posted Jun 29, 2010 10:31 AM by RXPic AutoMedix
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updated Jun 29, 2010 10:32 AM
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Teva Announces Launch of Generic ARIMIDEX®
Jerusalem, June 28, 2010 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today U.S. Food and Drug Administration (FDA) approval and commercial launch of Anastrozole Tablets 1 mg, the Company's generic version of AstraZeneca's ARIMIDEX®. The product is indicated for treatment of certain forms of breast cancer in postmenopausal women.
The brand product had annual sales of approximately $916.8 million in the United States, based on IMS sales data.
About Teva
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.
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®, Lotrel® and Protonix®, 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® (including potential generic and oral competition for Copaxone®), 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").
Company Contacts:
Investor Relations:
Elana Holzman
Teva Pharmaceutical Industries Ltd.
972 (3) 926-7554
Kevin Mannix
Teva North America
(215) 591-8912
Media:
Yossi Koren
Teva Pharmaceutical Industries Ltd.
972 (3) 926-7590
Denise Bradley
Teva North America
(215) 591-8974
source:http://www.tevapharm.com/
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posted Jun 26, 2010 10:58 PM by RXPic AutoMedix
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updated Jul 4, 2010 2:55 PM
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APP Pharmaceuticals Announces Approval of Ganciclovir for Injection, USP SCHAUMBURG, Ill., Jun 22, 2010 (BUSINESS WIRE) --APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Ganciclovir for Injection, USP. Ganciclovir for Injection, USP is therapeutically equivalent to the reference-listed drug Cytovene (R)-IV, which is marketed by Roche Laboratories, Inc. APP will soon launch Ganciclovir for Injection and will package the product in single dose, 500 mg vials. APP's Ganciclovir for Injection is AP-rated, latex-free and bar-coded. According to IMS Health, sales of this product for 2009 in the United States were approximately $13.5 million1. Ganciclovir for Injection is an antiviral drug, which is used in the treatment of Cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS), as well as for the prevention of CMV disease in transplant recipients at risk for CMV disease. CMV disease is a serious illness that can lead to blindness, transplant graft loss and potential loss of life. "This approval reinforces APP's commitment to provide our customers, and the patients they treat, with a consistently expanding portfolio of products," said John Ducker, president and chief executive officer of APP Pharmaceuticals. "The addition of Ganciclovir for Injection further strengthens APP's broad anti-infective portfolio and market leadership position." About Ganciclovir for Injection, USP Ganciclovir for Injection is indicated for the treatment of CMV retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Ganciclovir for Injection is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease. SAFETY AND EFFICACY OF GANCICLOVIR FOR INJECTION HAS NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE, NOR FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS, NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS. About APP Pharmaceuticals, Inc. APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008. For more information about APP Pharmaceuticals, Inc., please visit the company's Web site at www.APPpharma.com. About Fresenius Kabi AG Fresenius Kabi AG is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific. Fresenius Kabi's core product range includes infusion solutions, blood volume substitutes, I.V. drugs and parenteral nutrition, as well as products for enteral nutrition. Furthermore, the company provides concepts for ambulatory health care and is focused on managing and providing home therapies. With the philosophy "caring for life" and a comprehensive product portfolio, the company aims at improving the quality of life of critically and chronically ill patients all over the world. In 2009, Fresenius Kabi achieved sales of EUR 3,086 million and an operating profit of EUR 607 million. For more information visit the company's Web site atwww.fresenius-kabi.com. Fresenius Kabi AG is a 100% subsidiary of Fresenius SE. Forward-Looking Statement The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of our products. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. Additional relevant information concerning risks are discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Fresenius Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2009 and other documents the company has filed with the Securities and Exchange Commission. The information contained in this news release is as of the date of this release. Fresenius Kabi Pharmaceuticals Holding, Inc. does not assume any obligation to update or revise these forward-looking statements to conform the statement to actual results, new information, developments or changes in the company's expectations. Cytovene(R)-IV is a registered trademark of Roche Laboratories, Inc. 1 Per IMS Dataview © IMS Health as of December 31, 2009 
SOURCE: APP Pharmaceuticals, Inc. APP Pharmaceuticals, Inc.
