2008 Citi Investment Research Global Health Care Conference
|
|
- Monica Foster
- 5 years ago
- Views:
Transcription
1 0
2 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including the timing and results of our clinical trials, potential indications for our product candidates, development timelines and the future financial results. The Company s forward-looking statements t t are subject to anumber of known and unknown risks and uncertainties ti thatt could cause actual results, performance or achievements to differ materially from those described or implied in the forwardlooking statements, including, but not limited to, our ability to secure FDA approval for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel technology; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product candidates, particularly VIAject and VIAtab ; our ability to secure additional patents for VIAject and our other product candidates; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly and annual reports on Forms 10-Q and 10-K, respectively. The Company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release. 1
3 Company Overview Experienced Focused Management Team Lead By Dr. Solomon Steiner (Founder NASDAQ: BIOD, EMIS, and MNKD preceded by PDC) Proprietary platform technology to modify protein delivery and kinetics Currently focused on multi-billion dollar enhanced insulin market Phase III product candidate with best in class profile Phase I, II & interim III safety data support a best in class clinical profile 505(b)(2) regulatory pathway Phase III enrollment complete with NDA expected end of
4 Pipeline to Fuel Continuing Growth Pre Clinical Phase I Phase II Phase III Approval Injectable prandial insulin (NDA 08) Diabetes Oral sublingual prandial insulin Oral sublingual PTH 1-34 Osteoporosis Oral sublingual calcitonin 3
5 Physiologic Insulin PK and Replacement Basal level of insulin to cover glucose from hepatic glucogenesis Long acting insulin (Lantus, Levemir) is the pharmacological replacement First Phase insulin release covers glucose from the GI tract and signals the liver to cease the production of glucose (hepatic glucogenesis) RA insulin (Novolog, Humlog and Apidra) is the pharmacological replacement 120 Plasm a Insulin (µu U/ml) Meal Meal Meal Time 4
6 An Improvement, But Current RA Insulins Still Do Not Mimic Normal PK Early ½ Tmax >20 min vs <10 min healthy Tmax >60 min vs <15 min healthy Late ½ Tmax >150 min vs <60 min healthy Taken from Humalog Package Insert 5
7 Unmet Clinical Needs Current therapies inadequately mimic First Phase Insulin Release Rapid Acting Insulin Analogs: Humalog NovoLog Apidra Insufficient i Glycemic Control Blindness Hyperglycemia: Cardiovascular and kidney disease Stroke Little material p differentation Nerve damage Amputation Weight gain Hypoglycemia: Loss of consciousness Coma and death 1.2 serious hypoglycemic gy events per patient per year 6
8 VIAject : Significant Advantages Over Current Therapies is an Ultra Rapid Acting Insulin Faster Absorption and Faster Clearance More closely mimics normal first phase PK Better able to cover rapid onset of glucose from meal More consistently shuts off hepatic glucogenesis Improved Glycemic Control Lower Dose Less Variability Less Hyper/ Hypoglycemia Safer Therapy Statistically significantly fewer hypoglycemic events 7
9 Insulin Market Growth Has Been Driven By Innovative New Product Classes 4,000 3,500 3,000 $ MM 2,500 2,000 1,500 Rapid Acting Long Acting Regular Insulin 1, E 2008 F 8
10 Superior Insulin Products Grow the Market and Take Share 2,500 US Basal Insulin Market Lantus has the longest 2,000 duration and flattest PK of all the basal insulins $ MM 1,500 1,000 VIAject has the shortest and most rapid PK profile of all the meal time insulins LANTUS LEVEMIR HUMULIN N NOVOLIN N 9
11 Market for Rapid-Acting Insulins 3.0 US & Top 5 European Markets 2.5 Proprietary Rapid Insulins 3 X Price of RHI 2.0 ($Bn) Humalog NovoLog Apidra 10
12 Insulin Absorption from the s.c. Tissue Cutis Subcutaneous Adipose Tissue Insulin Blood Vessels 11
13 Similar RA Technology has Led to Similar Results Novolog All 3 have modified the primary structure by 2 amino acids There is a limit to reengineering due to the need to maintain biological activity, specificity and avoid antibody formation Humalog, Apidra, 12
