DOCSLIB.ORG

Zp7570: a Novel Glp-1/Glp-2 Dual Acting Peptide with Potential As The

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Zp7570: a Novel Glp-1/Glp-2 Dual Acting Peptide with Potential As The ZP7570: A NOVEL GLP-1/GLP-2 DUAL ACTING PEPTIDE PT01.2 WITH POTENTIAL AS THE NEXT GENERATION THERAPY FOR SHORT BOWEL SYNDROME Jolanta Skarbaliene1; Wayne Russell1; Jon Griffin1, Per-Olof Eriksson1 1Zealand Pharma A/S, Smedeland 36, 2600 Glostrup, Denmark INTRODUCTION CONCLUSION The GLP-2 analog teduglutide is approved for use in adult short bowel syndrome (SBS), where it improves intestinal adaptation by The novel dual acting GLP-1/GLP-2 peptide ZP7570 increasing intestinal trophicity, causing reduction in parenteral possesses specific and potent GLP-1 and GLP-2 receptor support requirements. The GLP-1 analogs exendin-4 and agonist effects in vivo, evidenced as reduced intestinal motility liraglutide have shown positive effects in small clinical studies in and anti-hyperglycemic actions, and intestinotrophic effects in SBS patients, possibly through reducing intestinal motility and / or rodents. improving intestinal absorptive capacity. Our hypothesis is that combining GLP-1 and GLP-2 activity in one molecule will provide The motility and intestinotrophic effects are expected to result additional benefits for patients, such as reducing the rate of in increased absorption of fluid and nutrients in SBS patients. intestinal transit and thus improving nutritional uptake. Furthermore, due to its GLP-1 agonist activity ZP7570 is also expected to protect against hyperglycemia and liver injury, which are both frequently associated with parenteral support. AIM To evaluate the intestinotrophic, gastrointestinal motility and glycemic effects of the GLP-1/GLP-2 dual acting peptide ZP7570 These findings warrant clinical evaluation of ZP7570 as a in rodents. future treatment for SBS. RESULTS ZP7570 is a potent GLP-1/GLP-2 dual acting Pharmacokinetics of ZP7570 in rats and mice peptide Peptide hGLP-1R hGLP-2R ZP7570 Rat (sc) Rat (iv) Mouse (sc) Mouse (iv) EC50 EC50 (cAMP; nM) (cAMP; nM) Variable Mean Mean Mean Mean ZP7570 0.19±0.029 (n=3) 0.21±0.054 (n=4) Vdss (mL/kg) 60.8 69.3 CL (mL/hr/kg) 5.64 8.76 Liraglutide 0.03±0.001 (n=4) ND* T½ (h) 7.7 8.8 3.6 5.5 Tmax (h) 9.0 4.5 Teduglutide ND* 0.019±0.01 (n=121) F (%) 58 71 Table 1. Effect of reference compounds and ZP7570 on the GLP-1 and GLP-2 receptors Table 2. Pharmacokinetic profiles of ZP7570 in rats and mice after sc and iv administration of measured as cAMP formation in HEK293 cells stably expressing human (h) GLP-1 or GLP- 10 nmol/kg. 2 receptor. Data are mean ± SD. *Not Determined. Dose-dependent effects of ZP7570 on intestinal growth in rats A B C 20 2.5 200 * *** *** *** *** *** 15 *** 2.0 150 * 1.5 10 100 %↑ 1.0 vs Vehicle 5 0.5 50 -1% 4% 2% 32% 97% 100%113% -4% -2% 2% 3% 8% 23% 16% -1% 4% -1% 7% 17% 20% 19% Intestinal length (cm) length Intestinal Small Intestine weight (g) weight Intestine Small 0 (g) weight intestine Large 0.0 0 Vehicle Vehicle Vehicle ZP7570 6nmol/kg ZP7570 6nmol/kg ZP7570 6nmol/kg ZP7570 25nmol/kg ZP7570 ZP75700.1nmol/kgZP7570 0.4nmol/kg 1.5nmol/kgZP7570 25nmol/kg ZP7570 25nmol/kg ZP7570ZP7570 0.1nmol/kg ZP75700.4nmol/kg 1.5nmol/kg ZP7570ZP7570 100nmol/kg 225nmol/kg ZP7570ZP7570 100nmol/kg 