On Nov 28, 2007 Manhattan Ph. Inc. announced the publication of POSITIVE clinical results for Hedrin(tm), the company's novel, non-insecticide product candidate for the treatment of head lice. These results appeared in the November issue of PLoS One, a leading international, peer-reviewed journal published by the Public Library of Science (PLoS).
The study findings demonstrate Hedrin's SUPERIOR EFFACY compared to malathion, a widely used insecticide treatment in both Europe and North America. In this randomized, controlled, assessor blinded, parallel group clinical trial, 73 adult and child subjects with active head lice infestations were treated with Hedrin or malathion liquid. Using intent-to-treat analysis, Hedrin achieved a statistically significant cure rate of 70% compared to 33% with malathion liquid. Using the per-protocol analysis Hedrin achieved a highly statistically significant cure rate of 77% compared to 35% with malathion. Additionally, Hedrin treated subjects experienced no irritant reactions, and Hedrin showed clinical equivalence to malathion in its ability to inhibit egg hatching. Overall, investigators and study subjects rated Hedrin as less odorous, easier to apply, and easier to wash out. Further, subjects treated with Hedrin stated they were significantly more inclined to use the product again (97%) versus those using malathion (31%).
"These findings are striking in that the data demonstrate such a dramatic increase in the head lice cure rate of Hedrin as compared to malathion," stated principal investigator, and head lice expert Ian Burgess, PhD, Director of Insect Research and Development Limited. "In addition to being shown to be a significantly more effective treatment alternative, Hedrin also appears to provide patients with key ease-of-use and lifestyle advantages over malathion. In their totality, these findings make a strong argument for Hedrin as a far superior head lice treatment option as compared to malathion."
To date, Hedrin has been clinically studied in 326 subjects and is currently marketed as a device in Western Europe and as a pharmaceutical in the United Kingdom (U.K.). In Europe, Hedrin has been launched in 21 countries and has achieved annual sales through its licensees of approximately $45 million at in-market public prices (which equates to a projected 21% market share), and is the market leader in the U.K. with $11 million in sales (23% market share) and France with a 21% market share. In the United States Manhattan Pharmaceuticals is planning to pursue a development pathway for Hedrin as a medical device, and will initiate that process in the fourth quarter of 2007. The company owns North American rights to Hedrin.
