Pfizer’s PD-1 drug succeeds; AbbVie writes down $3.5B in Cerevel assets

 Pfizer on Friday said its PD-1 inhibitor sasanlimab, when combined with standard therapy in people with bladder cancer, delayed death and disease complications longer than standard therapy alone. The Phase 3 trial could give Pfizer’s subcutaneous immunotherapy an edge over rival drugs, like Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo, which are approved to treat people with more advanced disease. Pfizer tested sasanlimab with an immunotherapy called Bacillus Calmette-Guérin in people whose cancer hadn’t spread beyond the bladder lining after surgery. If sasanlimab wins Food and Drug Administration approval, it could be the fourth PD-1 or PD-L1 inhibitor cleared as an under-the-skin shot. The FDA has already approved subcutaneous versions of Roche’s Tecentriq and Opdivo, and Merck has positive Phase 3 data in hand for under-the-skin Keytruda. 

AbbVie has recorded an approximately $3.5 billion impairment charge related to its purchase of Cerevel Therapeutics, according to a new financial filing. Through its $8.7 billion acquisition, which completed last summer, AbbVie got a pipeline of experimental brain drugs, including one that looked to be a promising new therapy for schizophrenia. But that drug suffered a major clinical setback late last year. The “outright failure” — as one analyst described it — was so significant that AbbVie subsequently lost more than $40 billion in market value. — Jacob Bell

Royalty Pharma is simplifying its corporate structure, announcing Friday a deal to absorb the management company that’s run Royalty since its founding in 1996. Royalty will acquire RP Management LLC using equity and some $100 million in cash, along with assuming RP Management’s debt. By internalizing RP Management, Royalty will no longer pay it a 6.5% fee and a small cut of the investments it makes. Royalty expects the roughly $1.1 billion in total transaction value will be “more than offset” by cash savings of at least $1.6 billion over the next decade. Royalty Pharma acquires stakes in experimental drugs, buying up rights to future royalties once they are approved.

Eli Lilly has licensed rights to an experimental drug for idiopathy pulmonary fibrosis, announcing Friday a deal with biotechnology company Mediar Therapeutics. The antibody drug, dubbed MTX-463, is set to enter Phase 2 testing later this year, which Mediar will handle. Afterwards, Lilly can lead all further development and marketing, a right for which it is paying Mediar $99 million in upfront and near-term milestone fees. Mediar could receive up to $687 million more in additional milestone payments. MTX-463 targets a protein called WISP1 that’s been linked to fibrosis. 

Barinthus Biotherapeutics on Friday said it would reduce its workforce by 65% after deciding to refocus its research on immunology and inflammation. As part of the changes, Barinthus’ chief operating officer and chief financial officer will step down, and the company will close a site in the U.K. Notably, Barinthus no longer plans to invest in a hepatitis B treatment it was developing and will instead seek a partner for the program. Moving forward, the firm will prioritize a celiac disease drug program that’s expected to deliver Phase 1 data this year. All told, the changes extend Barinthus’ cash runway into 2027. 

Biogen is adding yet another new member to its leadership team, announcing Thursday the appointment of Adam Feire as head of business development and external innovation. Feire most recently held a top position in Novartis' business development unit. His addition is the latest in a string of changes to Biogen's C-suite that have taken place since Christopher Viehbacher, who led Sanofi for six years, took over as CEO in late 2022. In his short time at the helm, Viehbacher has made dealmaking more of a priority for Biogen, as exemplified by the company’s $7.3 billion purchase of Reata Pharmaceuticals and $1.2 billion acquisition of HI-Bio.

Alkeus Pharmaceuticals on Thursday said it plans to submit an approval application to the FDA sometime this year for a Stargardt disease drug it’s developing. The drug, called gildeuretinol acetate, has been tested in several trials, among them an open-label study of people in the earliest stages of the progressive eye disease. New results from that study, summarized by Alkeus Thursday, show two more treated individuals had stable vision over two years post-treatment. Alkeus hopes the treatment can preserve sight. Data from a placebo-controlled study are expected this year.

https://finance.yahoo.com/news/pfizer-pd-1-drug-succeeds-114300500.html