Tofacitinib Citrate

A Bristol Myers Squibb drug that was first in its class to hit a certain immunological target now has positive data from two pivotal tests in psoriatic arthritis that could support expanding use of the product to this inflammatory autoimmune condition. Expanding approval of the drug, Sotkytu, to include psoriatic arthritis would grow revenue for a product that so far has fallen short of the blockbuster expectations that followed its 2022 approval in plaque psoriasis. Meanwhile, competition is heating up as competitors make headway with their own drug candidates for the target, an enzyme called TYK2. Psoriatic arthritis is an autoimmune disease that leads to painful swelling in joints and ligaments as well as skin lesions. First-line treatment includes disease-modifying antirheumatic drugs, both small molecules and biologics. For those whose disease does not respond to these therapies, a class of drugs called Janus kinase (JAK) inhibitors offer another treatment option. BMS’ Sotyktu could bring patients another option, and a potentially earlier one that also has a better safety profile. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions BMS said Monday that its TYK2 inhibitor met the main goal of two Phase 3 tests in active psoriatic arthritis, one that enrolled patients who were not previously treated with a disease-modifying antirheumatic drug and the other with patients who previously received TNF-alpha inhibitors, drugs from an older class of biologic medicines whose approved uses include treating psoriatic arthritis. Without releasing specific figures for the pair of 16-week studies, BMS said a significantly greater proportion of those treated with its drug achieved a 20% improvement or greater according to a composite measure of the signs and symptoms of the chronic autoimmune disorder. Also, the once daily pill met a key secondary goal measuring disease activity at week 16. TYK2, which is closely related to JAK proteins, is involved in signaling pathways associated with inflammation. Hitting TYK2 while avoiding JAKs is intended to be safer. The risks of hitting JAK proteins include cardiovascular and cancer complications. These risks are now flagged in a black box warning for the entire JAK inhibitor drug class. The FDA approved JAK-blocking drugs for psoriatic arthritis are Pfizer’s Xeljanz and AbbVie’s Rinvoq. JAK inhibitors were not used as a comparator in BMS’s placebo-controlled psoriatic arthritis tests, named POETYK PsA-1 and POETYK PsA-2. On measures of safety, BMS said the latest results are consistent with Sotyktu’s established safety profile from earlier clinical trials. In the pivotal study that led to the drug’s approval as a treatment for moderate-to-severe plaque psoriasis, the most common adverse event was upper respiratory tract infection. The company said it will work with clinical trial investigators to present detailed study results at upcoming medical conferences. Health IT Reducing Clinical and Staff Burnout with AI Automation As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers. By Dr. Michael Blackman, Chief Medical Officer at Greenway Health “These POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu,” Roland Chen, BMS’s senior vice president and head, immunology, cardiovascular and neuroscience development, said in a prepared statement. “We are encouraged by the positive data across both Phase 3 trials and look forward to discussing the results with health authorities.” With the latest data in psoriatic arthritis, BMS is trying to fend off competition. Takeda Pharmaceutical’s zasocitinib (formerly known as TAK-279), acquired in a $4 billion deal, has reached Phase 3 testing in psoriasis and mid-stage clinical development in psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Startup Sudo Biosciences, which emerged from stealth in 2022, is developing TYK2 inhibitors for neuroinflammatory disorders. BMS reported Sotyktu accounted for $163 million in revenue for the first nine months of 2024, a 52.3% increase compared to the same period in 2023. In addition to the psoriatic arthritis research, the drug has reached late-stage clinical development in Sjogren’s syndrome and systemic lupus erythematosus.

Dive Brief:Pfizer on Tuesday said it anticipates bringing in between $61 billion and $64 billion in revenue next year, matching this years expected sum and within range of Wall Street forecasts.The pharmaceutical company boosted its 2024 guidance two months ago to account for $1.2 billion in non-recurring revenue related to its COVID-19 antiviral Paxlovid. Excluding this impact, Pfizer estimates revenue in 2024 will be between $59.8 billion and $62.8 billion, which would make 2025s forecast an increase of as much as 5% versus the midpoint of this years range.Pfizer shares rose by over 4% in Tuesday morning trading. The drugmaker has been under pressure to improve its performance, sustaining a challenge from activist investor Starboard Value. The companys stock is down by more than 12% this year.Dive Insight:Pfizer hopes 2025 is the year its revenue becomes predictable again. The company soared to new heights during the pandemic as its COVID vaccine and Paxlovid became mainstay treatments and earned it tens of billions of dollars.But its executives have, over the past two years, struggled to accurately predict demand for booster shots, leading to guidance cuts, layoffs and reductions in spending. While issuing forecasts last year that widely missed Wall Street expectations, Pfizer laid out a plan to trim $4 billion from its budget by the end of 2024 a plan it has since expanded with a target of finding $1.5 billion in manufacturing-related savings.Both programs are on track, Pfizer said Tuesday, and moving forward the company anticipates less variability from its COVID products.We believe we are entering a phase of revenue stability as the uncertainty caused by COVID [is] mostly resolved, said CFO Dave Denton, in a call with analysts and investors.As Pfizer fends off Starboard, the company also wants to sell growth and, on Tuesday, predicted earnings per share would rise between 10% and 18% from 2024s baseline on an adjusted, diluted basis. Its 2025 forecast of $2.80 and $3.00 in earnings per share is higher than what hedge funds had predicted before Tuesdays call, according to Jefferies analyst Akash Tewari, and encompasses the higher sell side expectations of around $2.90 per share.Pfizer anticipates selling, general and administrative expenses will come in about $500 million lower in 2025 than in 2024, while research and development costs will fall by about $300 million.We will be focused on driving efficiency in our R&D organization, with any resulting operational savings expected to be strategically adjusted in research to further fuel innovation and our long term product development, said Denton.However, Pfizer will face new headwinds from the Inflation Reduction Act, a law that in addition to permitting the U.S. government to negotiate certain drug prices within Medicare made a raft of changes to the Part D benefit.A new $2,000 cap on out-of-pocket spending will help Pfizers business, the company said, but be offset by the addition of new required discounts and the expiration of a coverage gap-related program. Overall, Pfizer expects the Part D redesign to have a $1 billion, or 1.6%, negative impact on its topline revenue.The laws impact is greater on higher-cost medicines, Denton said, such as its rare disease drug Vyndaqel, breast cancer medicine Ibrance and arthritis treatment Xeljanz. '