Rx and OTC Strategy
Focus on a Large Market with Unmet Needs and Low Competition
The Rx cough market is about 27 million prescriptions per year but has had no new NDA approved products in over 20 years. There are significant unmet needs in the Rx market and detailing and other promotion is very low. There are also important consumer needs in the OTC cough market.
Add Value With Useful Products
Our products meet important safety and efficacy issues that are not currently being met in the cough market. Significant, life threatening safety issues have been clearly identified by FDA. Other Rx and OTC cough treatment needs have been identified through consumer and doctor market research. Our products address these important issues in simple but patentable ways.
Avoid Clinical Efficacy Trials
A critical part of our strategy is to avoid clinical efficacy trials that are expensive and risky. Our goal is to bring to market products through 505(b)(2) NDAs so that they can be Orange Book listed with patents. PK trials that use only blood level measurements are far cheaper and have a much lower risk and a much higher chance of success than true clinical efficacy trials. To achieve our goal of PK only trials, we have built on our experience at Adams where all three Mucinex formulations were approved without any clinical efficacy trials.
We have met officially with FDA to discuss our Rx product research program. Because of comprehensive preparation supported with citations from the Code of Federal Regulations, previous NDA approvals and critical articles from the scientific and medical literature, we had a number of highly successful pre-IND meetings. We now have written confirmation from FDA that these products can be approved with pharmacokinetic (PK) trials only and with no clinical, safety or pre-clinical trials required.
Develop A Flexible, Proprietary Platform
It is very important to select a drug delivery platform that provides flexibility for current and future products and that would be difficult to duplicate by a generic company. We have chosen the ion exchange resin (IER) model and added certain proprietary modifications which have lead to patent applications that will protect our products from generic competition for a long period of time.
Create Strong IP
Even the best of products need a chance to grow without direct competition. Meeting this goal requires a portfolio of patents that will create multiple levels of defense around the products.
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