Categories
Health

15 States Attain a Deal With Purdue Pharma Over Opioids

At a press conference Thursday to announce the settlement, the Massachusetts, New York and Minnesota attorneys general pointedly noted that they had asked the Sacklers for years to admit guilt and apologize, but family members refused.

Government lawyers said that instead of spending years looking for more money to meet urgent needs created by the opioid epidemic, they agreed to step back in order to free funds faster.

New York Democrat Rep. Carolyn B. Maloney and California Democrat Mark DeSaulnier introduced a law they call the Sackler Act that would allow states to prosecute company owners in bankruptcy proceedings that the attorneys general are tracking down strongly support own statements. But even if Congress passed such a law, the attorneys general added, the Sacklers and Purdue would almost certainly have closed the case long ago and would have escaped the scope of the bill.

As such, Purdue will cease to exist as such and re-emerge as a new company that would manufacture limited quantities of OxyContin and overdose reversal drugs, according to the overall bankruptcy filing. It would be overseen by an appointed board of directors. The profits would feed payments to funds for distant plaintiffs that would primarily support drug treatment and prevention programs.

Lawyers involved in the negotiations underlined the importance of the public document archive, which can hardly be surpassed in its breadth and depth. Although Purdue has already produced 13 million documents during the litigation, it has now added 20 million more. The size of this one company’s documents rivals that uncovered by the entire tobacco industry, a coveted consequence of the Big Tobacco litigation some 20 years ago.

The Purdue documents will contain statements, emails, and letters that go back two decades. They are expected to reveal detailed details of Purdue’s behind-the-scenes contacts with federal investigators and Food and Drug Administration officials as the company fended off tougher penalties for promoting turbo sales that touted OxyContin as effective and non-addictive. Experts assume that the considerations and mandates of Dr. Richard Sackler, a former President and CEO of Purdue.

In Thursday’s briefing, Maura Healey, the Massachusetts attorney general who was the first to suing Sacklers, said the document pool served as a promise to the families of opioid victims. “It will tell the whole story, all of the conversations, all of the discussions, all of the planning, all of the ways they make money and evade accountability and regulation,” she said.

Categories
Health

Fosun Pharma falls as Hong Kong suspends BioNTech Covid vaccinations

Vaccination program branding on the clothing of a staff member outside a community vaccination center administering the BioNTech Covid-19 vaccine imported by Fosun Pharma on Wednesday March 17, 2021 in Hong Kong, China.

Chan Long Hei | Bloomberg via Getty Images

Shares in China’s Shanghai Fosun Pharmaceutical Group fell after Hong Kong and Macau announced on Wednesday that they would suspend vaccinations for BioNTech Covid.

Fosun Pharma, BioNTech’s partner in the development and distribution of the Comirnaty Covid-19 vaccine in Greater China, has informed the cities of a packaging error in batch 210102 of the vaccine.

Hong Kong and Macau said they would suspend vaccinations made in Germany as a precaution.

The cities said BioNTech and Fosun Pharma are investigating the cause of the vial cap failure, adding that there is currently no reason to doubt the vaccine’s safety.

Macau says all of its messenger RNA or mRNA vaccines belong to the affected batch. Hong Kong said it would also temporarily suspend vaccinations from batch 210104 until the investigation is completed.

Hong Kong-listed Fosun Pharma shares fell 4.83% in the city on Wednesday afternoon.

Hong Kong approved the BioNTech emergency vaccine in January, while Macau gave the vaccine a special import permit in late February. Both areas received their first shots in late February.

BioNTech’s mRNA-based vaccine has a proven efficacy of 95% in adults, according to data from its global Phase 3 clinical trial. Real-world data has shown that Pfizer-BioNTech’s two-dose Covid vaccine delivers “very strong” results after just one shot.

The news comes as countries around the world struggle to vaccinate their populations amid rising Covid cases in most regions.

More than 124 million infections have been reported worldwide and the death toll from Covid has exceeded 2.7 million, according to Johns Hopkins University.