14 VIAject Technology - + I - + I Monomeric Insulin I - Neutral Charge 2 Zn 2+ I I EDTA Zn I - I - + Hexameric Insulin - Charged I + - I I I I
15 VIAject Absorption from the s.c. Tissue Cutis Monomeric Insulin Subcutaneous Adipose Tissue VIAject Blood Vessels 14
16 Intellectual Property The United States Patent and Trademark Office issued U.S. Patent No. 7,279,457 to Biodel Composition of matter patent This patent encompasses VIAject and VIAtab The patent t will expire in January, 2026 Multiple patents filed internationally All IP invented in-house 15
17 Clinical Program Objectives Regulatory: FDA Approval (FDA dictated RHI Comparator in Phase III) Commercial: Market Differentiation Phase II: vs. RHI and analog Phase III: vs. common RHI Yard Stick Phase IIIb: vs. analogs 16
18 Regulatory Path Typical Path Path New Chemical Entity Insulin + GRAS Ingredients Full NDA 505(b)(2) years to approval 4 6 years to approval $800+ M development cost $40 60M development cost Expected NDA Filing:
19 First Phase Insulin Release Response to an i.v. Glucose Challenge Plasma Insulin (µu/ml) Pfeifer et al., (30) Time (Minutes) Normal Type 2 18
20 Mean Normalized Insulin Concentration Percent (% %) Time (min) Humulin Humalog VIAject 19
21 Phase 1 VIAject v. Humalog Time (min) 0-5 Speed Advantage Over Comparator Humulin R % Improvement -15 Humalog 53% Improvement -32 Scale represents time to ½ t-max GIR; Dose = 12IU 20
22 Phase II Meal Study Pharmacokinetics PK-Parameters Parameters Humulin R Humalog VIAject p-value Early ½ Tmax (min) 33±4 a, c a, c 29 29±4 b, c b, c 13 a < ±1 a, b b < c = n.s. Ins Tmax (min) a < ± ±8 34±7 b < 0.02 c < Late ½ Tmax (min) a < ±16 217± ±1212 b < c <
23 Phase II Meal Study Better Glycemic Control Blood Glucose [mg/dl] ADA Limit Patient A All Conditions 160 Hyperglycemic Ideal Glycemic Control Hypoglycemic Glucose Infusion Time (Hours) Humulin R Humalog VIAject TM 22
24 Mean Curves Improved Postprandial Glycemic Control Patients Average Blood Glucose 160 RHI Humulin R od Glucose (m mg/dl) VIAject Lispro Humalog Blo Meal Time (min) Humulin R Humalog VIAject 23
25 Phase II Meal Study Less Glycemic Variability (mg/dl*min) 90,000 80,000 70,000 60, ,000 40,000 30,000 20,000 10,000 AUC Above and Below Normal Range Over 8 Hrs. ( mg/dl) 0 Humulin R Humalog VIAject 24
26 Phase II Meal Study Fewer Hypoglycemic Events # of Patient Hours Hours Post Dose Humulin R Humalog VIAject 25
27 Robust Phase 3 Study Design vs. Humulin R (per FDA EOP2) Two open label studies 400 Type 1 patients (1:1) 400 Type 2 patients (1:1) 6 month duration Non-inferiority HbA1c Safety (Hypoglycemia) Weight Dose 26
28 Phase III Data as of March 07 Significantly Fewer Mild & Moderate Hypoglycemic Events # of Hypoglycemic Events Type 1 Type 2 p<.01 Humulin R VIAject p<
29 Phase III Data as of March 07 Significant Weight Change 2.5 Mean weight change over 6 weeks (lbs.) lbs. mean weight difference -1.0 Humulin R VIAject 28
30 Phase III Data as of March 07 Change in % Prandial Dose- Type 1 & Type 2 Perc cent Chan nge Type 1 Type % 2.27 % (IU 0.21) NS (IU-6.28**) % **p<.01 (IU 0.86) NS (IU-22.79**) Humulin R % **p<.01 VIAject 29
31 Most Pivotal Trials Used RHI as a Comparator; Few Superiority Claims have Been Achieved Claim Versus RHI PK /PD (onset and offset of insulin level and effect) Safety (hypoglycemia) in Type I and dtype 2 Glycemic Control - HbA1C Best of Humalog, Novolog, Apridra Claims Superior to RHI Narrow superiority claim; A single trial demonstrated superiority it in just Type I for only nocturnal (12AM to 6AM) Equivalent to RHI Timing i Relative to a Meal Superior to RHI Weight Equivalent to RHI Dose Equivalent to RHI Post Prandial Glycemic Control Superior to RHI 30
32 Only a Apidra Has Used Another Mealtime Insulin as a Comparator - With no Advantage Versus Another RA Insulin Possible Claim Apridra O Only (vs Humalog ) PK /PD Equivalent Safety (hypo) Equivalent HbA1C Equivalent 31
33 VIAject's Profile May Be Superior to the other RA Insulins Possible Claim Best of Humalog, Novolog, Apridra Claims VIAject Targeted Claims (based on interim Phase III and Phase I & II results) PK /PD Superior to RHI Superior to RHI and Humalog Safety (hypo) Narrow Superiority Claim vs. RHI Broadly Superior vs. RHI HbA1C Equivalent to RHI Equivalent to RHI Meal Timing Superior to RHI Superior to RHI Weight Equivalent to RHI Superior to RHI Dose Equivalent to RHI Superior to RHI Post Prandial Glyc. Superior to RHI Superior to RHI and Humalog 32
