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Biovail Acquires Pharma PASS Companies for $190 Million.


Business Editors/Health and Medical Writers

TORONTO--(BUSINESS WIRE)--Dec. 11, 2002

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
)(TSE See Tokyo Stock Exchange.

TSE

1. See Tokyo Stock Exchange (TSE).

2. See Toronto Stock Exchange (TSE).
:BVF)
-- Expands Biovail's pipeline through the acquisition of numerous ongoing development programs

-- Acquisition provides complementary drug delivery technologies and strengthens patent portfolio

-- Acquisition includes an economic interest in a number of products; including generic Prilosec(R)


Biovail Corporation (NYSE:BVF)(TSE:BVF) announced today that it has acquired Pharma PASS LLC (Logical Link Control) See "LANs" under data link protocol.

LLC - Logical Link Control
, an Irvine, California Irvine is an incorporated city in Orange County, California, United States. It is a planned city, mainly developed by the Irvine Company since the 1960s. Formally incorporated on December 28 1971, the 69.7 square mile (180.5 km²) city has a population of 202,079 (as of 2007).  company, and Pharma PASS SA, a company based in France, both of which belong to the Pharma PASS group (Pharma PASS). Pharma PASS is a developer of advanced oral controlled release technologies and formulations that have been licensed to pharmaceutical companies in Europe and the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Both companies were purchased for approximately $190 million. The acquisition significantly enhances Biovail's portfolio of drug delivery technologies as well as Biovail's patent portfolio estate.

"This is an exciting and very strategic acquisition for Biovail," commented Eugene Melnyk, Chairman and Chief Executive Officer of Biovail. "Pharma PASS is headed by its principal owner, Dr. Pawan Seth who is a highly prolific developer of controlled release technologies and has been a long-standing developmental partner of Biovail. With this transaction, we have acquired not only a novel advanced drug delivery platform and two exciting enhanced absorption formulations, but have also significantly expanded Biovail's pipeline potential with numerous product development programs targeting commercialization in 2005 to 2007."

As part of this transaction, Biovail has acquired a number of New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) products under development, including an enhanced absorption fenofibrate product, for treatment of hypercholesterolemia Hypercholesterolemia Definition

Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal.
Description

Cholesterol circulates in the blood stream. It is an essential molecule for the human body.
, and an enhanced absorption venlafaxine venlafaxine /ven·la·fax·ine/ (ven?lah-fak´sen) an inhibitor of serotonin and norepinephrine reuptake that potentiates neurotransmitter activity in the central nervous system; used as the hydrochloride salt as an antidepressant and  product, for the treatment of depression. Biovail believes that improvements in the absorption and delivery of these molecules can significantly enhance the performance of these compounds and create marketing opportunities for Biovail or potential partners. Currently marketed versions of these products include Tricor(R) (fenofibrate), marketed in the United States by Abbott Laboratories with current annualized annualized

Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared.
 sales of $421 million and Effexor(R) (venlafaxine), marketed in the United States by Wyeth Pharmaceuticals with current annualized sales of $1.6 billion. A substantial portion of the acquisition price is attributable to these and other ongoing developmental programs. As a result, Biovail will take a one-time in process Research and Development charge related to the value of these developmental programs in the fourth quarter 2002.

Biovail is also acquiring an immediate, material economic interest in two licensed products including the currently marketed Tricor(R) (mentioned above) and a recently launched generic version of Prilosec(R) (omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with ), which is licensed to Kremers Urban Development Company (KUDCo). Pharma PASS, the inventor and developer of this product, developed the only generic version of Prilosec(R) found not to infringe the original product's patent. Also, through this acquisition, Biovail extinguishes any future financial obligations to Pharma PASS in respect of product development services previously provided by Pharma PASS in collaboration with Biovail.

This transaction also provides Biovail with two new drug delivery technologies -- a Zero Order Release System (ZORS), a technology that controls the rate and release of a drug and/or significantly enhances the systemic absorption of a drug molecule, and an oral Colonic Drug Delivery technology designed for the targeted release of medication into the lower intestine and upper colon. Biovail and Dr. Seth intend to continue to develop novel products utilizing both of these technologies.

Biovail also confirmed its intention to launch its novel once daily version of diltiazem, Cardizem(R) LA (previously referred to as Cardizem(R) XL), upon Final Approval by the 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.
) in the near term. Although the timing of such approval from the FDA is expected in the coming weeks, it is difficult to predict with any certainty the exact date of such approval. Biovail's recently announced arrangement with Reliant Pharmaceuticals LLP LLP - Lower Layer Protocol , in addition to Biovail's internally expanded sales force, provides over 800 experienced field sales representatives to begin detailing Cardizem(R) LA in the first quarter of 2003 as expected.

The Pharma PASS acquisition was initiated by Biovail Ventures, a division of Biovail with a mandate to expand Biovail's product pipeline by identifying and investing in New Chemical Entities (NCEs), New Biological Entities (NBEs) and novel drug delivery technologies for future commercialization in North America through Biovail's fully-integrated sales and marketing organization. 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 further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.

"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.
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Publication:Business Wire
Geographic Code:1CANA
Date:Dec 11, 2002
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