEO of Intercardia. "We regain the U.S. rights for the product and
also receive a payment to help fund development. BEXTRA is in late-stage Phase
III clinical trials for heart failure, the most common reason for
hospitalization in patients over the age of 65, and as a result has attracted
the interest of other pharmaceutical companies. Regaining the rights to BEXTRA
opens new partnering possibilities."
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 2,500 patients in 90
medical centers throughout the U.S. and Canada.
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 is estimated that 5.0 million people in Europe and 4.7
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.
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
research programs and to enter into collaborations and licensing agreements with
corporate partners for final product development, manufacturing and marketing.
Intercardia and BASF Pharma/Xxxxx XX 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.
Astra Pharmaceuticals, L.P. is responsible for marketing all Astra
prescription products, including gastrointestinal, cardiovascular, respiratory,
pain control medications and several other hospital products. In addition to
Toprol-XL(R), other major products include the anti-secretory agent Prilosec(R)
(omeprazole), the cardiovascular agents Atacand(R) (candesartan cilexetil),
Plendil(R) (felodipine) and Lexxel(R) (enalapril maleate-felodipine ER), the
respiratory agents Pulmicort Turbuhaler(R) (budesonide
inhilation powder) and Rhinocort(R) Nasal Inhaler (budesonide) and the topical
anesthetic Xlylocaine(R) (lidocaine HCl).
The statements in this press release that are not purely statements of
historical fact are forward-looking statements, and actual results may differ
materially from those anticipated. With respect to Intercardia, important
factors that could cause results to differ include risks associated with funding
of operations, results of the BEST study, product development activities and
regulatory decisions which are described in Intercardia's reports on Form 10-K,
Form 10-Q and Form 8-K filed with the Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Intercardia assumes no
obligation to update the information in this release.
