Attached files
file | filename |
---|---|
8-K - NOVADEL PHARMA INC | c59957_8k.htm |
Exhibit 99.1
NovaDel Pharma Inc.
Positioned for Growth
NVDL.OB
Forward Looking Statement
Except for historical information contained herein, this presentation 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 ability of third parties to
commercialize
the Company's products, the successful completion of its pilot pharmacokinetic feasibility studies,
the ability to develop products (independently and through collaborative arrangements), the Company's ability to
obtain additional required financing
to fund its research programs, 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 2009 financial results and its product pipeline, please review
the Company's SEC filings on Form 10-Q at the Investor Relations section of www.novadel.com.
NovaDel Oral Spray Drugs
Positioned for Growth
Two product launches in 2010
NitroMist®
Zolpimist
Substantial near-term opportunity with
Duromist
Oral spray Sildenafil citrate for erectile
dysfunction (active ingredient in Viagra®)
Additional products based on proven
technology
NitroMist® for Angina
FDA-approved nitroglycerine oral spray for the
treatment of angina
Advantage compared to tablet formulation
nitroglycerine is ease of use and durable
potency
Licensed to Mist/Akrimax
Launch planned for second half of 2010
Current market size $200 million
ZolpiMist
FDA-approved proprietary zolpidem tartrate
oral spray for the treatment of insomnia
Active ingredient in multiple approved
treatments for insomnia including Ambien®
Advantage of oral spray version is ease-of-use
Licensed to HiTech Pharmacal
Launch planned for second half of 2010
Insomnia market size $1.5 billion
2010: A Year of Milestones
Launch of Nitromist® and ZolpiMist through
commercial partners
Royalties to NovaDel begin
Initiating pivotal studies for our next
candidate, Duromist
Same technology and regulatory pathway as our
two approved products
Pivotal data on Duromist before year end
Duromist
Sildenafil citrate oral spray for the treatment
of erectile dysfunction (ED)
Active ingredient in Viagra®
Development plan initiated
Product launched when Viagra® patent
protection ends
NovaDel will participate in commercialization
Erectile Dysfunction Market
$4 billion U.S. market
Viagra dominates with $2 billion
Viagra patent expires Q2 2012
Active generic market anticipated with
innovative products in development for ED
Duromist is ideally positioned through ease
of administration and potential label
differentiation
Duromist Development Advantages
Rapid and cost-efficient regulatory pathway
for Viagra label
Concurrent pathway for potential faster onset
label
Allows product launch upon patent expiration
Duromist Development Timeline
2010
Q2 formulation and pilot PK trial completed
Q4 pivotal PK trial completed
Q4 Initiate faster onset efficacy trial
2011
Q1 NDA submission for bioequivalence to Viagra®
Q2 faster onset efficacy trial completed
Q3 NDA submission for faster onset label
2012
Q1 NDA approval for bioequivalence to Viagra®
Q2 NDA approval for faster onset label
Q2 Launch
Commercialization:
Sildenafil Key Attributes
Improves important personal activity
Widespread consumer and cultural awareness
Extensive use
Well defined, favorable safety and side effect
profile
Wide dosing range enables dosing titration
Commercialization:
Duromist Innovative Opportunity
Potential to utilize non-personal selling tools to
access market
Internet tools provide product access through direct
doctor-patient consult
Patient education requirements are vastly reduced
due to extensive direct-to-consumer (DTC)
advertising
Other DTC trial tools available i.e., coupons to reduce
patient co-pay costs
Lower marketing and sales costs
Positioned for Growth
Virtual business model for cash efficiency and
focus on product development
Development milestones and product
royalties from licensing to begin in 2010
Clean balance sheet
Cash sufficient to reach proof of concept for
Duromist
NovaDel Investment Thesis
Two product launches with revenues
beginning 2010
Proven technology de-risks future product
development
Significant opportunity in Duromist with
2010 milestones
Product pipeline of attractive candidates
NovaDel Pharma Inc.
Positioned for Growth