About EDGAR Online | Login
 
The following is an excerpt from a 8-K SEC Filing, filed by NEW RIVER PHARMACEUTICALS INC on 2/7/2006.
Next Section Next Section Previous Section Previous Section
NEW RIVER PHARMACEUTICALS INC - 8-K - 20060207 - EXHIBIT_99
Exhibit 99.1
Merrill Lynch
Healthcare Conference 2006
RJ Kirk (Chairman and CEO)
Krish Krishnan (CFO/COO)
 
0

 
Forward Looking Statements
This presentation may contain forward-looking statements that
reflect management’s current views as to the Company’s 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 Company’s 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.
 
1

 
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
 
2

 
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
 
3

 
NRP290
 
4

 
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
 
5

 
 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  
 
6

 
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(C max ), ln(AUC last ) and ln(AUC inf ) 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(C max )
was within 80% to 125%. The upper limit of 90% confidence intervals for overall
exposure parameters of hydrocodone based on ln(AUC last ) and ln(AUC inf )
were slightly higher(128.51% and 134.67%). 
n
Intact NRP290 conjugates
No intact NRP290 conjugates observed in systemic circulation in either dose.
 
7

 
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
 
8