Patents Assigned to Veloxis Pharmaceuticals A/S
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Patent number: 10864199Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.Type: GrantFiled: February 11, 2016Date of Patent: December 15, 2020Assignee: VELOXIS PHARMACEUTICALS A/SInventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Patent number: 10548880Abstract: A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.Type: GrantFiled: August 14, 2017Date of Patent: February 4, 2020Assignee: VELOXIS PHARMACEUTICALS A/SInventor: Per Holm
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Patent number: 10485793Abstract: The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.Type: GrantFiled: August 21, 2017Date of Patent: November 26, 2019Assignee: VELOXIS PHARMACEUTICALS A/SInventor: William J. Polvino
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Patent number: 10166190Abstract: The invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.Type: GrantFiled: January 13, 2017Date of Patent: January 1, 2019Assignee: VELOXIS PHARMACEUTICALS A/SInventors: Nikolaj Skak, Per Holm
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Patent number: 9775834Abstract: The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.Type: GrantFiled: September 28, 2015Date of Patent: October 3, 2017Assignee: VELOXIS PHARMACEUTICALS A/SInventor: William J. Polvino
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Patent number: 9763920Abstract: A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.Type: GrantFiled: November 6, 2015Date of Patent: September 19, 2017Assignee: VELOXIS PHARMACEUTICALS A/SInventor: Per Holm
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Patent number: 9757362Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.Type: GrantFiled: September 16, 2015Date of Patent: September 12, 2017Assignee: VELOXIS PHARMACEUTICALS A/SInventors: Per Holm, Tomas Norling
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Patent number: 9549918Abstract: The invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.Type: GrantFiled: February 17, 2011Date of Patent: January 24, 2017Assignee: VELOXIS PHARMACEUTICALS A/SInventors: Nikolaj Skak, Per Holm
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Patent number: 9295653Abstract: A process for the preparation of a particu 1265 late material by a controlled agglomeration method, i.e. a method that enables a controlled growth in particle size. The method is especially suitable for use in the preparation of pharmaceutical compositions containing a therapeutically and/or prophylactically active substance which has a relatively low aqueous solubility and/or which is subject to chemical decomposition. The process comprising i) spraying a first composition comprising a carrier, which has a melting point of about 5 DEG C. or more which is present in the first composition in liquid form, on a second composition comprising a material in solid form, the second composition having a temperature of at the most a temperature corresponding to the melting point of the carrier and/or the carrier composition and ii) mixing or others means of mechanical working the second composition onto which the first composition is sprayed to obtain the particulate material.Type: GrantFiled: August 16, 2013Date of Patent: March 29, 2016Assignee: VELOXIS PHARMACEUTICALS A/SInventors: Per Holm, Anders Burr, Michiel Ringkjøbing-elema, Birgitte Møllgaard, Jannie Egeskov Holm, Kirsten Schultz
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Patent number: 9173847Abstract: Stable tablets and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved or dispersed in an non-aqueous vehicle with improved bioavailability, thereby eliminating the food effect so that the tablet or composition can be administered to a patient irrespective of being in fed or fasted state.Type: GrantFiled: June 9, 2006Date of Patent: November 3, 2015Assignee: VELOXIS PHARMACEUTICALS A/SInventors: Per Holm, Tomas Norling
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Patent number: 9168246Abstract: The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.Type: GrantFiled: June 27, 2014Date of Patent: October 27, 2015Assignee: VELOXIS PHARMACEUTICAL A/SInventor: William J. Polvino
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Patent number: 9161907Abstract: A modified release composition comprising tacrolimus which is useful for the treatment or prevention of rejection reactions by transplantation of organs or tissues.Type: GrantFiled: November 13, 2013Date of Patent: October 20, 2015Assignee: VELOXIS PHARMACEUTICALS A/SInventors: Per Holm, Tomas Norling
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Patent number: 8889185Abstract: A modified release composition comprising tacrolimus which is useful for the treatment or prevention of rejection reactions by transplantation of organs or tissues.Type: GrantFiled: November 13, 2013Date of Patent: November 18, 2014Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Patent number: 8889186Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.Type: GrantFiled: November 13, 2013Date of Patent: November 18, 2014Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Publication number: 20140179731Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.Type: ApplicationFiled: December 26, 2013Publication date: June 26, 2014Applicant: Veloxis Pharmaceuticals A/SInventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Patent number: 8685998Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.Type: GrantFiled: July 7, 2009Date of Patent: April 1, 2014Assignee: Veloxis Pharmaceuticals A/SInventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Publication number: 20140086991Abstract: A process for the preparation of a particu 1265 late material by a controlled agglomeration method, i.e. a method that enables a controlled growth in particle size. The method is especially suitable for use in the preparation of pharmaceutical compositions containing a therapeutically and/or prophylactically active substance which has a relatively low aqueous solubility and/or which is subject to chemical decomposition. The process comprising i) spraying a first composition comprising a carrier, which has a melting point of about 5 DEG C. or more which is present in the first composition in liquid form, on a second composition comprising a material in solid form, the second composition having a temperature of at the most a temperature corresponding to the melting point of the carrier and/or the carrier composition and ii) mixing or others means of mechanical working the second composition onto which the first composition is sprayed to obtain the particulate material.Type: ApplicationFiled: August 16, 2013Publication date: March 27, 2014Applicant: Veloxis Pharmaceuticals A/SInventors: Per HOLM, Anders Burr, Michiel Ringkjøbing-Elema, Birgitte Møllgaard, Jannie Egeskov Holm, Kirsten Schultz
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Publication number: 20140073665Abstract: A modified release composition comprising tacrolimus which is useful for the treatment or prevention of rejection reactions by transplantation of organs or tissues.Type: ApplicationFiled: November 13, 2013Publication date: March 13, 2014Applicant: Veloxis Pharmaceuticals A/SInventors: Per HOLM, Tomas Norling
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Publication number: 20140065225Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.Type: ApplicationFiled: November 13, 2013Publication date: March 6, 2014Applicant: Veloxis Pharmaceuticals A/SInventors: Per HOLM, Tomas Norling
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Publication number: 20140066473Abstract: A modified release composition comprising tacrolimus which is useful for the treatment or prevention of rejection reactions by transplantation of organs or tissues.Type: ApplicationFiled: November 13, 2013Publication date: March 6, 2014Applicant: Veloxis Pharmaceuticals A/SInventors: Per HOLM, Tomas NORLING