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Sacklers protected again, Medicare negotiation safeguards, & Pfizer's hemophilia win

May 31, 2023
Biotech Correspondent

Today, we explore why drugmakers may have a hard time poking holes in Medicare negotiations over pricing, a federal court agreed that the Sackler family can be shielded by Purdue Pharma over allegations of their involvement in the opioid crisis, and Pfizer has a positive readout for its hemophilia antibody drug. 

hemophilia

Pfizer's hemophilia antibody performs well in Phase 3

Pfizer's experimental antibody drug for hemophilia, marstacimab, reduced bleeding compared to placebo in a key clinical trial — paving the way for the pharma giant to possibly beat out a similar medicine from Novo Nordisk. Phase 3 results show that, among patients who received factor replacement therapy, marstacimab reduced bleeds by 92% when administered weekly, Reuters writes. And compared to prophylaxis, the antibody drug reduced the annualized bleeding rate by 35%.

The FDA rejected Novo Nordisk's hemophilia antibody, concizumab, earlier this month. Regulators cited safety concerns, particularly over reports of blood clots. Pfizer plans to file for approval for marstacimab in the next few months, after hearing feedback from regulators.


opioid crisis

The Sacklers can be shielded by Purdue, court says

A federal appeals court backed the wealthy Sackler family in their latest legal dispute — allowing Purdue Pharma to shield its owners from the thousands of lawsuits that claim they exacerbated the opioid crisis. Several states are taking issue with this decision — but the federal court backed the Sacklers' request for immunity, calling it "equitable and appropriate under the specific factual circumstances of this case."

The Sackler family released a statement saying they "believe the long-awaited implementation of this resolution is critical to providing substantial resources for people and communities in need." Under a bankruptcy settlement, some Sackler family members will relinquish ownership of Purdue, which will become a new company called Knoa. Its profits — which are projected to range between $5.5 billion and $6 billion — are meant to be used for the opioid crisis and its survivors.

Read more.



layoffs

Rain Oncology laying off 65% of staff

A recent Phase 3 flop from Rain Oncology has meant the company is now parting ways with its chief medical officer, ending certain programs, and laying off 65% of its staff. The changes are an effort to shore up costs and stay solvent through 2026, FierceBiotech writes.

This news comes on the heels of Rain's lead asset, milademetan, failing to improve progression-free survival compared to chemotherapy in patients with liposarcoma. Rain acquired the small molecule drug from Daiichi Sanyo in 2020 and built its pipeline around it. Now, Rain is suspending enrollment in a Phase 2 trial that tests milademetan in patients with certain advanced solid tumors.


drug pricing

Medicare negotiations may be untouchable

The new law that allows Medicare to negotiate drug prices has ruffled some biopharma feathers — to the point that some drugmakers have hinted they may sue the government payer. But a new report suggests that some parts of the legislation can't be challenged, unless courts decide otherwise.

Protections for Medicare have been built into the negotiation process. For example, negotiators representing industry have been barred from talking about the proceedings with Medicare and must destroy all relevant documents used during negotiations. This weakens the industry's position, former FDA commissioner Scott Gottlieb recently said, because it prevents them from creating precedents that the industry can lean on in future negotiations.

Read more.


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  • A short supply of cancer drugs has doctors and patients worried: 'We're at a critical juncture,' USA Today


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