225nmol/kg ZP7570 ZP75700.1nmol/kgZP7570 0.4nmol/kg 1.5nmol/kg ZP7570ZP7570 100nmol/kg 225nmol/kg Figure 1. Evaluation of small intestine wet weight (A), large intestine wet weight (B), and total intestinal length (small and large intestine; C) after treatment with vehicle or ZP7570 for 14 days. Data were compared by 1-way ANOVA followed by Dunnett’s multiple comparison test and presented as mean +SEM. *p < 0.05 or ***p < 0.001 vs. Vehicle group, n=6. Effects of ZP7570 on intestinal transit and gastric Effects of ZP7570 on glucose tolerance and intestinal emptying in rats growth in mice A 100 A B Vehicle 16 80 * Liraglutide, 50 nmol/kg, bid *** Teduglutide, 250 nmol/kg, bid 14 ZP7570, 6 nmol/kg, qd 60 ZP7570, 250 nmol/kg, qd 1.6 *** 12 *** *** 40 *** 1.4 Figure 2. Evaluation of 10 intestinal transit (A) ** ** Intestinal transit Intestinal 20 (% barium transit) (% barium and gastric emptying 1.2 8 (B) after treatment with 0 vehicle or ZP7570 for 6 1.0 B 14 days. Rats were 4 fasted for 16 hrs and 0.8 compounds (mM) glucose Blood 4 administered prior to *** all treatments (except Teduglutide) Intestine weight (g) weight Intestine 3 barium sulfate gavage. 2 0.6 Data was compared by 1-way 0 0.4 2 ANOVA followed by 15 30 120 Dunnett’s multiple Time (min) comparison test and Vehicle 1 presented as mean Gastric emptying Gastric +SEM. *p < 0.05 or (Content (g)/B.W.)(Content ***p < 0.001, vs. Vehicle group, n=6. ZP7570 (6 nmol/kg) 0 ZP7570 (250 nmol/kg) Liraglutide (50 nmol/kg) Teduglutide (250 nmol/kg) Figure 3. Effects of vehicle, GLP-2 receptor agonist (Teduglutide), GLP-1 receptor agonist Vehicle (Liraglutide), or ZP7570 on blood glucose levels during an OGTT (after a single s.c. administration; A), and on total intestine (small and large) wet weight (after 3-days treatment; B) in C57BL/6J mice. Data were compared by 2-way ANOVA followed by Bonferroni posttests (A) or by 1-way ANOVA ZP7570 6nmol/kg followed by Dunnett’s multiple comparison test (B) and presented as mean +SEM. *p < 0.05 or ***p ZP7570 25nmol/kg ZP7570ZP7570 0.1nmol/kg ZP75700.4nmol/kg 1.5nmol/kg ZP7570 ZP7570100nmol/kg 225nmol/kg < 0.001, vs. Vehicle group , n=6. METHODS Study in rats Wistar rats (n=6/group) were dosed SC (QD) with vehicle or ZP7570 (0.1-225 nmol/kg) for 14 days. Gastric emptying and intestinal transit were determined after an overnight fast using a barium sulfate assay (oral gavage of 1 g/mL barium sulfate in salt-free water). At time 60 minutes post-gavage (PG) the stomach was excised, weighed, and then emptied and re-weighed. Also at 60 minutes post-PG the intestinal tract (pylorus to rectum) was removed, and the length of the intestine and the length travelled by barium sulfate recorded. For trophic effects, small and large intestine were carefully cleaned and weighed. Study in mice C57BL76 mice (n=6) were dosed subcutaneously (SC) once daily (QD) with vehicle or ZP7570 (6 and 250 nmol/kg) for 3 days, and compared to reference compounds liraglutide (50 nmol/kg, bid) and teduglutide (250 nmol/kg, bid). After a 6h fasting period, animals were dosed a single s.c. administration (day 1) and an oral glucose tolerance test was performed (0-120 minutes). At sacrifice (after days 3 treatment) the intestinal tract was carefully removed, cleaned and weighed. Zealand Pharma A/S.