Debra Lynn Ross, ABC
Director, Corporate Communications
847-969-8026
dross@apppharma.com |
posted Jun 26, 2010 10:50 PM by RXPic AutoMedix
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updated Jul 4, 2010 2:54 PM
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Johnson & Johnson Pharmaceutical Research & Development Reports Phase 2b Clinical Trial Results Evaluating Canagliflozin to Treat Type 2 Diabetes Global Phase 3 Trials Involving Over 10,000 Patients InitiatedORLANDO, Fla., June 26 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that canagliflozin, an investigational, oral, selective sodium-glucose transporter-2 (SGLT2) inhibitor, improved glycemic control, and was also associated with a decrease in body weight, in a Phase 2b dose-ranging trial in patients diagnosed with type 2 diabetes who were concurrently treated with metformin. The data were presented at the 70th American Diabetes Association (ADA) Scientific Sessions. Canagliflozin is a member of a new class of antihyperglycemic therapies under development to treat type 2 diabetes. Blood glucose filtered in the kidney is mainly reabsorbed into the blood stream by SGLT2. Inhibiting SGLT2 is believed to reduce blood glucose levels by increasing the amount of glucose excreted in the urine, which may also lead to a loss of calories. "Most people with type 2 diabetes require treatment with combinations of drugs from multiple classes to attain and sustain good glycemic control," said lead investigator Julio Rosenstock, M.D., Director of the Dallas Diabetes and Endocrine Center at Medical City and also a clinical professor of medicine at the University of Texas Southwestern Medical School. "Our study suggests that inhibiting SGLT2 with canagliflozin in combination with metformin could potentially offer a good alternative for treating patients with type 2 diabetes who are not reaching their goals with metformin alone. These are promising data that need to be confirmed in long-term trials, and I am looking forward to reviewing the results from those ongoing studies." In this 12-week Phase 2b dose-ranging study of 451 patients with type 2 diabetes concurrently receiving the oral antidiabetic drug metformin, canagliflozin was administered at once-daily doses of either 50, 100, 200 or 300 mg, or 300 mg twice a day. Patients randomized to these arms had observed mean A1C reductions from baseline(1) of 0.8, 0.8, 0.7, 0.9 and 0.9 percent, respectively. A group randomized to receive a once-daily 100 mg dose of another oral antidiabetic, sitagliptin, in an active reference arm had observed mean A1C reductions of 0.7 percent from baseline. In subjects randomized to placebo, A1C decreased by 0.2 percent. Body weight, a key secondary endpoint, decreased from baseline in patients receiving canagliflozin by 2.3 to 3.4 percent compared to a 1.1 percent weight loss in subjects in the placebo arm. Patients on sitagliptin lost 0.6 percent of body weight from baseline. The study was not powered to compare efficacy between canagliflozin and sitagliptin. In general, adverse events were mild to moderate and the overall incidence was balanced across all arms of the study. Similar incidences of serious adverse events and discontinuations due to adverse events across treatment arms were observed. A non-dose-dependent increase in vulvovaginal candidal infections was seen in subjects receiving canagliflozin. The incidence of hypoglycemic events was low and similar in the canagliflozin and placebo treatment groups. No safety signals in laboratory studies, electrocardiogram or vital signs were observed. To access the abstract, visithttp://ww2.aievolution.com/ada1001/index.cfm?do=cnt.page&pg=1009 and enter abstract number 0077-OR. "We are encouraged by these results and by the initiation of our Phase 3 program, which includes a large, prospective study assessing cardiovascular outcomes," said Martin Fitchet, M.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, J&JPRD. "The size and scope of our canagliflozin late-stage development program also reflects our commitment to build a leading portfolio of pharmaceutical treatments for the care of people with diabetes." Recruitment for the global Phase 3 canagliflozin clinical program is currently underway, and is expected to enroll more than 10,000 patients with type 2 diabetes. The trials are being conducted to assess the safety and efficacy of canagliflozin dosed at 100 or 300 mg as monotherapy and in combination with oral antihyperglycemic agents and/or insulin. The Phase 3 program also includes CANVAS (CANagliflozin cardioVascular Assessment Study), a prospective Phase 3 study to evaluate the safety and glycemic efficacy in approximately 4,500 patients with type 2 diabetes, who also have either a history of, or high risk of cardiovascular disease. Study overviews are available at http://www.clinicaltrials.gov. About Canagliflozin J&JPRD and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Ortho-McNeil-Janssen Pharmaceuticals, Inc. has marketing rights in North America, South America, Europe, Middle East,Africa, Australia, New Zealand and parts of Asia. About Johnson & Johnson Pharmaceutical Research & Development Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com. Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from J&JPRD's and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov,www.jnj.com or on request from Johnson & Johnson. Neither J&JPRD nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments. (1) Baseline A1C levels for patients randomized to canagliflozin ranged from 7.6 to 8.0. Baseline A1C in the placebo arm was 7.7. Baseline A1C in the sitagliptin active reference arm was 7.6. SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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