Dominari Holdings, Inc.

One gastroenterologist called the price of Rezdiffra "problematic." Madrigal Pharmaceuticals already has physicians singing from its hymn sheet. Shortly after the biotech won approval in metabolic dysfunction-associated steatohepatitis (MASH), most gastroenterologists said they were familiar with its drug and planning to trial the brand within six months of its launch. Spherix Global Insights captured the views in a survey that asked 81 gastroenterologists for their opinion on the liver disease drug and projected uptake of the brand post-launch. More than 80% of the doctors reported unaided awareness of Rezdiffra’s approval. Seventy percent of the respondents said they are at least moderately familiar with Rezdiffra, a significant increase over the awareness level one year ago. More than three-quarters of the gastroenterologists expect to trial the brand within six months of its launch. The gastroenterologists said more than one-third of the MASH patients they look after are eligible for the drug, a finding Spherix said further bolsters the chances of swift uptake and utilization.  Interest in Rezdiffra reflects the fact it is the first MASH treatment and evidence that it can improve liver scarring. One physician told Spherix it is “nice to have a daily oral pill to help reduce hepatosteatosis and possibly reverse liver damage,” while another gastroenterologist noted the “good safety profile.”  Spherix heard some dissenting voices, though. One respondent commented on some gastrointestinal side effects and efficacy data that suggest the drug will fail “a large number” of patients. Another person called the list price—$47,400—“problematic,” adding that “we will have to see what third-party payer barriers are thrown up to its use.” Madrigal said the “price reflects value as first-and-only therapy for NASH” when it won approval. The biotech pointed to best-in-class health economics and outcomes research data along with the experience of its team to contend it can handle the market access side of the launch. Madrigal is aiming to achieve 80% commercial coverage by the end of 2024 and quickly cut the time to fill prescriptions to 30 days.  The Rezdiffra launch will focus on around 14,000 specialists, including 6,000 “top treaters,” who care for the 315,000 MASH patients with moderate to advanced fibrosis. If Rezdiffra can stop those patients from progressing to cirrhosis, it could prove its value by preventing liver failure, transplants and deaths.

A Spherix report shows that the size of Velsipity’s user base after three months—with about a third of gastroenterologists surveyed already prescribing the drug—was comparable to Rinvoq’s at the same point in its own launch, while decently outstripping Zeposia’s first-three-months performance. In its first few months of U.S. availability, Pfizer’s Velsipity has already made a splash in the moderate to severe ulcerative colitis (UC) space, where it’s up against BMS’ Zeposia, a fellow S1P receptor modulator, as well as biologics including AbbVie’s Humira and Rinvoq, J&J’s Stelara, Takeda’s Entyvio and Eli Lilly’s Omvoh, the last two of which were approved within weeks of Velsipity last fall. But Pfizer will need to step up its game to continue warding off those competitors, according to a report from GlobalData. In the report, healthcare analyst Filippos Maniatis noted that Velsipity has a leg up over Humira and other biologics for UC treatment because of its oral administration. It’s also backed by a strong showing in clinical trials, in which Velsipity appeared to produce better efficacy over placebo than Zeposia did in its own studies. Even so, Pfizer will need to pay close attention to both its competition—and especially close rival Zeposia—and the needs of patients to carve out a lasting future in the UC treatment space, per GlobalData, especially as future challengers emerge from the pipeline to join an increasingly popular field. “The UC market has become highly competitive in recent years, and can be considered a very dynamic field, with multiple therapies receiving approvals for the treatment of UC. Ongoing unmet needs in the field as well as the healthcare burden of the disease highlight the need for the development of advanced therapies,” Maniatis said. “There is an anticipation that pipeline agents in development for UC will eventually be able to address the need for highly efficacious treatment alternatives should these agents receive approval.” Pfizer declined Fierce Pharma Marketing’s request for comment. Data recently compiled by Spherix Global Insights about Velsipity’s first three months on the U.S. market since its approval last October indicate the drug’s potential to overtake its competitors in the space. The Spherix report shows that the size of Velsipity’s user base after three months—with about a third of gastroenterologists surveyed already prescribing the drug—was comparable to Rinvoq’s at the same point in its own launch, while decently outstripping Zeposia’s first-three-months performance. And while doctors are still in the early days of prescribing Velsipity, Spherix suggested that its user base, estimated to be 1.1% of the market as of the February analysis, could more than double in the next six months, bringing its market share close to Zeposia’s 4.3%. They’ll both still trail the brand share of Entyvio, Humira, Stelara and Rinvoq, however, especially as S1Ps continue to rank low on doctors’ views of the safest and most effective mechanisms of action in UC treatments—though the physicians surveyed by Spherix did praise Velsipity’s oral administration as a major plus. “Use and manufacturer launch perceptions for Velsipity are outpacing those of its S1P predecessor at the same point in its launch. Pfizer has a leg up on BMS as a respected and known entity in gastroenterology as the pioneer in the development of oral assets in IBD,” Jim Hickey, head of Spherix’s gastroenterology franchise, said in a statement sent to Fierce Pharma Marketing. “Gastroenterologists clearly desire to have an efficacious oral in the pre-biologic space,” Hickey continued. “While prescribers show a strong affinity for Rinvoq, the product’s label limits first-line use, creating a real opportunity for Pfizer with Velsipity. However, for Pfizer to be truly successful they will need to overcome pre-existing S1P perceptions stemming from Zeposia.”

