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8-K - NOVADEL PHARMA INCform8k101609.htm
EX-99 - PRESS RELEASE - NOVADEL PHARMA INCexhibit99-2101609.htm

Safe Harbor Statement

Except for historical information contained herein, this document may contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve
known and unknown risks and uncertainties that may cause the Company’s actual results or outcomes to
be materially different from those anticipated and discussed herein including, but not limited to, the
successful completion of its pilot pharmacokinetic feasibility studies, the ability to develop products
(independently and through collaborative arrangements), the ability to commercialize and obtain FDA and
other regulatory approvals for products under development and the acceptance in the marketplace for oral
spray products. The filing of an NDA with the FDA is an important step in the approval process in the
United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved,
nor does it represent an evaluation of the adequacy of the data submitted. Further, the Company operates
in industries where securities may be volatile and may be influenced by regulatory and other factors
beyond the Company’s control. In addition, our inability to maintain or enter into, and the risks resulting
from our dependence upon, collaboration or contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution of any of our products could materially
impact the Company's actual results. Important factors that the Company believes might cause such
differences are discussed in the risk factors detailed in the Company’s most recent Annual Report on Form
10-K and Registration Statements, filed with the Securities and Exchange Commission. In assessing
forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary
statements contained in such filings. For more detailed information regarding NovaDel’s financial results
and its product pipeline, please review the Company’s SEC filings on Form 10-Q and 10-K at the Investor
Relations section of
www.novadel.com.

2

Investment Highlights

NovaMist™: Proprietary oral spray technology for
systemic delivery

Strong pipeline with multiple products

Products primarily satisfy medical need for faster
onset of action

Targeting large, growing dollar markets

Series of value creating events over the next year

3

Executive Team

Steven B. Ratoff - Chairman, Interim Chief Executive
Officer:

Venture Partner, ProQuest Investments; Director, Torrey Pines Therapeutics;
Former Chairman/Interim CEO, CIMA Labs; Senior VP/CFO Pharma Group,
Bristol-Myers Squibb. B.S. Business Administration, Boston University; M.B.A.
University of Michigan. CPA

David H. Bergstrom, Ph.D.- Chief Operating Officer:

Senior VP/GM, Cardinal Health; Vice President, Guilford Pharmaceuticals.  
Senior management positions: Hoechst Marion Roussel; Hoechst-Roussel
Pharmaceuticals; CIBA-Geigy.  Ph.D. in Pharmaceutics University of Utah;
M.S. in Pharmaceutical Chemistry University of Michigan; B.S. in Pharmacy
Ferris State University

4

Business Strategy

Progress NovaMist pipeline focusing on differentiated
products based on advantages of faster onset of action
and lower potential dose

Minimize development risk and time-to-market by
improving the performance of approved pharmaceutical
products

Maximize value by partnering products once key clinical
milestones are achieved

5

NovaMist™ Pipeline

Product

Indication

Drug

Preclinical

Phase 1

Phase 2/3

NDA

Approved

Status

NitroMist

Angina pectoris

nitroglycerin

Zolpimist

Insomnia

zolpidem

Zensana

Nausea/Vomiting

ondansetron

Zolpimist

Middle-of-the-

Night Awakening

zolpidem

NVD-401

Erectile Dysfunction

sildenafil

NVD-301

Pre-Procedure

Anxiety

midazolam

6

Commercial Environment

Product

Indication

Drug

Market

Size (US)

Existing Products

Future Products

NitroMist

Angina pectoris

nitroglycerin

~ $0.2 B

Nitrolingual™ pumpspray

Generic sublingual tablets

Transdermal patches

Zolpimist

Insomnia

zolpidem

Ambien® /Ambien CR

Generic zolpidem

Lunesta®

Sublinox™

Silenor™

Indiplon MR

> $1.5 B

Zensana

Nausea/Vomiting

ondansetron

Zofran®  Aloxi®  Kytril®

Emend®    Anzemet®

Generic ondansetron

APF530   Aloxi tablet

Sancuso

Generic granisetron

> $1.5 B

Zolpimist

Middle-of-the-

Night Awakening

zolpidem

Intermezzo™

Indiplon IR

est. > $0.5 B

NVD-401

Erectile Dysfunction

sildenafil

Viagra® Levitra®

Cialis®

Generic sildenafil

~ $1.6 B

NVD-301

Pre-Procedure

Anxiety

midazolam

Versed®

Generic midazolam

(intravenous, oral syrup)

est. > $0.5B

Nasal spray

7

NitroMist
(nitroglycerin oral spray)

Nitroglycerin is the leading short-acting nitrate for the
treatment of angina pectoris

Target Label

Relief of acute relief of an attack or acute prophylaxis of angina pectoris
due to coronary artery disease

Target Product Advantages

Ease of use

Little or no waste due to shelf-life

8

Zensana
(ondansetron oral spray)

Active ingredient in Zofran® , the world’s leading 5-HT3
antagonist for CINV/RINV

Target Label

Prevention of nausea and vomiting associated with cancer therapy

Prevention of postoperative nausea and/or vomiting

Target Product Advantages

More reliable dosing/adherence by avoiding loss of dose due to vomiting

No need to take with water

Licensed to Par Pharmaceuticals in the US; BioAlliance
in Europe

9

Zolpimist
(zolpidem tartrate) Oral Spray

Active ingredient in Ambien® /Ambien CR®/Stilnox ®,
the world’s leading hypnotic for treatment of insomnia

Approved by the FDA December 2008

Label

The short-term treatment of insomnia characterized by difficulties with
sleep initiation

Product Advantages

Faster rise in blood levels

No need to take with water

Low-dose clinical program opportunity

10

Zolpimist™- MOTN
(zolpidem tartrate) Oral Spray

Takes advantage of the low-dose program

Target Label

Short-term treatment of middle-of-the night (MOTN) awakenings with an
expectation of 4 hours of sleep

Target Product Advantages

Faster onset of action

Distinct labeling for MOTN

No need to take with water

11

Milestones

12

Summary

NovaMist™: Proprietary oral spray technology for
systemic delivery

Strong pipeline with multiple products

Products primarily satisfy medical need for faster
onset of action

Targeting large, growing dollar markets

Series of value creating events over the next year

13