34 Phase 3 Enrollment Complete for VIAject Completed enrollment of both Phase III studies in December of 2007 Enrolled in excess of 400 patients with Type 1 diabetes and 400 patients t with Type 2 diabetes Study completion expected July 2008 Data analysis expected 2nd half of 2008 NDA filing for complete VIAject suite of products expected by end of
35 Suite of VIAject Products VIAject A (liquid) Single Vial Fridge or Freeze Ship & Store VIAject B (lyo + diluent) Two Vials Room Temp. Ship & Store 100 IU/cc, 10cc 100 IU/cc, 10cc 25 IU/cc, 10cc 25 IU/cc, 10cc Pen Cartridge Presentations VIAject A (liquid) Single Cartridge Fridge or Freeze Ship & Store 100 IU/cc, Adult Pen 3cc, 1 IU Increment 25 IU/cc, Pediatric Pen 3cc, ¼ IU Increment 34
36 Financial Position 3/31/08 Shares Outstanding 23.6 MM Cash and Investments ($MM) $111.7 MM Second Quarter Net Loss $9.6 6MM 35
37 Thank you 36
Novel Formulations to Modify Mealtime Insulin Kinetics
Novel Formulations to Modify Mealtime Insulin Kinetics Alan Krasner, Roderike Pohl, Patrick Simms, Philip Pichotta, Robert Hauser, Errol De Souza Biodel, Inc. Danbury, CT Disclosure All authors are employees
More informationJanuary 7, 5:00 p.m. EST
Study 3-151 Phase 2 Trial: Preliminary Results BIOD-531, a Concentrated Ultra-Rapid-Acting Prandial/Basal Insulin, Demonstrates Superior Post-Meal Glucose Control Compared to Marketed Prandial/Basal Insulins
More informationA novel ph-neutral formulation of the monomeric insulin VIAject has a faster onset of action than insulin lispro
A novel ph-neutral formulation of the monomeric insulin VIAject has a faster onset of action than insulin lispro Leszek Nosek, Tim Heise, Frank Flacke 2, Alan Krasner 2, Philip Pichotta 2, Lutz Heinemann,
More informationInsulin Prior Authorization with optional Quantity Limit Program Summary
Insulin Prior Authorization with optional Quantity Limit Program Summary 1-13,16-19, 20 FDA LABELED INDICATIONS Rapid-Acting Insulins Humalog (insulin lispro) NovoLog (insulin aspart) Apidra (insulin glulisine)
More informationLilly Diabetes: Pipeline Update
Lilly Diabetes: Pipeline Update June 16, 2014 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ
More informationSponsor / Company: Sanofi Drug substance(s): insulin glargine (HOE901) According to template: QSD VERSION N 4.0 (07-JUN-2012) Page 1
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationComprehensive Diabetes Treatment
Comprehensive Diabetes Treatment Joshua L. Cohen, M.D., F.A.C.P. Professor of Medicine Interim Director, Division of Endocrinology & Metabolism The George Washington University School of Medicine Diabetes
More informationNewer Insulins. Boca Raton Regional Hospital 15th Annual Internal Medicine Conference
Newer Insulins Boca Raton Regional Hospital 15th Annual Internal Medicine Conference Luigi F. Meneghini, MD, MBA Professor of Internal Medicine, UT Southwestern Medical Center Executive Director, Global
More informationStroke Hyperglycemia Insulin Network Effort (SHINE) Trial Treatment Protocols. Askiel Bruno, MD, MS Protocol PI
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Treatment Protocols Askiel Bruno, MD, MS Protocol PI SHINE Synopsis Acute ischemic stroke
More informationAVENUE THERAPEUTICS, INC. NASDAQ: ATXI JANUARY 2018
AVENUE THERAPEUTICS, INC. NASDAQ: ATXI JANUARY 2018 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward-looking statements within the meaning
More informationObjectives. Navigating New Insulins. Disclosures. Diabetes: The Stats. Normal Insulin Release Individuals without diabetes. History of Insulin 5/23/17
Objectives Compare and contrast currently available products. Navigating New s Diana Isaacs, PharmD, BCPS, BC-ADM, CDE Clinical Pharmacy Specialist Cleveland Clinic Diabetes Center Determine the factors
More informationInitiation and Titration of Insulin in Diabetes Mellitus Type 2
Initiation and Titration of Insulin in Diabetes Mellitus Type 2 Greg Doelle MD, MS April 6, 2016 Disclosure I have no actual or potential conflicts of interest in relation to the content of this lecture.
