Harmony Biosciences Names Adam Zaeske as Chief Commercial Officer to Lead the Next Phase of Commercial Growth as Its Portfolio Expands
Harmony Biosciences (Nasdaq: HRMY) has appointed Adam Zaeske as Executive Vice President and Chief Commercial Officer (CCO), effective March 31, 2025, replacing Jeffrey Dierks who is stepping down for personal reasons.
Zaeske brings 25 years of pharmaceutical industry leadership experience, most recently serving as Head of Central, South, and Eastern Europe at Takeda Pharmaceuticals, where he managed a $2 billion business across 25 countries. At Harmony, he will lead the commercial organization, drive market expansion, and oversee execution across all brands and geographies.
The appointment comes as Harmony builds on the commercial success of WAKIX® (pitolisant) in narcolepsy and prepares to advance its late-stage pipeline assets. The company maintains its 2025 revenue guidance and projects WAKIX to be a $1B plus opportunity in adult narcolepsy alone.
Harmony Biosciences (Nasdaq: HRMY) ha nominato Adam Zaeske come Vicepresidente Esecutivo e Direttore Commerciale (CCO), con effetto dal 31 marzo 2025, sostituendo Jeffrey Dierks che si dimette per motivi personali.
Zaeske porta con sé 25 anni di esperienza nella leadership del settore farmaceutico, avendo recentemente ricoperto il ruolo di Responsabile dell'Europa Centrale, Meridionale e Orientale presso Takeda Pharmaceuticals, dove ha gestito un business da 2 miliardi di dollari in 25 paesi. Presso Harmony, guiderà l'organizzazione commerciale, promuoverà l'espansione del mercato e supervisionerà l'esecuzione in tutti i marchi e le aree geografiche.
La nomina arriva mentre Harmony capitalizza sul successo commerciale di WAKIX® (pitolisant) nella narcolessia e si prepara a far avanzare i suoi asset in fase avanzata. L'azienda mantiene le previsioni di fatturato per il 2025 e prevede che WAKIX rappresenti un'opportunità di oltre 1 miliardo di dollari solo nella narcolessia adulta.
Harmony Biosciences (Nasdaq: HRMY) ha nombrado a Adam Zaeske como Vicepresidente Ejecutivo y Director Comercial (CCO), a partir del 31 de marzo de 2025, reemplazando a Jeffrey Dierks, quien se retira por motivos personales.
Zaeske aporta 25 años de experiencia en liderazgo en la industria farmacéutica, habiendo sido recientemente Jefe de Europa Central, del Sur y del Este en Takeda Pharmaceuticals, donde gestionó un negocio de 2 mil millones de dólares en 25 países. En Harmony, liderará la organización comercial, impulsará la expansión del mercado y supervisará la ejecución en todas las marcas y geografías.
El nombramiento se produce mientras Harmony aprovecha el éxito comercial de WAKIX® (pitolisant) en la narcolepsia y se prepara para avanzar en sus activos en etapas avanzadas. La empresa mantiene su guía de ingresos para 2025 y proyecta que WAKIX será una oportunidad de más de 1 mil millones de dólares solo en narcolepsia adulta.
하모니 바이오사이언스 (Nasdaq: HRMY)는 아담 자에스케를 2025년 3월 31일부로 부사장 겸 최고 상업 책임자(CCO)로 임명하며, 개인적인 사유로 사임하는 제프리 디어크스를 대체합니다.
자에스케는 최근 타케다 제약에서 중앙유럽, 남유럽 및 동유럽 책임자로 25개국에서 20억 달러 규모의 비즈니스를 관리한 25년의 제약 산업 리더십 경험을 보유하고 있습니다. 하모니에서는 상업 조직을 이끌고, 시장 확장을 추진하며, 모든 브랜드와 지역에서 실행을 감독할 것입니다.
이번 임명은 하모니가 WAKIX® (피톨리산)의 기면증 상업적 성공을 바탕으로 후속 단계 파이프라인 자산을 발전시키기 위해 준비하는 가운데 이루어졌습니다. 회사는 2025년 수익 가이던스를 유지하며, WAKIX가 성인 기면증에서만 10억 달러 이상의 기회를 제공할 것으로 예상하고 있습니다.
Harmony Biosciences (Nasdaq: HRMY) a nommé Adam Zaeske au poste de Vice-Président Exécutif et Directeur Commercial (CCO), à compter du 31 mars 2025, remplaçant Jeffrey Dierks qui démissionne pour des raisons personnelles.
