Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2007-04-24
2011-11-15
Kam, Chih-Min (Department: 1656)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S011400, C514S002600, C514S014800, C530S317000, C530S322000, C530S344000, C435S886000
Reexamination Certificate
active
08058238
ABSTRACT:
The invention discloses highly purified daptomycin and to pharmaceutical compositions comprising this compound. The invention discloses a method of purifying daptomycin comprising the sequential steps of anion exchange chromatography, hydrophobic interaction chromatography and anion exchange chromatography. The invention also discloses a method of purifying daptomycin by modified buffer enhanced anion exchange chromatography. The invention also discloses an improved method for producing daptomycin by fermentation ofStreptomyces roseosporus. The invention also discloses high pressure liquid chromatography methods for analysis of daptomycin purity. The invention also discloses lipopeptide micelles and methods of making the micelles. The invention also discloses methods of using lipopeptide micelles for purifying lipopeptide antibiotics, such as daptomycin. The invention also discloses using lipopeptide micelles therapeutically.
REFERENCES:
patent: 4331594 (1982-05-01), Hamill et al.
patent: 4482487 (1984-11-01), Abbott et al.
patent: 4524135 (1985-06-01), Abbott et al.
patent: 4537717 (1985-08-01), Abbott et al.
patent: RE32310 (1986-12-01), Debono
patent: RE32311 (1986-12-01), Debono
patent: RE32333 (1987-01-01), Hamill et al.
patent: RE32455 (1987-07-01), Hamill et al.
patent: 4800157 (1989-01-01), Eaton et al.
patent: 4874843 (1989-10-01), Baker
patent: 4882164 (1989-11-01), Ferro et al.
patent: 4885243 (1989-12-01), Huber et al.
patent: 5271935 (1993-12-01), Franco et al.
patent: 5387670 (1995-02-01), Roy et al.
patent: 5573936 (1996-11-01), Kreuzman et al.
patent: 5629288 (1997-05-01), Lattrell et al.
patent: 5912226 (1999-06-01), Baker et al.
patent: 5955509 (1999-09-01), Webber et al.
patent: 6194383 (2001-02-01), Hammann et al.
patent: RE39071 (2006-04-01), Baker et al.
patent: 0095295 (1983-11-01), None
patent: 0178152 (1986-04-01), None
patent: 0294990 (1988-12-01), None
patent: 0337731 61 (1989-10-01), None
patent: 0386951 (1990-09-01), None
patent: WO 99/27954 (1999-06-01), None
patent: WO 99/27957 (1999-06-01), None
patent: WO 99/43700 (1999-09-01), None
patent: WO 00/18419 (2000-04-01), None
patent: WO 01/44271 (2001-06-01), None
patent: WO 01/44272 (2001-06-01), None
patent: WO 01/44274 (2001-06-01), None
DeBono, M. et al.; “Enzymatic and Chemical Modifications of Lipopeptide Antibiotic A21978C: The Synthesis and Evaluation of Daptomycin (LY146032),” J. Antibiotics; 41; 1988; pp. 1093-1105.
Desai, J. D., et al.; “Microbial Production of Surfactants and Their Commercial Potential,” Microbiology and Molecular Biology Review, vol. 61; No. 1; 1997; pp. 47-64; American Society for Microbiology.
Fostel, Jennifer M., et al.; “Emerging Novel Antifungal Agents,” DDT; vol. 5; No. 1; Jan. 2000; pp. 25-32; Elsevier Science Ltd.
Horowtz, Sarah, et al; “Isolation and Characterization of a Surfactant Produced byBacillus licheniformis86,” J. Industrial Microblol.; 6; 1990; pp. 243-248; Society for Industrial Microbiology.
Kirsch, Lee E., et al.; “Kinetics of the Aspartyl Transporation of Daptomycin, a Novel Lipopeptide Antibiotic,” Pharmaceutical Research; vol. 6; No. 5; 1989; pp. 387-393; Plenum Publishing Corporation.
Lasic, Dan D., et al.; “Novel Applications of Liposomes,” Trends Biotechnology; vol. 16; Jul. 1998; pp. 307-321; Elsevier Science Ltd.
