September 21, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Sarepta Therapeutics just can’t stay out of the news. The company announced on Monday the dramatic and still controversial decision by the U.S. Food and Drug Administration (FDA) to approve eteplirsen for Duchenne Muscular Dystrophy (DMD).
Today, Sarepta announced other business-related news. First, it plans to open its manufacturing facility located in Andover, Massachusetts. The company has owned the plant since 2014. The company indicates it expects to begin hiring for that facility soon, although it declined to specify how many jobs.
Sarepta currently employs 220 people.
The facility is 60,000 square feet and was previously used by Japan-based Eisai. In March, Sarepta announced it was closing a 53,000-square-foot facility in Corvallis, Oregon, and consolidating most of its employees to Massachusetts. The company was originally founded in Corvallis. The former chief executive officer, Chris Garabedian, who reorganized the company to focus on DMD, told the Boston Business Journal several years ago ago that the move to Cambridge came about because when he was expanding the company, most of the people applying for jobs were either already there or said they’d be willing to move there.
The second news today was that Sarepta’s board of directors appointed Edward Kaye president and chief executive officer, and to serve on the board. He will also continue as chief medical officer, which he has been since June 2011. Kaye, 67, has been the company’s interim chief executive officer since March 31, 2015.
As part of the deal, Kaye’s base salary will be $550,000 with a target annual bonus equal to 65 percent of his annual base salary.
Kaye also serves on the board of directors of Cytokinetics . He has held a variety of executive and officer positions, including group vice president of Clinical Development at Genzyme.
In addition to the official appointment of Kaye, other executive changes were made. Jayant Aphale, was promoted from senior vice president of Technical Operations to vice president of Technical Operations. Sandesh Mahatme will be senior vice president and chief financial officer. David Tyronne Howton, Jr., will be senior vice president, general counsel and corporate secretary. Shamim Ruff will act as senior vice president, Regulatory Affairs and Quality. Alexander “Bo” Cumbo will be vice president, Head of Commercial, and Joan Wood will be vice president of Human Resources.
Despite the company’s approval for eteplirsen, which will be sold as Exondys 51, it is still running follow-up trials required by the FDA as a condition of the drug’s approval. One trial which should be completely enrolled by the end of the year, will give the drug to 60 to 80 patients for two full years compared to untreated boys. The second trial, expected to start soon, will test a related dug on patients with DMD caused by a different mutation, and will be compared to patients on a placebo. The third trial will evaluate higher doses of Exondys 51.
The second trial, in particular, is being criticized for being unethical, which is only part of the drama of the drug’s regulatory history. DMD is a progressive, fatal muscle-wasting disease that primarily affects boys, who generally die from it in their early twenties. The criticism is whether it is ethical to place children on a placebo for two years rather than a possibly effective drug.
The drug approval was based on a clinical trial of only 12 boys, with no placebo controls.
