Claims for Patent: 9,540,449

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Summary for Patent: 9,540,449

Title:	Anti-PCSK9 antibodies with pH-dependent binding characteristics
Abstract:	The present invention provides antibodies and antigen-binding fragments thereof that specifically bind proprotein convertase subtilisin/kexin-9 (PCSK9) with greater affinity at neutral pH than at acidic pH. The antibodies of the invention may possess one or more amino acid changes as compared to antibodies that do not exhibit pH-dependent binding properties. For example, the present invention includes anti-PCSK9 antibodies which possess one or more histidine substitutions in one or more complementarity determining regions. The antibodies of the invention, with pH-dependent binding properties, remain in circulation and exhibit cholesterol lowering activity for prolonged periods of time in animal subjects as compared to anti-PCSK9 antibodies that do not exhibit pH-dependent binding properties. The antibodies of the invention are therefore useful for treating diseases and disorders related to elevated HDL cholesterol, wherein the antibodies of the invention can be administered to a patient at a lower dose and/or with less frequent dosing as compared to antibodies that do not exhibit pH-dependent binding properties.
Inventor(s):	George D. Yancopoulos, Nicholas J. Papadopoulos, Andrew J. Murphy, Neil Stahl
Assignee:	Regeneron Pharmaceuticals Inc
Application Number:	US13/964,159

Details for Patent 9,540,449

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	July 24, 2015	⤷ Start Trial	2033-08-12
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 9,540,449

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Country	Patent Number	Estimated Expiration
Argentina	092098	⤷ Start Trial
Australia	2013302925	⤷ Start Trial
Canada	2881679	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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