Curriculum Vitae: Marc Stephen Rendell, Md
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(12) United States Patent (10) Patent No.: US 7,700,128 B2 Doken Et Al
US007700128B2 (12) United States Patent (10) Patent No.: US 7,700,128 B2 Doken et al. (45) Date of Patent: Apr. 20, 2010 (54) SOLID PREPARATION COMPRISING AN 5,726,201 A * 3/1998 Fekete et al. ................ 514,471 INSULIN SENSITIZER, AN INSULIN 6,599,529 B1* 7/2003 Skinha et al. .... ... 424/458 SECRETAGOGUE ANDA 2003/0147952 A1* 8, 2003 Lim et al. ................... 424/468 POLYOXYETHYLENE SORBITAN EATTY 2003. O180352 A1 9, 2003 Patel et al. ACD ESTER 2004/O147564 A1 7/2004 Rao et al. 2004/0175421 A1* 9, 2004 Gidwani et al. ............. 424/465 (75) Inventors: Kazuhiro Doken, Osaka (JP); Tetsuya FOREIGN PATENT DOCUMENTS Kawano, Osaka (JP); Hiroyoshi EP O749751 A2 12/1996 Koyama, Osaka (JP): Naoru FR 2758461 7, 1998 Hamaguchi, Osaka (JP) GB 23990 15 9, 2004 JP 58065213 * 4f1983 (73) Assignee: Takeda Pharmaceutical Company WO WO95/12385 5, 1995 Limited, Osaka (JP) WO WO98, 11.884 3, 1998 WO WO 98,31360 7, 1998 (*) Notice: Subject to any disclaimer, the term of this WO WO 98/36755 8, 1998 patent is extended or adjusted under 35 WO WO98,57649 12/1998 U.S.C. 154(b) by 711 days. WO WO99.03476 1, 1999 WO WO99.03477 1, 1999 (21) Appl. No.: 10/544,581 WO WO99.03478 1, 1999 WO WOOO,274O1 5, 2000 WO WOOO.28989 5, 2000 (22) PCT Filed: Oct. 21, 2004 WO WOO1? 41737 A2 6, 2001 WO WOO1, 51463 T 2001 (86). PCT No.: PCT/UP2004/O15958 WO WOO2,04024 1, 2002 WO WO O2/O55009 T 2002 S371 (c)(1), WO WO 03/066028 A1 8, 2003 (2), (4) Date: Apr. -
WO 2016/118476 Al 28 July 2016 (28.07.2016) W P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/118476 Al 28 July 2016 (28.07.2016) W P O P C T (51) International Patent Classification: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61K 38/46 (2006.01) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (21) International Application Number: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PCT/US2016/013847 PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (22) International Filing Date: SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 19 January 2016 (19.01 .2016) TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (30) Priority Data: TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/105,342 20 January 2015 (20.01.2015) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicant: THE CHILDREN'S MEDICAL CENTER LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, CORPORATION [US/US]; 300 Longwood Avenue, Bo SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, ston, Massachusetts 021 15-5724 (US). -
203313Orig1s000 203314Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 203313Orig1s000 203314Orig1s000 PROPRIETARY NAME REVIEW(S) PROPRIETARY NAME MEMORANDUM Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) *** This document contains proprietary information that cannot be released to the public*** Date of This Review: September 1, 2015 Application Type and Number: NDA 203313 Product Name and Strength: Ryzodeg 70/30 (insulin degludec and insulin aspart) injection, 100 units/mL Product Type: Combination (Drug + Device) Rx or OTC: Rx Applicant/Sponsor Name: Novo Nordisk Panorama #: 2015-1341036 DMEPA Primary Reviewer: Sarah K. Vee, PharmD DMEPA Team Leader: Yelena Maslov, PharmD Reference ID: 3813971 1 INTRODUCTION The Applicant submitted the proposed proprietary name, Ryzodeg on March 26, 2015 (b) (4) Division of Medication Error Prevention and Analysis (DMEPA) found the name conditionally acceptable in our previous