On September 15, 2019, Purdue Pharma L.P. announced a preliminary agreement to settle the opioid litigation facing the Company.
Benefits of the Settlement:
- The settlement would deliver more than $10 billion in value and address the opioid crisis by, among other things, providing needed funds, as well as millions of doses of lifesaving opioid addiction treatment and overdose reversal medicines.
- The settlement is designed to quickly deliver resources to states and local communities to abate the opioid crisis versus delay, expense and value destruction from endless litigation or a many years long bankruptcy process.
- Purdue would become a public benefit company (PBC) with a focus on addressing the opioid crisis, established for the benefit of claimants and the American people.
- 100% of Purdue’s assets would be transferred to this new structure.
We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications, and we have the capability to manufacture others for medication assisted treatment.
Injectable Nalmefene – Purdue has received FDA fast-track designation for injectable nalmefene, which has the potential to reverse overdoses from powerful synthetic opioids such as fentanyl. (This information discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that injectable nalmefene will successfully gain FDA approval.)
Nasal naloxone – Purdue continues to support the development of a low-cost over-the-counter (OTC) naloxone nasal spray by Harm Reduction Therapeutics, Inc. which can be used to reverse the effects of opioid overdoses. (This information discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that HRT’s OTC naloxone nasal spray will successfully complete development or gain FDA approval.)
Buprenorphine/naloxone – As part of the proposed settlement structure, Purdue has offered to make tens of millions of tablets of a generic formulation of buprenorphine and naloxone sublingual tablets available for free over 10 years. Buprenorphine/naloxone tablets are a leading maintenance treatment of opioid dependence.
Continuity of Care: The company will continue to serve patients who rely on its FDA-approved medicines and other products. We also continue to develop and distribute consumer health and wellness products. We have a diverse portfolio and pipeline of medicines in development that address important medical needs in multiple therapeutic areas such as non-opioid pain relief, oncology, central nervous system disorders, and digestive health.
Important Milestones in the Chapter 11 Bankruptcy: On September 15, 2019, Purdue Pharma L.P. announced a preliminary agreement to settle the opioid litigation facing the Company. Purdue is working to build additional support for the settlement.
1. Preliminary Injunction:
In November 2019, the Bankruptcy Court approved Purdue’s motion for a preliminary injunction to halt all lawsuits against the Company. In September 2020, the Bankruptcy Court extended the stay of litigation to March 1, 2021.
2. Claim Submission and Bar Date:
In February 2020, Purdue began formally notifying potential creditors of the bar date – the date by which they can file a claim against the Company seeking compensation. The deadline for filing proofs of claim against the Debtors was July 30, 2020. More information can be found here.
3. Voluntary Injunction and Independent Monitor:
Upon entering bankruptcy, we agreed to be bound by – and continue to comply in good faith with – an unprecedented self-injunction that places strict limits on our ability to promote opioid products. In February 2020, Purdue announced the appointment of former US Agriculture Secretary and Iowa Governor, Tom Vilsack, as Monitor. In this role, Secretary Vilsack reports on Purdue’s compliance with the terms of the voluntary injunction.
In March 2020, the Bankruptcy Court approved an order establishing mediation procedures for non-federal public claimants and private claimants. We are pleased with the progress of the mediation to date, and specifically with the growing support for using the vast majority of settlement proceeds to abate the opioid crisis.