Attached files
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| 8-K - CURRENT REPORT - NOVADEL PHARMA INC | form8k62711.htm |
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 clinical trials, including pilot
pharmacokinetic feasibility studies, the successful completion of its preclinical 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
Quarterly Report on Form 10-Q for the period ended March 31, 2011 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.
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 clinical trials, including pilot
pharmacokinetic feasibility studies, the successful completion of its preclinical 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
Quarterly Report on Form 10-Q for the period ended March 31, 2011 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.
NovaDel Technology
• Patented technology
• Rapid onset
• Improved safety profile
• Ease of use
NovaMist Advantages
NovaDel Opportunity
• Two products, Zolpimist™ and NitroMist®,
launched in Q1, 2011
launched in Q1, 2011
• Duromist™ IND open and development plan
initiated.
initiated.
NovaDel Team
|
Team Member
|
Previous Experience
|
|
Steven Ratoff
Chairman, President &
CEO |
ProQuest Venture Partner;
Axonyx; CIMA Labs; Brown-Forman; Bristol-Myers Squibb |
|
David Bergstrom, PhD
SVP & COO
|
Cardinal Health; Guilford Pharmaceuticals;
Hoechst Marion Roussel; CIBA-Geigy |
|
Craig Johnson
SVP & CFO
|
Ardea Biosciences Board Member;
TorreyPines Therapeutics; MitoKor; Price Waterhouse |
Positioned for Growth
Zolpimist™ & Nitromist®
Zolpimist™
• FDA-approved zolpidem oral spray for the
treatment of insomnia
treatment of insomnia
• Zolpidem is the active ingredient in Ambien®
• Advantage of oral spray version is ease-of-use
• Insomnia market size $1.5 billion
Zolpimist™
Zolpimist™
Nitromist®
• FDA-approved nitroglycerine oral spray for the
treatment of angina
treatment of angina
• Advantage of oral spray version is ease of use
and durable potency
and durable potency
• Current market size $200 million
• Q2 royalties received of approximately
$130,000
$130,000
Nitromist®
Positioned for Growth
Duromist™
Duromist™
• Duromist™ is sildenafil oral spray for the
treatment of erectile dysfunction (ED)
treatment of erectile dysfunction (ED)
• Sildenafil is the active ingredient in Viagra®
• Technology and regulatory pathway is the
same as for our two approved and licensed
products
same as for our two approved and licensed
products
Erectile Dysfunction Market
• Multi-billion dollar market
• Viagra® dominates with half the market
• Viagra® patent expires 2012
• Active generic market anticipated with
innovative products in development for ED
innovative products in development for ED
Viagra® and Duromist™
Viagra® 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
Duromist™ Potential Advantages
• Faster onset of action
• Improved Safety/Side Effect Profile
• No food effect
• Convenience and ease of use
Positioned for Growth
Duromist™
Clinical Program
Duromist™ PK Trial Results
Pharmacokinetics Results
• 20 mg of Duromist ™ is bioequivalent to 25mg Viagra Tablet
with respect to systemic exposure (AUC)
with respect to systemic exposure (AUC)
• Tmax for the 20 mg oral spray dose was equivalent to the 25 mg
Viagra® tablet
Viagra® tablet
• Increased AUC observed with the 20 and 30 mg oral spray doses
compared to the Viagra® tablet is suggestive of transmucosal
absorption
compared to the Viagra® tablet is suggestive of transmucosal
absorption
• Lower rate of metabolite formation with the oral spray
compared to the Viagra® tablet is consistent with transmucosal
absorption
compared to the Viagra® tablet is consistent with transmucosal
absorption
Duromist™ PK Trial Results
Safety and Tolerability Results
• Excellent safety profile and well tolerated
• No evidence of oral irritation
• No serious adverse events reported after
administration of up to 3 sprays of Duromist™
administration of up to 3 sprays of Duromist™
Duromist™ Development Plan
• Completed modification of spray head to
deliver 50mg equivalent in two sprays
deliver 50mg equivalent in two sprays
• Complete PK based clinical trials and file NDA
• 2012 - NDA approval
• Focus development on Duromist 50mg
equivalent dose
equivalent dose
• Continue development of improved product
• Seeking a US/European licensee
Duromist™ Strategy
Financial Snapshot
• Market cap ≈ $7 million
• Shares outstanding ≈ 135 million
• Cash balance estimated at ≥ $0.75 million at
JUNE 30, 2011
JUNE 30, 2011
• Zolpimist™ and Nitromist® launched in the
market
market
• Significant product opportunity in Duromist™
• Duromist development milestones clear and
near term
near term
• Funding required to execute plan
Positioned for Growth
NovaDel Pharma Inc.
Positioned for Growth
NVDL.OB
Duromist™ PK Trial Protocol
Study Design
• Randomized, single dose, four period, four treatment, open-label, crossover
study under fasting conditions
study under fasting conditions
Study Subjects
• Twenty-four healthy male adult subjects
Dosing Regimen
• 1 spray (10 mg sildenafil) after an overnight fast given as a single dose
• 2 sprays (20 mg sildenafil) after an overnight fast given as a single dose
• 3 sprays (30 mg sildenafil) after an overnight fast given as a single dose
• 1 tablet of Viagra® (25 mg sildenafil) with 8 ounces water after an overnight
fast given as a single dose
fast given as a single dose
Pharmacokinetic Sampling
• 0, 5, 10, 15, 20, 30, 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours
post dose
post dose