review1 . On August 19, 2015, the Agency recommended that the Applicant consider including the modifier “70/30” to the proposed proprietary name to indicate the concentrations of the two insulins in the formulation. Since Ryzodeg is a mixed insulin formulation containing 70 % insulin degludec and 30 % insulin aspart, the addition of the modifier 70/30 would be consistent with current naming approach for mixed insulins. Thus, the Applicant submitted the name, Ryzodeg 70/30, for review on August 21, 2015. We note that the product characteristics are the same. This memorandum is to communicate that DMEPA finds the proposed proprietary name, Ryzodeg 70/30 (b) (4) is acceptable from both a misbranding and safety perspective. -
Effects of Long-Term Treatment with Ranirestat, a Potent Aldose Reductase Inhibitor, on Diabetic Cataract and Neuropathy in Spontaneously Diabetic Torii Rats
Hindawi Publishing Corporation Journal of Diabetes Research Volume 2013, Article ID 175901, 8 pages http://dx.doi.org/10.1155/2013/175901 Research Article Effects of Long-Term Treatment with Ranirestat, a Potent Aldose Reductase Inhibitor, on Diabetic Cataract and Neuropathy in Spontaneously Diabetic Torii Rats Ayumi Ota,1 Akihiro Kakehashi,1 Fumihiko Toyoda,1 Nozomi Kinoshita,1 Machiko Shinmura,1 Hiroko Takano,1 Hiroto Obata,1 Takafumi Matsumoto,2 Junichi Tsuji,2 Yoh Dobashi,3 Wilfred Y. Fujimoto,3,4 Masanobu Kawakami,3 and Yasunori Kanazawa3 1 Department of Ophthalmology, Jichi Medical University, Saitama Medical Center, 1-847 Amanuma-cho, Omiya-ku, Saitama-shi 330-8503, Japan 2 Pharmacology Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., Osaka 554-0022, Japan 3 Department of Integrated Medicine I, Jichi Medical University, Saitama Medical Center, Saitama 330-8503, Japan 4 Division of Metabolism, Endocrinology and Nutrition, University of Washington School of Medicine, Seattle, WA, USA Correspondence should be addressed to Akihiro Kakehashi; [email protected] Received 22 December 2012; Accepted 29 January 2013 Academic Editor: Tomohiko Sasase Copyright © 2013 Ayumi Ota et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. We evaluated ranirestat, an aldose reductase inhibitor, in diabetic cataract and neuropathy (DN) in spontaneously diabetic Torii (SDT)ratscomparedwithepalrestat,thepositivecontrol.Animalsweredividedintogroupsandtreatedoncedailywithoral ranirestat (0.1, 1.0, 10 mg/kg) or epalrestat (100 mg/kg) for 40 weeks, normal Sprague-Dawley rats, and untreated SDT rats. Lens opacification was scored from 0 (normal) to 3 (mature cataract). -
Aldose Reductase
Aldose Reductase Aldose reductase is a small, cytosolic, monomeric enzyme which belongs to the aldo-keto reductase superfamily. Aldose reductase catalyzes the reduced form of nicotinamide adenine dinucleotide phosphate (NADPH)-dependent reduction of a wide variety of aromatic and aliphatic carbonyl compounds. It is implicated in the development of diabetic and galactosemic complications involving the lens, retina, nerves, and kidney. Aldose reductase is both the key enzyme of the polyol pathway, whose activation under hyperglycemic conditions leads to the development of chronic diabetic complications, and the crucial promoter of inflammatory and cytotoxic conditions, even under a normoglycemic status. Aldose reductase represents an excellent drug target and a huge effort is being done to disclose novel compounds able to inhibit it. www.MedChemExpress.com 1 Aldose Reductase Inhibitors 6-Methoxytricin Aldose reductase-IN-1 Cat. No.: HY-N6883 Cat. No.: HY-18967 6-Methoxytricin (Compound 6) is