Focus on Rx and OTC Cough/Cold Products
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.
It is our core belief that the prescription cough market is large and underserved with significant opportunities for new products, particularly those products with patent protection.
As the figure below shows, there were approximately 26 million patient visits for cough in 2007. IMS Health™ data shows that approximately 25 million cough medicine prescriptions are filled annually, so the ratio of visits to prescriptions is high.
Physician Visits by Indication
FDA Has Recently Increased the Opportunity
The FDA has significantly increased the market opportunity for prescription cough products over the past few years. This process started in 2007 when the FDA ordered the withdrawal from the market of over 400 unapproved cough products. In 2011, FDA followed up by ordering an additional 500 unapproved prescription cough products off the market.
In total, FDA has removed more than 1,000 unapproved cough products from the market. This has created a massive hole in the Rx cough market. The cough market is ripe for new FDA-approved prescription cough products.
Cough Co’s development strategy emphasizes speed, low research & development costs, and efficient regulatory and marketing strategies. Cough Co has had 6 pre-IND meetings with the FDA. These meetings can be used to gain valuable insights into FDA’s view of the proposed development path. As a result of these meetings, Cough Co can develop its products using the 505(b)(2) route. No clinical efficacy trials and no safety or pre-clinical studies are required. Instead, Cough Co will conduct pharmacokinetic studies (PK). The Company has written correspondence from the FDA supporting these points.
Most currently available products are liquid formulations dosed four times a day. We are developing oral-solid twice-daily formulations with an estimated sales potential of between $50 million and $75 million annually per product.
Summary of Cough Opportunity
- Cough is a 25 million Rx/year market
- More than 1,000 unapproved products recently removed from cough market by FDA
- At $60/Rx, cough is a $1.5 billion annual market
- Currently very little promotion in the market