Emprumapimod

Pfizer suffered its first quarterly revenue dip since its BioNTech-partnered Covid vaccine was authorized in 2020, CEO Albert Bourla revealed on Tuesday. And if that isn’t bad enough, he expects patent expiries to cost the company around $17 billion between 2025 and 2030. Which is why, he emphasized on the Q3 call, “It’s all about what’s next.” Bourla outlined ambitious plans to bring 19 new products or indications to market over the next year and a half. He spies blockbuster potential in more than two-thirds of those, including 15 in-house projects that could earn $20 billion in 2030 alone, he said. Myfembree’s endometriosis indication is on the list, as well as an mRNA flu vaccine expected to launch in 2024, if all goes according to plan. Chief business innovation officer Aamir Malik added that the company is actively scoping out deals and continues to be “agnostic to size.” “We believe we not only can overcome these expected declines, but also can potentially generate strong growth through the end of the decade,” Bourla said on the call. Pfizer’s stock $PFE was up more than 3% on Tuesday afternoon. The news comes as Pfizer posts an 66% drop in Comirnaty sales this quarter, which totaled about $4.4 billion. That decline was expected, the company said, and was partly due to an 86% operational decline in ex-US sales caused by shifts in expected deliveries, including an amendment to the EU’s supply deal that postponed the delivery of all doses anticipated from June through August to the fourth quarter. “The slight decrease compared to last year was in line with our expectations, given the phasing of scheduled deliveries of Comirnaty which we discussed in our earnings call last quarter,” CFO David Denton said on the call. Covid vaccine revenue in the US, on the other hand, was up 83% on the heels of recently launched BA.4/BA.5-specific bivalent boosters, Pfizer reported. Despite slow uptake in the US —  just 7.3% of those 5 years old and up have received a bivalent booster, according to the CDC’s vaccine tracker — Pfizer is upping its full-year Comirnaty guidance by $2 billion, anticipating a total around $34 billion for the year. As for Paxlovid, Pfizer reaffirmed its $22 billion guidance. “Regardless of the guidance, we’re far less enthusiastic about the booster opportunity for the updated Omicron-adapted COVID-19 vaccines,” Third Bridge analyst Lee Brown said in a note to investors on Tuesday. Reports recently emerged that Pfizer plans on roughly quadrupling the price of Comirnaty after government funding dries up, but Brown noted that the “price hike may not be enough to meet revenue forecasts for 2023 and beyond.” As government funding dries up, Pfizer expects to charge private payers $110+ for Covid-19 vaccine Bourla said on the call that pricing the vaccine at a “very, very low price” during the pandemic was the “right thing to do,” but coming out of that period, “we are pricing the vaccine according to the cost effectiveness.” Pfizer said Phase I work is underway on a second-gen oral therapeutic, and its modRNA flu program is now in Phase III. A Phase I is expected to start shortly on a combination vaccine that combines its quadrivalent modRNA candidate with its Omicron-adapted Covid vaccine. “I think all respiratory diseases eventually will have coverage like we have right now like we have in flu,” Bourla said. That includes RSV. Earlier this morning, Pfizer announced that it’s stopping enrollment in its Phase III RSV trial after meeting one of two primary endpoints at an interim analysis, and is prepping for a BLA submission later this year. While RSV infections are typically mild for adults, they can be serious for the elderly and newborns, and Pfizer says its candidate protects newborns when administered to mothers during pregnancy. Pfizer declares 'first-ever' PhIII win for RSV vaccine in infants — and it's steering straight to FDA Prevnar sales saw an 11% boost last quarter, benefiting from an approval of Prevnar 20 for adults last June. Pfizer beat Merck’s 15-valent pneumococcal conjugate vaccine to the punch with Prevnar 20, and chief commercial officer Angela Hwang said on the call that the shot holds a 95% market share. “We’re obviously anticipating the launch of pediatric Prevnar 20, but in the meantime, Prevnar 13 is competing really well,” she added. Meanwhile, Xeljanz sales were down 18% last quarter due to “ongoing shifts in prescribing patterns related to Janus kinase (JAK) class label changes,” Pfizer said. The FDA previously slapped boxed warnings on Xeljanz, Olumiant and Rinvoq after concluding that Pfizer’s drug carried an increased risk of heart conditions such as stroke. The EMA followed suit last week, recommending that a group of JAK inhibitors used for chronic inflammatory disorders is only used in certain at-risk patients if no alternatives are available. EMA limits use of JAK inhibitors for at-risk groups in wake of safety concerns Pfizer also revealed a pipeline cut on Tuesday, including PF-07265803, an LMNA-related dilated cardiomyopathy candidate that was deemed unlikely to meet its primary endpoint in a Phase III study. The decision to discontinue was not based on safety concerns, Pfizer noted.

When Pfizer acquired Array Biopharma for $11.4 billion three years ago, the focus was its FDA-approved cancer drugs. The buyout also came with drug candidates in development for other diseases, and it’s the end of the road for one of them. Pfizer is stopping work on PF-07265893, a drug that had reached Phase 3 testing for symptomatic dilated cardiomyopathy, a type of heart muscle disease. The oral small molecule was designed to address forms of the disease that stem from a particular genetic mutation. Symptoms of dilated cardiomyopathy include fatigue and shortness of breath. The condition, which has no specific FDA-approved treatment, can also lead to heart failure that can become fatal. The Pfizer drug is designed to block a pathway associated with the disease’s progression. In an open-label Phase 2 test, results showed improvement measured according to a test that measures the distance patients can walk in the span of six minutes. The six-minute walk test was also the main goal of the placebo-controlled, 24-week Phase 3 study of PF-07265893. Secondary goals include assessing the six-minute walk at weeks four and 12, and assessing a change in score according to a cardiomyopathy questionnaire. Pfizer said late Wednesday that an interim analysis found the study was unlikely to meet its main goal. The company did not release specific findings of that analysis, but said that the decision to discontinue work on the drug was not based on any safety concerns. More detailed data from the clinical trial will be presented at future medical meetings, the company said. “This development confirms the complexity of advancing new treatments for rare cardiovascular diseases and the need to further increase knowledge in this space,” Chris Boshoff, Pfizer’s chief development officer for oncology and rare disease, said in a prepared statement. The Phase 3 trial for PF-07265803 started under Array Biopharma. That Boulder, Colorado-based company had commercialized two cancer drugs, Braftovi and Mektovi, as a combination treatment for melanoma characterized by a particular genetic mutation. Pfizer’s 2019 acquisition of Array followed positive Phase 3 data testing the drug combo in colorectal cancer. Braftovi won an additional approval in colorectal cancer in 2020. Under Pfizer, neither Braftovi nor Mektovi have become big sellers. Braftovi accounted for $187 million in revenue last year, according to Pfizer’s 2021 annual report. Mektovi accounted for $155 million in sales. Pfizer said it is working with regulators, clinical trial investigators, and community groups to wind down the PF-07265893 clinical trial.