Load more

Recommended publications
  • The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands
    The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands Clare Louise Wishart Submitted in accordance with the requirements for the degree of Doctor of Philosophy of Science University of Leeds School of Biomedical Sciences Faculty of Biological Sciences September 2013 I Intellectual Property and Publication Statements The candidate confirms that the work submitted is her own and that appropriate credit has been given where reference has been made to the work of others. This copy has been supplied on the understanding that it is copyright material and that no quotation from the thesis may be published without proper acknowledgement. The right of Clare Louise Wishart to be identified as Author of this work has been asserted by her in accordance with the Copyright, Designs and Patents Act 1988. © 2013 The University of Leeds and Clare Louise Wishart. II Acknowledgments Firstly I would like to offer my sincerest thanks and gratitude to my supervisor, Dr. Dan Donnelly, who has been nothing but encouraging and engaging from day one. I have thoroughly enjoyed every moment of working alongside him and learning from his guidance and wisdom. My thanks go to my academic assessor Professor Paul Milner whom I have known for several years, and during my time at the University of Leeds he has offered me invaluable advice and inspiration. Additionally I would like to thank my academic project advisor Dr. Michael Harrison for his friendship, help and advice. I would like to thank Dr. Rosalind Mann and Dr. Elsayed Nasr for welcoming me into the lab as a new PhD student and sharing their experimental techniques with me, these techniques have helped me no end in my time as a research student.
    [Show full text]
  • Gattex Teduglutide Rdna Origin
    Subject: Gattex (teduglutide [rDNA origin]) Original Effective Date: 5/30/2014 Policy Number: MCP-176 Revision Date(s): Review Date(s): 12/16/15; 9/15/2016; 6/22/2017 DISCLAIMER This Medical Policy is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina medical coverage policy (MCP) document and provide the directive for all Medicare members. FDA INDICATIONS � ∑ Short bowel syndrome: For the treatment of adult patients with short bowel syndrome who are dependent on parenteral support.
    [Show full text]
  • Teduglutide for Treating Short Bowel Syndrome
    Teduglutide for treating short bowel syndrome Produced by Aberdeen HTA Group Authors Graham Scotland1,2 Daniel Kopasker1 Neil Scott3 Moira Cruickshank1 Rodolfo Hernández 1 Cynthia Fraser1 Mairi McLean4 Alistair McKinlay5 Miriam Brazzelli2 1 Health Economics Research Unit, University of Aberdeen 2 Health Services Research Unit, University of Aberdeen 3 Medical Statistics Team, University of Aberdeen 4 School of Medicine, Medical Sciences & Nutrition, University of Aberdeen 5 Consultant Gastroenterologist, NHS Grampian Correspondence to Graham Scotland Senior Research Fellow University of Aberdeen Health Economics Research Unit Foresterhill, Aberdeen, AB25 2ZD Email: [email protected] Date completed 20 September 2017 Version 1 Copyright belongs to University of Aberdeen HTA Group, unless otherwise stated Copyright 2017 Queen's Printer and Controller of HMSO. All rights reserved. CONFIDENTIAL UNTIL PUBLISHED Source of funding: This report was commissioned by the NIHR HTA Programme as project number 15/07/04. Declared competing interests of the authors Alistair McKinley reports that he previously acted in a brief advisory capacity for Shire, through participation in an expert advisory meeting on short bowel syndrome in Scotland. All other authors have no competing interests to declare. Acknowledgements The authors are grateful to Lara Kemp for her administrative support. Copyright is retained by Shire for Tables 1, 3, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 24, 25, 26, 27, 28 , 29, 39, 31, 32, and 33, and for Figures 1, 2, 5, 6 , 7, 9, 10, 11, and 12. Rider on responsibility for report The view expressed in this report are those of the authors and not necessarily those of the NIHR HTA Programme.
