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Neumora's depression data, RSV antibody approved, & Pfizer's big Flagship deal

July 18, 2023
Biotech Correspondent

A major deal between Pfizer and Flagship, a new antibody drug's approved to prevent severe respiratory disease in young children with RSV, a deep dive into donanemab data, and so much more.

Plus: Now that biosimilars for Humira are beginning to hit the market, what's next? STAT will have a video confab with a number of experts on the subject at 1 p.m. ET today. Sign up here.

big deals

A $7 billion partnership for Pfizer and Flagship

Pfizer and Flagship want to develop new medicines together — teaming up in a $7 billion deal that will focus on the latter's portfolio companies. They companies will start out by spending $50 million apiece to develop 10 drug candidates. Pfizer gets the first rights to acquire each for up to $700 million, plus royalties. Flagship's portfolio companies will benefit from any payments that come from the partnership.

The deal with Pfizer will focus on areas like oncology, immunology, vaccines, and other diseases that affect large portion of the population. Pfizer has a ton of cash on hand thanks to its Covid vaccines and treatments: It expects between $67 billion and $71 billion this year. In comparison, Pfizer's revenues were $51.8 billion in 2019.

Read more.


depression

Neumora's depression drug performed well in Phase 2

Navapracant, a depression medication made by the privately held Neumora, led to statistically significant improvements in patients with moderate to severe forms of the disease, new data show. The mid-stage trial showed that the medicine improved anhedonia, which was self-reported by the patients. The 171-person trial also included patients with mild to moderate depression, but navapracant's efficacy didn't hit the threshold to be considered statistically significant.

"For me, the results from the subpopulation were inspiring," one psychiatry professor told STAT. "You're getting an effective antidepressant, but you're also getting efficacy in the dimension of anhedonia, which is as relevant to depression as pain is to a pain disorder."

Neumora will now move onto three Phase 3 studies, with plans to enroll patients with moderate to severe major depressive disorder. It plans to have data ready for potential FDA approval in 2025.

Read more.



rsv

FDA approves antibody for RSV in the young 

RSV is the leading cause of hospitalization in young children and infants. The FDA has just approved AstraZeneca's antibody drug Beyfortus to help prevent severe illness in this vulnerable population. It still needs to be recommended by the Advisory Committee on Immunization Practices, an independent panel that advises the CDC. On Aug. 3, the ACIP will meet to decide whether or not it will recommend the antibody or add it to the Vaccines for Children program.

Beyfortus is already licensed in the E.U., the U.K., and Canada. It'll be marketed in the U.S. by Sanofi. Late-stage trials have shown real efficacy. 

"If we're looking at a 75% reduction in physician visits for kids who get nirsevimab, and a 75% reduction in RSV hospitalizations, that's a huge impact on parents and on the health care system," one infectious disease expert told STAT.

Read more.


crispr

Sanofi licenses Scribe's CRISPR tool to bolster its experimental sickle cell treatment

Sanofi is licensing a CRISPR enzyme from Scribe Therapeutics, with aims to develop a safer and more scalable cure for sickle cell disease. It will pay Scribe $40 million upfront, with another $1.2 billion promised in potential milestone payments to get access to a gene editing enzyme called CasX that was developed in CRISPR pioneer Jennifer Doudna's lab.

There already is a CRISPR-based treatment for sickle cell disease that could be approved this year — but the Vertex infusion is likely to only be given to patients with the most severe forms of the disease, since the side effects are marked, and it's complicated to administer.

Read more.


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