an flavonoid Aldose reductase-IN-1 is a inhibitor of aldose isolated from Artemisia iwayomogi. reductase with IC50 of 28.9 pM. IC50 value: 28.9 pM Target: aldose reductase Detailed information please refer to WO2014113380 A1 and US20130225592. Purity: >98% Purity: 99.86% Clinical Data: No Development Reported Clinical Data: No Development Reported Size: 5 mg Size: 10 mM × 1 mL, 5 mg, 10 mg, 50 mg, 100 mg Alrestatin Alrestatin sodium (AY-22284) Cat. No.: HY-B1202 (AY-22284A) Cat. No.: HY-B1202A Alrestatin is an inhibitor of aldose reductase, an Alrestatin sodium is an inhibitor of aldose enzyme involved in the pathogenesis of reductase, an enzyme involved in the pathogenesis complications of diabetes mellitus, including of complications of diabetes mellitus, including diabetic neuropathy. -
George Grunberger, M.D., F.A.C.P., F.A.C.E
GEORGE GRUNBERGER, M.D., F.A.C.P., F.A.C.E. Chairman, Grunberger Diabetes Institute Clinical Professor, Department of Internal Medicine Clinical Professor, Center for Molecular Medicine & Genetics Wayne State University School of Medicine Professor, Department of Internal Medicine Oakland University William Beaumont School of Medicine Visiting Professor, First Faculty of Medicine Charles University, Prague (Czech Republic) Phone: (248) 335-7740 43494 Woodward Ave, ste 208, Bloomfield Hills, MI 48302 Fax: (248) 338-7979 e-mail: [email protected] EDUCATION 1973 BA degree (Biochemistry), Columbia College, New York, NY 1977 MD degree, New York University School of Medicine, New York, NY TRAINING 1977-1980 Residency, Internal Medicine Case Western Reserve University University Hospitals of Cleveland, Cleveland, Ohio 1980-1983 Fellowship (clinical and basic research), Endocrinology and Metabolism, Diabetes Branch, National Institute of Arthritis, Diabetes, Digestive and Kidney Diseases National Institutes of Health, Bethesda, Maryland FACULTY APPOINTMENTS, Wayne State University, Detroit, Michigan 1986-1992 Associate Professor (tenured), Department of Internal Medicine Associate Professor (tenured), Department of Molecular Biology and Genetics 1992-2002 Professor (tenured), Department of Internal Medicine 1995-1996 Interim Chairman, Department of Internal Medicine 1992-1994 Professor (tenured), Department of Molecular Biology & Genetics 1994-present Professor (tenured), Center for Molecular Medicine & Genetics 1986-present Regular member -
Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0 -
(12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr
US008158152B2 (12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr. 17, 2012 (54) LYOPHILIZATION PROCESS AND 6,884,422 B1 4/2005 Liu et al. PRODUCTS OBTANED THEREBY 6,900, 184 B2 5/2005 Cohen et al. 2002fOO 10357 A1 1/2002 Stogniew etal. 2002/009 1270 A1 7, 2002 Wu et al. (75) Inventor: Nageswara R. Palepu. Mill Creek, WA 2002/0143038 A1 10/2002 Bandyopadhyay et al. (US) 2002fO155097 A1 10, 2002 Te 2003, OO68416 A1 4/2003 Burgess et al. 2003/0077321 A1 4/2003 Kiel et al. (73) Assignee: SciDose LLC, Amherst, MA (US) 2003, OO82236 A1 5/2003 Mathiowitz et al. 2003/0096378 A1 5/2003 Qiu et al. (*) Notice: Subject to any disclaimer, the term of this 2003/OO96797 A1 5/2003 Stogniew et al. patent is extended or adjusted under 35 2003.01.1331.6 A1 6/2003 Kaisheva et al. U.S.C. 154(b) by 1560 days. 2003. O191157 A1 10, 2003 Doen 2003/0202978 A1 10, 2003 Maa et al. 2003/0211042 A1 11/2003 Evans (21) Appl. No.: 11/282,507 2003/0229027 A1 12/2003 Eissens et al. 2004.0005351 A1 1/2004 Kwon (22) Filed: Nov. 18, 2005 2004/0042971 A1 3/2004 Truong-Le et al. 2004/0042972 A1 3/2004 Truong-Le et al. (65) Prior Publication Data 2004.0043042 A1 3/2004 Johnson et al. 2004/OO57927 A1 3/2004 Warne et al. US 2007/O116729 A1 May 24, 2007 2004, OO63792 A1 4/2004 Khera et al. -
