Claims for Patent: 7,378,105

Summary for Patent: 7,378,105

Title:	Drug delivery systems, kits, and methods for administering zotarolimus and paclitaxel to blood vessel lumens
Abstract:	A system and compositions including zotarolimus and paclitaxel are disclosed, as well as methods of delivery, wherein the drugs have effects that complement each other. Medical devices are disclosed which include supporting structures that include at least one pharmaceutically acceptable carrier or excipient, which carrier or excipient can include one or more therapeutic agents or substances, with the carrier including at least one coating on the surface thereof, and the coating associated with the therapeutic substances, such as, for example, drugs. Supporting structures for the medical devices that are suitable for use in this invention include, but are not limited to, coronary stents, peripheral stents, catheters, arterio-venous grafts, by-pass grafts, and drug delivery balloons used in the vasculature. These compositions and systems can be used in combination with other drugs, including anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, cytotoxic drugs, agents that inhibit cytokine or chemokine binding, cell de-differentiation inhibitors, anti-lipaedemic agents, matrix metalloproteinase inhibitors, cytostatic drugs, or combinations of these and other drugs.
Inventor(s):	Burke; Sandra E. (Libertyville, IL), Cromack; Keith R. (Gurnee, IL), Mack; Matthew (Chicago, IL), Toner; John L. (Libertyville, IL)
Assignee:	Abbott Laboratories (Abbott Park, IL)
Application Number:	11/464,659
Patent Claims:	1. A drug delivery system, comprising a supporting structure including at least one pharmaceutically acceptable carrier or excipient; a therapeutic composition including zotarolimus or prodrugs or salts thereof and paclitaxel or derivatives, prodrugs, or salts thereof, and; wherein neointimal hyperplasia is reduced when the system is implanted in a lumen of a blood vessel of a subject when compared to a control system. 2. The system of claim 1, wherein neointimal hyperplasia is reduced by .gtoreq.10% when compared to the control system. 3. The system of claim 1, wherein neointimal hyperplasia is reduced by .gtoreq.15% when compared to the control system. 4. The system of claim 1, wherein neointimal hyperplasia is reduced by .gtoreq.21% when compared to the control system. 5. The system as in claims 2, 3, or 4, wherein hyperplasia reduction is measured by at least one selected from the group consisting of neointimal area measurements, neointimal thicknesses measurements and percent area stenosis measurements. 6. The system of claim 1, wherein the subject is a pig. 7. The system of claim 1, wherein the subject is a human. 8. The system of claim 1, wherein zotarolimus and paclitaxel are present in ratio, r, of zotarolimus:paclitaxel that exerts an additive effect. 9. The system of claim 1, wherein the ratio, r, of zotarolimus:paclitaxel by weight is 10:7.ltoreq.r.ltoreq.10:0.01. 10. The system of claim 9, wherein r=10:1. 11. The system of claim 1, wherein the drug delivery system comprises a stent. 12. The system of claim 11, wherein the ratio, r, of zotarolimus:paclitaxel exerts an additive effect. 13. The system of claim 11, wherein the ratio, r, of zotarolimus:paclitaxel by weight is 10:7.ltoreq.r.ltoreq.10:0.01. 14. The system of claim 13, wherein r=10:1. 15. The system of claim 14, wherein the concentration of zotarolimus is about 10 .mu.g/mm of stent, and the concentration of paclitaxel is about 1 .mu.g/mm. 16. The system of claim 1, further comprising a third therapeutic substance. 17. The system of claim 16, wherein the third therapeutic substance is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents and thrombolytic agents. 18. The system of claim 17, wherein the anti-inflammatory agent is one selected from the group consisting of steroidal and non-steroidal anti-inflammatory agents, dexamethasone, hydrocortisone, estradiol, acetaminophen, ibuprofen, naproxen, fluticasone, mometasone, triamcinolone, clobetasol, adalimumab and sulindac. 19. The system of claim 17, wherein the third therapeutic substance comprises an antibody. 20. A method of treating a subject, comprising placing the system of claim 1 in a vessel. 21. A kit, comprising the system of claim 1.

Details for Patent 7,378,105

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2017-09-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2017-09-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2017-09-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2017-09-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2017-09-26