Michael V. Novinski President and Chief Executive Officer July 29, 2008 Eligen ® B12 – Human Clinical Results.

Slides:



Advertisements
Similar presentations
September Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of With.
Advertisements

Development of Evaluation and Consultation on Bridging Studies: Thailand Experiences Suchart Chongprasert, Ph.D. Investigational New Drug Subdivision Food.
Shareholders Meeting August 22, 2013 CONFIDENTIAL1.
1 FIRST QUARTER 2009 INVESTOR CONFERENCE CALL. 2 Today ’ s Hosts Steve Romano Chairman & Chief Executive Officer Jim Baumgardner President & Chief Operating.
2014 Annual Meeting of Stockholders Dan Moore, President & Chief Executive Officer September 18, 2014.
Q and 2015 Targets investor conference call February 12, 2015 Darren Entwistle, Executive Chair Joe Natale, President and Chief Executive Officer.
Fuel Cell Forum-12 March 2007 Considerations on the purpose, feasibility, and design of incentives for Alternative Energy adoption.
Standard Register Fourth Quarter and Full Year 2007 Conference Call February 22, 2008.
Black Box Corporation 2012 East Coast IDEAS Conference June 5, 2012.
May 6, 2015 Q Corporate Update and Financial Results.
Robert McFarlane EVP & Chief Financial Officer January 20, 2012 CIBC World Markets Whistler Institutional Investor Conference.
FEBRUARY 22, DAVID GALLOWAY Chairman of the Board.
FYQ Investor Call February 18, 2011 Bill Lucia, CEO Walter Hosp, CFO.
1 Value Assessment of Development-Stage Assets Pharmaceutical Products, Medical Devices, and Related Intellectual Property Frank S. Castellana, M.D., Eng.Sc.D.
Commodity Hedging Overview May 10, 2012 The following information is current as of May 10, Memorial Production Partners LP (MEMP) intends to provide.
Grattan Institute / MEI Energy Futures Event Dr Fiona Wild Vice President, Environment and Climate Change 5 March 2015 Newman, Iron Ore.
Black Box Corporation Overview. Black Box Corporation 2 Forward-Looking Statements - Any forward-looking statements contained in this presentation are.
ArTiMist™ Clinical Trial Results By Mr Calvin Ross Sofitel Wentworth Hotel Sydney 14 April 2008 Eastland Medical Systems Ltd.
ASX: LCT - OTCQX: LVCLY ‘Preparing for the Upturn’ SIT, Invercargill 16 July 2009.
May 13, 2009 First Quarter 2009 Earnings Review. Highlights  First quarter 2009 net sales of $46.6 million -- within the Company’s forecasted range 
Medicines Differentiation Analysis Multiple Sclerosis 18 January 2011 Mary Perkins Expected Launch Date: 3/31/2013.
1 CXP Analyst and Investor Meeting Denver – September 2007 Dave Grove – President Furniture Corporate Express US Analyst Meeting Denver – September.
Michael V. Novinski President and Chief Executive Officer May 8, 2008 Annual Shareholder’s Meeting.
Needham 11 th Annual Growth Conference January 6, 2009 NASDAQ: BBOX.
ABLE LABORATORIES, INC.. Safe Harbor Statement Except for historical facts, the statements in this presentation, as well as oral statements or other written.
Title Slide – Option 1. Title Slide – Option 2 Insert Text.
1 Michael V. Novinski President and Chief Executive Officer November 6, 2008 Third Quarter 2008 Earnings Conference Call.
Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.
Week 6- Bioavailability and Bioequivalence
Joint Meeting of Anti-Infective Drugs & Drug Safety and Risk Management Advisory Committees December 14-15, 2006 Ketek  (telithromycin) Regulatory History.
