Icagen Inc has received a milestone payment from McNeil Consumer & Specialty Pharmaceuticals (McNeil) related to the continued development of ICA-17043 for the treatment of sickle cell disease following the Company's recent end-of-Phase II meeting with the US Food and Drug Administration.
In June 2004, the two companies announced that they had entered into an agreement to collaborate on the clinical development and commercialization of ICA-17043, a novel small molecule under development for the chronic treatment of sickle cell anemia and related genetic variants, which are referred to collectively as sickle cell disease. Icagen has recently completed a phase II clinical trial of ICA-17043, which is being developed for once- daily oral administration. ICA-17043 has received both Orphan Drug Designation and Fast Track Status from the FDA, a company release says.
Under the previously announced terms of the agreement, Icagen and McNeil, a Johnson & Johnson company, are jointly developing and will jointly commercialize ICA-17043 in the United States and equally share development expenses and commercial returns. Icagen received an upfront payment and is eligible to receive payments upon the achievement of specified clinical and regulatory milestones. In markets outside the United States, other than Canada where the two companies may also collaborate on development and commercialization at Icagen's option, McNeil will have rights to develop and commercialize the product, with Icagen receiving a royalty based upon any net product sales in those countries.
ICA-17043 represents a novel approach to the treatment of sickle cell disease by targeting a specific ion channel, known as the Gardos channel, located on the membrane of red blood cells. In a recently completed Phase II clinical trial in 90 patients with sickle cell anaemia, ICA-17043 was shown to improve the hemolytic anemia that is characteristic of the disease.