Pennsylvania

Harmony Biosciences Announces New Data Analysis for WAKIX® at SLEEP 2021 Annual Meeting | Status

Plymouth Meeting, Pennsylvania, June 7, 2021 / PRNewswire / –Harmony Bioscience Holdings (“Harmony”) (Nasdaq: HRMY) to develop and commercialize innovative treatments for patients with rare neurological disorders with unmet medical needs A dedicated pharmaceutical company today announced the following results: Two post-hoc analyzes from the WAKIX® clinical development program will be presented at the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS) known as “SLEEP 2021”.The meeting is effectively held June 10-13..

One of the poster presentations is a new analysis that calculates the number needed to treat (NNT) and the magnitude of the WAKIX effect and shows the magnitude of its clinical effect. The second poster is based on an analysis of atonic seizure data from WAKIX’s clinical development program.

“The analysis presented at this year’s SLEEP conference highlights the strengths of WAKIX’s efficacy data,” said Harmony’s Chief Healthcare Officer. Jeffrey Dino, MD “Analysis emphasizes the clinical relevance of findings by using traditional approaches to presenting efficacy data and understanding the overall clinical benefit using NNT and effect size. Both are included. “

The data presented by Harmony is available in the conference’s ePoster gallery. June 9th-November 30th, And include:

  • Assessment of the clinical benefits of Pitrizant for excessive daytime sleepiness and atonic seizures in adults with narcolepsy (Poster 504). Meskill, G, Davis, C, Zarikransky, D, Driva, M, Schwartz JC, Dino, J.
    • An analysis that evaluated the number and effect size required for treatment with NNT for excessive daytime sleepiness and atonic seizures from a 7-week or 8-week randomized controlled trial of HARMONY-1 and HARMONY-CTP adults. Narcolepsy.
  • Efficacy of Pitrizant in the treatment of adult atonic seizures in narcolepsy (Poster 505). Davis, C, Zarikransky, D, Driva, M, Dino, J, Schwartz, JC.
    • An analysis assessing the frequency of atonic seizures from a 7-week or 8-week randomized controlled trial in adult patients with HARMONY-1 and HARMONY-CTP.

About Wakix® (Pitrisant) Tablets

A leading drug, WAKIX is approved by the US Food and Drug Administration for the treatment of excessive daytime sleepiness or atonic seizures in adult patients with narcolepsy. WAKIX has been available in the US since the fourth quarter of 2019. In 2010, it was designated as an orphan drug for the treatment of narcolepsy, and in 2018, it was designated as a breakthrough therapy for the treatment of atonic seizures. WAKIX is selective histamine 3 (H3) Receptor antagonist / inverse agonist. The mechanism of action of WAKIX is unknown. However, its effectiveness can be mediated by its activity in H.3 This increases the synthesis and release of the arousal-promoting neurotransmitter histamine. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture, and commercialize Pitrisanto in the United States.

Important safety information

WAKIX is contraindicated in patients with known hypersensitivity to the components of pitrisant or the drug, and in patients with severe hepatic dysfunction. WAKIX is extensively metabolized in the liver and exposure to WAKIX is significantly increased in patients with moderate disability.

WAKIX extends the QT interval. Avoid using WAKIX in combination with patients with known QT prolongation or with other drugs known to prolong the QT interval. Patients with a history of cardiac arrhythmias, and may increase the risk of developing Torsades de Pointe or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital arrhythmias Avoid using WAKIX in patients with certain other situations. QT interval.

Patients with liver or kidney damage may be at increased risk of QT prolongation due to high levels of pitrisant. Monitor the increase in QTc in these patients. Dose changes are recommended for patients with moderate hepatic dysfunction and moderate or severe renal dysfunction. WAKIX is not recommended for patients with end-stage renal disease (ESRD).

In a placebo-controlled clinical trial conducted in patients with narcolepsy with or without atonic seizures, the most common side effects of WAKIX (2 times placebo in ≥5%) were insomnia (6%) and nausea (6%). , I was anxious (5%). ). Other side effects that occur more frequently than placebo-treated patients in ≥2% include headache, upper respiratory tract infection, musculoskeletal pain, increased heart rate, illusion, hypersensitivity, abdominal pain, sleep disorders, loss of appetite, weakness attacks, and mouth. Thirsty, and rash.

Narcolepsy is a rare, chronically debilitating neurological disorder that affects approximately 165,000 Americans and affects approximately 165,000 Americans. Rush into awakening. EDS is the inability to wake up and be alert during the day and is a symptomatology seen in all people with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin, a neuropeptide in the brain that supports the stabilization of sleep-wakefulness. The disorder affects men and women equally, with typical symptoms occurring in adolescence or young adulthood. However, it can take up to 10 years to be properly diagnosed.

About Harmony Bioscience

Harmony Biosciences is a pharmaceutical company headquartered in the United States. Plymouth Meeting, Pennsylvania. The company was founded by Paragon Biosciences, LLC with the vision of offering new treatment options to people with rare neurological disorders who have unmet medical needs. For more information on Harmony, please visit their website. www.harmonybiosciences.com..

Statement on future prospects

This press release contains forward-looking statements in the sense of the Private Placement Litigation Reform Act of 1995. All non-historical statements contained in this press release should be considered forward-looking statements, including statements regarding our products. Wakix. These statements are not promises or warranties, but known and unknown risks, uncertainties, and other facts, performance, or outcomes of our company that may differ materially from future outcomes, performances, or outcomes. Includes important factors. Statement including, but not limited to, WAKIX’s commercialization efforts and strategies. If approved, Pitrisanto in additional indications, and the rate and degree of market acceptance and clinical utility of other product candidates that we may develop or acquire if approved Additional indications Our R & D program, including a plan to investigate the therapeutic potential of Pitrisanto in. Ongoing and planned clinical trials. Ability to extend the scope of license agreements with Bioprojet. Favorable insurance coverage and availability of WAKIX refunds. COVID-19 Pandemic Impact; Timing and Ability to Obtain Pitrisanto Regulatory Approval for Other Indications and Other Product Candidates. Our estimates of costs, future revenues, capital requirements, and the need for additional financing; our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives. Our commercialization, marketing, manufacturing capacity and strategy. Significant competition in our industry. The location of our intellectual property; the loss or retirement of key members of management; the failure to execute growth strategies, including delays in planned future growth. Not able to maintain effective internal control. Impact of government laws and regulations. Volatility and fluctuations in the price of our common stock. Large costs and required management time as a result of operating as a public company. The fact that the price of Harmony’s common stock fluctuates and can fluctuate significantly. Considerable cost and required management time as a result of operating as a public company.These and other important factors discussed under the caption “Risk Factors” in the Form 10-K Annual Report submitted to the Securities and Exchange Commission (“SEC”). March 25, 2021, And other submissions to the SEC, may cause actual results to differ materially from those expressed in the forward-looking statements made in this press release. These forward-looking statements represent management estimates as of the date of this press release. We may choose to update such forward-looking statements at some point in the future, but we are obliged to update even if subsequent events change our view. I will not bear it.

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Harmony Biosciences Announces New Data Analysis for WAKIX® at SLEEP 2021 Annual Meeting | Status

Source link Harmony Biosciences Announces New Data Analysis for WAKIX® at SLEEP 2021 Annual Meeting | Status

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