Categories
Health

Purdue Pharma Provides Plan to Finish Sackler Management and Mounting Lawsuits

In a message marking the beginning of the end of the most notorious prescription opioid maker in the country, Purdue Pharma unveiled its bankruptcy restructuring plan just before midnight on Monday. The blueprint requires members of the billionaire Sackler family to give up control of the company and transform it into a new business whose revenues are solely aimed at alleviating the addiction epidemic that caused its signature pain reliever, OxyContin.

The 300-page plan is the company’s formal offer to end thousands of lawsuits and includes the Sacklers pledge to pay $ 4.275 billion out of their personal assets – an additional $ 1.3 billion than their original offer – to reimburse states, communities, tribes and other plaintiffs for the costs associated with the epidemic.

If the plan is approved by a majority of the company’s creditors and Judge Robert D. Drain of Federal Bankruptcy Court in White Plains, NY, payments will flow into three buckets: one to compensate individual plaintiffs, such as families whose relatives have overdosed , or legal guardians of infants with newborn abstinence syndrome as well as hospitals and insurers; another for tribes; and the third – and largest – for state and local governments devastated by the cost of a drug epidemic that only worsened during the Covid-19 pandemic.

“With drug overdose still at record levels, it is time to use Purdue’s fortune to help tackle the crisis,” said Steve Miller, chairman of the Purdue board of directors, in a statement. “We are confident that this plan will achieve this important goal. ”

It remains to be seen whether the plan will be adopted. Since the company filed for bankruptcy in 2019, 24 states and the District of Columbia have denounced it, arguing that the lawsuit would preclude their ability to take legal action directly against individual Sackler family members who they consider to be inadequate contributions.

Although some details of the settlement terms are still being worked out, Purdue officials said the Sacklers would not be exempt from criminal investigations that could be launched by a handful of states for violating consumer protection laws. However, the plan exempts them from further civil litigation.

The new application, filed minutes before a court-set deadline, marks a milestone in Purdue’s long, troubled history as the maker and marketer of OxyContin, the prescription pain reliever that has become addicting hundreds of thousands of people. Federal and state agencies spent years trying to curb Purdue’s marketing tactics. In 2007, the Justice Department reached an agreement with Purdue and top executives on $ 634.5 million to resolve criminal charges related to its marketing practices.

As of 2015, when the opioid epidemic hit the country, the lawsuit engulfed cities, counties, states, tribes, families, hospitals and insurers, drug distributors, pharmacies and manufacturers, including Purdue boss. The cases almost consistently claim that OxyContin helped lay the foundation for the prescription and illicit drug addiction epidemic that killed more than 400,000 people over 20 years.

To halt the growing civil lawsuit that cost Purdue $ 2 million a week in legal costs, the company filed for bankruptcy protection in 2019.

The legal dispute before a federal court against other companies continues.

The biggest difference between Purdue’s earlier proposals and this latest plan is that the Sacklers increased their payments by $ 1.3 billion and extended their payment schedule by an additional two years (from seven to nine).

Another notable change concerns control of the new company. The original 2019 proposal called for it to be monitored by state-appointed officials. The restructuring plan now describes it as a private company run by independent managers selected by the states and local governments that sued Purdue. The largest groups of applicants – tribes and the government – own the company and would ensure that the proceeds are used solely for crisis management programs.

The company’s managers could sell to private owners by 2024, but those owners would also be bound by the same rules of conduct and income directions.

As it worked its way through the bankruptcy process, Purdue pleaded guilty in November of fraud against health officials and violating anti-kickback laws.

Individual members of the Sackler family agreed to pay the federal government civil fines of $ 225 million, but said in a statement that they “acted ethically and lawfully.” Although the Sacklers were not charged, the Justice Department reserves the right to file criminal charges later.

A key goal of the new Purdue plan is to install guard rails to ensure that settlement money is used to alleviate the epidemic, rather than being paid out more generally to cover budget constraints. Such payouts were a major criticism of the 1998 settlement that ended widespread legal disputes against the large tobacco companies that opioid disputes are sometimes compared to.

