Shots: Shots: The P-III ADVANCE study involves assessing of Otezla (apremilast, 30mg, bid for 16wks.) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis. Later, patients will receive Otezla during an open-label extension phase @32wks. The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, […]Read More
Shots: Health Canada’s marketing authorization transfer of Otezla from Celgene follows Amgen’s acquisition of the global rights of Otezla completed in Nov’2019 The addition of Otezla bolster Amgen’s portfolio of innovative biologics and biosimilar products and complements its expertise in mod. to sev. PsO and active PsA Otezla is a selective PDE4 inhibitor, inhibiting the […]Read More
Shots: Amgen to acquire Otezla for $13.4B in cash and will receive its related intellectual property including patents primarily covering apremilast with all assets and liabilities related to Otezla along with Celgene’s employees associated with the Otezla BMS to divest Otezla in order to get regulatory approval for its pending Celgene merger. The closing of […]Read More
Shots: The approval is based on P-III RELIEF study results assessing Otezla (30mg, bid) vs PBO in 207 patients in a ratio (1:1) with Behçet’s Disease with active oral ulcers prior treated with at least one nonbiologic medication and systemic therapy for 64wks. across 10 countries The P-III RELIEF study results: @12wks. reduction in pain […]Read More
Shots: BMS plans to divest Otezla to address US Federal Trade Commission concern to close pending Celgene acquisition for $74B more quickly In Jan’2019, BMS announced to acquire Celgene with its expected closing of the transaction in H2’19 or H1’20. The divestiture of Otezla will accelerate BMS post-closing deleveraging plans Otezla is a PDE4 inhibitor, […]Read More
Shots: Results: ESTEEM 1, 2: NAPSI@32wk (31.3% vs 15.5), DLQI @16wks. (28.7% vs 8.1%); UNVEIL: NAPSI@32wks. (36.2% vs 37.2%), DLQI@16wks. (23.7% vs 10.6%) Though, Post-hoc analysis revealed that OTEZLA was not able to achieve PASi75@32/52wks A 5-year extension study of ESTEEM 1 and 2 is ongoing. OTEZLA (apremilast) (PDE4i) marketed as 30 mg PO indicated […]Read More
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