    [Show full text]
  • Membrane-Tethered Ligands Are Effective Probes for Exploring Class B1 G Protein-Coupled Receptor Function
    Membrane-tethered ligands are effective probes for exploring class B1 G protein-coupled receptor function Jean-Philippe Fortina, Yuantee Zhua, Charles Choib, Martin Beinborna, Michael N. Nitabachb, and Alan S. Kopina,1 aMolecular Pharmacology Research Center, Molecular Cardiology Research Institute, Tufts Medical Center, Tufts University School of Medicine, Boston, MA 02111; and bDepartment of Cellular and Molecular Physiology, Yale School of Medicine, New Haven, CT 06520 Edited by Solomon H. Snyder, Johns Hopkins University School of Medicine, Baltimore, MD, and approved March 6, 2009 (received for review January 6, 2009) Class B1 (secretin family) G protein-coupled receptors (GPCRs) peptide hormone complexes, providing important insight into modulate a wide range of physiological functions, including glu- the molecular mechanisms underlying PTH (3), corticotropin- cose homeostasis, feeding behavior, fat deposition, bone remod- releasing factor (CRF) (4), GIP (5), and exendin-4 (EXE4) (6) eling, and vascular contractility. Endogenous peptide ligands for interaction with their corresponding GPCRs. Notably, these these GPCRs are of intermediate length (27–44 aa) and include reports highlight that each of the peptides docks as an amphipathic receptor affinity (C-terminal) as well as receptor activation (N- ␣-helix in a hydrophobic groove present in the receptor ECD. terminal) domains. We have developed a technology in which a Peptide ligands that modulate class B1 GPCR function hold peptide ligand tethered to the cell membrane selectively modu- considerable promise as therapeutics. The peptidic GLP-1 mi- lates corresponding class B1 GPCR-mediated signaling. The engi- metic EXE4 (also known as exenatide or BYETTA) activates the neered cDNA constructs encode a single protein composed of (i)a GLP-1 receptor (GLP-1R) and represents the first incretin- transmembrane domain (TMD) with an intracellular C terminus, (ii) based pharmaceutical for the treatment of type 2 diabetes (7).
    [Show full text]
  • WO 2018/142363 Al 09 August 2018 (09.08.2018) W !P O PCT
    (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 2018/142363 Al 09 August 2018 (09.08.2018) W !P O PCT (51) International Patent Classification: TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, A61K 38/00 (2006.01) KM, ML, MR, NE, SN, TD, TG). (21) International Application Number: Published: PCT/IB20 18/050709 with international search report (Art. 21(3)) (22) International Filing Date: 05 February 2018 (05.02.2018) (25) Filing Language: English (26) Publication Langi English (30) Priority Data: 201741004264 06 February 2017 (06.02.2017) IN (71) Applicant: ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED [IN/IN]; P. NO. 53, Aleap Industrial Estate, Pragati Nagar, Kukatpally, Telangana, Hyderabad 500090 (IN). (72) Inventors: MOHAN, Mailatur Sivaraman; P. NO. 53, Aleap Industrial Estate, Pragati Nagar, Kukatpally, Telan gana, Hyderabad 500050 (IN). PATEL, Hiren; P. NO. 53, Aleap Industrial Estate, Pragati Nagar, Kukatpally, Telan gana, Hyderabad 500050 (IN). VALLABHBHAI PATEL, Bhaveshkumar; P.NO. 53, Aleap Industrial Estate, Pragati Nagar, Kukatpally, Telangana, Hyderabad 500050 (IN). KANNEKANTI, Raghu; P. NO. 53, Aleap Industrial Estate, Pragati Nagar, Kukatpally, Telangana, Hyderabad 500050 (IN). CHAKALI, Paramesh; P. NO. 53, Aleap In dustrial Estate, Pragati Nagar, Kukatpally, Telangana, Hy derabad 500050 (IN). BABUJI, Kantu; P. NO. 53, Aleap Industrial
    [Show full text]
  • Identification and Characterization of the Glucagon- Like Peptide-2 Hormonal System in Ruminants
