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Biovail Reaches FTC Settlement Regarding Adalat Agreement.


Business Editors/Health & Medical Writers

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 TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
:BVF) announced today that is has entered into a settlement with Elan Corporation, PLC (NYSE:ELN Noun 1. ELN - a Marxist terrorist group formed in 1963 by Colombian intellectuals who were inspired by the Cuban Revolution; responsible for a campaign of mass kidnappings and resistance to the government's efforts to stop the drug trade; "ELN kidnappers target ) and the Federal Trade Commission ("FTC FTC

See Federal Trade Commission (FTC).
") in which Elan and Biovail have agreed to dissolve their Licensing Agreement (the "Adalat Agreement") relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 the licensing of a generic version of Adalat. Under the terms of the settlement with the FTC, Biovail and Elan agreed to unwind the Adalat Agreement so that each of Elan and Biovail will henceforth be respectively responsible for the manufacturing and marketing of its own 30mg and 60mg generic Adalat products. The FTC settlement also allows Biovail a guaranteed supply of the 30mg generic Adalat product from Elan during Biovail's transition to internal production of this dosage. Biovail's commercialization of the current 30mg and 60mg products will continue unabated and without interruption. Moreover, the FTC settlement will have no material impact on Biovail's expected revenues from these products, or on its overall product strategies.

Biovail maintains that the Adalat Agreement is lawful and pro-competitive. The Adalat Agreement allowed Biovail to introduce into the marketplace Elan's 30mg generic version of Adalat CC earlier than otherwise possible, and subsequently Biovail's own 60mg generic version of Adalat. The Adalat Agreement also allowed Biovail to market effectively against the Adalat brand, introducing a combination of the 30mg and 60mg products earlier than either Elan or Biovail could have accomplished alone. Consumers benefited from increased supply and lower market price.

Biovail's Consent Agreement with the FTC, which provides for the unwinding of the Adalat Agreement, also specifically states that the Consent Agreement is for settlement purposes only and that it does not constitute an admission by Biovail that any law has been violated or that any FTC factual assertion is correct. Nevertheless, Biovail agreed to settle with the FTC in order to resolve these issues in a speedy and permanent manner. There are no financial or other penalties either expressed or envisioned by the settlement.

Biovail Corporation is a full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.

"Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
" 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 essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting 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.
 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, 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.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:4EUIR
Date:Jun 27, 2002
Words:456
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