Assessing the in Vitro Inhibitory Effects on Key Enzymes
molecules Article Assessing the In Vitro Inhibitory Effects on Key Enzymes Linked to Type-2 Diabetes and Obesity and Protein Glycation by Phenolic Compounds of Lauraceae Plant Species Endemic to the Laurisilva Forest Vítor Spínola and Paula C. Castilho * CQM—Centro de Química da Madeira, Universidade da Madeira, Campus da Penteada, 9020-105 Funchal, Portugal; [email protected] * Correspondence: [email protected]; Tel.: +351-291-705-102 Abstract: Methanolic leaf extracts of four Lauraceae species endemic to Laurisilva forest (Apollonias barbujana, Laurus novocanariensis, Ocotea foetens and Persea indica) were investigated for the first time for their potential to inhibit key enzymes linked to type-2 diabetes (α-amylase, α-glucosidase, aldose reductase) and obesity (pancreatic lipase), and protein glycation. Lauraceae extracts revealed significant inhibitory activities in all assays, altough with different ability between species. In general, P. indica showed the most promissing results. In the protein glycation assay, all analysed extracts displayed a stronger effect than a reference compound: aminoguanidine (AMG). The in vitro anti- diabetic, anti-obesity and anti-glycation activities of analysed extracts showed correlation with their flavonols and flavan-3-ols (in particular, proanthocyanins) contents. These Lauraceae species Citation: Spínola, V.; Castilho, P.C. Assessing the In Vitro Inhibitory have the capacity to assist in adjuvant therapy of type-2 diabetes and associated complications, Effects on Key Enzymes Linked to through modulation of the activity of key metabolic enzymes and prevention of advanced glycation Type-2 Diabetes and Obesity and end-products (AGEs) formation. Protein Glycation by Phenolic Compounds of Lauraceae Plant Keywords: type-2 diabetes; Lauraceae; polyphenols; digestive enzymes inhibition; aldose reductase Species Endemic to the Laurisilva inhibition; protein glycation inhibition Forest. -
Anatomical Classification Guidelines V2020 EPHMRA ANATOMICAL
EPHMRA ANATOMICAL CLASSIFICATION GUIDELINES 2020 Anatomical Classification Guidelines V2020 "The Anatomical Classification of Pharmaceutical Products has been developed and maintained by the European Pharmaceutical Marketing Research Association (EphMRA) and is therefore the intellectual property of this Association. EphMRA's Classification Committee prepares the guidelines for this classification system and takes care for new entries, changes and improvements in consultation with the product's manufacturer. The contents of the Anatomical Classification of Pharmaceutical Products remain the copyright to EphMRA. Permission for use need not be sought and no fee is required. We would appreciate, however, the acknowledgement of EphMRA Copyright in publications etc. Users of this classification system should keep in mind that Pharmaceutical markets can be segmented according to numerous criteria." © EphMRA 2020 Anatomical Classification Guidelines V2020 CONTENTS PAGE INTRODUCTION A ALIMENTARY TRACT AND METABOLISM 1 B BLOOD AND BLOOD FORMING ORGANS 28 C CARDIOVASCULAR SYSTEM 35 D DERMATOLOGICALS 50 G GENITO-URINARY SYSTEM AND SEX HORMONES 57 H SYSTEMIC HORMONAL PREPARATIONS (EXCLUDING SEX HORMONES) 65 J GENERAL ANTI-INFECTIVES SYSTEMIC 69 K HOSPITAL SOLUTIONS 84 L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS 92 M MUSCULO-SKELETAL SYSTEM 102 N NERVOUS SYSTEM 107 P PARASITOLOGY 118 R RESPIRATORY SYSTEM 120 S SENSORY ORGANS 132 T DIAGNOSTIC AGENTS 139 V VARIOUS 141 Anatomical Classification Guidelines V2020 INTRODUCTION The Anatomical Classification was initiated in 1971 by EphMRA. It has been developed jointly by Intellus/PBIRG and EphMRA. It is a subjective method of grouping certain pharmaceutical products and does not represent any particular market, as would be the case with any other classification system. -