    University of Kentucky UKnowledge University of Kentucky Doctoral Dissertations Graduate School 2009 IDENTIFICATION AND CHARACTERIZATION OF THE GLUCAGON- LIKE PEPTIDE-2 HORMONAL SYSTEM IN RUMINANTS Christina C. Taylor Edwards University of Kentucky, [email protected] Right click to open a feedback form in a new tab to let us know how this document benefits ou.y Recommended Citation Edwards, Christina C. Taylor, "IDENTIFICATION AND CHARACTERIZATION OF THE GLUCAGON-LIKE PEPTIDE-2 HORMONAL SYSTEM IN RUMINANTS" (2009). University of Kentucky Doctoral Dissertations. 734. https://uknowledge.uky.edu/gradschool_diss/734 This Dissertation is brought to you for free and open access by the Graduate School at UKnowledge. It has been accepted for inclusion in University of Kentucky Doctoral Dissertations by an authorized administrator of UKnowledge. For more information, please contact [email protected]. ABSTRACT OF DISSERTATION Christina C. Taylor Edwards The Graduate School University of Kentucky 2009 IDENTIFICATION AND CHARACTERIZATION OF THE GLUCAGON-LIKE PEPTIDE-2 HORMONAL SYSTEM IN RUMINANTS _____________________________________ ABSTRACT OF DISSERTATION _____________________________________ A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy in the College of Agriculture at the University of Kentucky By Christina C. Taylor Edwards Lexington, Kentucky Director: Dr. David Harmon, Professor of Animal Science Lexington, Kentucky 2009 Copyright © Christina C. Taylor Edwards 2009 ABSTRACT OF DISSERTATION IDENTIFICATION AND CHARACTERIZATION OF THE GLUCAGON-LIKE PEPTIDE-2 HORMONAL SYSTEM IN RUMINANTS The hormone glucagon-like peptide-2 (GLP-2) is important in the regulation of intestinal growth and blood flow in nonruminant animals. However, no research reports the existence of GLP-2 in ruminants.
    [Show full text]
  • WO 2019/069274 Al 11 April 2019 (11.04.2019) W 1P O PCT
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization III International Bureau (10) International Publication Number (43) International Publication Date WO 2019/069274 Al 11 April 2019 (11.04.2019) W 1P O PCT (51) International Patent Classification: TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, C07K 14/605 (2006.01) KM, ML, MR, NE, SN, TD, TG). (21) International Application Number: Published: PCT/TB2018/057736 with international search report (Art. 21(3)) (22) International Filing Date: 04 October 2018 (04. 10.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 20170100453 04 October 2017 (04. 10.2017) 20180100447 03 October 2018 (03. 10.2018) (71) Applicant: CHEMICAL & BIOPHARMACEUTICAL LABORATORIES OF PATRAS S.A. [GR/GR] ; Industri¬ al Area of Patras Building, Block 1, 26000 Patras (GR). (72) Inventors: BARLOS, Kleomenis; c/o Chemical & Bio- pharmaceutical Laboratories of Patras S.A., Industrial Area of Patras Building, Block 1, 26000 Patras (GR). BARLOS, Konstantinos; c/o Chemical & Biopharmaceutical Labo¬ ratories of Patras S.A., Industrial Area of Patras Build¬ ing, Block 1, 26000 Patras (GR). GATOS, Dimitrios; c/o Chemical & Biopharmaceutical Laboratories of Patras S.A., Industrial Area of Patras Building, Block 1, 26000 Patras (GR). VASILEIOU, Zoi; c/o Chemical & Biopharmaceu¬ tical Laboratories of Patras S.A., Industrial Area of Patras Building, Block 1, 26000 Patras (GR). (74) Agent: D YOUNG & CO LLP; 120 HOLBORN,
    [Show full text]
  • ADOCIA Corporate Presentation
