AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) look to be feeling good about the future of their diabetes drug Forxiga. The drugmakers have yanked the diabetes treatment from the market in Germany because they couldn't get the reimbursement they wanted from medical insurers. The nose-thumbing move came the day after an FDA panel recommended the drug for approval in the U.S.
In a joint statement, the diabetes treatment partners said Friday the Type 2 diabetes drug would not be available in Germany after Dec. 15, Reuters reports. They have been unable to arrive at an agreeable price with the German association of statutory medical insurers. That group has said that it did not find any additional benefits to Forxiga, a new class of treatment, over other options, a position that means the drug can't command a premium price. The drugmakers said they would reconsider their decision to withdraw the drug "after the mediation procedure is concluded." The move does not affect its availability in other European countries.
Drugmakers have been particularly critical of Germany's price-setting strategy, put in place several years ago in the throes of the economic slump in Europe. Boehringer Ingelheim and partner Eli Lilly ($LLY) in 2011 cited pricing for passing the German market with their diabetes drug Trajenta.
In its second shot at FDA approval, a panel Thursday said Forxiga deserves approval after the companies presented additional safety data about the drug. Forxiga is one of a new class of therapies that inhibit sodium-glucose transport proteins (SGLT2) and so move the body to eliminate excess sugars through the urine. But the FDA shot the application down two years ago.
While it looks to be on its way to an FDA approval early next year, the delay has dimmed forecasts for its potential sales. As FierceBiotech points out, consensus estimates are now for peak sales of $300 million a year, less than half the $700 million the partners once suggested was possible.
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