Lasic, Danilo D., et al.; “Mixed Micelles in Drug Delivery,” Nature; vol. 355; Issue No. 6357; Jan. 16, 1992; pp. 279-280.
Lin, S.-C. et al., “General Approach for the Development of High-Performance Liquid Chromatography Methods for Biosurfactant Analysis and Purification,” J. Chromatography; 825; 1998; pp. 149-159.
Lin, S.-C. et al.; “Recovery and Purification of the Lipopeptide Biosurfactant ofBacillus subtillisby Ultrafiltration,” Biotechology Techniques; vol. 11; No. 6; Jun. 1997; pp. 413-416; Chapman Hall.
Mulligan, Catherine N., et al., “Recovery of Biosurfactants by Ultrafiltration,” J. Chem. Tech. Biotechnology.; 47; 1990; pp. 23-29; Society of Chemical Industry; Printed in Great Britian.
Schott, H.; “Colloidal Dispersions,” Remington: The Science and Practice of Pharmacy; vol. 1; 19th Edition; 1995; pp. 252-277; Mack Publishing Company; Easton, Pennsylvania USA.
Shaw, Duncan J.; “Liquid-Gas and Liquid-Liquid Interfaces,” Introduction to Colloid and Surface Chemistry; 1989; pp. 64-114; 4th Edition; Butterworth-Heinemann Ltd. Great Britian.
Sterling, John; “Membrane-Based System Combines Selective Separation with High-Volume Throughput,” Genetic Engineering News; vol. 19; No. 20; Nov. 15, 1999; pp. 1, 34.
Supersaxo, Andreas et al.; “Mixed Micelles as Proliposomal, Lymphotropic Drug Carrier,” Pharmaceutical Research; vol. 8; No. 10; 1991; pp. 1286-1291; Plenum Publishing Corporation.
Sweadner, Kathleen J. et al., “Filter Removal of Endotoxin (Pyrogens) In Solution in Different States of Aggregation,” Applied and Environmental Microbiology; vol. 34; No. 4; 1977; pp. 382-385; American Society for Microbiology; Printed in the USA.
Tally, F.P., et al.; “Daptomycin: A Novel Agent for Gram Positive Infections,” Exp. Opinion Invest Drugs; 8; 1999; 1223-1238.
Thimon, L et al., “Surface-Active Properties of Antifungal Lipopeptides Produced byBacillus substillis,” J. Am. Oil Chem. Soc.; 69; 1992; pp. 92-93.
Yakimov, Michell M. et al.; “Characterization of a New Lipopeplide Surfactant Produced by Thermotolerant and Halotolerant SubsurfaceBacillus licheniformisBAS50,” Applied and Environmental Microbiology; vol. 61; No. 5; 1995; pp. 1706-1713; American Society for Microbiology.
U.S. Appl. No. 07/060,148, filed Jun. 10, 1987, Baker et al.
Agreement between Cubist Pharmaceuticals, Inc. and Eli Lilly and Company dated Nov. 7, 1997. (Redacted form from SEC Edgar).
Agreement between Cubist Pharmaceuticals, Inc. and Eli Lilly and Company dated Oct. 6, 2000. (Redacted form from SEC Edgar).
Assignment of US Re 39,071 from Eli Lilly and Company to Cubist Pharmaceuticals, Inc. recorded on Apr. 23, 2007. Reel/Frame: 019181/0916.
Maio, et al., “Daptomycin biosynthesis inStreptomyces roseosporus: cloning and analysis of the gene cluster and revision of peptide sterochemistry,” Microbiology, (vol. 151), (p. 1507-1523), (2005).
Molloy, M. et al., Abstract, “Structure & Anhydro-Daptomycin and Iso-Daptomycin,” ACS 200th Meeting, 1990.
Molloy, M. et al., Poster, “Structure & Anhydro-Daptomycin and Iso-Daptomycin,” ACS 200th Meeting, 1990.
DeCourcey Joseph P.
Kelleher Thomas
Lai Jan-Ji
Lynch Paul
Tagliani Auro
Cubist Pharmaceuticals, Inc.
Kam Chih-Min
LandOfFree
High purity lipopeptides does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with High purity lipopeptides, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and High purity lipopeptides will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4304388