The real story behind the unexpected departure of Chimerix Inc. President and CEO Kenneth Moch 29 days after the company extricated itself from a public relations crisis will probably never be known. It certainly wasn't because of the stock's performance.

The stock climbed steadily even as the embattled company tried to explain its initial refusal to grant compassionate access to brincidofovir for Josh Hardy, a pediatric cancer patient.

Hardy had contracted a potentially fatal adenovirus infection following bone marrow transplant and could not withstand the nephrotoxic effects of cidofovir, the marketed drug upon which brincidofovir is based (see BioCentury, March 31).

But Chimerix had ceased providing the antiviral under compassionate access in December 2012 - at the end of a contract from HHS's Biomedical Advanced Research and Development Authority (BARDA) that had funded the access program - in order to focus resources on controlled trials designed to lead to FDA approval.

When the Josh Hardy storm erupted, brincidofovir was in Phase III development for a different virus, cytomegalovirus (CMV).

Between March 7 and March 11, as the Hardy family launched a desperate campaign for access to brincidofovir, Chimerix and Moch were vilified in both traditional and social media.

As the public outcry grew, including death threats to company management, Moch was repeatedly quoted in the media as saying Chimerix had an ethical obligation to focus finite resources on Phase III trials and approval of brincidofovir for the thousands of patients who needed it, and that the company could not grant compassionate access to some patients and not others.

The solution was announced the evening of March 11: FDA and Chimerix agreed on a clinical trial in which Hardy could enroll the next day, and which also could help support approval of brincidofovir in the adenovirus indication.

Shares of Chimerix gained $5.68 (30%) to $24.58 between March 6, before the crisis hit the media, and March 12, the first trading day after Chimerix brought the saga to a close with a new clinical trial.

Overnight, the focus of media coverage changed to how well Hardy was responding to Chimerix's potent antiviral, and supporters of Josh Hardy tweeted thanks to Chimerix and praise for the company, Moch and FDA for devising a solution that allowed the child to be treated.

Chimerix closed that week up $8.41 (45%) to $27.14 and on March 17 hit a 52-week high of $27.69 (see "Chimerix Chronicles").

Most of those gains had been given back by the time the company announced on April 9 that CMO M. Michelle Berrey would succeed Moch as president and CEO "following his resignation from that role to pursue other interests."

Neither Moch, the company nor several members of its board contacted by BioCentury are talking about the circumstances that led to his departure and the installation of Berrey into the role, which she takes on in addition to her responsibilities as CMO.

Chimerix lost $2.56 (11%) to $19.85 last week. The BioCentury 100 Index was down 4% last week, the NASDAQ fell 3% and the Dow Jones Industrial Average was off 2%.


Chimerix Inc. (NASDAQ:CMRX), Durham, N.C.

U.S. Department of Health & Human Services (HHS), Washington, D.C.

U.S. Food and Drug Administration (FDA), Silver Spring, Md.