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Chimerix: Josh Hardy will get free experimental cancer medicine, says Chimerix

Chimerix has announced that Josh Hardy – a 7-year-old dying from a rare form of liver cancer – will receive an unapproved, experimental cancer drug free of charge. The drug maker’s decision comes after a protracted and arduous battle on behalf of Josh was fought by his family and by online supporters, who shamed the drug maker into action.

"After days of pleading with drug company executives, Josh Hardy's parents got what they'd been praying for: a chance to get medicine that could help their son survive." -- CNN

According to MSN on Wednesday, Chimerix CEO Kenneth Moch says they will now offer Virginia boy Josh Hardy the $50,000 anti-viral treatment he needs. Hardy is battling an infection after receiving a bone marrow transplant. Previously, the North Carolina-based company said it could not afford to administer the dosage for free.

The drug is called Brincidofovir, and is thought able to take Josh’s infection away in two weeks. The drug has yet to be approved by the FDA, though the federal health watchdog did consent for its “compassionate use.”

According FDA definition, “Expanded access, sometimes called ‘compassionate use,’ is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.”

Josh Hardy certainly met that criteria, but Moch initially refused to allow his company to roll out an expanded use program, despite receiving $72 million in federal funding to develop Brincidofovir.

Consider the following conversation with Moch, as told by Richard Plotkin, vice chair of the Max Cure Foundation, who says Moch hung up the phone on him when Plotkin offered to pay the $50,000 to secure the drug. Per Fox News and Friends:

“I spoke to Mr. Moch [Tuesday] by phone. I told him that we had the $50,000 that I thought he was claiming he needed to supply the drug,” Plotkin said. “He then told me it isn’t about money. He told me it’s all about ethics. I said, ‘Fine, tell me why you will not give it to this little boy.’ If he does not get the drug, he will die this week, I’m told.”

Plotkin said Moch told him he “can’t make an exception.” So he tried another approach with the CEO, asking him to think of Josh as his own child or grandchild whose life is wasting away in a hospital bed. Plotkin said Moch refused to answer this question and then hung up the phone.

Plotkin made the same compassionate plea through the media to the Chimerix board of directors.

“As a result, it appears the final plea is to the board of directors at Chimerix,” Plotkin said. “I ask the board to close their eyes, and as you close your eyes, assume there’s a little boy lying in a hospital bed who says to his father, ‘Daddy, am I going to die? And if I’m going to die, who will take care of me in heaven?’”

After being humiliated in online social media posts and hundreds of news outlets, Moch caved, issuing the following statement Wednesday:

“Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir that will inform its use in adenovirus and other serious DNA viral infections. As we progressed to larger and more complex safety trials, we made the decision two years ago to stop the program and focus resources on earning FDA approval.”

Moch previously said that saying “yes” to Josh would open the door to hundreds, if not thousands of more petitions for the compassionate use of the drug, draining the company’s resources and preventing them from taking the necessary steps to obtain proper FDA approval.

“There’s no good excuse for us,” Josh’s mom Aimee Hardy said before Chimerix changed their mind. “There’s nothing they can say that will really keep us from asking. We’re begging them to give it to us.”

In young Josh Hardy’s life, he has battled kidney cancer four times in six years. In November of last year, it was found that Josh had developed a bone marrow disorder that had resulted from the multiple cancer and radiation treatments. Hardy received the needed bone marrow transplant at St Jude's Research Hospital in Memphis, Tennessee earlier this year, but a resulting infection is threatening to take his life.

“I feel that it’s just an excuse and we need them to totally change their stance, not only for us but for hundreds or even thousands of people that need [this drug],” Aimee Hardy said. “To me, it’s almost a crime to not make it available to everyone who needs it.”

According to CNN, Todd Hardy, Josh's father, said he got the call from the Chimerix president about a half hour before Moch's company released the public announcement.

"It was wonderful," Hardy said. "Truly wonderful. It was overwhelming."

In an emotional Facebook post, mother Aimee Hardy praised the company's decision.

"Glory to GOD!" she wrote. "They are releasing the drug for Josh!!!!!!!!!"

A SaveJosh Facebook page, which has over 26K likes as of today, wrote the following late Wednesday night:

Josh has received Chimerix CMX 001 Bricidofovir Thanks to your efforts, and collaboration between the FDA and Chimerix. Please pray that the drug is as effective in combating this virus as we hope.

A picture with the post showed Josh receiving the drug, as a smiling mom and dad looked on.

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