    ADOCIA INNOVATIVE MEDICINE FOR EVERYONE, EVERYWHERE Corporate Presentation – February 2019 INTRODUCTION Disclaimer This corporate presentation (the “Presentation”) has been prepared by ADOCIA (the “Company”) and is provided for information purposes only. It is not for promotional use. References herein to the Presentation shall mean and include this document, any oral presentation accompanying this document provided by the Company, any question and answer session following that oral presentation and any further information that may be made available in connection with the subject matter contained herein. The information and opinions contained in this document speak only as of the date of the Presentation and may be subject to significant changes. The Company does not undertake any obligation to update the information or opinions contained herein in light of any new information or future developments. The information contained in the Presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to the accuracy, completeness or appropriateness of the information and opinions contained in this document. The Company, its subsidiaries, its advisors and representatives accept no responsibility for and shall not be held liable for any loss or damage that may arise from the use of the Presentation or the information or opinions contained herein. The Presentation contains information on the Company’s markets and competitive position, and more specifically, on the size of its markets. This information has been drawn from various sources or from the Company’s own estimates. Investors should not base their investment decision on this information. The Presentation does not purport to contain comprehensive or complete information about the Company and is qualified in its entirety by the business, financial and other information that the Company is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Euronext Paris.
    [Show full text]
  • Presentation of Several Zealand Peptide Therapeutics at the Th American Diabetes Association’S (ADA) 74 Scientific Sessions
    Press release No. 2/2014 Presentation of several Zealand peptide therapeutics at the th American Diabetes Association’s (ADA) 74 Scientific Sessions - New data to be presented on Lyxumia® (lixisenatide) and on LixiLan, including results from an 8-week head-to-head pharmacodynamic study of Lyxumia® versus liraglutide and a Phase IIb study of the fixed-ratio combination of lixisenatide with ® Lantus (insulin glargine) - Zealand presents two novel diabetes therapeutics from its proprietary preclinical pipeline; a glucagon analogue for liquid formulation and a GLP-1/GLP-2 dual- acting agonist Copenhagen, 10 June 2014 – Zealand Pharma A/S (“Zealand”) (NASDAQ OMX Copenhagen: ZEAL) informs that new data will be presented on four products from the company’s portfolio of novel diabetes peptide therapeutics at the upcoming 74th Scientific Sessions of the American Diabetes Association (ADA) to be held in San Francisco, 13-17 June 2014. Zealand’s own-invented product, lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of Type 2 diabetes, developed and marketed as Lyxumia® under a global license agreement with Sanofi, will feature in 11 abstracts. These include the presentation of results from an 8-wk clinical study of lixisenatide versus liraglutide (Victoza®) under the title: “Effect of lixisenatide vs liraglutide on glycemic control, gastric emptying, and safety parameters in optimized insulin glargine T2DM ± metformin” – Abstract # 1017 – POSTER PRESENTATION Two abstracts will also be presented on LixiLan, the fixed-ratio combination of lixisenatide with Lantus®, including results from a Phase IIb trial under the title: “The benefits of a fixed-ratio formulation of once-daily insulin glargine/lixisenatide (LixiLan) versus glargine in Type 2 Diabetes (T2DM) inadequately controlled on Metformin - Abstract # 332 – ORAL PRESENTATION.
