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Biovail announces Forest Laboratories to make cash tender offer for 1.8 million Biovail shares at U.S. $42 per share; Licenses rights to Tiazac, its once-daily formulation of Diltiazem to Forest Laboratories.


TORONTO, Canada--(BUSINESS WIRE)--Sept. 12, 1995--Biovail Corporation International (AMEX AMEX

See: American Stock Exchange
, TSE See Tokyo Stock Exchange.

TSE

1. See Tokyo Stock Exchange (TSE).

2. See Toronto Stock Exchange (TSE).
:BVF BVF Biovail Corporation (stock symbol)
BVF Berufsverband der Frauenärzte eV (Muenchen, Germany)
BVF Bearing Versus Frequency
) today announced the following corporate developments:

CASH TENDER OFFER

Forest Laboratories (AMEX:FRX FRX Frame Relay Exchange (provides backbone connectivity for HUB sites)
FRX Frequently Repeated Line
FRX Fox Pro Report
), an international pharmaceutical manufacturer and marketer, has announced that it will make a cash tender offer to purchase, on a pro rata [Latin, Proportionately.] A phrase that describes a division made according to a certain rate, percentage, or share.

In a Bankruptcy case, when the debtor is insolvent, creditors generally agree to accept a pro rata share of what is owed to them.
 basis, 1.8 million shares of Biovail, representing approximately 20% of the fully diluted outstanding shares of Biovail, for U.S. $42 per share. The tender offer is unconditional and will be filed with the Securities and Exchange Commission not later than Monday, September 18, 1995 and is expected to be completed within 45 days. Major shareholders of Biovail have indicated they intend to tender enough of their holdings to assure that the tender offer is completed.

DILTIAZEM RECEIVES 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.
 APPROVAL

Biovail has received approval from the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 to market, in the United States, Tiazac(R), its once-daily extended release formulation of Diltiazem. This FDA approval reflects the disposition of all outstanding patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver.  litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 pending against Biovail's product and clears the way for a successful, unencumbered product launch.

Tiazac(R) has been approved for the treatment of hypertension and will compete in the $3.2 billion (U.S.) calcium channel blocker calcium channel blocker
n.
Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders.
 market. Diltiazem is one of the most widely used calcium channel blockers Calcium Channel Blockers Definition

Calcium channel blockers are medicines that slow the movement of calcium into the cells of the heart and blood vessels.
 and accounts for nearly one third of all calcium channel blocker prescriptions currently written. Once-daily formulations now account for approximately 80% of all Diltiazem prescriptions and the trend towards once-daily formulations is increasing rapidly. Biovail believes that Tiazac(R) offers patients certain advantages over the other products currently available on the market, which include among others a wider dosing range. According to the approved labeling, "hypertensive hypertensive /hy·per·ten·sive/ (-ten´siv)
1. characterized by increased tension or pressure.

2. an agent that causes hypertension.

3. a person with hypertension.
 patients controlled on Diltiazem alone or in combination with other antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this.

an·ti·hy·per·ten·sive
adj.
Reducing high blood pressure.

n.
 medications may be safely switched to Tiazac(R) capsules at the nearest equivalent total daily dose."

BIOVAIL LICENSES RIGHTS TO TIAZAC(R) TO FOREST

Biovail has also announced today that it has entered into a license and supply agreement with Forest. The term of the agreement is 16 years during which period Forest will pay royalties to Biovail based on net sales in the U.S. In addition, Forest will make certain advanced payments toward manufacturing supplies of the product, which Biovail has agreed to manufactures for the same term.

Also pursuant to this agreement, both Biovail and Forest have agreed to enter into product development opportunities within the North American context.

Biovail looks forward to working with Forest's salesforce, one of the most respected in the industry, to penetrate the vast Diltiazem market which is projected to exceed $1 billion this year. Currently, Forest is engaged in a substantial expansion of its sales force with the addition of 200 representatives and managers and plans to increase its investments in its marketing and medical education programs.

Biovail has already begun full-scale production of Tiazac(R) and expects to begin shipping product to Forest in November. Shipments to the marketplace are expected to begin in the fourth quarter of 1995 with Forest initiating its formal marketing program in the first quarter of 1996.

Commenting on these recent developments, Eugene Melnyk, Chairman of the Board of Biovail said, "We are pleased that Forest has recognized the value inherent today in Biovail's future prospects. Furthermore, it is rewarding to see that Biovail's strategy of controlling all aspects of the development process and licensing its products at a late stage, as with Tiazac(R), leads to licensing and supply agreements with very favorable terms. We expect these terms to result in improved profitability as Biovail remains committed to its goal of continued growth through product development, resulting in enhanced shareholder value."

Commenting on the tender offer and new licensing agreement, Howard Solomon, President of Forest said, "Our 20% equity interest in Biovail will allow us to share in their manufacturing profits of Tiazac(R) as well as on their sales of Tiazac(R) in Canada. We believe there are favorable prospects for both companies from the additional product opportunities to be developed by Biovail and Forest, and sold in both markets. Biovail's newly announced decision to create its own salesforce in Canada can provide distribution for Forest's products in Canada."

Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical evaluation, registration and manufacture of drug products utilizing advanced drug delivery technologies.

CONTACT: FOR: Biovail Corporation International

CONTACT: Eugene Melnyk

c/o Morgen-Walke Associates

or: Donna Stein/Sue Rodney

(212) 850-5600

or

PRESS CONTACT: Stacy Berns

Morgen-Walke Associates

(212) 850-5675
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 12, 1995
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