Claims for Patent: 7,078,376

Summary for Patent: 7,078,376

Title:	Therapeutic methods for treating subjects with a recombinant erythropoietin having high activity and reduced side effects
Abstract:	The invention discloses several novel therapeutic properties and methods of treatment using the recombinant erythropoietin prepared by expression from the Apa I restriction fragment of human genomic erythropoietin DNA transformed into baby hamster kidney cells (BHK) according to U.S. Pat. No. 5,688,697 to Powell. This recombinant erythropoietin designated herein as Epoetin Omega is shown to possesses several unexpected and superior qualities over other recombinant erythropoietins such as those designated Epoetin Alfa and Beta which are prepared from genomic or cDNA expressed in Chinese Hamster Ovary (CHO) according to U.S. Pat. Nos. 4,703,008 and 5,955,422 to Lin. The superior properties of Epoetin Omega include, but are not limited to, a much higher potency, a much more rapid response (i.e., no latency), longer effective serum levels, much lower antigenicity in human subjects, therapeutic activity in subjects non-responsive to the other epoetins, fewer adverse side effects such as incidents of thrombosis, reduced nausea, reduced pain at the site of injection, reduction in body pain, and most significantly, the absence of, or reduced risk of, increased blood pressure or hypertension. These novel properties provide for novel therapeutic methods including, treatment of anemia and treatment of conditions other than anemia such as fatigue or vascular pain, treatment in patients adversely effected by hypertension such as patients with heart conditions or at increased risk of thrombosis, treatment in oncology settings with and without chemotherapy or radiation therapy, and treatment with novel dosing regiments that include much lower doses and lower administration frequencies of as few as once per week or less.
Inventor(s):	Thompson; Lawrence H. (Tequesta, FL)
Assignee:	Baxter Healthcare S.A. (Zurich, CH)
Application Number:	09/637,962
Patent Claims:	1. A method for treating an anemic condition in a subject, the method comprising administering to the subject a therapeutic amount of a recombinant erythropoietin produced in baby hamster kidney cells, the recombinant erythropoietin consisting of Epoetin Omega, wherein the amount of recombinant erythropoietin administered is selected to provide a therapeutic benefit within a treatment period, and wherein the subject is non responsive when treated with a therapeutic amount of Epoetin Alfa or Beta. 2. The method of claim 1 wherein the anemic condition is associated with an anemia associated with a renal condition. 3. The method of claim 1 wherein the therapeutic benefit is selected from the group consisting of increased RBC, increased HCT, increased hemoglobin and increased vigor. 4. The method of claim 1 wherein the recombinant erythropoietin is administered at a dose of about 5 to about 150 IU/Kg, one to three times per week. 5. The method of claim 1 wherein the recombinant erythropoietin is administered at a dose of about 10 to about 100 IU/Kg, one to two times per week. 6. The method of claim 1 wherein the recombinant erythropoietin is administered at a dose of about 10 to about 75 IU/Kg, one to two times per week. 7. The method of claim 1 wherein the recombinant erythropoietin is administered at a dose of about 25 to about 60 IU/Kg, two times per week. 8. The method of claim 1 wherein the recombinant erythropoietin is administered at a dose of about 25 to about 35 IU/Kg, two times per week. 9. The method of claims wherein the recombinant erythropoietin is administered at a dose of about 75 to about 150 IU/Kg, once per week. 10. The method of claim 1 wherein the recombinant erythropoietin is administered at a dose of about 75 to about 100 IU/Kg, once per week. 11. The method of claim 1 wherein the treatment period includes a titration period and the recombinant erythropoietin is administered at an initial dose of about 50 to about 100 IU/Kg per week during the titration period and is adjusted by about 5 to about 25 IU/Kg/week to obtain a hemoglobin count of about 10 to about 12 g/dl. 12. The method of claim 1 wherein the treatment period further includes a maintenance period, and the recombinant erythropoietin is administered at a dose of about 40-60 IU/Kg per week during the maintenance period. 13. A method for treating an anemic condition in a subject, the method comprising administering to the subject a therapeutic amount of a recombinant erythropoietin produced in baby hamster kidney cells, the recombinant erythropoietin consisting of Epoetin Omega, wherein the amount of recombinant erythropoietin administered is selected to provide a therapeutic benefit within a treatment period, and wherein the subject has discontinued a treatment with Epoetin Alfa or Beta due to an adverse side effect of treatment with Epoetin Alfa or Beta. 14. The method of claim 13 wherein the adverse effect is selected from the group consisting of hypertension, headache, arthralgia, nausea, edema, fatigue, diarrhea, vomiting, chest pain, skin rash, dizziness, thrombosis and increased blood platelets. 15. The method of claim 13 wherein the recombinant erythropoietin is administered at a dose of about 5 to about 150 IU/Kg, one to three times per week. 16. The method of claim 13 wherein the recombinant erythropoietin is administered at a dose of about 10 to about 100 IU/Kg, one to two times per week. 17. The method of claim 13 wherein the recombinant erythropoietin is administered at a dose of about 10 to about 75 IU/Kg, one to two times per week. 18. The method of claim 13 wherein the recombinant erythropoietin is administered at a dose of about 25 to about 60 IU/Kg, two times per week. 19. The method of claim 13 wherein the recombinant erythropoietin is administered at a dose of about 25 to about 35 IU/Kg, two times per week. 20. The method of claim 13 wherein the recombinant erythropoietin is administered at a dose of about 75 to about 150 IU/Kg, once per week. 21. The method of claim 13 wherein the recombinant erythropoietin is administered at a dose of about 75 to about 100 IU/Kg, once per week. 22. The method of claim 13 wherein the treatment period includes a titration period and the recombinant erythropoietin is administered at an initial dose of about 50 to about 100 IU/Kg per week during the titration period and is adjusted by about 5 to about 25 IU/Kg/week to obtain a hemoglobin count of about 10 to about 12 g/dl. 23. The method of claim 13 wherein the treatment period further includes a maintenance period, and the recombinant erythropoietin is administered at a dose of about 40-60 IU/Kg per week during the maintenance period. 24. The method of claim 13 wherein the anemic condition is an anemia associated with a renal condition. 25. The method of claim 13 wherein the therapeutic benefit is selected from the group consisting of increased RBC, increased HCT, increased hemoglobin, and increased vigor.

Details for Patent 7,078,376

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	06/01/1989		2039-03-29
Amgen, Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234			2039-03-29
Amgen, Inc.	PROCRIT	epoetin alfa	Injection	103234			2039-03-29