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

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Wednesday, February 06, 2019

VANCOUVER, British Columbia - Novelion Therapeutics Inc. (NASDAQ:NVLN), 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.

About Novelion Therapeutics
Novelion, through Aegerion, is a global biopharmaceutical company dedicated to developing and commercializing therapies that deliver new standards of care for people living with rare and underserved metabolic diseases. Our goal is to develop and bring to market transformational therapies that have the potential to significantly change the treatment paradigm for patients affected by a variety of rare and metabolic diseases, including diseases associated with low leptin, such as low-leptin associated obesity. With a global footprint and an established commercial portfolio, including MYALEPT® (metreleptin) and JUXTAPID® (lomitapide), our business is supported by differentiated treatments that treat severe and rare diseases.

Novelion is the parent company of Aegerion, our operating subsidiary. References to "we," "our" and the "Company" refer to the entire enterprise, whose assets and operations reside at Aegerion.

U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION
JUXTAPID® (lomitapide) capsules is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). LIMITATIONS OF USE: The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.

JUXTAPID can cause elevations in transaminases, as well as increases in hepatic fat, with or without concomitant increases in transaminases. Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted distribution program called the JUXTAPID REMS PROGRAM. For more detailed information, please see additional Important Safety Information and the Prescribing Information for JUXTAPID.


Contact:

Amanda Murphy, Director
Investor Relations & Corporate Communications
Novelion Therapeutics
857-242-5024
amanda.murphy@novelion.com

Source: Novelion Therapeutics
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