Claims for Patent: 8,778,359

Summary for Patent: 8,778,359

Title:	Stable anthrax vaccine formulations
Abstract:	Formulations of anthrax protective antigen are provided that are stable in storage for prolonged periods. Methods of using the formulations to prepare vaccine are also provided. Vaccines comprising the formulations are useful, for example, to protect against anthrax infection.
Inventor(s):	Kaisheva; Elizabet (Belmont, CA)
Assignee:	Emergent BioSolutions Inc. (Rockville, MD)
Application Number:	13/056,378
Patent Claims:	1. A stable vaccine for stimulating an immune response to a Bacillus anthracis protective antigen comprising: a) a purified B. anthracis protective antigen protein; b) an alanine formulation buffer; and c) a pharmaceutically acceptable adjuvant. 2. The vaccine of claim 1, wherein said alanine formulation buffer comprises about 50 to 500 mM alanine. 3. The vaccine of claim 1, wherein said alanine formulation buffer comprises about 220 mM alanine, about 25 mM sodium phosphate and about 0.01% polysorbate 80. 4. The vaccine of claim 1, wherein said alanine formulation buffer further comprises glycine and/or proline. 5. The vaccine of claim 1, wherein said alanine formulation buffer is at about pH 6.2-8.0. 6. The vaccine of claim 1, wherein said adjuvant is selected from the group consisting of alhydrogel, CpG, an immunostimulatory sequence (ISS) and calcium phosphate. 7. The vaccine of claim 6, wherein said adjuvant is Alhydrogel. 8. The vaccine of claim 7, wherein said vaccine comprises about 750 .mu.g aluminum. 9. The vaccine of claim 1, wherein said purified B. anthracis protective antigen protein is produced from an asporogenic B. anthracis bacterium. 10. The vaccine of claim 9, wherein said asporogenic B. anthracis bacterium is a ASterne-1(pPA102)CR4 strain of bacteria. 11. The vaccine of claim 1, wherein said purified B. anthracis protective antigen protein comprises amino acids 30-735 of SEQ ID NO: 1. 12. The vaccine of claim 11, wherein said purified B. anthracis protective antigen protein comprises SEQ ID NO: 1. 13. The vaccine of claim 1, wherein said vaccine comprises at least about 25 .mu.g purified B. anthracis protective antigen protein. 14. The vaccine of claim 1, wherein said vaccine comprises at least about 25 .mu.g purified B. anthracis protective antigen protein and about 750 .mu.g aluminum. 15. A method of preventing or treating an anthrax disease comprising administering a pharmaceutically effective amount of the vaccine of claim 1 to a subject. 16. The method of claim 15, wherein said anthrax disease is inhalation anthrax. 17. A method of inducing an immune response in a subject comprising administering to the subject a vaccine of claim 1. 18. A method of vaccinating a subject against anthrax comprising administering to the subject a vaccine of claim 1. 19. The vaccine of claim 1, wherein the vaccine is a liquid solution or suspension.

Details for Patent 8,778,359

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	November 12, 1998	8,778,359	2029-07-30
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	July 20, 2023	8,778,359	2029-07-30

International Patent Family for US Patent 8,778,359

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010053610
United States of America	2015023998
United States of America	2011229507
European Patent Office	2320945