Harmony Biosciences Secures $200 Million Debt Financing to Advance Pitolisant for Narcolepsy in the U.S.

VCBeat (WeChat ID: vcbeat) has learned that biopharmaceutical company Harmony Biosciences recently announced a $200 million debt financing agreement with CR Group LP. The funding will support the U.S. launch of pitolisant, a treatment for narcolepsy, and provide capital for the company’s continued growth.

This round of financing was solely invested by CR Group LP. It is understood that in 2017, Harmony Biosciences completed a $270 million financing round jointly invested by several renowned institutions, including HBM Healthcare Investments, Fidelity Management & Research Company, and Vivo Capital. This transaction was the largest equity financing deal in the life sciences sector in the Pennsylvania region that year.

Harmony Biosciences is a Pennsylvania-based biopharmaceutical company founded in October 2017, dedicated to providing new treatment options for patients with rare orphan diseases. The company’s primary R&D focus is on central nervous system disorders, and its flagship product is Pitolisant, a medication primarily used to treat narcolepsy.

Narcolepsy is a chronic neurological disorder characterized by symptoms such as excessive daytime sleepiness (EDS), REM sleep behavior disorder, and cataplexy. In the United States, up to 200,000 individuals are affected by narcolepsy. Clinical studies have shown that most patients develop narcolepsy due to the loss of hypocretin, a neuropeptide in the brain that helps maintain stability. Hypocretin (also known as orexin) is widely distributed throughout the central nervous system and plays a role in regulating food intake and energy metabolism, while also performing critical physiological functions such as maintaining the sleep-wake cycle.

Narcolepsy affects men and women equally, with the aforementioned typical symptoms emerging during adolescence or early adulthood; however, it can take up to ten years from onset to final diagnosis. Narcolepsy imposes a heavy burden on patients and their families, impairing their ability to perform daily tasks and significantly reducing their quality of life.

Pitolisant is a drug specifically developed for the treatment of narcolepsy, which received approval from the European Medicines Agency in 2016. As a selective histamine H3 receptor antagonist/inverse agonist, pitolisant enhances the activity of histaminergic neurons in the brain, thereby suppressing symptoms such as cataplexy. The drug is currently marketed only in Europe and has not yet been approved by the U.S. Food and Drug Administration (FDA). If Harmony Biosciences obtains the marketing rights for this drug in the United States, pitolisant will become the only new product available on the U.S. market for the treatment of narcolepsy.

“Although we are a startup, Harmony Biosciences has been dedicated to the research and development of drugs for rare diseases since our inception,” said John C. Jacobs, President and Chief Executive Officer of Harmony Biosciences. “We hope that more investment institutions will support our continued research in this field, so as to provide better treatment options and information resources for patients with rare orphan diseases and for healthcare professionals in hospitals.”

Luke Duster, a partner at CR Group LP, stated, “The pitolisant drug launched by Harmony Biosciences will effectively transform the treatment landscape for narcolepsy in the United States.”

CR Group LP is a healthcare-focused venture capital firm with nearly $4 billion in assets under management. The firm provides growth capital in the form of long-term debt and equity financing to support healthcare startups. Headquartered in Texas, USA, CRG maintains offices in Boulder, New York, and Houston.

(Compiled by Feng Yutong)