EX-99.1 3 a04-1178_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

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[LOGO]

 

Creating Nitric Oxide Enhancing Medicines

 

[GRAPHIC]

 

JP Morgan Healthcare

 

 

Conference

 

January 12, 2004

 

 

 

Michael D. Loberg, Ph.D.

 

 

President and CEO

 

 

 



 

Forward Looking Statement

 

[GRAPHIC]

 

Any remarks that we may make about NitroMed’s future expectations, progress, plans, prospects, and target dates for research, development and clinical trial milestones, regulatory submissions, marketing approvals and product launches constitute forward looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.  Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2003, which is on file with the SEC. The forward looking information provided by NitroMed represents our estimates as of today.  Subsequent events may cause our estimates to change.  We may elect to update our estimates at some point in the future, but specifically disclaim any obligation to do so.

 

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NitroMed Highlights

 

 

 

Leader in Nitric Oxide-based drug development

 

             Near-term commercial opportunity - BiDil®

 

             Active strategic collaborations – [LOGO]  [LOGO]

 

             Transitioning to integrated pharmaceutical company

 



 

NitroMed Update

 

 

 

             Merck and NitroMed advanced lead NO-based COX-2 Inhibitor into Phase I testing;
$5MM milestone payment

 

             Boston Scientific and NitroMed extended NO drug coated stent agreement for 2 more years;
$3MM R&D payment

 

             BiDil® confirmatory clinical trial recruitment on schedule;
expected to conclude in Q3 2004.

 



 

[GRAPHIC]

 

BiDil®

 

(Isosorbide Dinitrate and Hydralazine)

 

 

NO-Enhancing Medicine

 

 

To Treat African Americans with Heart Failure

 



 

BiDil®

 

 

 

To reduce mortality and hospitalizations and improve quality-of-life in African Americans with heart failure

 

Attractive Commercial Potential

             Large, unmet medical need

             First-in-class Nitric Oxide Enhancing therapy

             Pricing flexibility

             Reached by focused sales force

 



 

Significant Unmet Need: CV Mortality

 

 

 

[CHART]

 

U.S. Dept. of Health Statistics, 1998

 



 

Heart Failure In African Americans

 

 

 

 

             African Americans suffer disproportionately

             18% of the disease; 11% of the population

 

             African Americans experience unique etiology

             younger age

             lower incidence of coronary artery disease

             higher incidence of hypertension

 

             Altered response to approved therapies

 

Yancy CW. J Card Fail. 2000;6:183-186.

 



 

CV Market in AAs is Underserved

 

 

 

Vasotec FDA Package Insert

 

“… in controlled clinical trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks”  …. “black patients … have a higher incidence of angioedema compared to non-blacks.”

 

Cozaar FDA Package Insert

 

“… the LIFE study provides no evidence that the benefits of Cozaar … apply to Black patients” … “this finding could not be explained on the basis of differences in the populations other than race.”

 

In 2003 Federal Register, FDA recommended collecting race/ethnicity data in all clinical trials.

 



 

BiDil®:  First In Class HF Medication

 

Neurohormones

Endothelial Nitric Oxide

[GRAPHIC]

 

Heart Failure is Associated with Neurohormonal Excess and Nitric Oxide Insufficiency

 

Neurohormonal Antagonists

Nitric Oxide Enhancers

 

 

Beta Blockers

BiDil; pending approval

 

 

Renin-Angiotensin Antagonists

 

 

 

 

Aldosterone Blockers

 

 

 

 



 

Attractive Commercial Potential

 

             U.S. heart failure market ~$50 billion annually

 

             BiDil market opportunity

~ 0.9 MM diagnosed AA heart failure patients at current Coreg pricing ($3.40/day)

~ $1.1 billion market opportunity

 

             Relatively easy to penetrate

             add-on therapy

             expected to be only drug indicated to improve outcomes in African Americans

             non-price sensitive

             reachable by <200 person sales force

 



 

Extensive BiDil Clinical Data

 

             Two, six-year mortality trials in heart failure patients

             1,446 patients; 395 of which were AA

 

             Medco research analyzed data without regard to race

             received a FDA non-approvable letter in 1997, p<0.06

 

             NitroMed

             analyzed the clinical data by race,

             reviewed the results with the FDA,

             acquired the NDA in 1999, and

             amended and refiled the NDA in 2000

 



 

Survival Benefit in African Americans

 

Non-African Americans

 

[CHART]

 

African Americans

 

[CHART]

 



 

FDA Response

 

“… a single, clearly positive study in a black CHF population would be a basis for approval of BiDil® for the treatment of heart failure in blacks.”

 

“… if the results of the study are convincing this would provide sufficient clinical evidence to support approval of BiDil®.”

