Indian firm will develop fixed-dose combination of fenofibrate and atorvastatin through partnerships.
Indian firm Athena Drug Delivery Solutions negotiated an exclusive license to Veloxis Pharmaceuticals’ lipid-lowering drug AtorFen™ in certain emerging markets. AtorFen is a fixed-dose combination of fenofibrate and atorvastatin, which has completed Phase II development in the U.S.
The deal gives Athena rights to manufacture, and in partnership with third parties, develop and commercialize AtorFen in its designated territories. The firm will establish and fund AtorFen manufacturing capabilities in India, and Danish firm Veloxis will transfer its manufacturing technology for the drug to Athena, which the latter will fund. Veloxis will retain 70% of all revenues generated (subject to a minimum royalty rate), along with the right to reclaim major territories where third party distributors haven’t been established by Athena within a certain time interval.
The agreement will allow Veloxis to establish a competitive presence fo AtorFen in emerging markets, comments William Polvino, M.D., Veloxis CEO. “Substantial future growth in the pharmaceutical industry is expected to come from this region where cardiovascular morbidity is on the rise,” he says. “This agreement is part of our strategy to outlicense our cardiovascular portfolio to partners who can realize the full value of these assets.”
Veloxis’ FDA-approved dyslipidemia drug, FenoChol™, is marketed as Fenoglide® and was developed using the firm’s MeltDose® technology. The firm’s lead in-house candidate, LCP-Tacro™, is in Phase III development for the treatment of immunosuppression in kidney and liver transplant patients. Top-line results from a pivotal study in stable kidney transplant patients were announced in June.