Opportunity
Ophthalmologists’ interest in a pharmaceutical treatment for dry AMD is high as evidenced by the following quotes excerpted from interviews performed with over a dozen ophthalmologists.
Pharmaceutical Industry Dilemma
In the next several years, the pharmaceutical industry will see many patents for existing drugs expire. The FDA reported generic drug applications grew from 307 in 2001, to a record 766 in 2005. Industry analysts forecast that almost $100 billion worth of brand name drugs will lose patent exclusivity during the next five years, creating a growing concern among pharmaceutical company executives who are focused on maintaining robust growth and shareholder value.
In order to remain competitive and continue generating revenue, pharmaceutical companies will need to pursue strategies that offset the sales decline resulting from patent expiration. Filling both near-term and longer-term development pipelines and launching new products will be key to remaining competitive. MacuCLEAR offers a significant near-term solution with "blockbuster" (annual sales greater than $5 billion) potential, a very attractive proposal for companies eager to offset near-term patent expirations and the intense pressure to replenish these product sales.
Growth Strategy
Given the severity of AMD and the devastating outcomes of significant vision loss and possible blindness, it is clear the market would benefit from a convenient-to-use drug to stop the progression of this debilitating disease. The growing trend in healthcare toward greater access to treatments focusing on disease prevention works in our favor, especially one with 505 (b) 2, and Fast Track status; a logical approach to preventing progression of AMD...and a relatively short time to market.
MacuCLEAR's focus will be to license MC-1101 in each major prescription drug market to a pharmaceutical company with an established ophthalmic drug franchise in the targeted market. MacuCLEAR's partner will be responsible for final drug approval, commercialization and associated pricing, promotion, and product distribution.