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Biovail, Schering-Plough Terminate CEDAX Agreements; Shionogi & Co. Ltd. to Market CEDAX in United States.


TORONTO -- Biovail Corporation (NYSE NYSE

See: New York Stock Exchange
:BVF BVF Biovail Corporation (stock symbol)
BVF Berufsverband der Frauenärzte eV (Muenchen, Germany)
BVF Bearing Versus Frequency
) (TSX:BVF) announced today that it has terminated its sub-licensing and manufacturing agreements with Schering-Plough Corporation to market and distribute CEDAX(R) (ceftibuten), an oral third-generation cephalosporin cephalosporin (sĕf'əlōspôr`ĭn), any of a group of more than 20 antibiotics derived from species of fungi of the genus Cephalosporium and closely related chemically to penicillin. Cephalosporins, e.g.  antibiotic, in the United States. Shionogi & Co, Ltd. of Japan will begin marketing and distributing CEDAX(R) in the United States through its affiliate, Shionogi USA, Inc.

CEDAX(R), which was originally discovered by Shionogi and licensed to Schering-Plough, received marketing approval from the U.S. Food and Drug Administration in 1995. Indicated for mild to moderate acute bacterial exacerbations of chronic bronchitis, acute bacterial otitis media, pharyngitis pharyngitis

Inflammation and infection (usually bacterial or viral) of the pharynx. Symptoms include pain (sore throat, worse on swallowing), redness, swollen lymph nodes, and fever.
 and tonsillitis tonsillitis

Inflammatory infection of the tonsils, usually with hemolytic streptococci (see streptococcus) or viruses. The symptoms are sore throat, trouble in swallowing, fever, and enlarged lymph nodes on the neck.
, the once-a-day medication was launched by Schering-Plough in 1996 and achieved peak sales of US$52 million in 1997. Biovail Pharmaceuticals Inc. has distributed CEDAX(R) in the United States since October 2000, following Biovail's acquisition of DJ Pharma Inc.

"For the past year, CEDAX(R) has represented an increasingly small portion of Biovail's legacy products portfolio," said Eugene Melnyk, Chairman and Chief Executive Officer of Biovail Corporation. "CEDAX(R) no longer represents a priority for us as we focus our sales efforts on more important therapeutically focused products, such as CARDIZEM(R) LA, TEVETEN(R) and ZOVIRAX(R). The mutual decision with Schering-Plough to terminate this agreement will further enable Biovail to focus additional resources toward growing marketing share for its other products and brands that are more in keeping with its long-term strategies for growth."

About Biovail Corporation

Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the company's Web site at www.biovail.com

For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.

"Safe Harbor" Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995

To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration ("FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
") and Canadian Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States.  ("TPD") approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, third parties, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission ("SEC") and the Ontario Securities Commission The Ontario Securities Commission (OSC) is a regulatory agency which administers and enforces securities legislation in the Canadian province of Ontario. The OSC is an Ontario Crown corporation which reports to the Ontario legislature through the Minister of Finance.  ("OSC O.S.C. n. short for Order to Show Cause. (See: Order to Show Cause) ").
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 27, 2004
Words:522
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