Arkansas Democrat-Gazette

CEO: Drugmaker weighs bankruptcy

- KATIE ZEZIMA

Purdue Pharma’s chief executive said the company is considerin­g bankruptcy as it faces a cascade of lawsuits alleging that the drugmaker played a key role in driving the nation’s opioid crisis, including aggressive­ly and deceptivel­y marketing the powerful painkiller OxyContin.

Purdue’s president and chief executive officer, Craig Landau, said in an interview with The Washington Post that the company has not yet decided whether to file bankruptcy, but he said it is something the company is weighing as it considers the effect of potential legal settlement­s or jury verdicts that could cost tens of billions of dollars.

“It is an option,” Landau said. “We are considerin­g it, but we’ve really made no decisions on what course of actions to pursue. A lot depends on what unfolds in the weeks and months ahead.”

Purdue has denied the allegation­s lodged against it in court and is mounting a vigorous defense. Most of the lawsuits are consolidat­ed in a federal court in Cleveland, where settlement talks have been ongoing for more than a year as lawyers simultaneo­usly prepare for two trials scheduled for the fall.

Declaring bankruptcy could halt litigation against the company, bankruptcy lawyers said, and it can be more difficult for plaintiffs to secure judgments in bankruptcy court than in civil court.

Purdue is one of a number of defendants in a separate Oklahoma state trial scheduled to begin May 28. It will be the first trial at which a jury could decide whether drug companies bear responsibi­lity for the opioid crisis; settlement talks are ongoing.

The company also is facing a lawsuit in Massachuse­tts that has made public numerous internal documents that the state attorney general argues are evidence the company disregarde­d safety and addiction as it pursued profits from patients who be-

came dependent on its products. Purdue said the lawsuit amounts to “oversimpli­fied scapegoati­ng” that is not supported by the law.

Landau declined to discuss the pending litigation. Purdue has argued that it controls just 2 percent to 3 percent of the market for opioid drugs. It also says it is not responsibl­e for overdose deaths from heroin and illicit fentanyl, a powerful synthetic opioid made overseas that has killed tens of thousands of people in recent years and is now the leading driver of overdose deaths.

Purdue announced Wednesday that it is developing a drug to reverse opioid overdoses. It claims the drug is far more powerful than naloxone, the wellknown opioid overdose antidote currently in use across the country.

The company said that the Food and Drug Administra­tion has granted the drug — an injection of nalmefene hydrochlor­ide — the agency’s fast-track designatio­n, which will speed up its pharmaceut­ical developmen­t and agency review. The FDA fast-tracked over-the-counter naloxone in January, and it is moving quickly on nonopioid drugs to treat pain.

The FDA said Tuesday that it could not comment on the designatio­n until the company announces it. The agency must approve the drug for use before it can reach consumers.

Landau said Purdue is making the drug as a pro bono effort to stem overdose fatalities.

“We’re not looking to make money, nor do we intend to profit in any way from the developmen­t and availabili­ty of this hopefully lifesaving treatment,” he said.

Landau said the drug has been in the pipeline for about two years and is intended to serve as an antidote to fentanyl overdoses; first responders have said that numerous doses of naloxone are needed to reverse some fentanyl overdoses because the drug is so potent.

Despite the fast-track designatio­n, it probably will take years for the drug to reach consumers. Landau said the goal is to get it to people who need it as soon as possible. No other antidote of its strength is currently available in the United States, he said.

Fentanyl is the third wave of the opioid epidemic, which started with prescripti­on painkiller­s. After the government cracked down on illicit prescriber­s and tried to address the flow of pills to the black market, those addicted to the painkiller­s turned to heroin.

Landau disputes claims that Purdue and its OxyContin pills were responsibl­e for sparking the opioid crisis.

“I don’t believe one company or one product was the cause of the opioid crisis. I and many others understand the opioid crisis to be very complicate­d, with many contributi­ng factors, but this program that we’re discussing is very simple,” Landau said. “The motivation has really nothing to do with who did or who didn’t cause an opioid crisis or litigation. It’s really meant to save lives.”

Purdue has launched numerous programs to combat opioid abuse. Several came after the company paid $600 million in fines in 2007 as part of a federal case. Company executives also pleaded guilty to criminal charges after claiming the product was not as addictive as other opioids.

The company’s initiative­s include providing millions of dollars to support the creation of an over-the-counter naloxone spray and training law enforcemen­t to administer the drug; supporting education on the proper storage and disposal of prescripti­on opioids; and conducting research into non-opioid painkiller­s.

Landau said creating the overdose antidote is another way the company is working to combat the opioid crisis.

“We believe we have a responsibi­lity as a pharmaceut­ical company to do what we can, and we’re leaning forward with what we believe could be a very meaningful solution and a very meaningful contributi­on to the public health,” Landau said.

 ?? Bloomberg News ?? Purdue Pharma, maker of the prescripti­on painkiller OxyContin, says it is not responsibl­e for opioid overdose deaths and is developing a drug to reverse them.
Bloomberg News Purdue Pharma, maker of the prescripti­on painkiller OxyContin, says it is not responsibl­e for opioid overdose deaths and is developing a drug to reverse them.

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