Biogen and its partner, Japanese drugmaker Eisai, earlier this month won fast-track approval from the Food and Drug Administration for Lekambi, a monoclonal antibody for the treatment of Alzheimer’s disease. Although Biogen’s shares are trading higher in the wake of this development, they are up only 4% or so year to date. In part, the modest gains are the result of a run-up in the stock ahead of the expected news. But some doubt that there will be big gains for Biogen after Lekembi. [lecanemab] Removes other obstacles that are still in front. For example, Lakenby still needs to get the blessing of the Centers for Medicare and Medicaid Services. After all, most patients with Alzheimer’s disease are Medicare recipients, and the CMS decision will determine whether patients can obtain coverage for the treatment, which is expected to cost $26,500 a year. Investors also want to see that patients are ready and able to receive the treatment, which requires visits to an infusion center every two weeks, and periodic MRI scans to monitor the effects of treatment. it occurs. This could be a deal breaker for patients in rural areas without access to those devices. “All investors, as well as not necessarily all practitioners, believe that profit [Biogen and Eisai] “What has been shown in clinical trials is necessarily clinically meaningful,” said Marshall Gordon, a senior research analyst at ClearBridge Investments. It’s going to be needed.” Despite these hurdles, Biogen’s achievement has been seen as a positive in a field starved of good news. Alzheimer’s is the most common form of dementia, but is still not fully understood. Disease Control And the Centers for Prevention estimates that 5.8 million Americans were living with the disease in 2020. With an aging population, the agency projects that number could nearly triple by 2060. “I think Alzheimer’s fields Everyone is looking at this as a start… , but this is our first step. It’s a significant one,” Gordon said. Opportunities and Doubts Goldman Sachs analyst Salvin Richter predicts that Lekembi could see peak global sales of $15.7 billion in 2031. Biogen and Eisenhower share profits for the drug Divided by. BIIB 6M Mountain Biogen’s stock is trading well above its lows. Lekembi treats Alzheimer’s disease by targeting amyloid-beta plaques in the brain. Sticky buildup of this protein is a hallmark of memory- robbing the neurodegenerative disorder. Researchers theorize that plaques injure neurons in the brain. Removing, or stopping, them could halt disease progression, drug makers say. But some skeptics note that this same approach Biogen and Christian’s previously used treatment, Adhelm. That drug proved controversial because the benefits were minimal. There was also the potential for side effects from brain swelling and fluid build-up leading to bleeding in the brain. Ultimately, CMS of Adhelm refused to pay for it, and it was a commercial flop. Clinical trial data for Lekembi has been more reliable in demonstrating that it can prevent disease. Patients who received treatment showed cognitive decline that was 27% slower at 18 months than those who did not receive treatment. CMS is evaluating the data for Lekambi and may agree to cover the drug. The agency issued a statement saying it wanted to see meaningful improvements in patients’ health, such as slowing of cognitive decline, in order to determine whether the benefits of its use outweigh the risks. An endorsement from CMS would likely be a catalyst for Biogen. Still, investors should be aware that Biogen has a lot riding on the drug’s success. The company has seen declining sales for other drugs in its portfolio, and Leqembi needs to succeed. At the moment, the stock has an average rating of overweight, with a $322 average price target. That’s up more than 11% from when the stock closed on Friday. The focus on Eli Lilly shares of other Alzheimer’s drug developers often mirrors Biogen’s moves. The group, including Eli Lilly and Roche, escalated in late September when Lekembi’s positive test data first emerged. Since then, Roche has suffered a setback with its Alzheimer’s treatment gantanerumab, while Lilly is moving forward with its donenumab, which is nearing the end of a phase three trial. LLY 6M Mountain Eli Lilly shares have pulled back from their recent highs after Roche’s treatment targets a different part of amyloid plaque, and the company wasn’t able to show that cognitive decline is slowing enough to be meaningful. happened. The belief that gantanerumab was not able to clear amyloid fast enough led to encouragement for rival treatments that have been more successful at removing buildup. Notably, patients in Roche’s study who saw greater plaque reductions showed greater signs of improvement, but those results were not statistically significant. Studies of Lilly’s donnemab have been more encouraging so far, and more data are expected in the second quarter of this year. SVB Securities analyst David Risinger said in a research note in mid-December that he was encouraged by Biogen and Eisai’s results and raised his odds for Lilly’s success to 40% to 60%. For investors, Lilly also has the advantage of a strong, diversified portfolio of drugs that includes Monzaro, a type 2 diabetes drug that could also become a blockbuster obesity treatment. Shares of Lilly have jumped 48% in the past year. Analysts have an average rating on Lilly of overweight, with a $389 price target, or more than 7% from where shares closed on Friday. Risinger’s price target on Lilly is above consensus, at $410, which represents a 13% gain from current levels, reflecting their expectations for progress on both donnemab and Monjaro, as well as Lilly’s existing GLP-1 diabetes treatment, Shows growth in Trulicity sales. One potential advantage of Lilly’s Alzheimer’s therapy is that it aims to administer treatments once a month, compared to the every-other-week dosing required for Lekambi. William Blair analyst Miles Minter said that if it succeeds in winning approval, Lilly will be Biogen and Eisai’s main competitor. Smaller drug developers Smaller Alzheimer’s drug developers have also received a boost from research developments. These include Prothena and Acumen Pharmaceuticals. Still in the early stages of its research, Prothena uses the business as a proxy for developments in Alzheimer’s treatments. The company hopes to develop an antibody that can be given to patients at home through a subcutaneous injection instead of an IV. That would be a big advantage for patients, according to Dan Lyons, a portfolio manager at Janus Henderson, which owns the stock. PRTA 6M Mountain Prothena: Another way to play off Alzheimer’s progress According to Janus, the approval of Biogen and Eisai’s therapy has helped other companies in the field because it established what the FDA believes that safely clearing plaques from the brain provides benefits for Alzheimer’s patients. , Cantor Fitzgerald has a $98 price target on Prothena, or about 66% upside from where the stock closed on Friday, and above the Street’s average target price of $86. But the debate over the “amyloid hypothesis” has intensified, and it is looking likely that a combination of therapies will be needed to prevent Alzheimer’s. Agustin Mohedas, a research analyst at Janus Henderson, noted an analogy with cancer treatment. “We didn’t cure cancer in one go,” Mohedas said. He said early treatments have shown some improvement for some patients, and since then developments have built on one another to the point that the American Cancer Society was able to report last week that cancer death rates have nearly tripled in the past three years. has decreased. decade . “People lose sight of how drug development really works because of that kind of pooh-pooh the results are minor,” he said. “It’s rare that … the first thing you find is a treat.” Meanwhile, other methods are also being explored. Janus has invested in Lexio Therapeutics, a privately held biotech working on developing gene therapy for people who have two copies of the APOE4 gene. People with this pair of genes are at a significantly higher risk for Alzheimer’s, and their disease progresses at a faster rate. About 10% of Alzheimer’s patients have this genetic marker. Research into Lexio is slow but early studies have shown that the treatment may be well tolerated. Patients who received it also had lower levels of tau and amyloid, both key markers of Alzheimer’s. There are also treatments that focus on removing tau, or on neuroinflammation, but those studies have yet to demonstrate benefit to patients. Over time, if removing tau is helpful, therapies could be developed that combine these approaches. While opinion is divided on the root cause of Alzheimer’s and how to treat it, there is one thing that cannot be argued over, Minter said. “We’ve never been able to offer this to our patients who have no hope,” he said. … There’s one thing we can guarantee is you’ll get worse… if you don’t intervene.”