Lev Pharmaceuticals, Inc has entered into multi-year agreements with CuraScript, CVS Caremark, and FFF Enterprises to serve as its specialty pharmacy, specialty distribution and patient services partners to support the US commercialization of Cinryze (C1 inhibitor, (human)), the company's investigational treatment for hereditary angioedema (HAE), also known as C1 inhibitor deficiency.
Lev also announced plans to launch LevCare, a programme designed to ensure that patients have ready access to Cinryze once it becomes commercially available in the US is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein.
On May 2, 2008, US Food and Drug Administration's (FDA) Blood Products Advisory Committee voted unanimously that there is sufficient evidence of safety and efficacy to support the approval of Cinryze for the prophylactic treatment of HAE. Cinryze is currently under review by the FDA.
"By employing a 'limited distribution model' through the comprehensive, coordinated and integrated services of CuraScript, CVS Caremark, FFF Enterprises and LevCare, we will be well positioned to provide patients with broad access to Cinryze pending FDA approval," said Judson Cooper, Lev's chairman. "We believe this proven specialty pharmaceutical model will facilitate favourable reimbursement coverage for and rapid uptake of Cinryze upon commercialization".
CuraScript and CVS Caremark will provide specialty pharmacy and specialty distribution services that deliver Cinryze directly to patients, clinics and physicians. FFF Enterprises will serve as Lev's 3PL (Third Party Logistics) provider and specialty distributor to supply Cinryze to hospitals, clinics and physicians. LevCare, which will be administered by TheraCom, a division of CVS Caremark, will provide support services to patients and physicians, such as benefit coverage investigations, prior authorizations, case management and broad-based reimbursement assistance.
HAE is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unrestricted, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients.
CuraScript, Inc. is a wholly owned subsidiary of Express Scripts, Inc., one of the nation's largest Pharmacy Benefit Managers (PBM's).