Patents Assigned to Unigene Laboratories, Inc.
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Publication number: 20130072446Abstract: Polypeptides having homology to regions of the N-terminal 50 residues of human Annexin 1 are provided for medical use as anti-inflammatory agents. Some of the polypeptides have homology to the N-terminal 48 residues of human Annexin 1, especially to residues 2-48 and 11-48 thereof. In some embodiments, properties of these compounds are improved by at least one modification at residues corresponding to residues 11, 22, 25 and/or 36 of human Annexin 1, and/or by C-terminal amidation of the polypeptide. Analogs of amino acids 2-26 of human Annexin 1, especially acetylated at the N-terminus and/or amidated at the C-terminus and having modifications at 11 and/or 22 are also disclosed for medical use as anti-inflammatory agents.Type: ApplicationFiled: June 15, 2012Publication date: March 21, 2013Applicant: UNIGENE LABORATORIES, INC.Inventors: ANGELO P. CONSALVO, NOZER M. MEHTA, MAURO PERRETTI, JESMOND DALLI
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Patent number: 8377863Abstract: 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: May 28, 2008Date of Patent: February 19, 2013Assignee: Unigene Laboratories Inc.Inventors: William Stern, Angelo P. Consalvo
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Publication number: 20130034897Abstract: 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: ApplicationFiled: July 9, 2012Publication date: February 7, 2013Applicant: Unigene Laboratories, Inc.Inventors: Nozer M. Mehta, Angelo P. Consalvo, Martha V.L. Ray, Christopher P. Meenan
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Publication number: 20130034600Abstract: 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: June 4, 2012Publication date: February 7, 2013Applicant: Unigene Laboratories Inc.Inventors: William Stern, Angelo P. Consalvo
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Publication number: 20120328666Abstract: 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: ApplicationFiled: August 26, 2011Publication date: December 27, 2012Applicant: Unigene Laboratories Inc.Inventors: Nozer M. Mehta, William Stern, James P. Gilligan
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Publication number: 20120315325Abstract: 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: June 4, 2012Publication date: December 13, 2012Applicant: Unigene Laboratories Inc.Inventors: William Stern, Angelo P. Consalvo
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Publication number: 20120302497Abstract: The present invention provides peptides and pharmaceutical compositions thereof for appetite suppression and weight control. Preferred peptides are calcitonin analogs, preferably with specific amino acid changes to make the peptide more amylin-like.Type: ApplicationFiled: July 9, 2012Publication date: November 29, 2012Applicant: Unigene Laboratories, Inc.Inventors: Nozer M. Mehta, Amy Sturmer, William Stern, James P. Gilligan
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Patent number: 8252580Abstract: 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: October 30, 2007Date of Patent: August 28, 2012Assignee: Unigene Laboratories, Inc.Inventors: Nozer M. Mehta, Angelo P. Consalvo, Martha V. L. Ray, Christopher P. Meenan
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Patent number: 8227241Abstract: 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: March 9, 2005Date of Patent: July 24, 2012Assignee: Unigene Laboratories, Inc.Inventors: Nozer M. Mehta, Angelo P. Consalvo, Martha V. L. Ray, Christopher P. Meenan
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Patent number: 8216822Abstract: 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: October 30, 2007Date of Patent: July 10, 2012Assignee: Unigene Laboratories, Inc.Inventors: Nozer M. Mehta, Angelo P. Consalvo, Martha V. L. Ray, Christopher P. Meenan
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Patent number: 8217139Abstract: The present invention provides peptides and pharmaceutical compositions thereof for appetite suppression and weight control. Preferred peptides are calcitonin analogs, preferably with specific amino acid changes to make the peptide more amylin-like.Type: GrantFiled: November 14, 2011Date of Patent: July 10, 2012Assignee: Unigene Laboratories, Inc.Inventors: Nozer M. Mehta, Amy Sturmer, William Stern, James P. Gilligan
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Publication number: 20120149635Abstract: The present invention provides peptides and pharmaceutical compositions thereof for appetite suppression and weight control. Preferred peptides are calcitonin analogs, preferably with specific amino acid changes to make the peptide more amylin-like.Type: ApplicationFiled: November 14, 2011Publication date: June 14, 2012Applicant: Unigene Laboratories Inc.Inventors: Nozer M. Mehta, Amy Sturmer, William Stern, James P. Gilligan
