- Company delays filing to avoid rush, respect employee holidays
- Stock fell 11 percent on news of the U.S. filing timeframe
Radius Health Inc. delayed a drug submission to U.S. regulators to avoid rushing its filing and to respect employees’ holiday plans, Chief Executive Officer Robert Ward said.
Radius fell 11 percent to $61.51 Tuesday after the company said in a statement that it was delaying submitting a new drug application to the U.S. Food and Drug Administration for its medicine to treat osteoporosis until the first three months of 2016, from an earlier target of the end of 2015. The statement didn’t mention the holidays, saying that Radius would get 12-month data for the drug in December and would start data analysis in January.
"We felt that to rush it at the end with the NDA with a self-imposed goal might unintentionally create risk," Ward said by phone on Tuesday, referring to a new drug application. "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 drugmaker is looking to gain approval for Abaloparatide-SC, a once-daily drug to treat osteoporosis, a bone disease that can lead to severe fractures. Radius said Tuesday that it had submitted its marketing authorization application to gain regulatory approval in Europe. Ward said that having just completed that filing, as well as an analysis of how the FDA has received recent submissions, made him cautious about moving to file so quickly after receiving the 12-month data.
Abaloparatide-SC would be the first drug approval for Radius, which debuted on the stock market in June 2014 and has no revenue. Ward joined Radius from AstraZeneca Plc, where he was a vice president who evaluated investment opportunities. The company, valued at $2.64 billion as of Tuesday’s close, has other treatments in human trials, including a patch version of Abaloparatide and a medication for breast cancer.
The FDA requires 12 months of data about Abaloparatide-SC’s stability, which can only be collected by December. The timing of that data might make a submission before 2016 risky, Ward said.
"When we think about the agency today we want a chance to dot every i and cross every t and take our time," Ward said. "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?"