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This week, we had eyes on data readouts, launch metrics, M&A, and more. Catch up with the latest news from Roche, AstraZeneca, Lundbeck, and AbbVie. What caught your eye this week?
Preliminary data suggests Roche's antibody may safely and quickly eliminate amyloid plaque for those diagnosed with Alzheimer's disease, yet the mid-stage study has been associated with one fatality.
The interim data from a phase 1b/2a clinical trial evaluating Roche's trontinemab in patients with mild-to-moderate Alzheimer's disease was presented at the end of October at the Clinical Trials on Alzheimer's Disease annual conference in Madrid. A patient died during the second of three research stages, which focused on dose expansion. On day 44 of the trial, the 78-year-old woman's death occurred due to a brain bleed in her right front lobe.
According to Roche, a screening MRI revealed evidence of cerebral amyloid angiopathy (CAA). In this disorder, amyloid (a protein linked to the advancement of Alzheimer's disease) accumulates on the walls of brain arteries and can cause bleeding. According to a presentation from the company, additional imaging indicated that the patient might have had a genetic predisposition, raising her risk of CAA.
After the woman’s death, a thorough analysis was conducted by Roche. Due to a protocol adjustment brought about by the evaluation, trial participants who have superficial siderosis—chronic bleeding that affects the brain or spinal cord and may be brought on by CAA—will not be allowed to continue.
This measure adheres to the recently released guidelines for the appropriate use of FDA-approved anti-amyloid beta medication Leqembi, Eisai, and Biogen. There are cautions regarding potential strokes brought on by brain hemorrhages on the labels for Kisunla by Eli Lilly and Leqembi.
The Roche trial is still ongoing, and based on the minor number of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) instances reported, researchers believe that trontinemab’s safety profile is favorable overall. ARIA is a concern for the class of amyloid medications as it indicates potential brain hemorrhage or edema.
Roche reported only three ARIA-E instances in the first two stages of the trial. More extensive future research will be necessary for the pharmaceutical company, although these adverse occurrences are very rare.
Two phase 3 trials conducted by Genentech, a Roche company, by the end of 2022 were unable to demonstrate the value of gantenerumab, an anti-amyloid beta antibody. The pharmaceutical company subsequently stopped developing the asset as its chances of passing the FDA's final review seemed increasingly slim.
For more details, check out the links below:
Brain disease-focused pharmaceutical company Lundbeck is acquiring Longboard for $2.5 billion after spotting blockbuster potential in the biotech's epilepsy medication.
Bexicaserin, a 5-HT2C receptor agonist at the center of the takeover, caused the California biotech's stock to soar in January after it was demonstrated in an early-stage trial to half the number of seizures in a group of people with challenging epileptic disorders. Lundbeck has now agreed to purchase Longboard for $60 per share, which was far more than the $38.90 closing price of the biotech's shares last week, generating a cash price of $2.5 billion.
The acquisition is part of the Danish pharmaceutical company's larger Focused Innovator strategy. In order to generate financial flexibility and reallocate resources to other growth prospects, the business has already implemented this strategy, giving its partner Takeda the U.S. rights to the depression medication Trintellix in the summer.
This significant deal will anchor Lundbeck's neuro-rare enterprise, which might accelerate expansion for the next ten years. For patients with severe and uncommon epilepsies, for which there are not many effective alternative therapies, bexicaserin meets a pressing need.
While the open-label extension of the phase1b/2a trial in uncommon epilepsy syndromes such as Dravet and Lennox-Gastaut syndrome is still ongoing, bexicaserin began a phase 3 trial in September for seizures linked to Dravet syndrome in patients two years of age and older.
Lundbeck plans to launch bexicaserin in the last quarter of 2028, hoping for global peak sales of between $1.5 billion and $2 billion. If all goes according to plan, the acquisition should diversify revenue growth and enhance Lundbeck's mid- to late-stage pipeline.
For more details, check out the links below:
AbbVie Raises Guidance on Skyrizi & Rinvoq
Skyrizi has surpassed Humira in quarterly sales, giving AbbVie a new top sales driver for the first time in years. Skyrizi has gradually overtaken the once-dominant Humira since the collapse of the leading immunology drug due to biosimilar competition. Skyrizi's sales during the third quarter surged 50% to $3.2 billion, overtaking Humira's $2.2 billion sales during the same period. Skyrizi’s profile sets a very high standard for competitors in about 30 nations.
Following its recent launch for the treatment of ulcerative colitis, Skyrizi has been received extremely well with positive initial prescription trends. Recently, Johnson & Johnson's TREMFYA also entered the ulcerative colitis market, triggering intense competition.
At the same time, Rinvoq now seems to be able to treat various immunology conditions, including both forms of IBD and psoriatic arthritis. AbbVie's product acts as a strong competitor in a severely underserved market following Rinvoq's victory over Regeneron and Sanofi's dominant Dupixent in a head-to-head atopic dermatitis study.
Rinvoq made $1.6 billion in the quarter (a 45% increase) and, when combined with Skyrizi, should generate over $17 billion in revenue this year. This estimate exceeds the company's initial projections by $1.3 billion.
AbbVie increased its full-year earnings-per-share projection (from $10.90 to $10.94) from its second-quarter estimate from $10.67 to $10.87, due to the pair's impressive performance. AbbVie's total quarterly profits of $14.4 billion included $7 billion from the company's immunology portfolio. AbbVie is now conducting a head-to-head study comparing Skyrizi to Bristol Myers Squibb's Sotyktu in the treatment of psoriasis, and it intends to pursue Takeda's Entyvio in the treatment of ulcerative colitis.
For more details, check out the links below:
AstraZeneca showcases 3 candidates at Obesity Week in San Antonio.
AZN are looking at options to test its oral PCSK9 inhibitor AZD0780 and its oral GLP-1 agonist AZD5004 alongside Farxiga. AstraZeneca was eager to remind delegates that it has three clinical-stage obesity prospects of its own, despite the excitement surrounding the phase 1 data for Viking Therapeutics' oral GLP-1/GIP dual agonist during Obesity Week in San Antonio, Texas.
The most notable of these is AZD50004, an oral GLP-1 agonist that the business paid Eccogene $185 million for a year ago. With readouts scheduled for the end of 2025 and early 2026 respectively, the candidate is presently undergoing evaluation in two phase 2b studies in type 2 diabetes and obesity. This comes after a preliminary investigation that showed the good safety and tolerability profile of AZD50004.
Additionally, AZD6234, a long-acting amylin, is part of a phase 2 obesity investigation. In the phase 1 trial, the asset showed a favorable tolerability profile with no safety issues. AstraZeneca is preparing to launch AZD6234 in a mid-stage trial alongside AZD9550, its weekly GLP-1/glucagon candidate. The threefold mechanism of this once-weekly combo medication should guarantee optimal weight loss while safeguarding organs and maintaining tolerability.
Executives highlight the possibility of combinations like these to help differentiate AstraZeneca's weight loss offering, given the abundance of competitors fighting for the same weight loss target and the lack of phase 2 evidence for the company's obesity prospects.
The pharmaceutical company is already looking at ways to test the AZD5004 in conjunction with AstraZeneca's oral PCSK9 inhibitor AZD0780 and its approved SGLT2 inhibitor Farxiga.
For more details, check out the links below:
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