Summary of Accomplishments
I. Completed Six FDA pre-IND Meetings
1. All six meetings had the same conclusions concerning our Rx products
a. No clinical efficacy trials needed, PK trials only
b. No pre-clinical work needed
c. No safety studies needed
d. The drugs can be approved through 505(b)(2)s
II. Proprietary Drug Delivery System Supported by Patent Applications
1. A series of applications filed for solid oral dosage forms of ion exchange resins
III. Established Complete Supply Chain
1. Formulators
2. Analytic lab
3. DEA certified commercial manufacturer
IV. Comprehensive Market Analysis
1. Over 1,500 patient responses reveal important unmet needs
2. Qualitative research with GPs/FPs/IMs strongly supportive
3. Scientific panel of experts support product concepts
4. Deciling data shows highly concentrated prescriber base
V. Rx Sales Force Design
1. Professional design of sale force by Innovex
2. Highly targeted strategy
3. Can start with 60 reps
VI. Pricing Analysis
1. Case studies of similar products suggests 2nd/3rd tier status
2. Price about $75/Rx
3. Qualitative interviews with formulary directors suggest $75 price
VII. Rx-to-OTC Switch
1. Three patent applications around the switch
2. Sales estimates in the $200+ range
3. Fills an important need in the respiratory space
VIII. Management Team
1. CEO formerly SR VP New Products/Biz Dev at Adams Respiratory
2. Sr. VP Regulatory formerly VP Regulatory with Adams Respiratory
3. Sr. VP Product Development a Novartis/Ciba Geigy veteran
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