More informationINSULIN OVERVIEW. Type Brand Name Onset Peak Duration Role in glucose management Page Rapid-Acting lispro min. 3-5 hrs min.
INSULIN OVERVIEW Type Brand Name Onset Peak Duration Role in glucose management Page Rapid-Acting lispro Humalog 15-30 min 30-90 min 3-5 hrs aspart glulisine Short-Acting Regular insulin NovoLog Apidra
More informationEli Lilly and Company Investment Community Meeting
Eli Lilly and Company Investment Community Meeting October 3, 2013 8:30 a.m. 12:30 p.m. Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current
More informationMerrill Lynch's Global Pharmaceutical, Biotechnology, and Medical Device Conference. February 7, 2007
Merrill Lynch's Global Pharmaceutical, Biotechnology, and Medical Device Conference February 7, 2007 Information related to forward-looking statements This presentation includes forward-looking statements
More informationUpdate on New Basal Insulins and Combinations: Starting, Titrating and Adding to Therapy
Update on New Basal Insulins and Combinations: Starting, Titrating and Adding to Therapy Jerry Meece, BPharm, CDE, FACA, FAADE Director of Clinical Services Plaza Pharmacy and Wellness Center Gainesville,
More informationMerck & Co, Inc. Announced Approval of JANUVIA TM (INN: sitagliptin), a new oral treatment of diabetes, by the US FDA
October 23, 2006 Ono Pharmaceutical Co., Ltd., Public Relations Phone: +81-6-6263-5670 Banyu Pharmaceutical Co., Ltd., Public Relations Phone: +81-3-6272-1001 Merck & Co, Inc. Announced Approval of JANUVIA
More informationMixed Insulins Pick Me
Mixed Insulins Pick Me Alvin Goo, PharmD Clinical Associate Professor University of Washington School of Pharmacy and Department of Family Medicine Objectives Critically evaluate the evidence comparing
More informationClinicalTrials.gov Identifier: sanofi-aventis. Sponsor/company:
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinicalTrials.gov
More informationAnti-IL-33 (ANB020) Program
Anti-IL-33 (ANB020) Program Phase 2a Peanut Allergy Clinical Trial Interim Data Update March 26 th 2018 NASDAQ: ANAB Safe Harbor Statement This presentation and the accompanying oral presentation contain
More informationMedia Contacts: Amy Rose Investor Contact: Graeme Bell (908) (908)
News Release FOR IMMEDIATE RELEASE Media Contacts: Amy Rose Investor Contact: Graeme Bell (908) 423-6537 (908) 423-5185 Tracy Ogden (267) 305-0960 FDA Approves Once-Daily JANUVIA, the First and Only DPP-4
More informationInnovation In Ophthalmics
Innovation In Ophthalmics Ophthalmic Innovation Summit @ AAO 2018 October 25, 2018 Mark Iwicki Chairman & CEO, Kala Pharmaceuticals Disclaimers and Notices This presentation contains forward-looking statements
More informationThese Aren t Your Average Rookies: A Primer on New and Emerging Insulins. Alissa R. Segal, Pharm.D, CDE, CDTC, FCCP
These Aren t Your Average Rookies: A Primer on New and Emerging Insulins Alissa R. Segal, Pharm.D, CDE, CDTC, FCCP Disclosures Eli Lilly & Company: Advisory board member Boehringer Ingelheim: Advisory
More informationAnnual Stockholder Meeting May 30, confidently live life with ease
Annual Stockholder Meeting May 30, 2018 confidently live life with ease Forward-Looking Statements This presentation contains certain forward-looking statements that involve risks and uncertainties that
More informationHalozyme Therapeutics, Inc.