    [Show full text]
  • BCBSM Clinical Drug List (Formulary)
    Blue Cross Blue Shield of Michigan ® ® Clinical Drug List (Formulary) Please note that this listing of medications contained in this Blue Cross Blue Shield of Michigan Clinical Drug List (Formulary) is current at the time that the list is posted to this website, and is subject to change. INTRODUCTION Blue Cross Blue Shield of Michigan is pleased to provide the Clinical Drug List as a useful reference and educational tool to assist providers in selecting cost-effective therapies. Please familiarize yourself with this information. To provide effective high-quality care, this Clinical Drug List requires the continuing support of physicians and phar - macists. Your questions and suggestions are welcome. PREFACE The Blue Cross Blue Shield of Michigan Clinical Drug List is a list of FDA-approved prescription drug medications reviewed by the BCBSM/BCN Pharmacy and Therapeutics (P&T) Committee. The Clinical Drug List will assist in maintaining the quality of patient care and containing cost for the member’s drug benefit plan. Providers, physicians, and pharmacists are encouraged to refer to the Clinical Drug List when selecting prescription drug therapy for eligible plan members. Physicians are encouraged to prescribe med ications included in the Clinical Drug List whenever possible. If a prescrip tion is written for a nonpreferred drug or for a drug or dose not recommended for use in the elderly or pregnant, phar macists are encouraged to contact the physician. The benefit plan administrator will monitor provider- specific drug list prescribing and communicate with providers to optimize compliance. The Clinical Drug List is divided into major therapeutic categories (chapters) for easy use.
    [Show full text]
  • GATTEX (Teduglutide) RATIONALE for INCLUSION in PA PROGRAM
    GATTEX (teduglutide) RATIONALE FOR INCLUSION IN PA PROGRAM Background Gattex is used to treat patients with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition). SBS is a condition that results from the partial or complete surgical removal of the small and/or large intestine. Extensive loss of the small intestine can lead to poor absorption of fluids and nutrients from food needed to sustain life. As a result, patients with SBS often receive parenteral nutrition. Gattex is an injection administered once daily that helps improve intestinal absorption of fluids and nutrients, reducing the frequency and volume of parenteral nutrition (1). Regulatory Status FDA-approved indication: Gattex (teduglutide [rDNA origin]) for injection is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support (1). Gattex has the potential to cause hyperplastic changes including neoplasia. Before initiating treatment with Gattex, a colonoscopy of the entire colon with removal of polyps should be done within 6 months prior to starting treatment. A follow-up colonoscopy (or alternate imaging) is recommended after 1 year. Gattex therapy should be discontinued in patients with active gastrointestinal malignancy (GI tract, hepatobiliary, pancreatic). The clinical decision to continue Gattex in patients with non-gastrointestinal malignancy should be made based on risk and benefit considerations. In case of diagnosis of colorectal cancer, Gattex therapy should be discontinued (1). In patients who develop intestinal or stomal obstruction, Gattex should be temporarily discontinued pending further clinical evaluation and management.
    [Show full text]
  • Press Release
    PRESS RELEASE Adocia to Present New Clinical Data on BioChaperone® Technology at the 12th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2019) Lyon, France February 12th, 2019 – Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on the treatment of diabetes and other metabolic diseases with innovative formulations of approved proteins, today announced that four abstracts featuring its BioChaperone® technology have been accepted for presentation at the 12th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2019) being held February 20-23, 2019 in Berlin, Germany. “The data presentations at the ATTD Annual Meeting demonstrate the potential of our BioChaperone technology to improve diabetes care and management,” commented Dr. Olivier Soula, Deputy General Manager at Adocia. “Specifically, BioChaperone Lispro showed a PK/PD profile at least equivalent to faster insulin aspart, the only approved ultra-rapid insulin and the first results obtained with BioChaperone Pramlintide Insulin, the first combination of its kind tested in clinics, encourage us to rapidly develop this combination of two essential hormones.” Details of the four accepted abstracts are presented below: • Oral Presentation # ATTD19-0192: The Ultra-Rapid Insulin BioChaperone Lispro Bolused By Insulin Pump Shows Favourable Pharmacodynamics And Pharmacokinetics vs. Faster Aspart and Insulin Aspart Presenting Author: Dr. Grégory Meiffren Session: Oral Presentations
    [Show full text]