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Publication number: 20120142586Abstract: The present invention provides peptides and pharmaceutical compositions thereof for appetite suppression and weight control. Preferred peptides are calcitonin analogs, preferably with specific amino acid changes to make the peptide more amylin-like.Type: ApplicationFiled: November 14, 2011Publication date: June 7, 2012Applicant: Unigene Laboratories Inc.Inventors: Nozer M. Mehta, Amy Sturmer, William Stern, James P. Gilligan
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Patent number: 8163871Abstract: Conversion in vitro of X-Gly to X-alpha-hydroxy-Gly or X-NH2 (X being a peptide or any other compound having a carbonyl group capable of forming a covalent bond with glycine) is accomplished enzymatically in the presence of keto acids, or salts or esters thereof, to provide a good yield without the necessity of catalase or similar enzymatic reaction enhancers. Peptidylglycine ?-amidating monooxygenase (PAM) is a preferred enzyme for catalyzing the conversion. Alternatively, peptidylglycine ?-hydroxylating monooxygenase (PHM) is utilized to convert X-Gly to X-alpha-hydroxy-Gly which may be recovered, or optionally may be simultaneously or sequentially converted to an amide by either a Lewis base or action of the enzyme peptidyl ?-hydroxyglycine ?-amidating lyase (PAL). Both PHM and PAL are functional domains of PAM.Type: GrantFiled: September 22, 2008Date of Patent: April 24, 2012Assignee: Unigene Laboratories, Inc.Inventors: Angelo P. Consalvo, Nozer M. Mehta, William Stern, James P. Gilligan
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Publication number: 20120071410Abstract: Calcitonin products and therapies for treating inflammatory or degenerative diseases are disclosed herein. The pharmaceutical compositions disclosed herein include a first therapeutic agent that is calcitonin, in free or salt form; a second therapeutic agent selected from the group consisting of a protease inhibitor, an antibiotic, a non-steroidal anti-inflammatory agent, a COX-2 inhibitor and a steroidal anti-inflammatory agent other than glucocorticoid; and a pharmaceutically acceptable excipient, carrier or diluent.Type: ApplicationFiled: September 21, 2011Publication date: March 22, 2012Applicant: Unigene Laboratories Inc.Inventors: Nozer M. Mehta, James P. Gilligan
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Publication number: 20120040000Abstract: 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: October 27, 2011Publication date: February 16, 2012Applicant: Unigene Laboratories Inc.Inventors: William Stern, Angelo P. Consalvo
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Patent number: 8093207Abstract: A finished pharmaceutical product adapted for oral delivery of a physiologically active peptide agent, wherein the product comprises a therapeutically effective amount of the active peptide agent; at least one pharmaceutically acceptable pH-lowering agent; and at least one absorption enhancer effective to promote bioavailability of the active agent, wherein the pH-lowering agent is present in the finished pharmaceutical product in a quantity which, if the product were added to 10 milliliters of 0.1M aqueous sodium bicarbonate solution, would be sufficient to lower the pH of the solution to no higher than 5.5, and wherein an outer surface of the product is substantially free of an acid-resistant protective vehicle. The product is adapted for use in a method for enhancing the bioavailability of a therapeutic peptide active agent delivered orally.Type: GrantFiled: December 6, 2006Date of Patent: January 10, 2012Assignee: Unigene Laboratories, Inc.Inventor: William Stern
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Patent number: 8088734Abstract: Bioavailability of peptide active agents to be administered orally is enhanced by a pharmaceutical composition providing an active peptide that is amidated at a site that is not naturally amidated.Type: GrantFiled: January 20, 2004Date of Patent: January 3, 2012Assignee: Unigene Laboratories Inc.Inventors: Nozer M. Mehta, William Stern, James P. Gilligan
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Patent number: 8076291Abstract: The present invention provides peptides and pharmaceutical compositions thereof for appetite suppression and weight control. Preferred peptides are calcitonin analogs, preferably with specific amino acid changes to make the peptide more amylin-like.Type: GrantFiled: January 22, 2010Date of Patent: December 13, 2011Assignee: Unigene Laboratories Inc.Inventors: Nozer M. Mehta, Amy Sturmer, William Stern, James P. Gilligan
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Patent number: RE43580Abstract: A liquid pharmaceutical composition is disclosed comprising calcitonin or an acid addition salt thereof and citric acid or salt thereof in a concentration from about to about 50 mM, said composition being in a form table for nasal administration. A liquid pharmaceutical composition is provided for nasal administration of calcitonin or an acid addition salt thereof. The nasal pharmaceutical formulations contain a component selected from the group consisting of citric acid, citric acid salt and a combination thereof.Type: GrantFiled: June 29, 2009Date of Patent: August 14, 2012Assignee: Unigene Laboratories, Inc.Inventor: William Stern