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Biovail Acquires Teveten and Teveten HCT U.S. Marketing Rights From Solvay Pharmaceuticals Marketing and Licensing AG.


Business Editors/Health & Medical Writers

TORONTO--(BW HealthWire)--March 18, 2002

- Biovail reconfirms 30% to 35% earnings growth -

- 2002 and 2003 revised earnings guidance provided -

Biovail Corporation (NYSE NYSE

See: New York 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
) announced today that it has acquired United States marketing rights for Teveten(R) (eprosartan mesylate ep·ro·sar·tan mesylate
n.
An angiotensin II receptor antagonist used to treat hypertension.


eprosartan mesylate

Teveten

Pharmacologic class: Angiotensin II receptor antagonist

) and Teveten(R) HCT Hct
abbr.
hematocrit


HCT Hematocrit, see there
 (eprosartan mesylate and hydrochlorothiazide hydrochlorothiazide /hy·dro·chlo·ro·thi·a·zide/ (-klor?o-thi´ah-zid) a thiazide diuretic, used for treatment of hypertension and edema.

hy·dro·chlo·ro·thi·a·zide
n. Abbr.
 combination) (the Products) from Solvay Pharmaceuticals Marketing & Licensing AG (Solvay Pharmaceuticals), an affiliate of Solvay, for approximately $94 million. Biovail forecasts that sales for Teveten(R) and Teveten(R) HCT will be in the range of $25 million in 2002. Solvay Pharmaceuticals will retain marketing rights to the product in the rest of the world.

Teveten(R) is an angiotensin-II receptor blocker (ARB) for the treatment of hypertension and is indicated for use either alone or in conjunction 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. Teveten(R) HCT, which includes a diuretic diuretic (dī'yərĕt`ĭk), drug used to increase urine formation and output. Diuretics are prescribed for the treatment of edema (the accumulation of excess fluids in the tissues of the body), which is often the result of underlying , was approved November 2001 by the 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 provides Biovail the opportunity to launch a new cardiovascular product into a market segment characterized by year over year growth in excess of 50%.

Under the terms of the agreement, Solvay Pharmaceuticals will manufacture and supply the Products with an option to transfer U.S. manufacturing to Biovail, in a phased in approach, upon receipt of the necessary regulatory approvals. Solvay Pharmaceuticals will continue to manufacture and market the products in areas outside of the U.S. Biovail and Solvay Pharmaceuticals will form a joint business development committee to discuss future clinical and product development options that can enhance the performance or expand the utilization of the Products. Solvay Pharmaceuticals has the option to acquire all potential future modifications and innovations developed for the Products by Biovail for worldwide markets excluding the United States.

Eugene Melnyk, Chairman of Biovail, commented, "The acquisition of the U.S. marketing rights to Teveten(R) strengthens our cardiovascular product line and will allow us to further leverage our expanding sale force. Teveten(R) is an excellent strategic fit with our Cardizem franchise as recognition is growing that multiple treatment options are an integral part of aggressively lowering blood pressure to goal, especially in patients with concomitant diseases such as diabetes. With Teveten(R), we enter one of the fastest growing segments of antihypertensives with a New Chemical Entity that has patents in place until 2011. Biovail will continue to develop and acquire products to build franchises in targeted therapeutic areas of focus and further leverage its Primary Care salesforce capabilities."

"This agreement between Solvay Pharmaceuticals Marketing and Licensing and Biovail will provide the resources needed to give Teveten(R) increased focus in the U.S. and will allow the two companies to work together to optimize the Teveten(R) brand globally," said Eric Verpoorte, Vice President, Business Development, Solvay Pharmaceuticals Marketing & Licensing. "It will also allow Solvay Pharmaceuticals, Inc. to focus its primary care sales force on enhancing the development of our recently launched ACE inhibitor ACE inhibitor (ā'sē'ē`, ās) or angiotensin-converting enzyme inhibitor (ăn'jēōtĕn`sĭn) , ACEON(R) (perindopril erbumine perindopril erbumine

Aceon, Coversyl (UK)

Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester),
) Tablets."

Biovail today reconfirmed its comfort with achieving 30% to 35% diluted earnings per share diluted earnings per share

An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of
 year over year for 2002 and 2003. Biovail also reconfirmed the guidance issued February 21, 2002 regarding its comfort with 2002 growth in diluted earnings per share per quarter of 30% to 35% over 2001 quarterly results. Biovail currently expects the following ranges for 2002 and 2003 revenue and diluted earnings per share, excluding charges:


------------------- ---------------- ----------------- ---------------
                      First Quarter    Second Quarter   Third Quarter
Range of Results     Ending 3/31/02        Ending      Ending 9/30/02
                                           6/30/02
------------------- ---------------- ----------------- ---------------
------------------- ---------------- ----------------- ---------------
Total Revenues         $145 - $160      $165 - $185      $185 - $210
($US Millions)
------------------- ---------------- ----------------- ---------------
------------------- ---------------- ----------------- ---------------
Diluted EPS           $0.27 - $0.32    $0.35 - $0.40    $0.45 - $0.50
------------------- ---------------- ----------------- ---------------


------------------- ---------------- ----------------- ---------------
                     Fourth Quarter
Range of Results     Ending 12/31/02
                                           2002             2003
------------------- ---------------- ----------------- ---------------
------------------- ---------------- ----------------- ---------------
Total Revenues         $200 - $230      $720 - $775    $900 - $1,000
($US Millions)
------------------- ---------------- ----------------- ---------------
------------------- ---------------- ----------------- ---------------
Diluted EPS           $0.55 - $0.60    $1.70 - $1.80    $2.25 - $2.35
------------------- ---------------- ----------------- ---------------


Teveten(R):

Teveten(R) is marketed by Solvay in more than 20 countries worldwide. Solvay will continue to launch Teveten(R) in other countries outside of the U.S. as approvals are received. Teveten(R) has been evaluated in greater than 3,300 patients and healthy volunteers in worldwide pre-registration clinical trials. Teveten(R) combines a unique chemical structure and a dual mechanism of action that may differentiate it from other ARBs and may offer advantages in the elderly population, especially those patients with elevated systolic blood pressure Systolic blood pressure
Blood pressure when the heart contracts (beats).

