CASE STUDY

In less than three years,
Harmony Biosciences, launched by Paragon Biosciences and its founder and CEO Jeff Aronin:

  • Received U.S. Food & Drug Administration (FDA) approval for its first-in-class medication to treat adults living with narcolepsy;

  • Closed an upsized initial public offering (IPO); and

  • Grew to employ more than 150 people.

This seemingly extraordinary journey of accelerated innovation is exactly what Paragon Biosciences was built to do—we raise visionary companies.

In October 2017, Harmony Biosciences was formed to seek U.S. FDA approval and launch the drug pitolisant (WAKIX®). Seven months later, after assembling talent with decades of drug development experience in clinical, regulatory, manufacturing and commercial expertise, Harmony received FDA Breakthrough Therapy and Fast Track designations for its investigational drug, pitolisant.

Realizing early on that space was paramount to success, renovations to a nearly 16,000 square-foot leased headquarters in Plymouth Meeting, PA was underway and completed in September 2018.

All this in under a year.

From private to public in under three years.

From private to public in under three years.

Slide October 2017 Harmony Biosciences was formed to seek U.S. FDA approval and launch the drug pitolisant (WAKIX). September 2018 Renovations to a nearly 16,000
square-foot leased headquarters in Plymouth Meeting, PA was completed.
February 2019 The FDA accepted Harmony’s New Drug Application (NDA) filing for pitolisant and granted it Priority Review, paving the way for its approval by the end of the year. As part of its unique model, Paragon worked closely with the Harmony team on the regulatory submission to achieve this milestone. August 2019 22 months after formation, Harmony received FDA approval for WAKIX, a first-in-class medication for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration. November 2019 WAKIX became commercially available. August 2020 Harmony closed its upsized initial public offering, raising $150 million with a market cap over $2.5 billion. October 2020 The FDA granted WAKIX an expanded indication for the treatment of cataplexy in adult patients with narcolepsy.
Harmony’s vision of developing and commercializing novel treatment options for people living with rare, neurological diseases is realized, though its work is unceasing.

Looking for more opportunities to help those impacted by rare neurological diseases, Harmony announced the closing of its upsized initial public offering in August 2020, raising $150 million with a market cap over $2.5 billion. Its cash position from the IPO provided Harmony with the financial resources to continue to support its commercialization efforts, advance its clinical programs and pursue the acquisition of additional assets complementary to its commercial footprint and core areas of expertise.

Harmony’s work continued with the FDA granting WAKIX an expanded indication for the treatment of cataplexy in adult patients with narcolepsy in October 2020. Recently, the company has begun clinical trials to treat excessive daytime sleepiness in people living with Prader-Willi Syndrome and myotonic dystrophy.

Harmony’s success is just one example of the work being done at Paragon. We have a vision, proven process and skilled team that make innovation happen. Our success is not by chance or luck. We are uniquely equipped to transform the imaginable into tangible.

Important Safety Information

WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation and in patients with severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment. WAKIX prolongs the QT interval. Avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use of WAKIX in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is not recommended in patients with end-stage renal disease (ESRD).In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. Please see the Full Prescribing Information for WAKIX for more information.