Claims for Patent: 5,846,534

Summary for Patent: 5,846,534

Title:	Antibodies to the antigen campath-1
Abstract:	An antibody is produced, which will bind effectively with the antigen Campath-1, and which has at least one complementarity determining region of rat origin, as identified in FIG. 2, which may be combined with a range of different foreign variable domain framework regions as desired, including framework regions of human origin.
Inventor(s):	Waldmann; Herman (Cambridge, GB), Clark; Michael R. (Cambridge, GB), Winter; Gregory P. (Cambridge, GB), Riechmann; Lutz (La Jolla, CA)
Assignee:	British Technology Group Limited (London, GB)
Application Number:	08/235,705
Patent Claims:	1. An antibody which binds effectively to the antigen Campath-1, having a constant region of human origin, heavy and light chain variable domain framework regions which are of human origin, and complementarity determining regions defined by amino acid residues 31 to 35, 50 to 65 and 95 to 102 of the heavy chain as shown in FIG. 2a, and amino acid residues 24 to 34, 50 to 56 and 89 to 97 of the light chain as shown in FIG. 2b, the heavy chain variable domain framework region having a phenylalanine residue at 27. 2. An antibody according to claim 1, in which the heavy chain variable domain framework region has a threonine residue at 30. 3. An antibody according to claim 1, having a light chain variable domain containing residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, and a heavy chain variable domain containing residues 1 to 26, and 28 to 113, as identified in the upper lines of sequence information in FIG. 2a, residue 27 being phenylalanine. 4. An antibody according to claim 1, having a light chain variable domain containing residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, and a heavy chain variable domain containing residues 1 to 26, 28, 29 and 31 to 113, as identified in the upper lines of sequence information in FIG. 2a, residue 27 being phenylalanine and residue 30 being threonine. 5. An antibody as defined in claim 1, wherein the heavy chain constant domains are of an IgG class. 6. An antibody as defined in claim 1, wherein the heavy chain constant domains are of the IgG1 class. 7. A composition for administration to patients comprising an antibody according to claim 1, together with a physiologically acceptable diluent or carrier. 8. An antibody composition according to claim 7, wherein said antibody is of a purity such that it contains no more than 5% by weight of other biological materials. 9. A composition according to claim 7, which is adapted for intravenous administration. 10. A composition according to claim 7, which additionally comprises another therapeutic antibody. 11. A composition according to claim 7, which comprises a unit dosage of 1 to 20 mg of the antibody. 12. A composition according to claim 11, wherein the unit dosage is 5 mg. 13. A method of treating a human patient having a lymphoid malignancy, which comprises administering an antibody which binds effectively to the antigen Campath-1, having a constant region of human origin, heavy and light chain variable domain framework regions which are of human origin, and complementarity determining regions defined by amino acid residues 31 to 35, 50 to 65 and 95 to 102 of the heavy chain as shown in FIG. 2a, and amino acid residues 24 to 34, 50 to 56 and 89 to 97 of the light chain as shown in FIG. 2b, the heavy chain variable domain framework region having a phenylalanine residue at 27. 14. A method according to claim 13, wherein the patient has a lymphoma. 15. A method according to claim 13, wherein the antibody is administered intravenously. 16. A method according to claim 15, wherein the antibody is administered together with another therapeutic antibody. 17. A method according to claim 13, wherein a unit dosage of 1 to 20 mg of the antibody is employed. 18. A method according to claim 17, wherein the unit dosage is 5 mg.

Details for Patent 5,846,534

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2015-12-08
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2015-12-08
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2015-12-08

International Patent Family for US Patent 5,846,534

Country	Patent Number	Estimated Expiration
Austria	E95068
Australia	3062689
Australia	618989
Canada	1339198
Germany	10199051
Germany	68909441
Denmark	174854