Pipeline

Hedrin

Hedrin™ for the Treatment of Head Lice

In February 2008, Manhattan Pharmaceuticals announced that it had entered into a joint venture agreement with Nordic Biotech Advisors ApS (Nordic) to develop and commercialize Hedrin, a novel, convenient, non-insecticide treatment for pediculosis (head lice).  A 50/50 joint venture entity was formed that now owns, will develop, and will secure a commercialization partner for the product in North America.  Manhattan Pharmaceuticals will manage the day-to-day operations of the joint venture entity.  The joint venture entity has been independently funded and will be responsible for all costs associated with the Hedrin project, including any necessary United States ("U.S.") clinical trials, patent costs, and future milestones owed to the original licensor, Thornton & Ross Limited.

Hedrin is a unique, proprietary combination of silicones (dimethicone and cyclomethicone) that acts as a pediculicidal (lice killing) agent by disrupting the osmotic balance within the insect.  Most currently available lice treatments contain chemical insecticide.  Because Hedrin kills lice by smothering, rather than by acting on the central nervous system, the insects cannot build up resistance to the treatment.  Both silicones in Hedrin are used extensively in cosmetics and toiletries.

Hedrin is currently marketed as a device in Western Europe and as a pharmaceutical in the U.K.  In Europe Hedrin achieved sales of $45 million (21% market share) within 12 months of product launch, and is the market leader in the U.K. with $11 million in sales (23% market share).  Manhattan Pharmaceuticals is pursuing Hedrin as a medical device, and has initiated discussions with the FDA's Center for Devices and Radiological Health.

To date Hedrin has been clinically studied in 326 subjects.  In a randomized, controlled equivalence, clinical study conducted in Europe and published in 2005, Hedrin was administered to 253 adult and child subjects.  These study results demonstrated Hedrin’s equivalence compared to the insecticide treatment, phenothrin, another widely-used insecticide lice treatment in the U.K.  According to this study, the Hedrin-treated subjects also experienced significantly less irritation (2%) than those treated with phenothrin (9%).

A new randomized, controlled, assessor-blinded clinical study, published in November 2007, compares Hedrin to malathion liquid, a widely prescribed insecticide head lice treatment in the U.K.  Hedrin was administered to 68 adult and child subjects with head louse infestation. The study results demonstrated Hedrin’s superior efficacy with a cure rate of 70% compared to malathion liquid with 33%.  Study participants also rated Hedrin as less odorous, easier to apply, and easier to wash out than malathion liquid.   In addition, 97% of Hedrin treated subjects stated they would be inclined to use the product again, versus only 31% with malathion.