Halozyme Therapeutics, Inc. The Next Chapter Begins: Creating Value Through Growth Jefferies 2014 Global Health Care Conference June 2014 Helen Torley, M.B. Ch. B., M.R.C.P. President and Chief Executive
More informationEli Lilly and Company
Eli Lilly and Company Strategic Diabetes Alliance with Boehringer Ingelheim January 11 th, 2011 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's
More informationAccelerating our business from peptides to patients
Accelerating our business from peptides to patients Jeffries Global Healthcare Conference London, 19 November 2015 Zealand Pharma A/S Disclaimer This presentation does not constitute or form part of and
More informationInsulin Prior Authorization Criteria For Individuals Who Purchased BlueCare/KS Solutions/EPO Products
Insulin Prior Authorization Criteria For Individuals Who Purchased BlueCare/KS Solutions/EPO Products FDA LABELED INDICATIONS 1-13,16-21 Rapid-Acting Indication Onset Peak Duration Insulins Admelog (insulin
More informationDynavax Corporate Presentation
Dynavax Corporate Presentation Forward-Looking Statements This presentation contains forward-looking statements, including statements regarding our HEPLISAV-B TM regulatory submissions, product profile,
More informationBEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC)
BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) June 2017 Review: June 2020 (earlier if required see recommendations) Bulletin 255: Insulin aspart New Formulation - Fiasp JPC Recommendations:
More informationDetermined to realize a future in which people with cancer live longer and better than ever before Q Conference Call
Reimagining Cancer Treatment Determined to realize a future in which people with cancer live longer and better than ever before Q1 2016 Conference Call 1 Forward-Looking Statements Disclosure This presentation
More informationFor patients uncontrolled on multiple daily injections of insulin. A quick-start guide for your practice ALL-DAY CONTROL WITH
For patients uncontrolled on multiple daily injections of insulin A quick-start guide for your practice Dosing guidance 1,* V-Go: 3 options 1 For initiating V-Go in patients switching from MDI The majority
More informationADMELOG, NOVOLIN, NOVOLOG, and FIASP
ADMELOG, NOVOLIN, NOVOLOG, and FIASP Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy
More informationInsulin Prior Authorization Criteria For Individuals who Purchased BlueCare / KS Solutions products
Insulin Prior Authorization Criteria For Individuals who Purchased BlueCare / KS Solutions products FDA LABELED INDICATIONS 1-13,16-20 Rapid-Acting Indication Onset Peak Duration Insulins Fiasp (insulin
More informationEmisphere Technologies, Inc. Announces 2008 Second Quarter Financial Results
August 11, 2008 Emisphere Technologies, Inc. Announces 2008 Second Quarter Financial Results Conference Call/Webcast to be Held Monday, August 11 at 10:00 AM EDT CEDAR KNOLLS, N.J., Aug 11, 2008 /PRNewswire-FirstCall
More informationST. JUDE MEDICAL / THORATEC TRANSACTION HIGHLIGHTS July 22, 2015
ST. JUDE MEDICAL / THORATEC TRANSACTION HIGHLIGHTS July 22, 2015 1 FORWARD LOOKING STATEMENT This presentation contains forward-looking statements within the meaning of the Private Securities Litigation
More informationCompany Overview February 26, 2019
Company Overview February 26, 2019 SAFE HARBOR Cautionary Note Regarding Forward-Looking Statements Certain statements in this presentation constitute forward-looking statements, including, without limitation,
More informationHypoglycemia a barrier to normoglycemia Are long acting analogues and pumps the answer to the barrier??
