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Pipeline Prospector July 2024: Indices continue to climb; Lilly buys Morphic for US$ 3.2 bn, Kisunla bags FDA nod
The biotechnology sector ended in the green for the third month in a row in July, significantly outperforming the broader market. The Nasdaq Biotechnology Index (NBI) climbed by a robust 6.6 percent, closing at 4,843.6, up from a close of 4,545.28 in June. Similarly, the SPDR S&P Biotech ETF (XBI) index surged by 6.8 percent, reaching 99.06, up from June’s closing of 92.71. The S&P Biotechnology Select Industry Index (SPSIBI) followed suit, jumping 6.8 percent to 7,716.95 compared to a 4.25 percent rise in June, when it closed at 7,225.07.
The month saw a few significant deals. Eli Lilly announced the acquisition of Massachusetts-based Morphic Holding for approximately US$ 3.2 billion in cash, bolstering its presence in the US$ 26.65 billion inflammatory bowel disease (IBD) market. Lilly also signed a strategic deal with radiopharmaceutical company Radionetics Oncology for US$ 140 million, with an option to purchase the entire company for US$ 1 billion. As the month drew to a close, Boehringer Ingelheim said it is acquiring Nerio Therapeutics for up to US$ 1.3 billion, in order to expand its immuno-oncology portfolio.
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Lilly’s donanemab finally gets approved; Dupixent okayed as add-on therapy for COPD
With the Alzheimer's Association International Conference (AAIC) taking place in Philadelphia (in the US), the spotlight was firmly on Alzheimer’s disease. In the last week of July, the US Food and Drug Administration (FDA) approved Alpha Cognition’s Zunveyl (benzgalantamine) to treat mild-to-moderate Alzheimer’s disease.
In early July, and weeks prior to the conference, the FDA had granted a long-awaited approval to Eli Lilly’s donanemab, to be marketed as Kisunla, for the treatment of early symptomatic Alzheimer’s disease.
In other approvals, European regulators became the first in the world to approve Sanofi and Regeneron’s Dupixent as an add-on therapy for chronic obstructive pulmonary disease (COPD) patients with high levels of certain white blood cells.
In May, FDA had extended its target action date of its priority review of Dupixent as an add-on maintenance treatment for COPD by three months. The revised target action date is now September 27, 2024.
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Merck’s RSV jab shows efficacy in infants; GSK’s Dovato measures up to Gilead’s Biktarvy
Merck said its monoclonal antibody jab to protect infants against RSV-related infections has met the main goals of a mid-to-late-stage trial. Clesrovimab reduced medically attended lower respiratory infections caused by RSV through day 150. Merck plans to submit the data to global regulators. Currently, Sanofi and Astra’s Beyfortus is approved by the FDA to prevent RSV in children up to 24 months.
In the largest study of its kind, GSK’s HIV drug Dovato was found to be non-inferior to Gilead Sciences’ Biktarvy, which is seen as the benchmark for HIV treatment. Significantly, Dovato did so with lesser weight gain in a 48-week head-to-head study of virologically suppressed HIV-1 patients. Both Dovato and Biktarvy are single pill treatments for HIV given once a day. Biktarvy raked in US$ 11.9 billion in 2023.
Pfizer’s gene therapy for hemophilia A, giroctocogene fitelparvovec, showed promising results in a late-stage trial by significantly reducing the number of annual bleeding episodes. This brings Pfizer closer to securing FDA approval, competing with BioMarin’s Roctavian. Pfizer also said it is moving ahead to mid-stage trials with a once-daily version of its glucagon-like peptide 1 (GLP-1) drug danuglipron for weight loss. In December, Pfizer had discontinued a twice-daily version of danuglipron on account of side effects. Pfizer’s stock also benefited from its healthy second quarter (Q2) results.
Swiss drugmaker Roche is reintroducing Susvimo in the US after voluntarily recalling it in October 2022. The implant used to treat patients with neovascular age-related macular degeneration (wet AMD) requires a one-time surgery to be inserted into the eye.
Roche also revealed that a second drug candidate from its up to US$ 3.1 billion buyout of Carmot Therapeutics — an obesity drug — has delivered promising results in an early-stage trial. This once-daily weight-loss pill CT-996 reduced on average 6.1 percent of participants’ starting weight after four weeks. CT-996 works in a similar manner as other blockbuster weight loss drugs, such as Wegovy and Zepbound.
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Biogen-Sage’s essential tremor drug rejected; Novo’s weekly insulin hit with FDA’s CRL
Several drugmakers faced setbacks last month. Novo Nordisk received a complete response letter (CRL) from the FDA, declining approval for its weekly insulin Awiqli. The agency requested additional information related to the manufacturing process, as well as on the type 1 diabetes indication. In May, an FDA panel had voted seven to four against the benefits of Awiqli outweighing its risks.
Sage and Biogen’s partnership experienced another setback after the failure of their drug SAGE-324 in a phase 2 trial for essential tremor, a disorder that causes uncontrollable shaking of hands, arms and other parts of the body. This follows the previous failure of Zurzuvae to secure an FDA approval for clinical depression.
Meanwhile, Eisai and Biogen’s Alzheimer’s drug Leqembi, faced a setback in Europe when the EU drugs regulator rejected its approval. The European Medicines Agency said the drug’s meager benefit on slowing cognitive decline in early Alzheimer’s did not outweigh the risk it brings of serious brain swelling. Leqembi is approved in the US market, where it has a new competitor — Lilly’s Kisunla.
Also, BMS walked away from its rights to the ADC farletuzumab ecteribulin after having paid Japanese drugmaker Eisai US$ 650 million. As part of its portfolio reprioritization, BMS decided to end the co-development agreement.
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Our view
As July drew to a close, several pharma majors announced their second quarter (Q2) earnings, including Pfizer, Merck, AbbVie and, AstraZeneca. Most of these drugmakers ended up beating Wall Street expectations. For instance, Pfizer saw revenue growth in Q2 after shrinking for five quarters. It posted revenues of US$ 13.3 billion in the second quarter of 2024, compared to US$ 13 billion in the corresponding quarter last year. It has subsequently raised its 2024 guidance by US$ 1 billion. This means it’s not just the indices and share prices, but even the brass tacks — the top line and the bottomline of drugmakers — are looking up. And that may bring more cheer to the markets in August.
Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)
Pharma & Biotech Newsmakers in July 2024
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