Claims for Patent: 8,586,045

Summary for Patent: 8,586,045

Title:	Methods of using anti-CGRP antagonist antibodies
Abstract:	The invention features methods for preventing or treating CGRP associated disorders such as vasomotor symptoms, including headaches (e.g., migraine, cluster headache, and tension headache) and hot flushes, by administering an anti-CGRP antagonist antibody. Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described.
Inventor(s):	Zeller; Joerg (Ann Arbor, MI), Poulsen; Kristian T. (San Francisco, CA), Abdiche; Yasmina Noubia (Mountain View, CA), Pons; Jaume (San Bruno, CA), Collier; Sierra Lee Jones (Menlo Park, CA), Rosenthal; Arnon (Woodside, CA)
Assignee:	Labrys Biologics, Inc. (San Mateo, CA)
Application Number:	13/179,846
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,586,045
Patent Claims:	1. A method for reducing incidence of or treating at least one vasomotor symptom in an individual, comprising administering to the individual an effective amount of an anti-CGRP antagonist antibody, wherein said anti-CGRP antagonist antibody is a human monoclonal antibody or a humanized monoclonal antibody. 2. The method according to claim 1, wherein the anti-CGRP antagonist antibody is: (a) an antibody having a CDR H1 as set forth in SEQ ID NO: 3; a CDR H2 as set forth in SEQ ID NO: 4; a CDR H3 as set forth in SEQ ID NO: 5; a CDR L1 as set forth in SEQ ID NO: 6; a CDR L2 as set forth in SEQ ID NO: 7; and a CDR L3 as set forth in SEQ ID NO: 8; or (b) a variant of an antibody according to (a) as shown in Table 6. 3. The method according to claim 1, where said vasomotor symptom is selected from the group consisting of hot flush, a migraine with or without aura, hemiplegic migraine, cluster headache, migrainous neuralgia, chronic headache, and tension headache. 4. The method according to claim 1, wherein the anti-CGRP antagonist antibody has a binding affinity (K.sub.D) to human .alpha.-CGRP of 50 nM or less as measured by surface plasmon resonance at 37.degree. C. 5. The method according to claim 1, wherein the anti-CGRP antagonist antibody comprises a V.sub.H domain comprising SEQ ID NO: 1 and a V.sub.L domain comprising SEQ ID NO: 2. 6. The method according to claim 1, wherein the anti-CGRP antagonist antibody comprises a light chain produced by the expression vector with ATCC Accession No. PTA-6866. 7. The method according to claim 1, wherein the anti-CGRP antagonist antibody comprises a heavy chain produced by the expression vector with ATCC Accession No. PTA-6867. 8. The method according to claim 1, wherein the individual is human. 9. The method of claim 1, wherein said vasomotor symptom is a migraine. 10. The method of claim 1, wherein said anti-CGRP antagonist antibody binds the C-terminal fragment having amino acids 25-37 of CGRP or a C-terminal epitope within amino acids 25-37 of CGRP. 11. The method of claim 1, wherein said anti-CGRP antagonist antibody comprises an Fc region with an impaired effector function. 12. The method of claim 1, wherein route of administration of said anti-CGRP antagonist antibody is selected from the group consisting of systemically, intravenously, subcutaneously, intramuscularly, and transdermally. 13. The method of claim 1, wherein said anti-CGRP antagonist antibody comprises a heavy chain constant region derived from a human IgG2 constant region. 14. The method of claim 1, wherein said anti-CGRP antagonist antibody is formulated with a pharmaceutically acceptable carrier, excipient, and/or stabilizer. 15. The method of claim 1, wherein said anti-CGRP antagonist antibody is a humanized monoclonal antibody. 16. The method of claim 1, wherein the dose of said anti-CGRP antagonist antibody is at least about 3 .mu.g/kg. 17. A method for reducing incidence of or treating headache in a human, comprising administering to the human an effective amount of an anti-CGRP antagonist antibody, wherein said anti-CGRP antagonist antibody is a human monoclonal antibody or a humanized monoclonal antibody. 18. The method according to claim 17, wherein the anti-CGRP antagonist antibody is: (a) an antibody having a CDR H1 as set forth in SEQ ID NO: 3; a CDR H2 as set forth in SEQ ID NO: 4; a CDR H3 as set forth in SEQ ID NO: 5; a CDR L1 as set forth in SEQ ID NO: 6; a CDR L2 as set forth in SEQ ID NO: 7; and a CDR L3 as set forth in SEQ ID NO: 8; or (b) a variant of an antibody according to (a) as shown in Table 6. 19. The method according to claim 17, where said headache is a migraine with or without aura, hemiplegic migraine, cluster headache, migrainous neuralgia, chronic headache, or tension headache. 20. The method according to claim 17, wherein the anti-CGRP antagonist antibody has a binding affinity (K.sub.D) to human .alpha.-CGRP of 50 nM or less as measured by surface plasmon resonance at 37.degree. C. 21. The method according to claim 17, wherein the anti-CGRP antagonist antibody comprises a V.sub.H domain comprising SEQ ID NO: 1 and a V.sub.L domain comprising SEQ ID NO: 2. 22. The method according to claim 17, wherein the anti-CGRP antagonist antibody comprises a light chain produced by the expression vector with ATCC Accession No. PTA-6866. 23. The method according to claim 17, wherein the anti-CGRP antagonist antibody comprises a heavy chain produced by the expression vector with ATCC Accession No. PTA-6867. 24. The method of claim 17, wherein said headache is a migraine. 25. The method of claim 17, wherein said anti-CGRP antagonist antibody binds the C-terminal fragment having amino acids 25-37 of CGRP or a C-terminal epitope within amino acids 25-37 of CGRP. 26. The method of claim 17, wherein said anti-CGRP antagonist antibody comprises an Fc region with an impaired effector function. 27. The method of claim 17, wherein route of administration of said anti-CGRP antagonist antibody is selected from the group consisting of systemically, intravenously, subcutaneously, intramuscularly, and transdermally. 28. The method of claim 17, wherein said anti-CGRP antagonist antibody comprises a heavy chain constant region derived from a human IgG2 constant region. 29. The method of claim 17, wherein said anti-CGRP antagonist antibody is formulated with a pharmaceutically acceptable carrier, excipient, and/or stabilizer. 30. The method of claim 17, wherein said anti-CGRP antagonist antibody is a humanized monoclonal antibody. 31. The method of claim 17, wherein the dose of said anti-CGRP antagonist antibody is at least about 3 .mu.g/kg.

Details for Patent 8,586,045

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089	09/14/2018		2025-11-14
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089	01/27/2020		2025-11-14

International Patent Family for US Patent 8,586,045

Country	Patent Number	Estimated Expiration
Australia	2006313434
Brazil	PI0618705
Canada	2626120
China	101309704