Patents Assigned to Enteris Biopharma, Inc.
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Publication number: 20250073309Abstract: The present disclosure relates to methods, formulations and dosage regimen for treating pediatric central precocious puberty. The solid oral dosage form of the present disclosure provides an improved alternative to other methods of treatment of central precocious puberty, which are all injectable products. An oral tablet formulation of leuprolide offers a convenient and painless treatment option that allows for flexible dose adjustment or stopping treatment, in contrast to the injectable depot formulations.Type: ApplicationFiled: April 7, 2022Publication date: March 6, 2025Applicant: Enteris Biopharma, Inc.Inventors: Gary A. Shangold, Paul P. Shields, John S. Vrettos
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Patent number: 11998640Abstract: Room-temperature stable dosage forms for oral delivery of calcitonin are disclosed herein. Dosage forms for oral delivery of calcitonin with low water content are also disclosed herein. Further disclosed herein are methods for producing such room-temperature stable dosage forms and low-water content dosage forms. Methods of treatment comprising the administration of such room-temperature stable dosage forms and low-water content dosage forms are also disclosed herein.Type: GrantFiled: February 18, 2022Date of Patent: June 4, 2024Assignees: Park Therapeutics, Inc., Enteris Biopharma, Inc.Inventors: James P. Gilligan, George R. Maurer, Aniruddha M. Railkar, Phillip Bauer, Thomas A. Daggs, Paul P. Shields
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Patent number: 11285113Abstract: Room-temperature stable dosage forms for oral delivery of calcitonin are disclosed herein. Dosage forms for oral delivery of calcitonin with low water content are also disclosed herein. Further disclosed herein are methods for producing such room-temperature stable dosage forms and low-water content dosage forms. Methods of treatment comprising the administration of such room-temperature stable dosage forms and low-water content dosage forms are also disclosed herein.Type: GrantFiled: February 5, 2019Date of Patent: March 29, 2022Assignees: TAURUS DEVELOPMENT COMPANY LLC, ENTERIS BIOPHARMA, INC.Inventors: James P. Gilligan, George R. Maurer, Aniruddha M. Railkar, Phillip Bauer, Thomas A. Daggs, Paul P. Shields
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Patent number: 9833411Abstract: The present invention provides pharmaceutical compositions suitable for oral delivery of active agent, such as peptides and small molecules, and methods for treating subjects in need thereof. The pharmaceutical compositions of the present invention enhance the bioavailability of therapeutic active agents.Type: GrantFiled: January 12, 2016Date of Patent: December 5, 2017Assignee: Enteris BioPharma, Inc.Inventors: John Vrettos, Thomas Daggs, Paul Shields, Raymundo Claudio
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Patent number: 9744140Abstract: The present invention provides pharmaceutical compositions suitable for oral delivery and methods of treating subjects in need thereof. The pharmaceutical compositions of the present invention enhance bioavailability of at least one compound classified as BCS Class II, BCS Class III or BCS Class IV.Type: GrantFiled: November 16, 2016Date of Patent: August 29, 2017Assignee: Enteris Biopharma, Inc.Inventors: Stephen M. Carl, John Stanley Vrettos, William Stern
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Patent number: 9526785Abstract: The present invention provides pharmaceutical compositions suitable for oral delivery and methods of treating subjects in need thereof. The pharmaceutical compositions of the present invention enhance bioavailability of at least one compound classified as BCS Class II, BCS Class III or BCS Class IV.Type: GrantFiled: June 16, 2016Date of Patent: December 27, 2016Assignee: ENTERIS BIOPHARMA, INC.Inventors: Stephen M. Carl, John Stanley Vrettos, William Stern
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Patent number: 9504727Abstract: Bioavailability of peptide active agents to be administered orally is enhanced by a pharmaceutical composition providing targeted release of the peptide to the intestine by combining the composition with an absorption enhancer. Bioavailability is further significantly increased by administering the composition in an acid-resistant protective vehicle which transports components of the invention through the stomach. The composition may optionally further include a sufficient amount of a pH-lowering agent to lower local intestinal pH. All components are released together into the intestine with the peptide.Type: GrantFiled: September 12, 2014Date of Patent: November 29, 2016Assignee: Enteris BioPharma, Inc.Inventors: Nozer M. Mehta, William Stern, James P. Gilligan
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Patent number: 9457086Abstract: The present invention provides solid oral dosage forms and methods of treating subjects in need thereof. The solid oral dosage forms of the present invention provide a mixture including at least one compound classified as BCS Class II, BCS Class III or BCS Class IV, where the compound does not include a peptide bond in the compound's molecular structure; an absorption enhancer; and coated organic acid particles; an enteric coating; and a water soluble barrier positioned between the mixture and the enteric coating.Type: GrantFiled: March 5, 2014Date of Patent: October 4, 2016Assignee: Enteris BioPharma, Inc.Inventors: Stephen M. Carl, John Stanley Vrettos, William Stern
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Patent number: 9399017Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.Type: GrantFiled: January 17, 2014Date of Patent: July 26, 2016Assignee: Enteris BioPharma, Inc.Inventors: William Stern, Angelo P. Consalvo
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Publication number: 20140335169Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.Type: ApplicationFiled: January 17, 2014Publication date: November 13, 2014Applicant: Enteris BioPharma, Inc.Inventors: William Stern, Angelo P. Consalvo
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Patent number: 8835161Abstract: Expression systems are disclosed for the direct expression of peptide products into the culture media where genetically engineered host cells are grown. High yield was achieved with a special selection of hosts, and/or fermentation processes which include careful control of cell growth rate, and use of an inducer during growth phase. Special universal cloning vectors are provided for the preparation of expression vectors which include control regions having multiple promoters linked operably with coding regions encoding a signal peptide upstream from a coding region encoding the peptide of interest. Multiple transcription cassettes are also used to increase yield. The production of amidated peptides using the expression systems is also disclosed.Type: GrantFiled: July 9, 2012Date of Patent: September 16, 2014Assignee: Enteris BioPharma, Inc.Inventors: Nozer M. Mehta, Angelo P. Consalvo, Martha V. L. Ray, Christopher P. Meenan
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Patent number: 8815583Abstract: Cell lines are provided for expressing peptidylglycine alpha-amidating monooxygenase (PAM), or one of its two catalytic domains. High levels of enzyme expression are achieved while utilizing a non-animal source, low protein tissue culture medium. A robust two-step downstream purification results in high enzyme purity. Resulting PAM, or its PHM catalytic domain, is used to catalyze the enzymatic conversion of X-Gly to X-alpha-hydroxy-Gly or X—NH2 (X being a peptide or any chemical compound having a carbonyl group to which a glycine group can be covalently attached). Methods of preparing preferred cell lines are also set forth.Type: GrantFiled: June 23, 2006Date of Patent: August 26, 2014Assignee: Enteris BioPharma, Inc.Inventors: Duncan A. Miller, Nozer M Mehta, Angelo P Consalvo
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Patent number: 8664178Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.Type: GrantFiled: June 4, 2012Date of Patent: March 4, 2014Assignee: Enteris BioPharma, Inc.Inventors: William Stern, Angelo P. Consalvo
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Patent number: 8592366Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.Type: GrantFiled: June 4, 2012Date of Patent: November 26, 2013Assignee: Enteris Biopharma, Inc.Inventors: William Stern, Angelo P. Consalvo
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Patent number: 8513183Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.Type: GrantFiled: October 27, 2011Date of Patent: August 20, 2013Assignee: Enteris Biopharma, Inc.Inventors: William Stern, Angelo P. Consalvo