Hypoglycemia a barrier to normoglycemia Are long acting analogues and pumps the answer to the barrier?? Moshe Phillip Institute of Endocrinology and Diabetes National Center of Childhood Diabetes Schneider
More informationSpending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices
Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices Authors: Jean Fuglesten Biniek William Johnson January 2019 Insulin Prices Were the Primary Driver of Rapid
More informationRevolutionizing the Treatment of Cancer
Revolutionizing the Treatment of Cancer March 2014 Safe Harbor Statement The statements that follow (including projections and business trends) are forward-looking statements. Rexahn's actual results may
More informationCOMPANY OVERVIEW. April 26, 2018
COMPANY OVERVIEW April 26, 2018 SAFE HARBOR & NON-GAAP FINANCIAL MEASURES Forward Looking Statements Certain statements in this presentation constitute forward-looking statements, including, without limitation,
More informationResults of Phase III Studies of Sitagliptin, new oral treatment of diabetes, were presented by Merck & Co., Inc. at ADA (The 2 nd Announcement)
June 14, 2006 Ono Pharmaceutical Co., Ltd., Public Relations Tel: +81-6-6263-5670 Banyu Pharmaceutical Co., Ltd., Public Relations Tel: +81-3-6272-1001 Results of Phase III Studies of Sitagliptin, new
More informationADAPTIMMUNE INVESTOR PRESENTATION. August 2016
ADAPTIMMUNE INVESTOR PRESENTATION August 2016 DISCLAIMER This presentation contains forward-looking statements, as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
More informationBuilding a Premier Oncology Biotech
Building a Premier Oncology Biotech August 208 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within
More informationPosition Statement of ADA / EASD 2012
Management of Hyperglycemia in Type2 Diabetes: A Patient- Centered Approach Position Statement of ADA / EASD 2012 Cause of : Type 2 diabetes Cardiovascular disorders Blindness End-stage renal failure Amputations
More informationINSULIN THERAY دکتر رحیم وکیلی استاد غدد ومتابولیسم کودکان دانشگاه علوم پزشکی مشهد
INSULIN THERAY DIABETES1 IN TYPE دکتر رحیم وکیلی استاد غدد ومتابولیسم کودکان دانشگاه علوم پزشکی مشهد Goals of management Manage symptoms Prevent acute and late complications Improve quality of life Avoid
More informationCorporate Presentation. Nasdaq: ORMP July 2015
Corporate Presentation Nasdaq: ORMP July 2015 Safe Harbor Certain statements contained in this material are forward-looking statements. These forward-looking statements are based on the current expectations
More informationCorporate Overview. May 2017 NASDAQ: CYTR
Corporate Overview May 2017 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER MATERIALLY
More informationLantus levemir conversion
Lantus levemir conversion Search Learn about starting insulin-naïve patients with type 2 diabetes on Levemir. Read Important Safety & Prescribing Info on the HCP Website. Lantus and Levemir have a variety
More informationAmylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes
Amylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes Daniel M. Bradbury President & Chief Executive Officer JPMorgan Healthcare Conference January 12, 2009 Safe Harbor Statement
More informationInsulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children
Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children December 2008 This technology summary is based on information available at the time of research and a limited literature
More informationType I Type II Insulin Resistance
Insulin An aqueous hormonal solution made in the pancreas. Affects metabolism by allowing glucose to leave the blood and enter the body cells, preventing hyperglycemia. It is measured in units, e.g. 100
More informationCorporate Overview June 2014 Jefferies Healthcare Conference NASDAQ: GLYC
Corporate Overview June 2014 Jefferies Healthcare Conference NASDAQ: GLYC Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts
More informationNew SEL-212 Phase 2 Data Presented at EULAR. June 15, 2018
New SEL-1 Phase Data Presented at EULAR June 15, 1 Safe Harbor / Disclaimer Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. ( the company
More informationCorporate Overview. February 2018 NASDAQ: CYTR
Corporate Overview February 2018 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER
More informationRevolutionizing the Treatment of Cancer
Revolutionizing the Treatment of Cancer January 2014 Safe Harbor Statement The statements that follow (including projections and business trends) are forward looking statements. Rexahn's actual results
More informationPATENCY-1 Top-Line Results
PATENCY-1 Top-Line Results December 13, 2016 2016 Proteon Therapeutics, Inc. Cautionary Note Regarding Forward-Looking Statements This presentation contains statements that are, or may be deemed to be,
More informationNexus BioPharma, Inc. Opportunity Overview
Nexus BioPharma, Inc Opportunity Overview Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Securities Act of 1933, as amended, the Securities Exchange
More informationEgalet Corporate Presentation
Egalet Corporate Presentation Specialty Pharmaceutical Company Focused on Pain 1 NASDAQ: EGLT Forward-Looking Statements Statements included in this presentation that are not historical in nature are "forward-looking
More informationWhat s New in Type 2 Diabetes? 2018 Diabetes Updates