 

Robert Temple, M.D., Director Drug Evaluation I

 



 

A-HeFT

African-American Heart Failure Trial

 

A PLACEBO-CONTROLLED TRIAL OF BIDIL® ADDED TO STANDARD THERAPY IN AFRICAN-AMERICAN PATIENTS WITH HEART FAILURE

 



 

A-HeFT Trial Summary

 

             Trial in 1,100 class III/IV AA heart failure patients

 

             BiDil additive to all standard therapies

 

             Combined endpoint of mortality, hospitalization and quality-of-life

 

             DSMB interim analysis on first 313 patients

             No significant adverse reactions

             900 patients required to achieve p<0.048 FDA efficacy target

             1,100 patients required to achieve p<0.02

 

             Currently over 75% enrolled

 



 

BiDil® Coalition

 

[LOGO]

 

[LOGO]

 

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BiDil® - Near Term Commercialization

 

             Attractive commercial potential

             large, unmet medical need

             first-in-class therapy

             pricing flexibility

             reachable by focused sales force

 

             FDA approval dependent on A-HeFT

             large body of NDA data

 

             Approval risk mitigated

             positive A-HeFT interim results

 



 

[LOGO]

 

Our Pipeline
and
Strategic Collaborations

 

 

Making the best medicines better.

 



 

[LOGO]

 

NO-based COX-2 Inhibitors

 

             Exclusive WW research and licensing collaboration

 

             NO-Based COX-2 inhibitors

             improved GI and renal profiles

             extensive NitroMed IP

             $6 Billion market

 

             Lead candidate in Phase I clinical testing

 

             Two milestones and $23 million income in 2003

 

             Potential of up to $350 million in fees and milestones

 

             Traditional pharmaceutical royalties

 



 

[LOGO]

 

NO-Coated Stent

 

             Exclusive research & development license agreement

             extended for additional 2 years in January 2004

             3 products

 

             Nitric Oxide properties used to reduce restenosis

             antiplatelet, antiproliferative and promotes vascular re-endothelializaton

 

             $6.8 billion market in 2006

 

             Extensive NitroMed IP

 

             To date, $5.5 million in fees, R&D funding, and equity

 



 

 

Future Pipeline Candidates

 

 

 

 

 

U.S. Patents

 

 

 

 

 

Issued

 

Pending

 

Cardiovascular

 

 

13

 

5

 

 

Aspirin plus NO-Donor

 

 

 

 

 

 

NO-Enhancing Statins

 

 

 

 

 

 

NO-Enhancing ACE Inhibitors

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pain & Inflammation

 

 

15

 

3

 

 

NO-Enhancing NSAIDs

 

 

 

 

 

 

NO-Enhancing Steroids

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pulmonary

 

 

14

 

1

 

 

NO-Enhancing PDE inhibitors

 

 

 

 

 

 



 

NitroMed Corporate Details

 



 

FINANCIAL GUIDANCE

 

             2003 Year-End Financial Guidance

 

             total R&D Revenue of $12 to $13 MM

             total Operating Expenses of $21 to $24 MM

             Cash & Marketable Securities of $96 to $98 MM

 

             2004 Year-End Financial Guidance

 

             total R&D Revenue of $8 to $10 MM

             total Operating Expenses of $28 to $33 MM

             Cash & Marketable Securities of $66 to $76 MM

 



 

Anticipated Upcoming Milestones

 

BiDil®

 

Interim Safety Assessment

 

Q1 2004

 

 

 

 

 

Close of Recruitment

 

Q3 2004

 

 

 

 

 

Clinical Results

 

Q2 2005

 

 

 

 

 

NDA Supplement Filing

 

Q3 2005

 

 

 

 

 

BiDil Launch

 

Q1 2006

 

 

*Assuming FDA approval


 

 

[LOGO]

 

Phase I Trial Initiated

 

Q4 2003

 

 

 

Product Development

 

Stent Trials

 

ND

 

 

 

 

 

New Pharma Deals

 

ND

 

 



 

Company Highlights

 

               Late stage BiDil opportunity

             large, unsatisfied market

             reduced development risk

             all commercial rights retained

 

             Strong strategic collaborations                     [LOGO]   [LOGO]

             large markets

             market leaders

 

             Inherently lower-risk business model

             leading patent position

             multiple pre-clinical programs

 

             Experienced management team

 



 

NitroMed Management

 

Name

 

Position

 

Previous Affiliation

 

 

 

 

 

Jerry Karabelas, Ph.D.

 

Non-Exec Chairman, Partner Care Capital

 

Novartis

 

 

 

 

 

Michael D. Loberg, Ph.D

 

CEO & President

 

Bristol-Myers Squibb

 

 

 

 

 

Manuel Worcel, M.D.

 

Chief Medical Officer

 

Roussel Hoechst, Ciba

 

 

 

 

 

L. Gordon Letts, Ph.D

 

Senior VP & CSO

 

Boehringer Ingelheim, Merck

 

 

 

 

 

Joseph Grimm, M.B.A.

 

Senior VP & CFO

 

Alpha Beta Tech, Genetics Institute

 



 

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Creating Nitric Oxide-Enhancing Medicines