In the near term, Japan has been pegged as Leqembi's second biggest market behind the Americas. Despite weathering a host of launch challenges with Leqembi, Eisai still has big hopes for its amyloid-busting antibody in early Alzheimer’s disease. On Thursday, the Japan-based company solidified those ambitions with new estimates for eligible patient populations worldwide and potential sales. By Eisai’s 2026 fiscal year—which ends in March 2027—the company figures Leqembi can bring home 290 billion Japanese yen (nearly $2 billion) in global revenues. Come fiscal year 2032, those sales could potentially swell to a whopping 1.3 trillion yen ($8.8 billion), Eisai said in a new corporate update (PDF). Last year, Eisai said it expected global Leqembi revenue to hit 1 trillion yen (currently around $6.8 billion) by 2030.  Eisai projects there will be about 398,000 people eligible for its treatment worldwide in FY2026. The number should balloon to 3.32 million by FY2032 as diagnoses accelerate and the Leqembi treatment pathway is streamlined, the company said. Leqembi works by removing beta amyloid in the brain, which forms once of the central theories as to what causes Alzheimer’s. In order to access the drug, patients need to be tested to confirm the presence of beta amyloid. That said, a recent report by life sciences consultants at Spherix found that nearly half of 75 neurologists surveyed reported issues conducting the right sort of amyloid testing to get the go-ahead for Leqembi. Regarding diagnoses, Eisai earlier this week said it would drop upwards of $15 million to re-up its investment in Alzheimer’s blood test developer C2N Diagnostics. C2N’s Precivity blood tests are designed to suss out tau and beta amyloid proteins that have made their way into the bloodstream via plaques in the brain. C2N has demonstrated that its approach is comparable to expensive brain imaging scans and uncomfortable spinal tap biopsy procedures. Still, testing has proved just one stumbling block for Eisai’s drug, which it’s commercializing with the help of U.S. partner Biogen. Eisai had originally set the goal to reach 10,000 patients with Leqembi by the end of March—but as of Jan. 26, just 2,000 patients in the U.S. were receiving the drug, the company explained on a February analyst call. That level of progress made Eisai's goal “rather challenging” to achieve, the company’s global Alzheimer’s disease officer, Keisuke Naito, said at the time. Now, Eisai aims to significantly boost its field force of neurology account specialists by some 30% in the first quarter of the 2024 fiscal calendar, the company said Thursday. The company also plans to “enhance collaboration” with Biogen, which is tackling Leqembi commercial duties in the U.S. Nevertheless, the problems could run deeper for Leqembi, Spherix’s recent survey found. According to the poll, “few surveyed neurologists consider Leqembi to be a significant medical advance over other historical AD treatments,” the Spherix consultants said last month. Coverage has emerged as another hurdle, with Spherix’s report noting that, on average, two-fifths of patients who should be eligible weren’t prescribed Leqembi because they couldn’t secure Medicare or other insurance approvals. Lastly, logistics have become an issue, too. Leqembi needs to be infused at a specialist center, but three-fifths of patients, according to the Sphreix report, are receiving treatment at off-site infusion centers unrelated to the neurologists’ practice. Eisai, for its part, has said it hopes to expand its Alzheimer’s business by rolling out maintenance dosing and a subcutaneous formulation of Leqembi, which could make the experience of receiving the medication far simpler. In its corporate update Thursday, Eisai also said it wants to help shift medical care aware from a specialist-centric model to one in which primary care physicians also play a “major role" in addressing the disease. In Eisai’s latest third-quarter results, which ran from October to December, Leqembi generated a slim 1.1 billion yen in U.S. sales (around $7.4 million) over the three-month stretch. Analysts with GlobalData Healthcare have predicted Leqembi could reel in cumulative sales of $12.9 billion through 2028. At the time, another group, Evaluate Vantage, estimated that Leqembi would reach worldwide sales of $3 billion in 2028.