Pfizer’s inflammation and immunology product portfolio is based on Xeljanz, a blockbuster product that is now dragged down by stronger safety warnings on its drug labels.exist Acquired Arena Pharmaceuticals Pfizer acquired a late-stage compound for the treatment of inflammatory bowel disease for $6.7 billion, but the pharmaceutical giant said the deal was not intended to make up for the loss of revenue from its licensed immune products. Instead, Pfizer said that the new assets complement Xeljanz.
Inflammatory bowel disease, ulcerative colitis (UC) and Crohn’s disease are heterogeneous, which means that the presentation and progression of these diseases vary greatly among patients. Mike Gladstone, global president of Pfizer Immunology and Inflammation, said that no single drug is sufficient to treat patients. Arena drug etrasimod will be prescribed before Xeljanz, a JAK inhibitor, because patients will experience multiple treatment options. This also applies to the potential use of the drug in the treatment of skin diseases, such as atopic dermatitis (AD), which is currently solved by another Pfizer JAK blocking drug, Cibinqo.
“We don’t see this as a substitute of any kind,” Gladstone said in a conference call on Monday. “Arena represents our strategic fit and it complements our existing focus areas. We expect to use drugs like etrasimod before JAK. This leaves enough room for Cibinqo’s success. We again believe that it is a great fit Our patient population, for UC and AD, this really helps us meet the needs of patients throughout the process.”
Pfizer agreed to pay $100 in cash for each Arena stock, more than twice the stock’s closing price on Friday. The transaction is valued at $6.7 billion for Arena, which is headquartered in Park City, Utah but has most of its operations in San Diego.
Etrasimod is a small molecule discovered and developed by Arena to selectively target sphingosine 1 phosphate (S1P) receptors. These receptors are distributed throughout the body and play a role in a series of biological functions. Enzo Biochem and RedHill Biopharma are one of the developers of S1P targeted drugs, and both companies are focusing on this approach as a way to treat cancer.
Arena’s interest lies in the role S1P plays in transferring lymphocytes from the lymph nodes to the blood. The drug is designed to selectively target three types of S1P receptors. According to Pfizer investors, this method reduces the transport of T and B lymphocytes from the lymphatic organs into the blood. Therefore, there are fewer immune cells circulating in the blood, which can cause tissue damage.
“Lymphocytes are the generals of the immune system. They drive activities, such as the recruitment of eosinophils,” said Mike Vincent, Pfizer’s chief scientific officer of inflammation and immunology. “The mechanism of etrasimod is more about controlling the lymphocytes that guide inflammation, rather than locking them down.”
Vincent said that Arena drugs may become the best drug for the treatment of various immune inflammatory diseases including UC. Better security is another distinguishing feature. He added that Pfizer does not expect a boxed warning on the drug’s label.
At present, Pfizer’s main method of solving inflammatory diseases is to use drugs that block Janus kinase, usually called JAK. These enzymes play a role in cell signaling in inflammatory diseases and cancer. Xeljanz is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.
Such JAK blocking drugs have a higher risk of cardiovascular problems and cancer. These drugs were previously marked as black box warnings on the labels of these drugs, including products from AbbVie and Eli Lilly.Earlier this year, the The FDA concluded its review of the post-marketing Xeljanz study, which found that patients receiving Pfizer’s JAK drug are at higher risk Compared with patients treated with tumor necrosis factor blockers (an old arthritis drug), the risk of death, heart problems, cancer, and blood clots is higher. Based on these results, the agency requires stronger warnings on drug labels for all JAK inhibitors.
Xeljanz’s revenue last year exceeded $2.4 billion. The new warning appears to inhibit sales of the drug.exist Report In its third-quarter financial results, Pfizer stated that the drug’s sales in the United States fell by 13% compared to the same period in 2020, and the company attributed the decline to the FDA’s drug safety communications for the JAK drug category.
Arena has advanced etrasimod to two phase 3 studies of UC and phase 2/3 studies of Crohn’s disease. Two UC studies are expected to report data in 2022. The company also plans to conduct a phase 3 study of atopic dermatitis. Mid-term trials of the drug are being conducted in patients with eosinophilic esophagitis and alopecia areata.
The Arena pipeline also includes two clinical-stage cardiovascular drugs. The first, temanogrel, is in the second phase to test capillary obstruction and Raynaud’s phenomenon secondary to systemic sclerosis. ADP418 is in phase 2 testing for acute heart failure.
The board of directors of the two companies unanimously approved the transaction. According to a statement, if Arena terminates the transaction, it will owe Pfizer a $350 million termination fee. Regulatory filing.
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