Italian drugmaker Recordati (RECI: MI) has signed a license agreement with Aegerion Pharmaceuticals, a subsidiary of Novelion Therapeutics (Nasdaq: NVLN) for the exclusive rights to commercialize Juxtapid (lomitapide), currently approved for the treatment of homozygous familial hypercholesterolemia (HoFH), in Japan.
The agreement includes a right of first negotiation for product commercialization in Japan of any potential new indications that may be developed by Aegerion.
Under the terms of the agreement, Aegerion will receive a $25 million upfront payment, and an additional $5 million upon transfer of the Juxtapid marketing authorization in Japan to Recordati. Commercial milestone payments of up to an additional $80 million in the aggregate may become payable to Aegerion in prescribed increments, beginning at the end of the first quarter in which cumulative net sales in Japan reach $70 million, and continuing for each increase in cumulative net sales of $70 million thereafter, until cumulative net sales in Japan reach $700 million.
Juxtapid is a microsomal triglyceride transfer protein inhibitor. It was approved, and granted orphan market exclusivity, in September 2016 by Japan’s Ministry of Health, Labor & Welfare (MHLW) for patients with homozygous familial hypercholesterolemia (HoFH). HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C (“bad” cholesterol) from the body. Juxtapid was first approved in the USA in 2013, and then in Europe in 2013.
A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries
“We are very pleased to have entered into this partnership with Aegerion for the Japanese market,” declared Andrea Recordati, chief executive of the Italian firm. “The addition of Juxtapid to our portfolio of rare disease products in Japan is very important for the development of our recently established subsidiary in this country, given its potential for significant growth, and confirms our commitment to address the often unmet medical needs of patients affected by serious rare diseases.”