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|October 20, 2008 3:25 p.m.|
|Teva Announces FDA Approval and Commercial Launch of Fentanyl Transdermal System|
|Jerusalem, Israel, October 20, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and |
100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic®. Shipment of this product has commenced.
Total annual sales of this product for the strengths noted above, including both brand and generic sales, were approximately $1.2 billion in the United States for the twelve months that ended June 30, 2008, based on IMS sales data.
Teva's Fentanyl Transdermal System was developed and manufactured by Aveva Drug Delivery Systems, a Nitto Denko company, which is one of the world's largest manufacturers of, and a pioneer in, "drug in adhesive" transdermal patch technology. The product utilizes a proprietary matrix design which incorporates the drug into the adhesive. It is indicated for the management of persistent moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and that cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.
FDA's diligence in approving this ANDA ensures that patients continue to have access to this medicine.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
About Aveva Drug Delivery Systems
Aveva Drug Delivery Systems (www.avevadds.com) is a Nitto Denko company, with a proven track record for providing pharmaceutical partners with fully integrated, controlled-release transdermal products. The company offers a pipeline of products for license along with a full range of research, development and manufacturing capabilities to produce proprietary and generic transdermal drug delivery systems. For more information contact Robert J. Bloder at (954)-624-1374.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra® , Neurontin®, Lotrel® and Protonix®, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").