TORONTO, June 25 /CNW/ - Bayer Inc. and Teva Canada Limited today announced they have entered an agreement regarding Bayer's Adalat(R) XL(R) (nifedipine) 20, 30 and 60 mg product. Effective immediately, Bayer Inc. will supply Adalat(R) XL(R) exclusively to Teva Canada Limited and Teva Canada Limited will become the sole distributor in Canada of brand name Adalat(R) XL(R) product.
"We are very pleased to have been able to enter into this new agreement which will ensure Canadians continue to have access to Adalat XL," said Doug Grant, Senior Vice President and Head, Corporate Affairs, Bayer Inc. "In the new multisource environment, we want to make sure patients have consistent access to brand name medication at a competitive market price. We have a rich pipeline of cardiovascular products and remain committed to the cardiovascular health of Canadians."
"Teva Canada's mission is to provide affordable healthcare solutions to Canadians," said Barry Fishman, President and CEO, Teva Canada Limited. "In harmony with our mission, a key objective is to be the leader in meeting the needs of pharmacists and their patients with the highest market-coverage of affordable pharmaceutical products. Currently we market over 253 products in various therapeutic classes and the addition of Adalat XL to Teva Canada's existing cardiovascular product line increases our overall product offering to Canadians."
Under the agreement, Bayer will supply Adalat(R) XL(R) exclusively to Teva Canada Limited.
About Adalat(R) XL(R)
Adalat(R) (nifedipine) is a well-established calcium channel blocker (CCB) that has been widely used as an antihypertensive and anti-anginal agent for many years.
Adalat(R) XL(R) is indicated in the management of mild to moderate essential hypertension. Adalat(R) XL(R) should normally be used in those patients in whom treatment with diuretics or beta blocker has been ineffective, or has been associated with unacceptable adverse effects.
Adalat(R) XL(R) is also indicated in the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or nitrates, or who cannot tolerate these agents.
Adalat(R) XL(R) is contraindicated in: pregnancy, during lactation, and in women of childbearing potential; in patients with severe hypotension or cardiovascular shock and in patients with hypersensitivity to Adalat(R) XL(R). Nifedipine must not be used in combination with rifampicin because insufficient plasma levels of nifedipine may result due to enzyme induction.
In hypertension, the most common adverse events reported with Adalat(R) XL(R) were edema, which was dose-related and ranged in frequency from approximately 10 to 30% in the 30 to 120 mg dose range, headache (16.6%), fatigue (6.2%), dizziness (4.4%), constipation (3.5%) and nausea (3.5%). In angina, the most common adverse events reported were edema (10.1%), headache (3.1%), angina pectoris (3.1%).
For complete information, please see the Product Monograph.
About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials.
Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.
Bayer Inc. has approximately 800 employees across Canada and had sales of $853 million CDN in 2009. Globally, the Bayer Group had sales of over 31 billion Euro in 2009. Bayer Inc. invested approximately $50 million CDN in research and development in 2009. Worldwide, the Bayer Group spent the equivalent of over 2.7 billion Euro in 2009 in R&D. For more information, go to www.bayer.ca.
About Teva Canada Limited
Teva Canada Limited is a leader in providing affordable healthcare solutions to Canadians. Originally Novopharm Limited, Teva Canada specializes in the development, production and marketing of generic pharmaceuticals, and consistently provides high-quality, affordable pharmaceuticals. For 45 years, Teva Canada has built professional and consumer confidence as one of Canada's leading pharmaceutical companies. Teva Canada is proud to be a part of Teva Pharmaceutical Industries Ltd., the world's largest generic pharmaceutical company. For more information, visit www.tevacanada.com.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe. For more information, visit www.tevapharm.com.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Teva's 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, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin(R), Lotrel(R) and Protonix(R), the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone(R) (including potential generic and oral competition for Copaxone(R)), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").
SOURCE Bayer Inc.
For further information: For further information: Laura Burns, Senior Business Communications Partner, Bayer Inc., (416) 240-5466, firstname.lastname@example.org; Denise Bradley, Sr. Director, North America Corporate Communications, Teva North America, (215) 591-8974, email@example.com