Novartis’ Lucentis eye drug failed to win support from the National Institute for Health and Clinical Excellence, the U.K.’s health-cost agency, for the treatment of diabetic macular edema. In a statement to Bloomberg, NICE said that Novartis underestimated the cost of the medicine because some patients need therapy in both eyes and added that Novartis didn’t provide “a true reflection” of the cost-effectiveness for Lucentis as compared with laser therapy, the current standard treatment for the disease. Although NICE has already recommended Lucentis for wet age-related macular degeneration, its final guideline on the drug’s cost-effectiveness for diabetic macular edema disappointed Novartis. However, the company said it would continue to work with NICE towards finding a compromise. The disapproval from the health-cost agency also prompted diabetes and blindness charities to call for Novartis to lower the cost of Lucentis.
Takeda may be facing as many as 10,000 lawsuits over allegations that its Actos diabetes drug causes bladder cancer. After GlaxoSmithKline pulled Avandia, Actos’ biggest diabetes drug rival, from European markets in 2007, Takeda saw Actos become the world’s best-selling diabetes medication. In June 2011, however, U.S. regulators found that an analysis of a Takeda-sponsored study showed some Actos users faced an increased risk of developing bladder cancer, which prompted the company to pull Actos off the market in Germany and France. A Takeda spokesman said that the company has already revised the information on risks regarding bladder cancer in the United States and Japan and is in the process of updating information for patients in Europe. The company also says that it “remains confident on the efficacy of Actos for treating type 2 diabetes.” Takeda’s shares fell 2.2 percent after the news.
Novartis’ multiple sclerosis drug Gilenya was not approved by the National Institute for Health and Clinical Excellence, the U.K.’s health-cost agency, making it the second Novartis drug shut out by the agency this week. Despite new clinical data and a patient-access scheme that lowered the cost of the drug, NICE determined that based on evidence submitted by Novartis, offering Gilenya wouldn’t be cost-effective for the U.K.’s National Health Service as compared with other already-available treatments. Nevertheless, Novartis is optimistic that it is making progress with NICE and believes a solution can be made before the agency’s final guidance is due in April 2012.
Roche’s Genentech unit has agreed to pay $20 million to settle a whistleblower lawsuit brought by a former sales manager who alleged that Genentech’s immunosuppressant drug, Rituxan, had been marketed off-label. In his lawsuit John Underwood alleged that between 2000 and 2002, Genentech encouraged oncologists and other physicians to bill healthcare programs for various off-label uses. In exchange for their cooperation, Genentech paid some of the doctors up to tens of thousands of dollars to serve as speakers before other physicians about off-label usage. The off-label promotional activities caused federal healthcare programs, like Medicare and Medicaid, to inappropriately pay for the medication.
Ranbaxy may have to pay a penalty of $350 million to $400 million to the U.S. Food and Drug Administration to settle quality control and data reporting issues, the Economic Times reports. Ranbaxy has been trying to get the FDA to lift a 2008 ban on imports of drugs made at two of its Indian plants, which were cited for violating manufacturing quality rules. Though no official word of a penalty has become public, the announcement on December 1 that the FDA had approved Ranbaxy’s generic version of Lipitor suggests that a deal to settle the long-outstanding manufacturing issues has likely been reached.
Novartis has given notice to 183 workers that their jobs will be eliminated effective December 2. The job cuts are a follow up to the announcement in October that Novartis was planning to eliminate approximately 2,000 jobs. The layoffs are part of the company’s initiative to reorganize its clinical development division. While most of the clinical development staff cuts will be in the United States and Switzerland, Novartis does anticipate adding 700 people in China and India to fill in labor gaps in those countries.
December 02, 2011
http://www.burrillreport.com/article-uk%e2%80%99s_nice_nixes_novartis%e2%80%99_lucentis_for_diabetic_macular_edema.html