Zaeske apporte 25 ans d'expérience en leadership dans l'industrie pharmaceutique, ayant récemment occupé le poste de Responsable de l'Europe Centrale, du Sud et de l'Est chez Takeda Pharmaceuticals, où il a géré une entreprise de 2 milliards de dollars dans 25 pays. Chez Harmony, il dirigera l'organisation commerciale, stimulera l'expansion du marché et supervisera l'exécution à travers toutes les marques et géographies.
Cette nomination intervient alors qu'Harmony capitalise sur le succès commercial de WAKIX® (pitolisant) dans la narcolepsie et se prépare à faire avancer ses actifs en phase avancée. L'entreprise maintient ses prévisions de revenus pour 2025 et prévoit que WAKIX représentera une opportunité de plus de 1 milliard de dollars rien que pour la narcolepsie adulte.
Harmony Biosciences (Nasdaq: HRMY) hat Adam Zaeske zum Executive Vice President und Chief Commercial Officer (CCO) ernannt, mit Wirkung zum 31. März 2025, und ersetzt damit Jeffrey Dierks, der aus persönlichen Gründen zurücktritt.
Zaeske bringt 25 Jahre Führungserfahrung in der Pharmaindustrie mit, zuletzt als Leiter für Zentral-, Süd- und Osteuropa bei Takeda Pharmaceuticals, wo er ein Geschäft von 2 Milliarden Dollar in 25 Ländern leitete. Bei Harmony wird er die kommerzielle Organisation leiten, das Marktwachstum vorantreiben und die Umsetzung in allen Marken und geografischen Regionen überwachen.
Die Ernennung erfolgt, während Harmony auf dem kommerziellen Erfolg von WAKIX® (Pitolisant) in der Narkolepsie aufbaut und sich darauf vorbereitet, seine späten Pipeline-Assets voranzutreiben. Das Unternehmen hält an seiner Umsatzprognose für 2025 fest und erwartet, dass WAKIX allein in der Erwachsenen-Narkolepsie eine Möglichkeit von über 1 Milliarde Dollar darstellt.
- Appointment of experienced executive with proven track record of managing $2B business
- Maintained 2025 revenue guidance
- WAKIX projected to be $1B+ opportunity in adult narcolepsy
- Pipeline includes late-stage assets with global rights
- Current CCO stepping down, creating potential transition risks
Zaeske brings 25 years of global leadership across the pharmaceutical industry, building teams and transforming organizations in both the
“I am very excited to welcome Adam to the team as we build upon the commercial success of WAKIX in narcolepsy and prepare for our next phase of growth,” said Jeffrey M. Dayno, M.D.,
Zaeske most recently served as Head of Central, South, and
“I am impressed by the Harmony team, their clarity of purpose in helping people living with rare neurological diseases, and the success of WAKIX in narcolepsy,” said Zaeske. “I am very excited to be joining the organization at such a pivotal time with the opportunity to expand on that success with the next-generation pitolisant formulations as well as the late-stage products in their robust pipeline as they advance toward commercialization. My experiences in both rare disease and neurology were tremendously rewarding parts of my career, and I look forward to returning to these therapeutic areas and contributing to Harmony’s potential to help many more patients who are living with unmet medical needs.”
Zaeske’s appointment comes as Harmony’s portfolio is poised for significant growth, driven by a catalyst-rich pipeline with late-stage assets that have global rights, and strategic initiatives designed to expand its reach of innovative products to patients around the world.
About WAKIX® (pitolisant) Tablets
WAKIX, a first-in-class medication, is approved by the
Indications and Usage
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.
Important Safety Information
Contraindications
WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment.
Warnings and Precautions
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 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 contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD).
Adverse Reactions
In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥
In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥
Drug Interactions
Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half.
Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by
H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists.
WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment.
Use in Specific Populations
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.
The safety and effectiveness of WAKIX have not been established for treatment of excessive daytime sleepiness in pediatric patients less than 6 years of age with narcolepsy.
The safety and effectiveness of WAKIX have not been established for treatment of cataplexy in pediatric patients with narcolepsy.
WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment.
WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR <60 mL/minute/1.73 m2.
Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers.
Please see the Full Prescribing Information for WAKIX for more information.
To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2024 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe and the significant costs 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2025, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
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Harmony Biosciences Investor Contact:
Brennan Doyle
484-539-9700
bdoyle@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
Source: Harmony Biosciences Holdings, Inc.