Revisiting Lifitegrast Eye Drops from Novartis' $5.3 Billion Acquisition of Idra
On May 9, Novartis announced an agreement with Takeda Pharmaceutical to acquire the global rights to Idra (lifitegrast 5% eye drops). Idra is currently the only prescription drug approved for the treatment of dry eye disease and the improvement of its symptoms.
Lifitegrast is a first-in-class antagonist of lymphocyte function-associated antigen-1 (LFA-1). LFA-1 is a protein present on the surface of white blood cells. In dry eye disease, ICAM-1 is overexpressed in corneal and conjunctival tissues. The LFA-1/ICAM-1 interaction promotes the formation of immunological synapses, leading to T-cell activation and migration to target tissues.
Trade Name: Xiidra Generic Name: Lifitegrast CAS: 1025967-78-5, 1119276-80-0 (sodium salt) Physical Properties: White to off-white powder, soluble in water Originator: Shire Inc Code: SHP-606, SAR-1118 Approval Date: July 11, 2016 Indication: Adult dry eye disease (DED) Dosage Form and Strength: Eye drops, 5% Dosage and Administration: Topical, eye drops, twice daily, 1 drop per eye per dose
Mechanism of Action: Inflammation associated with dry eye disease is believed to be primarily mediated by T cells and related cytokines. Xiidra is a novel small-molecule integrin inhibitor that binds to lymphocyte function-associated antigen-1 (LFA-1) on the surface of white blood cells, thereby blocking the interaction between LFA-1 and its homologous ligand, intercellular adhesion molecule-1 (ICAM-1).
Prescription Composition: The active ingredient in Xiidra is Lifitegrast; inactive ingredients include sodium chloride, dibasic sodium phosphate anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide, hydrochloric acid, and water for injection.
Lifitegrast was acquired by Shire in 2013 for $160 million from U.S.-based SARcode Bioscience. The FDA granted it priority review status, with 5 years of market exclusivity (NCE). Predicted peak sales are expected to exceed $1 billion. Key intellectual property includes US7745460, US8084047, US7314938, US7928122, and others.
