July 24, 2023

The need-to-know this morning

Alnylam Pharmaceuticals signed a partnership with Roche to jointly develop its experimental RNAi-based treatment for high blood pressure. Under the agreement, Roche is paying $310 million upfront to Alnylam for rights to the medicine, called zilebesiran — currently in mid-stage clinical trials. Alnylam is also eligible for up to $2.8 billion in future milestone payments, plus a share of profits, if the drug is approved. Reaching the market is many years away, however, because the companies said data from a large cardiovascular outcomes study would be required before zilebesiran could be submitted to regulators.
Kodiak Sciences said it was discontinuing the development of a long-lasting treatment for eye disease following negative results from clinical trials. In twin studies involving patients with diabetic macular edema, injections of the Kodiak drug, called tarcocimab, did not improve vision more than a currently approved treatment, and also led to an "unexpected increase" in cataracts.
Bristol Myers Squibb made a $35 million equity investment in Immatics, a German-based developer of cell therapies for cancer.

Oncology

Gilead halts study of 'don't eat me' blood cancer drug

Gilead Sciences said Friday that it stopped a late-stage clinical trial of its experimental cancer drug called magrolimab after an interim analysis concluded it would not be effective. The study was investigating the use of magrolimab to treat patients with high-risk myelodysplastic syndrome, a type of blood cancer involving the bone marrow.

The setback casts fresh doubts over Gilead's deal-making acumen. Magrolimab was the centerpiece of the company's $4.9 billion acquisition of Forty-Seven in March 2020. Magrolimab isn't being written off entirely just yet — additional studies are underway in other types of blood cancers and solid tumors — but Gilead is unlikely to see a positive return on its investment, analysts said.

Magrolimab belongs to a class of experimental antibody medicines that block CD47, a protein used by cancer cells to send a "don't eat me" signal to the body's immune system. Development of anti-CD47 drugs has been challenging from a safety perspective because the same protein is found on healthy cells. In August 2021, Pfizer paid $2.3 billion to acquire Trillium Therapeutics, developers of its own anti-CD47 cancer therapy.

global warming

Drugmakers want suppliers to reduce carbon footprint

Suppliers to seven of the world's biggest drugmakers have been tasked with reducing their environmental impact. The companies — GSK, Sanofi, Roche, AstraZeneca, Novo Nordisk, Samsung Biologics, and Merck — pointed out that the health care sector contributes approximately 5% of global greenhouse gas emissions, with around half of this coming from healthcare supply chains.

So the companies instructed their suppliers to disclose the extent of their emissions by 2025. By 2030, they want suppliers to seek out green heat and transportation solutions.

"Joint action at scale is needed to move the needle," they wrote in a statement. "…Healthcare supply chains must become greener, more efficient and circular. We must work across the value chain to decarbonize operations and do all we can to move away from fossil-fueled heat and power… Shifting to net zero, climate-resilient health systems cannot be achieved in siloes."

translational science

A new lobby to support NIH's translational arm

This past April, a new lobby launched with an aim to help the NIH move lab discoveries from bench to bedside. The NCATS Alliance is pushing Congress to give its namesake organization, the National Center for Advancing Translational Sciences, a 16% boost in funding next year — bringing its budget to just over $1 billion. It's an ambitious goal, considering that Republicans are increasingly frustrated with the NIH, and Congress is collectively navigating budget caps.

The new lobby is led by Christopher Austin, a former NCATS director who is now a CEO-partner of Flagship Pioneering.

"NCATS is the only center at NIH that's there for all of us," said Ron Bartek, the new lobby's chair. "And we really strongly need the kind of technological breakthroughs that in NCATS alone can inspire and fund."

lobbying

After jumping the PhRMA ship, they're saving money

Three companies recently departed from PhRMA's ranks — and, since then, are spending far less on lobbying in general. AbbVie, which left the trade group in December, spent $2.1 million on lobbying this year, compared to $4.86 million in the same period last year. Teva left in February, and dropped from $2.7 million last year to $1.6 million this year. And AstraZeneca, which left PhRMA in May, saw second quarter spending drop from $830,000 in the second quarter last year to $430,000 this quarter.

None of the companies has worked with any new lobbying firms this year. Last year, AbbVie told STAT that "most" of its lobbying expenses came from membership dues to trade associations. PhRMA, for one, depends on these dues for much of its revenue.

shortages

Tornado damage to Pfizer plant isn't awful

The tornado that tore through a Pfizer manufacturing plant in North Carolina, didn't cause "major damage," the company said. Most of the wreckage happened at a warehouse storing raw materials, packaging supplies, and finished medicines in queue for oversight by the quality assurance team. So it's still unclear how much the tornado strike will impact the overall shortage of prescription drugs in U.S. hospitals. The Pfizer plant produces nearly 8% of all sterile injectables used in U.S. hospitals.

"Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies," the company said in a statement. The North Carolina plant is one of 10 Pfizer manufacturing sites in the U.S. It's responsible for products like anesthesia, analgesia, therapeutics, anti-infective, and neuromuscular blockers.

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