Exhibit 99.1
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Exhibit 99.1
Merrill Lynch
Healthcare Conference 2006
RJ Kirk (Chairman and CEO)
Krish Krishnan (CFO/COO)
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Forward Looking Statements
This presentation may contain forward-looking statements that
reflect managements current views as to the Companys clinical
trials, regulatory approval process, product development,
research programs and other future events and operations. These
forward-looking statements involve uncertainties and risks that
are detailed in the Companys Annual Report on Form 10-K filed
with the SEC on April 1, 2005, as well as other public filings with
the SEC. Actual results could differ materially from these
forward-looking statements.
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A platform technology yielding
proprietary products that offer significant clinical
advantages with low technical risk and
shorter development pathway, facing timely market
demand, in a favorable regulatory climate.
Investment Thesis
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n
NRP104
New Drug Application (NDA) on NRP104 accepted by the FDA
$50 million milestone payment received from Shire Pharmaceuticals
2 of 3 clinical abuse liability studies completed and met desired objectives
Remaining study is ongoing and will be submitted during the review cycle
n
NRP290
Second Phase I/II study completed
n
NRP388
IND on NRP388 anticipated by end of 2Q 2006
n
NRP409
Preclinical studies to date met desired objectives
IND on NRP409 anticipated by end of 2Q 2006
Pipeline Update
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NRP290
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NRP290
n
A conditionally bioreversible derivative of hydrocodone
n
Potential indications: pain (moderate to moderately severe)
n
Non-clinical studies to date have met their desired objectives
n
Second Phase I/II PK clinical study on NRP290 completed
n
Difficult to recover/extract hydrolyzed hydrocodone based on results to date
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Treatment A Test formulation (NRP290); Dose = 1 x 12 mg solution; 1 x 500 mg
acetaminophen
tablet
Treatment B Test formulation (NRP290); Dose = 1 x 24 mg solution; 2 x 500 mg
acetaminophen
tablet
Treatment C Reference Product (Vicodin®); Dose = 1 x 5/500 mg tablet
Treatment D Reference Product (Vicodin®); Dose = 2 x 5/500 mg tablet
A Single-Dose, 4-Treatment, 4-Period, Crossover Pharmacokinetic Study to
Assess Relative Bioavailability of Two Investigational Formulations of
NRP290 (1 x 12 mg and 1 x 24 mg) solution versus Vicodin® (1 x 5/500 mg
and 2 x 5/500 mg) Tablet in Fasted State Healthy Adult Volunteers.
NRP290: Multi-Dose Study
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NRP290: Second Phase I study
n
Comparing hydrocodone from NRP290 (1x12mg) to Vicodin®(1x5/500mg)
The 90% confidence intervals for peak and overall exposure parameters of
hydrocodone based on ln(Cmax), ln(AUClast) and ln(AUCinf) were within
80% to 125%. Therefore, a single dose of NRP290 12 mg is bioequivalent to
the single dose of Vicodin® 5/500 mg under fasting conditions.
n
Comparing hydrocodone from NRP290 (1x24mg) to Vicodin®(2x5/500mg)
The 90% confidence intervals for peak of hydrocodone based on ln(Cmax)
was within 80% to 125%. The upper limit of 90% confidence intervals for overall
exposure parameters of hydrocodone based on ln(AUClast) and ln(AUCinf)
were slightly higher(128.51% and 134.67%).
n
Intact NRP290 conjugates
No intact NRP290 conjugates observed in systemic circulation in either dose.
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NRP290: Next Steps
n
Finalize Formulation on NRP290 (with and without APAP)
n
Request End-of-Phase 2 meeting with FDA in Q2/Q3 2006 to finalize
efficacy and safety studies and define regulatory strategy
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