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New Worldwide Partnership established
Dey, L.P. and Hartington Pharmaceutical have executed a licensing agreement whereby Dey received an exclusive option to develop, pursue regulatory approvals, manufacture and sell a novel drug for the treatment of acute, subacute, recurrent and chronic sinusitis in North America, Australia, New Zealand and Japan.
The licensed drug is derived from Cyclamen europaeum and is commercially available for the treatment of sinusitis in several European countries. Under the terms of option agreement, Dey plans to conduct preliminary clinical and technical studies immediately to gain further scientific insight prior to proceeding with the full development.
This is an exciting opportunity to satisfy an unmet medical need as there are no approved non-antimicrobial sinusitis treatments in U.S. The prevalence of sinusitis in U.S. is quite high and annual healthcare cost associated with it is in excess of $6.0 billion. The addition of such a product to development portfolio will further strengthen R&D pipeline for the branded products.
Growing doubts over the effectiveness of antibiotics in the treatment of Sinusitis. A recent study of adult patients with acute maxillary sinusitis, diagnosed by using clinical and radiographic examinations and treated with amoxicillin (in a dosage of 250 mg three times daily for seven days) or placebo, showed no significant difference in outcomes. Van Buchem FL, Knottnerus JA, Schrijnemaekers V J, Peeters ME, Primary-care-based randomized placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis.
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