What s New in Type 2 Diabetes? 2018 Diabetes Updates Gretchen Ray, PharmD, PhC, BCACP, CDE Associate Professor, UNM College of Pharmacy January 28, 2018 gray@salud.unm.edu OBJECTIVES Describe the most
More informationCapricor Therapeutics
Therapeutics Conference Call to Discuss the HOPE-2 Clinical Trial NASDAQ: CAPR November 29, 2017 Forward-Looking Statements Statements in this presentation regarding the efficacy, safety, and intended
More informationSponsor: Sanofi Drug substance(s): SAR342434
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor: Sanofi Drug substance(s):
More informationCompany Update. August 2017
Company Update August 2017 Forward-Looking Statements This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that
More informationAstraZeneca to Acquire Bristol- Myers Squibb Share of Global Diabetes Alliance. Becoming Global Leaders In Diabetes
AstraZeneca to Acquire Bristol- Myers Squibb Share of Global Diabetes Alliance Becoming Global Leaders In Diabetes 19th December 2013 Cautionary Statement Regarding Forward-Looking Statements In order,
More information8/13/2016. Insulin Basics. Rapid-Acting Insulin Analogs. Current Insulin Products and Pens. Basal Insulin Analogs. History of Insulin Therapy
Insulin Basics Anabolic hormone involved in metabolism Following carbohydrate ingestion insulin release is stimulated Suppresses hepatic glucose production Stimulates peripheral glucose uptake Commercially-available
More informationN a s d a q : I N S Y
N a s d a q : I N S Y 0 Safe Harbor Statement This presentation contains both historical information and forward-looking statements. Forward-looking statements are based on management's current expectations
More informationCorporate Presentation Asia Investment Series March 2018
Corporate Presentation Asia Investment Series March 2018 Safe Harbor Statement Factors Affecting Future Performance This presentation contains "forward-looking" statements within the meaning of the United
More informationNovember 2016 NASDAQ: ATRS
November 2016 NASDAQ: ATRS Safe Harbor Statement This presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of
More informationSAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines
SAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines Presented by Dan Browne, Co-Founder, President & CEO, and
More informationDrug Effectiveness Review Project Summary Report Long acting Insulins
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationJefferies Healthcare Conference
Jefferies Healthcare Conference June 7, 2016 NASDAQ: CHMA Forward-Looking Statements These slides contain forward-looking statements and information. The use of words such as may, might, will, should,
More informationCorporate Presentation
Corporate Presentation March 2018 Safe Harbor Statement Factors Affecting Future Performance This presentation contains "forward-looking" statements within the meaning of the United States Private Securities
More informationFor personal use only
ASX: LCT - OTCQX: LVCLY Diabetes Neurodegenerative Diseases Cell Encapsulation Consolidation & Acceleration CEO REPORT AGM 2012 SAFE HARBOR STATEMENT This document contains certain forward-looking statements,
More informationSunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results
Investor and Media Inquiries: David Pitts Argot Partners 212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717 Sunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results SOUTH
More informationInsulin Initiation and Intensification. Disclosure. Objectives
Insulin Initiation and Intensification Neil Skolnik, M.D. Associate Director Family Medicine Residency Program Abington Memorial Hospital Professor of Family and Community Medicine Temple University School
More informationCorporate Presentation January 2013
Corporate Presentation January 2013 0 Forward-Looking Statements Certain statements and information included in this presentation are forwardlooking statements under the Private Securities Litigation Reform
More informationLJPC-401 Phase 1 Results and Development Update. September 7, 2016
LJPC-401 Phase 1 Results and Development Update September 7, 2016 Forward-Looking Statements These slides contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform
More informationMANNKIND CORPORATION (NASDAQGM: MNKD)
UPDATE REPORT Biotechnology Industry July 20, 2010 MANNKIND CORPORATION (NASDAQGM: MNKD) FDA accepts amended NDA for Afrezza and sets PDUFA date of December 29 th. Securing a global marketing partner is
More informationBreathtaking science. Developing respiratory drugs to improve health and quality of life. H.C. Wainwright Global Life Sciences Conference April 2018
Breathtaking science Developing respiratory drugs to improve health and quality of life H.C. Wainwright Global Life Sciences Conference April 2018 www.veronapharma.com Forward-Looking Statements This presentation
More informationA Review of a Family of Ultra-Rapid-Acting Insulins: Formulation Development
Journal of Diabetes Science and Technology Volume 6, Issue 4, July 2012 Diabetes Technology Society SYMPOSIUM A Review of a Family of Ultra-Rapid-Acting Insulins: Formulation Development Alan, M.D., Roderike
More informationJanuary 2017 Investor Presentation. confidently live life with ease