UBS Technology and Services Conference June 8, 2009 NASDAQ : BBOX.
Robert McFarlane EVP & Chief Financial Officer January 7, 2009 Citigroup Annual Global Entertainment, Media and Telecommunications Conference.
Thomas J. McInerney EVP & Chief Financial Officer May 2006.
Bioavailability Dr Mohammad Issa.
2 Disclaimer This powerpoint contains identifying important factors that could cause actual results to differ from the projected results. All statements,
2011 Annual Meeting. Certain statements contained herein are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933.
© Mahindra Satyam 2009 Process Performance Baseline Summary – 2009 H2.
Duchenne Muscular Dystrophy Program Developing utrophin modulator therapies for the potential treatment of all DMD patients.
Using Product Development Information to Address the Bioequivalence Challenges of Highly-variable Drugs Lawrence X. Yu, Ph. D. Director for Science Office.
Recent CAP Clinical Trial Experience Michael T. Flavin, Ph.D. Chief Executive Officer.
Bank of America Merrill Lynch 2014 Media, Communications and Entertainment Conference September 16-17, 2014 John Gossling EVP & Chief Financial Officer.
BMO Capital Markets 15 th Annual Media and Telecom Conference September 9, 2014 Joe Natale President & Chief Executive Officer.
European Patients’ Academy on Therapeutic Innovation The key principles of pharmacology.
1 Pharmacokinetic Information Submitted to Support Valganciclovir Use in Maintenance Therapy for CMV Retinitis Robert O. Kumi, Ph.D. Reviewer, Pharmacokinetics.
BB&T Capital Markets 10 th Annual Commercial & Industrial Investor Conference March 23, 2016.
FOURTH QUARTER AND YEAR END 2012 RESULTS. The following is a Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press.
© 2015 CHS Inc. Getting Real: Navigating today’s world Carl Casale President and CEO March 2016.
Allon Therapeutics Inc. ©2010 Allon Therapeutics Inc. 1 Allon Therapeutics Inc. Corporate Overview ASENT Annual Meeting February 2010.
Fourth Quarter / Full Year Earnings 2008 Kimberly Ross Chief Financial Officer March 2, 2009.
Supertex Acquisition February 10, Supertex Acquisition/February 2014 l Cautionary Statement: Statements about the expected timing, completion,
THIRD QUARTER 2012 RESULTS.  Year-over-year revenue growth of 5.5% to $32.0 million, at the high end range of guidance  Adjusted fully diluted EPS of.
Products, Pipeline and Profitability The Changing Face of ISTA.
FOURTH QUARTER AND FULL YEAR 2013 RESULTS March 13, 2014.
TD Securities Telecom & Media Forum June 15, 2016 Dave Fuller, Executive Vice-President and President, TELUS Consumer and Small Business Solutions.
Omadacycline in Acute Skin and Skin Structure Infections Study (OASIS) A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and.
Morgan Stanley Technology, Media & Telecom Conference
The Stages of a Clinical Trial
Chapter 8 BIOAVAILABILITY & BIOEQUIVALENCE
Prof. Dr. Basavaraj K. Nanjwade
Standard Register First Quarter 2007 Conference Call April 27, 2007.
First Quarter Fiscal Year 2016
Annual Meeting of Stockholders Tuesday, May 22, 2018
Compal Electronics, Inc. 4Q17 Consolidated Financial Results
4th Quarter 2016 Earnings Call
2018 FIRST Quarter Results NASDAQ: fult
2018 THIRd Quarter Results NASDAQ: fult
4Q 2018 Earnings Presentation
2015 Annual Meeting April 30, 2015.
Introduction to Research Methods in Psychology
Propriety Drug Delivery Platform
Presentation transcript:

Michael V. Novinski President and Chief Executive Officer July 29, 2008 Eligen ® B12 – Human Clinical Results

2 Safe Harbor Safe Harbor Statement Regarding Forward-Looking Statements The statements in this presentation and oral statements made by representatives of Emisphere relating to matters that are not historical facts (including without limitation those regarding potential third party collaborations, future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of Such statements involve risks and uncertainties, including, but not limited to, the likelihood that one or more potential third party collaborations may not be consummated, that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of Emisphere and/or its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, or Emisphere's ability to fund such efforts with or without partners. Emisphere undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, filed on March 17, 2008.

Agenda Agenda  Introductory Remarks  B12 and Emisphere  B12 Clinical Data  Expert Commentary  Wrap-up 3

4 Introductory Remarks

Emisphere Objective ®  Commercialize the Eligen ® Technology Use B12 as a possible avenue 5

6 Why B12?  Vitamin B12 is an essential vitamin, but a poorly absorbed molecule/nutrient  For those who are B12 deficient or at-risk, current options are injections (painful ), or megadoses in tablet form (poorly absorbed with high uncertainty)  Currently 5 million people in the United States are taking 40 million injections annually, with 250 million injections estimated worldwide At least an estimated 600 million tablets are purchased annually by an additional 5 million people

B12 Program B12 Program  Animal studies High dose – one species Physiological dose – one species Physiological dose – second species  Human Studies High dose – absorption and rate Lower dose – absorption and rate versus IV and commercial tablet 7

8 Eligen ® B12 – Human Clinical Trial ®  Study conducted in 20 healthy males, with a single administration of Eligen ® B12 – well tolerated with no adverse reactions ®  Eligen ® B12 formulation bypasses normal absorption process ®  Eligen ® B12 formulation demonstrates 240% improvement in bioavailability versus standard oral tablet in healthy males ®  Absorption time with Eligen ® B12 was 30 minutes, versus 6.5 hours for standard oral tablet ®  Eligen ® B12 bioavailability of 5%

9 What Does This Mean?  Reduces uncertainty of megadose oral therapy and oral therapy in general Patients at-risk Individuals concerned about levels of this essential vitamin  Reduce dependence on injections taken by millions Improve compliance More convenient dosage formulation  Highly effective treatment through consistently enhanced bioavailability  Moving away from injections broadens application for oral therapy as a solution or approach to the problems associated with B12 supplementation

10 Eligen ® B12 – Human PK Study  Pharmacokinetic study conducted in 20 healthy male subjects divided into four arms Four patients received 1mg B12 intravenously Four patients received 10mg Eligen ® B12 Six patients received 5mg Eligen ® B12 Six patients received commercially available 5mg B12 tablet  10mg Eligen ® group served essentially as a pilot arm to determine appropriate dose for pharmacokinetic purposes  Following these results, dosage reduced by 50% to a level that is being used in certain commercially available formulations  Expect to be able to reduce dose further based on the data received and the linear relationship between the two Eligen ® groups

11 Eligen ® B12 – Human Clinical Data ®  Mean B12 peak blood levels were more than 10 times higher for the Eligen ® B12 formulation than the 5mg commercial tablet pg/mL and 1239 pg/mL, respectively  Time to reach peak concentration reduced by more than 90%, where mean Tmax was 0.5 hours for the 5mg Eligen ® B12 and 6.8 hours for the commercial 5mg dose  Mean AUC (24h) values were hr* pg/mL for Eligen ® B12 and hr* pg/mL for the commercial 5mg product

12 Eligen ® B12 – Mean PK Data Treatment Cmax (pg/mL) Tmax (hr) AUC 24 (hr* pg/mL) 5 mg B12 Commercial Formulation 1239±4506.8± ± mg B12 Eligen ® Formulation 12847±6613*0.5±0.2*54609±16405* *p<0.05, t-Test

13 Eligen ® B12 – Human Clinical Data

14 Eligen ® B12 – Human Clinical Data

15 Eligen ® B12 – Human Clinical Data

16 Conclusions  Eligen ® significantly enhances B12 delivery in humans  Eligen ® utilized a new mechanism of B12 delivery  B12 animal studies proved highly predictive of the observed human response Next steps  Clinical investigation of Eligen ® B12 pharmacokinetics at lower doses in target populations (Q3/2008)  Clinical investigation of Eligen ® B12 therapeutic efficacy in target populations (Q4/2008) Eligen ® B12 – Clinical Update

17 Eligen ® B12 – Why It’s Important for Patients  This presents a potential paradigm shift in the way we approach B12 deficiency and at-risk people  Emisphere’s carriers reduce the potential uncertainty associated with oral megadoses of B12  New formulation may prevent the substantial number of B12 injections given worldwide  This may be an effective recourse for people who are at-risk of B12 deficiency, are already identified as B12 deficient, and for people who are concerned about this important vitamin

18  Food fortification  Supplementation for those individuals concerned about B12  Supplementation for the at-risk populations  Supplementation for B12 deficient segments Eligen ® B12 – Commercial Application

19  Clinical strategy to support all segments  Regulatory strategy to allow access to all segments NDI GRAS  Evaluate each segment to maximize the potential valuation Eligen ® B12 – Commercial Application

20 Eligen ® B12 – Summary  All research indicates that Eligen ® B12 presents a significant improvement to help approach the problem of B12 supplementation, regardless of level of supplementation that may be required  Emisphere is committed to commercializing Eligen ® B12 as an opportunity for all defined segments  These data only further demonstrate the value of the Eligen ® Technology as a platform to improve the bioavailability for difficult to absorb molecules; including, but not limited to, other essential vitamins and minerals, prescription drug products, and even other possible molecules

21 Q&A