During the bankruptcy negotiations, pushed forward by the creditors, the company suggested in its plan that the payouts comply with the latest public health principles signed by at least two dozen major medical, drug policy, and academic institutions, and attention to drug prevention, youth education, and race set up justice and transparency.

Tens of thousands of parties vote on the plan. Confirmation hearings will follow and completion is expected in a few months. Since bankruptcy proceedings began 18 months ago, leaders of a large community bloc have signaled their support, as have 24 states.

Lloyd B. Miller, who represents numerous tribes including the Navajo Nation, said his customers were on board.

“It is critical that more funds go to the treatment of opioids in tribal communities, all the more given the extraordinary devastation tribes have suffered during the Covid pandemic,” he said.

But since 2019, when Purdue filed for bankruptcy, 24 other states – some controlled by Democrats, others by Republicans – and the District of Columbia have declined to take the move, finding that Purdue has continued to benefit from its OxyContin sales.

Maura Healey, the Massachusetts attorney general who was the first to sued individual members of the Sackler family, alleged that Sackler payments under this scheme would come from their investment returns rather than capital.

“The Sacklers became billionaires by causing national tragedy,” Ms. Healey said in a statement. “They shouldn’t be allowed to get away with paying a fraction of their investment returns over the next nine years and walking away richer than they are today.”

Opposing state attorneys general said the plan, while an improvement on previous proposals, still found it disappointing for several reasons. Among them, the plan should be amended to “achieve a speedy and orderly liquidation of the company that does not involve unduly states and other creditors”.

Two branches of the Sackler family – heirs to two brothers who founded the company – said: “Today is an important step in helping addicts and we hope that this proposed resolution signals the beginning of a far-reaching development. Make an effort to provide help where it is needed. “

The oldest brother, Dr. Arthur Sackler, sold his shares before OxyContin was launched, and his relatives are not part of the litigation.

A forensic review of the Sacklers’ finances commissioned by Purdue as part of bankruptcy investigations found that the family made more than $ 10 billion from the company from 2008 to 2017. Family lawyers said the full amount was illiquid: more than half went into taxes and investments in companies sold under the bankruptcy agreement.

Although states and other creditor blocs have protested vigorously against elements of the plan for the last 18 months, many factors seem to favor the likelihood of approval: the length of the litigation, the exorbitant costs for all parties, the urgency of the worsening opioid crisis, and the general depletion of public health resources due to the coronavirus pandemic.

The new company would continue to sell OxyContin, a pain reliever that is still approved by the Food and Drug Administration in limited circumstances. But it would diversify its products to include generics and a drug used to treat attention-deficit hyperactivity disorder, as well as new drugs to reverse overdose and treat addiction to be marketed as a public health initiative on a nonprofit basis.

Categories
Health

Tilray inventory rallies on pot distribution settlement with Develop Pharma

Tilray shares rose 38.8% on Tuesday after the company signed an agreement with Grow Pharma to import and distribute its medical cannabis products in the UK.

Under the contract, Tilray will be able to make these products available to UK patients on prescriptions obtained through the country’s National Health Service or a general practitioner. The company expects these products to be available in the UK next month.

“This partnership with Grow Pharma provides patients in need with access to sustainable supplies of GMP-certified, high-quality medical cannabis and is an important step towards improving access in the UK,” said Brendan Kennedy, CEO of Tilray, in a statement.

Pierre van Weperen, CEO of Grow Pharma, also noted that the agreement will provide British patients with “safe and sustainable supply of the highest quality medical cannabis products”.

This deal is Tilray’s latest move to expand its market share in the cannabis space. In December, Tilray announced it would merge with Aphria in an all-stock deal to create the world’s largest cannabis company when the deal is closed.

Tilray shares were on fire this year, rising nearly 400% as demand for cannabis products grows in the US and around the world.