Financing to support the anticipated launch of pitolisant in the U.S. in 2019 and continued company growth
PLYMOUTH MEETING, PA, March 13, 2019 — Harmony Biosciences, LLC (Harmony), a private biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it has entered into a $200 million debt facility with CR Group L.P. (CRG), a premier healthcare-focused investment firm, to provide additional working capital to fuel the company’s continued growth.
“This financing illustrates our confidence in the continued growth of the company and, importantly, in the significant potential of Harmony to bring new treatment options to those who live with rare diseases,” said John C. Jacobs, President and CEO of Harmony. “In addition to our original private equity raises totaling $295 million, the flexibility and strength afforded by this debt facility positions the company extremely well to achieve our future goals and address unmet medical needs, in line with our mission.”
John Vittoria, Harmony CFO added, “We are incredibly proud to have successfully closed on a historic debt facility supported by a premier healthcare-focused investment firm, CRG, who understands our needs and potential.”
On February 12, 2019, the FDA accepted for filing the New Drug Application for Harmony’s investigational product, pitolisant, and granted Priority Review for this NDA. Pitolisant is a first-in-class molecule with a novel mechanism of action; it is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist for the potential treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy.
“CRG is pleased to provide Harmony with flexible financing options as the company prepares to launch its anticipated treatment for narcolepsy in the U.S. and change the treatment landscape within this rare disease category,” said Luke Duster, Partner of CRG. “We look forward to the start of a long-term relationship with Harmony and are pleased to support the company’s financial growth objectives.”
Octagon Capital Group and Katten Muchin Rosenman advised Harmony, and Cooley advised CRG, in connection with this transaction.
Pitolisant is an investigational medication in the U.S. that is not approved by the FDA. It was granted orphan designation for the treatment of narcolepsy, Fast Track designation for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy, and Breakthrough Therapy designation for the treatment of cataplexy in patients with narcolepsy. Pitolisant, a first-in-class medication, is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist; it enhances the activity of histaminergic neurons in the brain that function to improve a patient’s wakefulness and inhibit attacks of cataplexy. It was designed and developed by Bioprojet, who has marketed the product in Europe since its approval by the European Medicines Agency in 2016. Harmony’s goal is to obtain FDA approval to market this new medication in the U.S. in 2019. If approved, pitolisant would represent the first new therapy in the U.S. in over 15 years for the treatment of both EDS and cataplexy in adult patients with narcolepsy.
About Harmony Biosciences, LLC
Harmony Biosciences, LLC, is a private biopharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare and orphan diseases, with an emphasis on central nervous system disorders, starting with patients living with narcolepsy. Harmony is committed to advancing the understanding of narcolepsy and providing information and resources to individuals who live with, and healthcare professionals who treat patients with, this disorder. For more information on Harmony Biosciences, visit www.harmonybiosciences.com.
CRG is a premier healthcare-focused investment firm with nearly $4 billion of assets under management. The firm seeks to commit investments across the healthcare spectrum, including medical devices, biopharmaceuticals, tools & diagnostics, services and information technology. CRG provides growth capital in the form of long-term debt and equity to support innovative, commercial-stage healthcare companies that address significant, unmet medical needs. The firm partners with public and private companies to provide flexible financing solutions and world-class support to achieve exceptional growth objectives with minimal dilution. CRG maintains offices in Boulder, New York, and Houston. For more information, please visit www.crglp.com.
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