Deuruxolitinib Phosphate

Sun Pharma will purchase Checkpoint’s complete outstanding shares. Credit: Nils Versemann/Shutterstock. Sun Pharmaceutical Industries has agreed to acquire Checkpoint Therapeutics, a company specialising in immunotherapy and targeted oncology treatments, for an aggregate upfront price of $355m. The acquisition is set to add Checkpoint’s US Food and Drug Administration (FDA)-approved Unloxcyt (cosibelimab-ipdl) to the global onco-derm franchise of Sun Pharma. Unloxcyt treats metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in the adult population who are not suitable for curative surgery or radiation. Sun Pharma will purchase Checkpoint’s complete outstanding shares. Stockholders of Checkpoint will obtain an upfront cash payment of $4.10 per share and are eligible for a non-transferable contingent value right of up to $0.70 per share if the therapy gains approval by certain dates in the European Union or specific European countries. The transaction will conclude in the second quarter of 2025, subject to regulatory approvals and the affirmative vote of Checkpoint’s shareholders. Sun Pharma managing director and chairman Dilip Shanghvi stated: “Combining Unloxcyt, an FDA-approved anti-programmed cell death ligand 1 (PD-L1) treatment for advanced cSCC, with Sun Pharma’s global presence means patients with cSCC may soon have access to an important, new treatment option.” A royalty agreement has been established between Checkpoint, Sun Pharma and Fortress Biotech, Checkpoint’s controlling stockholder. Post-closure, Fortress will gain royalties from future sales of the therapy, replacing previous royalty rights. Fortress will also vote in favour of the transaction. Checkpoint’s board of directors, advised by a special committee of independent directors, unanimously approved the transaction after a thorough review of strategic alternatives. Legal advice to Sun Pharma is being provided by Barack Ferrazzano Kirschbaum & Nagelberg, and Allen Overy Shearman Sterling US. Alston & Bird and Locust Walk are acting as Checkpoint’s legal advisor and exclusive and lead financial advisor, respectively. Sun Pharma received FDA approval in July l2024 for Leqselvi (deuruxolitinib), an oral treatment for severe alopecia areata.

Eli Lilly and Incyte’s once-daily oral JAK1/2 inhibitor Olumiant (baricitinib) demonstrated notable improvements in hair regrowth on the scalp, eyebrows and eyelashes in a Phase III study of adolescents with severe alopecia areata (AA), moving the drug a step closer to taking on Pfizer’s JAK3/TEC kinase inhibitor Litfulo (ritlecitinib) — the first alopecia medication approved for the younger age group in the US and EU. The findings were presented over the weekend at the American Academy of Dermatology (AAD) annual meeting.Backed by the BRAVE-AA1 and BRAVE-AA2 trials, Olumiant secured FDA authorisation in 2022 for adults with severe AA, making it the first systemic treatment approved in the US for the condition.The BRAVE-AA-PEDS study randomised 257 participants aged 12 to under 18 to receive daily baricitinib 2 mg, 4 mg or placebo — the primary efficacy goal being Severity of Alopecia Tool (SALT) score ≤20 at 36 weeks. Results showed that at this timepoint, 42.4% of patients receiving the 4-mg dose achieved the main goal, compared with 4.5% in the placebo group. Moreover, Olumiant 4 mg led to at least a 50% disease improvement in 60% of patients, while the 2 mg dose achieved the same in 36.9%, and placebo in 5.7%.Specifically, Olumiant 4 mg achieved 90% scalp hair coverage in 36.5% of patients, significant eyebrow regrowth in 50.0%, and eyelash regrowth in 42.9%, while the 2 mg dose showed 21.4%, 24.1%, and 25.5% improvement, respectively. In contrast, placebo results were 2.3% for scalp, 0% for eyebrows and 14.0% for eyelashes. Notably, outcomes in adolescents achieved at 36 weeks were comparable to those seen in adult studies at 52 weeks, suggesting faster hair regrowth in the former. Meanwhile, the safety profile in adolescents was consistent with previous Olumiant trials in juvenile idiopathic arthritis and atopic dermatitis. "With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata," remarked Anabela Cardoso, senior vice president of immunology medical affairs at Lilly. The drugmaker plans to present additional data from BRAVE-AA-PEDS later this year, whilst also discussing the findings with global regulators.Following the footsteps of Olumiant and Litfulo, Sun Pharmaceutical’s oral JAK1/2 inhibitor Leqselvi (deuruxolitinib) entered the severe AA market last year, albeit only approved for adults. Also at AAD this year, Q32 Bio unveiled upbeat mid-stage data for its IL-7/TSLP bifunctional receptor antagonist, bempikibart, in severe to very severe disease. For more on the severe AA space, read: Spotlight On: AAD25 – Lilly's data puts Pfizer on notice while Q32 Bio plays long game in alopecia areata.