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This week we've been looking at the competition heating up due to a combination of M&A, biosimilar entrants, and new clinical data. We're going to keep our Eyes On GLP-1's, bHumira/AbbVie, and IBD. Which hotspots have you been watching?
Competition Heats Up in IBD Drug Development
Takeda’s injectable inflammatory bowel disease Entyvio is facing a challenge in the form of Eli Lilly’s $3.2B buy-out of the oral competitor Morphic. Currently in phase 2 development for Crohn’s disease and ulcerative colitis, Morphic follows Lilly’s prior $2.4 billion Dice Therapeutics acquisition of a preclinical oral α4β7 program.
More than a year ahead of Gilead Sciences’ oral α4β7 competitor, Morphic’s MORF-057 entered its second phase in 2022. The oral molecule constrains α4β7, an integrin present in certain white blood cells, and as a result facilitates the control of intestinal inflammation.
Takeda’s injectable Entyvio is also faced with competition from Ensho Therapeutics’ recent acquisition of a phase 2-ready oral α4β7 candidate from EA Pharma (Eisai’s GI subsidiary).
Morphic’s stock rocketed after an initial report of a clinical remission rate signaling MORF-057’s possible efficacy match with its rival Entyvio. However, its subsequent inability to show the necessary endoscopic improvement decreased its stock value. At $57 a share, Morphic’s price failed to recover, enabling Lilly’s offer to come at 87% premium to the 30-day volume-weighted average trading price. Data from phase 2b trial in ulcerative colitis is due to be released at the beginning of 2025.
More Details on PharmaTell Studio
More Details on PharmaTell Studio
bHumira Competition is Beginning to Erode AbbVie's Market Share
AbbVie’s Humira continues to hold the majority of the biosimilar market, but gradual decrease of its share is on the horizon as signaled by the recent drop to 82%. Based on the analysis, Sandoz's Hyrimoz is accountable for "most biosimilar gains" under its Cordavis co-label. The first medication offered by CVS Health's new biosimilar subsidiary, Cordavis, was Hyrimoz. Prescriptions for Hyrimoz skyrocketed after CVS Caremark pulled branded Humira from its nationwide commercial formularies in April. According to IQVIA data, 82% of prescriptions for Humira biosimilars were by Hyrimoz as of April 25. So far, the successful launch has helped Sandoz achieve 6% sales growth in the first quarter.
For their part, AbbVie collaborated with Cordavis on a Humira formulation under their joint brand. According to Samsung Bioepis' research, the product accounts for around 25% of the market for products labelled with the Cordavis brand.
In addition to providing large discounts, many businesses use two different price strategies. For instance, Boehringer Ingelheim's interchangeable Humira biosim Cyltezo was first offered as an 81% markdown on an unbranded version and as a 5% reduction from Humira when it was first introduced. Higher list prices are preferred by certain payers in order to maximise their rebates. However, from its July 2023 introduction, BI's Cyltezo has only received 1,487 prescriptions as of April, whereas Humira has received around 2.8 million prescriptions during the same period. Boehringer's Cyltezo customer-facing team even saw layoffs as a result of the delayed launch as the group shifted to a hybrid approach.
AbbVie has long planned to shift its focus to two more recent immunology medications, Skyrizi and Rinvoq, in order to make up for Humira's declining sales. Sales of Humira reached a record $21.2 billion in the previous year, but then dropped to $14.4 billion last year. Most recently, Skyrizi almost caught up with a $2 billion quarterly haul, but Humira sales plummeted 40% during the first quarter.
More Details on PharmaTell Studio
More Details on PharmaTell Studio
More Details on PharmaTell Studio
More Positive Data for Novo's GLP-1's
Semaglutide from Novo Nordisk has already been demonstrated to reduce the risk of kidney disease and cardiovascular events in trials. According to a recent Oxford study, Ozempic, the company's semaglutide type 2 diabetes medication, may lower the risk of dementia. Compared to Merck's type 2 diabetes medication Januvia (sitagliptin), Ozempic exhibited a 48% reduction in dementia, according to research intended to prove if the pill could create neurologic issues. The Oxford study also revealed that, in comparison to Januvia and Pfizer's previous type 2 diabetes medication, Glucotrol (glipizide), Ozempic offered a 28% reduction in "nicotine misuse."
The study made use of TriNetX electronic health records, which covered over 100,000 patients between May 2017 and May 2021. Three additional type 2 diabetes medications, including Eli Lilly and Boehringer Ingleheim's Jardiance (empagliflozin), were compared to semaglutide by researchers.
Throughout the course of a year of therapy, the research team examined the risks of 22 neurological and psychiatric outcomes related to different diabetic medications. Previous research has found that dementia is more likely to occur in diabetics. Studies reported by the Alzheimer's Association indicate that people with type 2 diabetes have a higher risk of developing Alzheimer's disease.
The findings contribute to the increasing array of advantages offered by GLP-1 therapies. However, the results lack the statistical significance that would be expected from a placebo-controlled trial, which would enable Novo and colleagues to conclusively determine whether the medication lowers the risk of dementia in a particular patient population.
In the meantime, Novo Nordisk is evaluating semaglutide in 1,800 patients with early Alzheimer's disease as part of two phase 3 trials called EVOKE and EVOKE+. Novo anticipates the investigations' read-out in 2026.
More Details from FiercePharma
Other Industry News
Aurobindo Pharma’s board plans to meet on Thursday the 18th of July to discuss, inter alia, a proposal for the company’s fully paid-up equity shares buyback. Following their announcement, shares of Aurobindo Pharma Ltd. gained 5% - a new record high – of Rs 1,394.35 apiece. The stock has increased 27% on a year-to-date basis and 67.55% in the last 12 months with the relative strength index at 73.85. This will be the company’s first buyback of its equity shares. The consensus 12-month average price forecast suggests a 3.3% decline.
More Details from Economic Times
The PDA/FDA (Parenteral Drug Association / Food and Drug Administration)Joint Regulatory Conference is planned to take place in Washington D.C. from the 9th-11th September 2024. Federal regulators will shed light on the contemporary goals and challenges faced by the FDA. Offering a unique perspective, this year’s agenda highlights the issue of quality culture improvement within organisations. Prioritising active involvement over reactive approaches with an emphasis on quality maturity, the attendees will learn how to address quality issues immediately and emphasize enacting preventative measures.
Key sessions will also include de-risking quality control settings and applying Quality Risk Manager (QRM) to improve laboratory systems through case studies of Out of Specification (OOS) and Out of Trend (OOT) results. Therefore, Current Good Manufacturing Practices (CGMP) will be the main focus, offering practical advice for those in operations and quality assurance. The conference will also explore AI's role in manufacturing and data integrity, highlighting the necessity for deployment with caution and forethought.
More Details from FiercePharma
PharmaTell Studio Hints
PharmaTell Studio includes many trackers including sales and prescriptions and launch tracking. Areas include those mentioned above - Generics and Biosimilars, GLP-1's (Diabetes), Immunology - and more. For areas you track regularly, use the personal alerts to create daily or weekly searches to ensure up-to-date information is delivered directly to your inbox.
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