Biovail to Commercialize Six Ethypharm Pipeline Products in North America; Biovail Announces Strategic Investment in Ethypharm S.A.Business Editors and Health/Medical Writers TORONTO--(BW HealthWire)--April 15, 2002 Cross Licensing of Technologies Strengthens Drug Delivery Platform 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 entered into multiple agreements with Ethypharm S.A. whereby Biovail, through a subsidiary, has acquired a 15% equity interest in Ethypharm S.A. and the right to license six on-going product development programs for marketing in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Mexico. Biovail and Ethypharm S.A., one of Europe's leading drug delivery companies, have also entered into a cross-license agreement whereby the two companies grant to each other non-exclusive licenses to use respectively Biovail's CEFORM(R) technology and Ethypharm S.A.'s Flashtab(R) technology with respect to the development of new rapid dissolve pharmaceutical products. Under the terms of the Product Development and Licensing Agreement, Biovail has licensed the marketing rights to six products from Ethypharm for commercialization in North America, Puerto Rico Puerto Rico (pwār`tō rē`kō), island (2005 est. pop. 3,917,000), 3,508 sq mi (9,086 sq km), West Indies, c.1,000 mi (1,610 km) SE of Miami, Fla. and Mexico, (the Biovail Territory). Ethypharm is entitled to receive up to $61 million in milestone payments upon regulatory approval of the Products within the Biovail Territory as well as royalties on the net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of the Products. Under the terms of the agreement, Ethypharm is committed to accelerate the developmental activities of the six licensed Products through completion of Phase III clinical trials and to support the Technology Transfer required to allow Biovail to efficiently and economically optimize the use of the Ethypharm Technology in the manufacture and marketing of each Product. Among the products licensed by Biovail is Ethypharm's novel dosage format of 5 FU (5 Fluouracil), which utilizes Ethypharm's biodegradable microspheres modified release technology for the treatment of gliblastoma, one of the most aggressive forms of brain cancer. This 5 FU formulation is in Phase IIb trials and has already received orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status in 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. (U.S.). Biovail and Ethypharm expect to begin Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials for this product in 2003 with the intent of full commercialization in the U.S. in 2005. Five additional products licensed to Biovail utilize Ethypharm's Flashtab(R) and/or controlled-release technologies including products targeting pain management to complement Biovail's existing tramadol programs and oral anti-viral products to complement Biovail's Zovirax(R) topical line. Under the terms of the Stock Purchase Agreement, Biovail has invested approximately $65 million to acquire 15% of the issued and outstanding shares of Ethypharm S.A. (Ethypharm). Biovail has an option to purchase up to an additional 5% interest in Ethypharm at the same price for a specified period and another 5% interest over a three-year period at predetermined pre·de·ter·mine v. pre·de·ter·mined, pre·de·ter·min·ing, pre·de·ter·mines v.tr. 1. To determine, decide, or establish in advance: prices. This strategic investment will help finance Ethypharm's growth strategies and gives Biovail access to complementary drug delivery technologies, a strong Intellectual Property position and access to six pipeline products, several of which are in late stages of development. Eugene Melnyk, Chief Executive Office and Chairman of the Board stated, "The opportunity with Ethypharm dramatically expands and compliments Biovail's more near term deep and rich product pipeline by adding pipeline opportunities for the 2005 to 2007 timeframe. The combination of Biovail's CEFORM(R) technology with Ethypharm's Flashtab(R) technology creates a superior rapid dissolve technological platform and opens up additional product and market opportunities." In addition, Rolf Reininghaus, President Biovail Ventures commented, "The transaction with Ethypharm provides Biovail with a point of entry into Europe for sourcing New Chemical Entities and novel biologics for commercialization in North America as well as the ability to access European opportunities for its currently manufactured and pipeline products." Biovail Venture's mandate is to expand the Company's product pipeline by identifying and investing in development stage New Chemical Entities and novel biologics for future commercialization in North America through Biovail Corporation's fully-integrated pharmaceutical sales and marketing organization. Ethypharm is a leader in providing drug delivery systems (DDS (1) (Digital Data Storage) See DAT. (2) (Data Dictionary System) See QuickBuild and OpenDDS. (3) (Dataphone Digital S ) that offer effective solutions in optimizing the delivery of active molecules in humans. Ethypharm technologies include Oral Modified Release, Orodispersable & Taste Masking, Oral Enhanced Absorption and Injectable Modified Release and these technologies have been used in the commercialization of over 50 products sold in more than 70 countries. Biovail Corporation is a leading fully-integrated specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies for chronic drug therapies. "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 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. Reform Act 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, the outcome of litigation, fluctuations in operating results and other risks detailed from time to time in the company's filings with the United States Securities and Exchange Commission. |
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