Felmetatug vedotin

Pfizer’s next deals are likely to be longer-term efforts to reload its R&D work rather than big-ticket, late-stage assets, the company’s top executives said Tuesday. “Looking forward, we are looking at more strategic opportunities right now, which will enhance the pipeline in areas that we would like to play, rather than near-term revenues,” CEO Albert Bourla told investors Tuesday. The company has about $10 billion to $15 billion it could put toward M&A this year, according to CFO Dave Denton. He previously guided that while there’s always “a little flexibility to do BD,” large transactions would likely be kicked to 2026 or beyond. Pfizer has made de-levering a priority, with billions in cost cuts initiated and executed, and billions more raised by selling off stakes in Haleon, a consumer health wing co-run with GSK. Like many other drugmakers, New York-based Pfizer is looking at the explosion of assets coming out of China. The number of deals being made there “has not escaped our attention,” chief strategy and innovation officer Andrew Baum said Tuesday. “They’re mostly fast followers, but I expect that will change as well,” Baum said. “It’s an area that we are very, very active in.” That shift to earlier-stage assets comes after a run of larger acquisitions that were meant to reload revenue as the company’s Covid franchise declined. Led by the $43 billion acquisition of Seagen, those deals have added $20 billion in 2030 revenues, Bourla said. Not all of those transactions have been successful, however. Last year, Pfizer pulled a sickle cell drug from the market that was part of its $5.4 billion acquisition of Global Blood Therapeutics in 2022. And on Tuesday, it said it was taking several write-downs related to drugs acquired from Seagen. That included a $1 billion write-down after discontinuing felmetatug vedotin, an antibody-drug conjugate. A Pfizer spokesperson said the decision came after data showed that it “is unlikely to achieve a meaningful improvement over standard-of-care chemotherapy in patients with advanced solid tumors, including triple-negative breast cancer.” A second $200 million write-off came from a second Seagen ADC, disitamab vedotin. The spokesperson said that development of the asset is continuing. A third, $400 million charge was related to Seagen’s Tukysa. Both felmetatug vedotin and disitamab vedotin were listed as potential future growth drivers at Pfizer’s oncology innovation day a year ago. Last year also brought activist investor Starboard Value , which sought more accountability for management after what the firm alleged was a badly underperforming slate of deals that held back the stock. Pfizer has largely been able to stave off Starboard’s most aggressive potential actions, such as pushing for a seat on the board.

The $200 million impairment charge related to disitamab vedotin reflects the reality of “emerging competition,\" Pfizer said.\n Pfizer has ended development of a B7-H4-directed antibody-drug conjugate (ADC), triggering a $1 billion impairment charge. The Big Pharma disclosed the blow alongside a $200 million charge linked to another ADC.  The $1 billion charge is tied to B7H4V, an ADC that Pfizer acquired in its takeover of Seagen late in 2023. Seagen began a phase 1 trial of the ADC in people with advanced solid tumors in 2022. Recruitment stopped in September 2023 but resumed again the next month. Seagen stopped enrollment again in December 2024. Now, Pfizer has revealed the latest halt is permanent.  “We have made a business decision to discontinue the felmetatug vedotin (FV) development program based on clinical data generated to date indicating that FV is unlikely to achieve a meaningful improvement over standard-of-care chemotherapy in patients with advanced solid tumors, including triple-negative breast cancer,\"  a Pfizer spokesperson said via email. \"There have been no new safety signals observed in patients taking FV.\"Pfizer talked up the prospects of the drug at an oncology day event 11 months ago, including the asset on a list of eight potential blockbusters that its pipeline could generate by 2030. The drugmaker used the event to tout early signs of antitumor activity in patients with two types of breast cancer: triple negative and HER-positive, HER2-negative. At the time, Pfizer was also targeting ovarian and endometrial cancer with the ADC.B7-H4 is a competitive space. AstraZeneca and GSK have rival ADCs in the clinic. Other drug developers have aimed bispecifics at the target but that race has thinned out in recent years, with Pfizer and Genmab terminating programs.   Pfizer reported (PDF) the discontinuation of B7H4V as part of $2.9 billion in intangible asset impairment charges in its fourth-quarter results. Another ADC, disitamab vedotin, accounted for $200 million of the charges.   Seagen took the HER2-directed ADC into a phase 3 trial in people with previously untreated urothelial cancer in 2023. The ADC, which Seagen bought for $200 million upfront in 2021, works in the same way as Enhertu but AstraZeneca and Daiichi Sankyo’s blockbuster is yet to win approval for first-line use in urothelial cancer.  The $200 million disitamab vedotin impairment charge reflects the reality of “emerging competition,” Pfizer said in its financial filing. RemeGen, the biotech that licensed ex-Asia rights to Seagen, won approval for disitamab vedotin in China in 2021.  As part of its financials, the New York pharma also revealed it has \"discontinued\" phase 2 work on heart failure hopeful ponsegromab. The drug is still being tested in cancer patients with wasting syndrome to help them gain weight.