January 2017 Investor Presentation confidently live life with ease Forward-Looking Statements This presentation contains certain forward-looking statements that involve risks and uncertainties that could
More informationmicrorna Therapeutics Harnessing the power of micrornas to target multiple pathways of disease
microrna Therapeutics Harnessing the power of micrornas to target multiple pathways of disease January 2018 Safe Harbor Statement Statements contained in this presentation regarding matters that are not
More informationCorporate Overview. July 2016 NASDAQ: CYTR
Corporate Overview July 2016 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES ASSOCIATED WITH A DEVELOPMENT-STAGE
More informationInvestor Presentation March 2015
Investor Presentation March 2015 1 Safe Harbor Statement This presentation and other matters discussed today or answers that may be given to questions asked include forward-looking statements within the
More informationRevolutionizing the Treatment of Cancer
Revolutionizing the Treatment of Cancer June 2014 Safe Harbor Statement The statements that follow (including projections and business trends) are forward looking statements. Rexahn's actual results may
More informationSER-287 Phase 1b topline study results in patients with mild-to-moderate Ulcerative Colitis October 2, 2017
SER-287 Phase 1b topline study results in patients with mild-to-moderate Ulcerative Colitis October 2, 2017 Leading the Microbiome Revolution Forward Looking Statements Some of the statements in this presentation
More informationCOMPANY OVERVIEW. July 30, 2018
COMPANY OVERVIEW July 30, 2018 SAFE HARBOR & NON-GAAP FINANCIAL MEASURES Forward Looking Statements Certain statements in this presentation constitute forward-looking statements, including, without limitation,
More informationValneva Reports Strong 2017 Revenues Driven by Double Digit Product Sales Growth
Valneva Reports Strong 2017 Revenues Driven by Double Digit Product Sales Growth Strong sales performance in 2017 (unaudited) Total revenues of 109.8 million in 2017 (2016-97.9 million) representing year-on-year
More informationWhat s New in Type 2 Diabetes? 2018 Diabetes Updates
What s New in Type 2 Diabetes? 2018 Diabetes Updates Jessica Conklin, PharmD, PhC, BCACP, CDE, AAHIP Associate Professor, UNM College of Phar macy jeconklin@salud.unm.edu Luis Gonzales, PharmD, PhC UNM
More informationDiabetes in Pregnancy
Diabetes in Pregnancy Ebony Boyce Carter, MD, MPH Division of Maternal Fetal Medicine Washington University School of Medicine Disclosures I have no financial disclosures to report. Objectives Review the
More informationArQule Jefferies Global Healthcare Conference June 2015
ArQule Jefferies Global Healthcare Conference June 2015 1 ArQule Corporate Update Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning
More informationJP Morgan Healthcare Conference. January 8, 2007
JP Morgan Healthcare Conference January 8, 2007 Safe Harbor Statement Except for the historical information set forth herein, the matters set forth in this presentation,including without limitation statements
More informationNYSE AMER: MTNB. MAT9001 OVERVIEW. September 2018
NYSE AMER: MTNB www.matinasbiopharma.com MAT9001 OVERVIEW September 2018 1 Forward Looking Statement This presentation contains "forward-looking statements" within the meaning of the Private Securities
More informationNph insulin conversion to lantus
Nph insulin conversion to lantus Search 26-2-2003 RESPONSE FROM AVENTIS. We appreciate the opportunity to respond to Dr. Grajower s request for information regarding Lantus ( insulin glargine [rdna origin.
More informationSanofi Announces Results of ORIGIN, the World s Longest and Largest Randomised Clinical Trial in Insulin in Pre- and Early Diabetes
PRESS RELEASE Sanofi Announces Results of ORIGIN, the World s Longest and Largest Randomised Clinical Trial in Insulin in Pre- and Early Diabetes Dublin, Ireland (15 June 2012) Sanofi presented results
More informationAcquisition of Novartis Influenza Vaccines Business. 27 th October 2014
1 Acquisition of Novartis Influenza Vaccines Business 27 th October 2014 2 Legal Notice Forward looking statements The materials in this presentation speak only as of the date of these materials, and include
More informationPhase 3c Topline Results. Page 1
Phase 3c Topline Results Page 1 Important Information Any statements in this presentation about future expectations, plans and prospects for the Company including the development and regulatory status
More informationInnovation In Ophthalmology
Innovation In Ophthalmology INVELTYS TM Approval August 2018 Disclaimers and Notices This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform
More informationObsEva Reports Third Quarter 2018 Financial Results and Provides Business Update
ObsEva Reports Third Quarter 2018 Financial Results and Provides Business Update IMPLANT 4 trial of nolasiban in IVF starting in Q4 2018, European MAA filing expected late 2019 24-week data from Phase
More informationSociety for Ambulatory Anesthesia Consensus Statement on Perioperative Blood Glucose Management in Diabetic Patients Undergoing Ambulatory Surgery
Society for Ambulatory Anesthesia Consensus Statement on Perioperative Blood Glucose Management in Diabetic Patients Undergoing Ambulatory Surgery Girish P. Joshi, MB BS, MD, FFARCSI Anesthesia & Analgesia
More information