Mentioned in: Hypertension
. Approximately 58,000 patients have been evaluated or enrolled in post-registration clinical studies. Teveten(R) has a unique chemical structure that inhibits the sympathetic nervous system activity in addition to the anti-angiotensin II action shared by other ARBs. Biovail expects to leverage the unique characteristics of Teveten(R) to differentiate it from other ARBs. Biovail can also leverage the success of the combination therapy of ARBs with hydrochlorothiazide. The introduction of Teveten(R) HCT provides physicians with additional dosing flexibility for the treatment of their patients.

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Teveten(R) Tablets should be discontinued as soon as possible. Please see a physician to obtain full prescribing information.

Angiotensin Receptor Blockers:

Since the first angiotensin-II receptor blockers (ARBs) were introduced in 1995, numerous clinical trials have been conducted on their use in patients with hypertension and their potential use in patients with congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. . ARBs, also known as angiotensin II receptor antagonists (AIIAs), are the newest class of medications approved for hypertension. These medications selectively bind the angiotensin II angiotensin II
n.
An octapeptide that is a potent vasopressor and a powerful stimulus for production and release of aldosterone from the adrenal cortex.
 type 1 receptor preventing the effects of angiotensin II.

The advantages of angiotensin-II receptor antagonists include good efficacy with once-daily dosing and a safety and tolerability profile that is generally comparable to that of placebo. These drugs are lipid neutral, which may make their use advantageous in patients with hyperlipidemia hyperlipidemia /hy·per·lip·id·emia/ (-lip?i-de´me-ah) elevated concentrations of any or all of the lipids in the plasma, including hypertriglyceridemia, hypercholesterolemia, etc. .

The ARB market segment is the fastest growing class of antihypertensive medications in the U.S. For the twelve month period ending November 2001, the U.S. ARB market achieved total sales of approximately $2.1 billion with 38.1 million total prescriptions (TRx's) for the same time period. Total sales grew by 38% over the previous year and the TRx volume grew by 26% for the same period. ARB combination products account for approximately 35% of the total ARB market and are growing in excess of 50% per annum Per annum

Yearly.
. Based on the current rate of growth, the ARB market will exceed $3 billion by 2004.

Market dynamics:

Hypertension is a major health problem in the world today. 50 million Americans aged sixty and older have high blood pressure - or about one in every four adults.

High blood pressure (hypertension) killed 42,565 Americans in 1997 and contributed to the deaths of about 210,000. Of the 50 million Americans with hypertension, 31.6% don't know Don't know (DK, DKed)

"Don't know the trade." A Street expression used whenever one party lacks knowledge of a trade or receives conflicting instructions from the other party.
 they have the disease, 14.8% are not on therapy (special diet or drugs), 26.2 % are on inadequate therapy and only 27.4% are on adequate therapy.

The cause of 90-95% of cases of high blood pressure is unknown. Hypertension is sometimes called "the silent killer silent killer Silent lesion Medtalk Popular for a condition that may progress to very advanced stages before manifesting itself clinically " because those inflicted with the disease do not experience any symptoms; yet untreated high blood pressure can cause serious damage to major organs of the body. It is a primary cause of stroke, heart disease, heart failure, kidney disease Kidney Disease Definition

Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease.
 and blindness. An individual not adequately being treated for hypertension has a three-fold increase in developing heart disease, a seven-fold increase of suffering a stroke and the likelihood of developing congestive heart failure increases six fold. Fortunately, high blood pressure is easily detected and usually controllable.
-- From 1987 to 1997 the death rate from high blood pressure increased 13.1%.

-- The breakdown for 1997 death rates per 100,000 population from high blood
pressure was 14.0% for white males, 50.2% for black males, 12.8% for white
females and 40.6% for black females.


Antihypertensives account for significant sales and prescription volume. For the twelve months ending November 2001, the U.S. antihypertensive market generated $12.3 billion in sales with a growth rate of 10.5% over the previous year. Total 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.
 (CCB CCB Calcium channel blocker, see there ) led the group accounting for $4.5 billion, followed by angiotensin-converting enzyme angiotensin-converting enzyme /an·gio·ten·sin-con·vert·ing en·zyme/ (-ten´sin kon-vert´ing en´zim) see peptidyl-dipeptidase A.

angiotensin-converting enzyme
n.
 (ACE) inhibitors at $4.2, ARBs at $2.1 billion and beta-blockers accounting for $1.2 billion in sales.

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.

Solvay Pharmaceuticals Marketing & Licensing A.G. is an affiliate of Solvay. Solvay is an international chemical and pharmaceutical Group with headquarters in Brussels. The Group employs about 32,000 people in 50 countries. In 2000 its consolidated sales amounted to EUR EUR

In currencies, this is the abbreviation for the Euro.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
 8.9 billion, generated by its four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals. Solvay is listed in the Euronext 100 index of top European companies.

"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 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.
COPYRIGHT 2002 Business Wire
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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