Chimerix CEO steps down, replacement named

Apr. 09, 2014 @ 06:45 PM

Durham-based Chimerix Inc. has named a successor for CEO Ken Moch, who is resigning about a month after a family’s request for access to the company’s experimental drug brincidofovir to save their 8-year-old son drew national attention.

While Chimerix declined to release the drug the way the family requested, the company was able to get the drug to Josh Hardy. Company leaders struck a deal with the U.S. Food and Drug Administration for the launch of a pilot study that was expected to be part of a larger clinical trial. Josh was the first patient enrolled, and more patients were expected to get access, too.
“We could not see a way, sadly – and I’m vilified for this – to make this available for just Josh Hardy,” Moch had said in an interview in March. “If we could figure out how to make this available for the many Joshes, we would, which we did.”
According to a news release issued Wednesday, Moch resigned from Chimerix to “pursue other interests.” Joseph T. Schepers, executive director for investor relations and corporate communications for Chimerix, said the resignation was effective Wednesday. Dr. M. Michelle Berrey, Chimerix’s chief medical officer, was named president and CEO in his place.
Ernest Mario, Chimerix’s board chairman, said in a statement that the company is grateful for Moch’s leadership when the company went public last year. The gross proceeds from the offering were about $118 million.
But Mario also said the company is entering a “critical stage” in the development of its lead product candidate: the experimental antiviral drug brincidofovir, which is in Phase 3 trials for the prevention of cytomegalovirus in patients who have received blood stem cell transplants.
“Our goal is to complete the requirements for regulatory approval of brincidofovir as rapidly as possible, and we believe Dr. Berrey has the qualifications and expertise in abundance to accomplish that objective,” Mario said in the statement.
Berrey became Chimerix’s chief medical officer in November 2012. Before that, she was chief medical officer at Pharmasset, Inc. from 2007 until its acquisition by Gilead Sciences Inc. in January 2012.
Chimerix did not respond to questions about whether the publicity from the Hardy family’s public plea for its drug impacted the decision. Hardy’s family had made the plea on social networks and through media to get access to brincidofovir.
While it has not yet been approved by the FDA, the family was calling for the company to release it through the FDA’s "compassionate use" track.
The track allows patients with serious or life-threatening diseases to access investigational drugs outside of clinical trials after they've exhausted all available treatment options.
The company declined to release the drug through the track, arguing it did not want to slow down the drug’s development to save one person, when it could help many when approved.
After the FDA agreed to the pilot study, Chrimerix shipped the drug to Hardy. After he received his first dose, officials from St. Jude Children's Research Hospital in Memphis, where Josh was in the intensive care unit, reported that he was tolerating it well. He later removed from the intensive care unit, according to a post on his Facebook page #Save Josh last month.
Schepers said the company officials are in discussion with the FDA about the development program for that clinical trial, and it’s not finalized yet. Attempts to reach Moch for comment were unsuccessful Wednesday.