Synergistic Effect of Glyburide and Milrinone Synergistische Wirkung Von Glyburide Und Milrinone Effet Synergique De Glyburide Et Milrinone
Europäisches Patentamt *EP001145717B1* (19) European Patent Office Office européen des brevets (11) EP 1 145 717 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.7: A61K 31/64, A61K 31/4545, of the grant of the patent: A61P 3/10 12.05.2004 Bulletin 2004/20 // (A61K31/64, 31:4545) (21) Application number: 01303020.0 (22) Date of filing: 30.03.2001 (54) Synergistic effect of glyburide and milrinone Synergistische Wirkung von Glyburide und Milrinone Effet synergique de glyburide et milrinone (84) Designated Contracting States: (56) References cited: AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU WO-A-98/36755 MC NL PT SE TR • PARKER J C ET AL: "EFFECT OF CYCLIC AMP (30) Priority: 13.04.2000 US 196728 PHOSPHODIESTERASE INHIBITORS ON INSULIN SECRETION AND GLYCEMIA" (43) Date of publication of application: DIABETOLOGIA, BERLIN, DE, vol. 39, no. SUPPL 17.10.2001 Bulletin 2001/42 1, 1 September 1996 (1996-09-01), page A225 XP001061977 ISSN: 0012-186X (73) Proprietor: Pfizer Products Inc. • FUJIMOTO SHIMPEI ET AL: "The novel Groton, Connecticut 06340 (US) insulinotropic mechanism of pimobendan: Direct enhancement of the exocytotic process of (72) Inventors: insulin secretory granules by increased Ca2+ • Fryburg, David Albert sensitivity in beta-cells." ENDOCRINOLOGY, Groton, Connecticut 06340 (US) vol. 139, no. 3, March 1998 (1998-03), pages • Parker, Janice Catherine 1133-1140, XP001070282 ISSN: 0013-7227 Groton, Connecticut 06340 (US) • HÖHN H ET AL: "Potential Antidiabetic Agents. Pyrazolo[3,4-b]pyridines" JOURNAL OF (74) Representative: Wood, David John et al MEDICINAL CHEMISTRY, AMERICAN PFIZER LIMITED, CHEMICAL SOCIETY. -
United States Patent (10) Patent No.: US 9.457,029 B2 Dugi Et Al
US0094.57029B2 (12) United States Patent (10) Patent No.: US 9.457,029 B2 Dugi et al. (45) Date of Patent: Oct. 4, 2016 (54) TREATMENT OF GENOTYPED DIABETIC 2,629,736 A 2f1953 Krimmel PATIENTS WITH DPP-IV INHIBITORS SUCH 2,730,544 A 1/1956 Melville AS LINAGLIPTIN 2,750,387 A 6, 1956 Krimmel (75) Inventors: Klaus Dugi. Dresden (DE); Eva Ulrike 3: A 3. A. et al. Graef-Mody, Ingelheim am Rhein 3.236,891. A 2, 1966 Seemiller (DE); Michael Mark, Biberach an der 3,454,635 A 7, 1969 Muth Riss (DE); Hans-Juergen Woerle, 3,673,241 A 6, 1972 Marxer Munich (DE); Heike Zimdahl-Gelling, 3,925,357. A 12/1975 Okada et al. Biberach an der Riss (DE) 4,005,208 A 1/1977 Bender et al. 4,061,753. A 12/1977 Bodor et al. (73) Assignee: Boehringer Ingelheim International 4,599.3384,382,091 A T.5/1983 1986 R",Beniamin et al. GmbH, Ingelheim am Rhein (DE) 4,639,436 A 1/1987 Junge et al. 4,687,777 A 8/1987 Meguro et al. (*) Notice: Subject to any disclaimer, the term of this 4,743.450 A 5/1988 Harris et al. patent is extended or adjusted under 35 i.S.S. A d 3. Sander et al. U.S.C. 154(b) by 0 days. 4,968,672w - A 1 1/1990 JacobsonCO et al. 5,041,448 A 8, 1991 Janssens et al. (21) Appl. No.: 13/511,771 5,051,509 A 9/1991 Nagano et al.