Concert Pharmaceuticals is preparing an FDA application for an experimental treatment for alopecia and is also exploring potential partnerships to help market the drug in the United States. It’s in the hands of big companies that have the resources to make it happen.
Sun Pharmaceuticals acquires Concert in a $576 million deal. Sun will pay $8 for each of his shares in Lexington, Massachusetts-based Concert, according to financial terms announced Thursday. That’s about 33% above the average biotech share price over the past month. Concert shareholders get even more benefits. The transaction includes contingent value rights requiring Mumbai, India-based Sun Pharma to pay up to an additional $3.50 per share if Concert’s drug deuruxolitinib meets sales targets. It contains. If approved, the product could compete with a competing Eli Lilly hair loss drug or another Pfizer hair loss drug.
Concert developed it to treat alopecia areata, a condition in which the immune system attacks the hair follicles. The hair loss that results from alopecia can be patchy or complete. It affects the scalp, but can also cause hair loss elsewhere on the body.This autoimmune disease affects both women and men and can occur at any age.
Concert tested deuruxolitinib (known as CTP-543 in early development) in two placebo-controlled Phase III trials. Results from the first study, which enrolled 706 patients, showed that both doses of twice-daily tablets produced statistically significant hair growth after 24 weeks of treatment. was reported last August in a second phase III trial that enrolled 517 patients. Concert said in its third quarter earnings call that it plans to file a New Drug Application for deurxolitinib in the first half of 2023. The company added that it is conducting pre-commercialization activities with the aim of commercializing the drug in the United States only. Or with the help of strategic partners.
Deulxolitinib is a small molecule designed to block JAK1 and JAK2.
Janus kinase enzyme involved in inflammation. Other drugs in the pharmaceutical class known as JAK inhibitors are on the market. These drugs pose potentially fatal cardiovascular and cancer risks and are flagged on the label. Because of these risks, the FDA is increasing scrutiny of his JAK blockers.
Two Phase 3 trials of deurxolitinib reported serious adverse events in 9 patients in the first Phase 3 trial and 5 patients in the second Phase 3 trial. Concert said only one of the adverse events in each late-stage study was considered potentially related to the experimental treatment. The drug was well tolerated. Concert reported that the most common side effects included Covid-19 infection. colds; higher levels of creatine kinase (an indicator of potential muscle damage); acne; and headaches.
Sun Pharma and Concert expect to complete the transaction later this quarter. If deurxolitinib hits the market, it will compete with Eli Lilly’s Olumiant, which the FDA approved last June to treat alopecia. Like concert drugs, Lily’s pills are his JAK inhibitors. Olumiant was first approved in 2018 for the treatment of moderate to severe rheumatoid arthritis. Meanwhile, Pfizer has already applied for regulatory approval in several markets for its JAK inhibitor ritresitinib, which treats alopecia.
Abhay Gandhi, CEO of Sun Pharma North America, said, “There is a significant unmet need in the alopecia areata area and concert efforts to support the alopecia areata patient community. “We are well positioned to bring this product to market globally.”
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