Pharma Focus Asia

Novelion Therapeutics Subsidiary Enters Into Licensing Agreement for JUXTAPID® in Japan

Thursday, February 07, 2019

Novelion Therapeutics Inc., a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare metabolic diseases (“Novelion”), announced that its subsidiary, Aegerion Pharmaceuticals, Inc. (“Aegerion”), has entered into an exclusive licensing agreement with Recordati Rare Diseases Inc. (“Recordati”) for the commercialization of JUXTAPID® (lomitapide) in Japan. The agreement includes exclusive rights in Japan for Recordati to commercialize JUXTAPID for the current approved indication, homozygous familial hypercholesterolemia (HoFH), and Aegerion grants Recordati an exclusive right of first negotiation for product commercialization in Japan of any potential new indications that may be developed by Aegerion.

“The licensing agreement for JUXTAPID in Japan is a positive step forward as we work to improve our near-term liquidity, reduce our operating expenses, and focus our efforts and resources with the goal of completing a comprehensive capital restructuring and creating a sustainable, cash-generating business,” said Ben Harshbarger, interim chief executive officer. “We believe Japan is an important market for JUXTAPID with meaningful potential for growth. Recordati has proven commercial capabilities and we are confident in their ability to deliver JUXTAPID to HoFH patients in need.”

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.

Recordati will also pay Aegerion on a quarterly basis a 22.5% royalty on net sales of JUXTAPID in Japan. Additional details pertaining to the agreement will be included in a Form 8-K to be filed by Novelion with the SEC, which can be accessed through the investor relations section of the Company’s website at https://ir.novelion.com/financial-information/sec-filings.

JUXTAPID was approved 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. 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.

Moelis & Company LLC acted as financial advisor to Aegerion in connection with the transaction.

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024