November 18, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Waltham, Mass.-based Radius Health, Inc. , announced yesterday that it has sent a Marketing Authorization Application (MAA) to European regulatory agencies for its abaloparatide-SC for postmenopausal osteoporosis. At the same time, the company indicated that it is delaying its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) until the beginning of 2016.
“We felt that to rush it at the end with the NDA with a self-imposed goal might unintentionally create risk,” Robert Ward, company chief executive officer, told BloombergBusiness. “Part of our assessment was—is this the time to ask everyone in our supply chain to work on an accelerated basis over a period of time when they all had personal plans? Or was it better for us to pick a timeline that was more respectful for what the overall work-life balance might be across our whole supply chain?”
The company had originally indicated, and investors had expected, that Radius would file with the FDA before the end of this year. Todd Campbell, writing for The Motley Fool, said, “Unfortunately, the delay in filing with the FDA pushes back any plans for commercialization in the U.S. and any potential insight into which company, if any, will partner up with Radius Health to help market it.”
Radius Health took a dip at the news, although it appears to be rebounding. Shares traded on Friday, Nov. 13 for $60.35, and dropped on Tuesday Nov. 17 to $57.30. They are currently trading for $58.64. The company stock has been quite volatile lately, with shares trading on Aug. 4 for $71.64, dropping on Aug. 26 to $50.70, rising again to $67 on Sept. 24, and dropping deeply to $41.32 on Oct. 15.
To date, the company does not market any products—abaloparatide-SC would be its first. If it is approved in the European Union, it will be the first new drug aimed at osteoporosis and bone-building in Europe since 2003. Approval in both the EU and the U.S. would fill a significant need, with the International Osteoporosis Foundation indicating an osteoporosis-connected bone fracture happens every three seconds globally.
The compound cut the percent of patients fracturing bones by 83 percent compared to patients on placebo. The clinical trials also compared abaloparatide-SC to Eli Lilly and Company ‘s Forteo. From a safety perspective, the two drugs were about the same. Forteo showed about a 78 percent reduction in fractures compared to abalopratide-SC’s 83 percent. Forteo had $349 million in worldwide sales for Eli Lilly in the last quarter.
Ward’s reference to work-life balance seems a little odd given the cutthroat nature of drug development, but it’s also a conservative approach with the desire to get everything right. He told Bloomberg that the company had data necessary for the FDA that wouldn’t be available until December.
“When we think about the agency today we want a chance to dot every i and cross every t and take our time,” Ward told Bloomberg. “It’s the holistic element, right—so it’s individuals in the company who just completed a huge milestone of submitting our MAA—did we really want to ask them to skip Thanksgiving and Christmas this year?”
Radius also had other products in clinical trials, including RAD1901, a potential oral treatment for breast cancer and vasomotor symptoms, and RAD140, also for breast cancer.
