Claims for Patent: 9,517,205

Summary for Patent: 9,517,205

Title:	Soluble needle arrays for delivery of influenza vaccines
Abstract:	Influenza vaccines are administered using solid biodegradable microneedles. The microneedles are fabricated from the influenza vaccine in combination with solid excipient(s) and, after penetrating the skin, they dissolve in situ and release the vaccine to the immune system. The influenza vaccine is (i) a purified influenza virus surface antigen vaccine, rather than a live vaccine or a whole-virus or split inactivated vaccine (ii) an influenza vaccine prepared from viruses grown in cell culture, not eggs, (iii) a monovalent influenza vaccine e.g. for immunizing against a pandemic strain, (iv) a bivalent vaccine, (v) a tetravalent or >4-valent vaccine, (vi) a mercury-free vaccine, or (vii) a gelatin-free vaccine.
Inventor(s):	O\'Hagan; Derek (Cambridge, MA), Singh; Manmohan (Cambridge, MA), Kwon; Sung-Yun (Cambridge, MA)
Assignee:	Seqirus UK Limited (Berkshire, GB)
Application Number:	13/817,814
Patent Claims:	1. A skin patch comprising a plurality of solid biodegradable microneedles, wherein the microneedles comprise (i) a biosoluble and biodegradable matrix material mixed with (ii) a purified influenza virus surface antigen vaccine, wherein the vaccine comprises hemagglutinin and 5-30 .mu.g of detergent per .mu.g of hemagglutinin. 2. A process for preparing a skin patch comprising a plurality of solid biodegradable microneedles, comprising steps of: (i) mixing a biosoluble and biodegradable matrix material with a purified influenza virus surface antigen vaccine, wherein the vaccine comprises hemagglutinin and 5-30 .mu.g of detergent per .mu.g of hemagglutinin; and (ii) adding the mixture from step (i) to a mold containing cavities for forming microneedles. 3. A skin patch comprising a plurality of solid biodegradable microneedles, wherein the microneedles comprise (i) a biosoluble and biodegradable matrix material mixed with (ii) a split influenza virus vaccine, a purified influenza virus surface antigen vaccine, an influenza virosomes vaccine, or a recombinant influenza virus surface antigen vaccine comprising an influenza virus hemagglutinin, wherein the amount of influenza virus hemagglutinin per patch is <16 .mu.g per strain, wherein the patch comprises 5-30 .mu.g of detergent per .mu.g of hemagglutinin. 4. The patch of claim 3, wherein the patch comprises the purified influenza virus surface antigen vaccine. 5. The patch of claim 1, wherein the influenza vaccine is an influenza vaccine prepared from viruses grown in cell culture. 6. The patch of claim 5, wherein the viruses are grown in a MDCK cell line. 7. The patch of claim 6, wherein the MDCK cell line is MDCK33016. 8. The patch of claim 1, wherein the influenza vaccine is a monovalent influenza vaccine. 9. The patch of claim 1, wherein the influenza vaccine is a bivalent influenza vaccine. 10. The patch of claim 1, wherein the influenza vaccine is a tetravalent influenza vaccine. 11. The patch of claim 1, wherein the influenza vaccine is a >4-valent influenza vaccine. 12. The patch of claim 1, wherein the influenza vaccine is a mercury-free influenza vaccine. 13. The patch of claim 1, wherein the influenza vaccine is a gelatin-free influenza vaccine. 14. The patch of claim 1, wherein the matrix material comprises one or more carbohydrates. 15. The patch of claim 14, wherein the matrix material comprises a cellulose and/or a dextrin and/or a disaccharide. 16. The patch of claim 1, wherein the microneedles are 100-2500 .mu.m long and are tapered with a skin-facing point. 17. The patch of claim 1, wherein a single patch has >20 microneedles. 18. The patch of claim 1, wherein the patch has an area of <2 cm.sup.2. 19. The patch of claim 1, wherein a skin-facing area of the patch includes an adhesive to facilitate adherence to a subject's skin. 20. The patch of claim 1, wherein the detergent is polysorbate 80. 21. The patch of claim 1, containing 1-15 .mu.g of hemagglutinin per influenza virus strain.

Details for Patent 9,517,205

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	11/03/1998		2030-08-20
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	12/09/1999		2030-08-20
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	12/23/1909		2030-08-20
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	05/09/2011		2030-08-20
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	06/07/2013		2030-08-20