Rhythm Pharmaceuticals Reacquires Licensing Rights to IMCIVREE® (setmelanotide) in China with Termination of Agreement with RareStone Ltd.
Rhythm Pharmaceuticals (RYTM) has announced the reacquisition of rights to IMCIVREE® (setmelanotide) in China, Hong Kong, and Macau through the termination of its 2021 licensing agreement with RareStone Group The company will repay $6.3 million in cash to RareStone and return all previously acquired RareStone shares without additional consideration.
The reacquisition aligns with Rhythm's strategy to develop setmelanotide and next-generation MC4R agonists globally. The company's global trial of setmelanotide in patients with acquired hypothalamic obesity is progressing as planned, with topline data expected in Q2 2025. The trial is currently being conducted across North America, Europe, and Japan.
Rhythm Pharmaceuticals (RYTM) ha annunciato la riacquisizione dei diritti su IMCIVREE® (setmelanotide) in Cina, Hong Kong e Macao attraverso la risoluzione del suo accordo di licenza del 2021 con RareStone Group. L'azienda rimborserà 6,3 milioni di dollari in contante a RareStone e restituirà tutte le azioni precedentemente acquisite di RareStone senza alcuna ulteriore considerazione.
La riacquisizione è in linea con la strategia di Rhythm di sviluppare setmelanotide e agonisti MC4R di nuova generazione a livello globale. La sperimentazione globale di setmelanotide in pazienti con obesità ipotalamica acquisita sta procedendo come previsto, con i dati preliminari attesi nel secondo trimestre del 2025. La sperimentazione è attualmente in corso in Nord America, Europa e Giappone.
Rhythm Pharmaceuticals (RYTM) ha anunciado la reacquisición de los derechos sobre IMCIVREE® (setmelanotide) en China, Hong Kong y Macao mediante la terminación de su acuerdo de licencia de 2021 con RareStone Group. La empresa reembolsará 6,3 millones de dólares en efectivo a RareStone y devolverá todas las acciones previamente adquiridas de RareStone sin ninguna consideración adicional.
La reacquisición se alinea con la estrategia de Rhythm de desarrollar setmelanotide y agonistas MC4R de próxima generación a nivel global. El ensayo global de setmelanotide en pacientes con obesidad hipotalámica adquirida avanza según lo previsto, con datos preliminares esperados para el segundo trimestre de 2025. El ensayo se está llevando a cabo actualmente en América del Norte, Europa y Japón.
리듬 제약 (RYTM)은 IMCIVREE® (setmelanotide)의 중국, 홍콩 및 마카오에 대한 권리를 RareStone Group과의 2021년 라이선스 계약 종료를 통해 재취득했다고 발표했습니다. 회사는 RareStone에 630만 달러를 현금으로 상환하고, 추가 고려 없이 이전에 취득한 RareStone의 모든 주식을 반환할 것입니다.
이번 재취득은 리듬의 setmelanotide 및 차세대 MC4R 효능제의 글로벌 개발 전략과 일치합니다. 세트멜라노타이드에 대한 글로벌 시험은 획득한 시상하부 비만 환자를 대상으로 계획대로 진행되고 있으며, 2025년 2분기에 주요 데이터가 예상됩니다. 이 시험은 현재 북미, 유럽 및 일본에서 진행되고 있습니다.
Rhythm Pharmaceuticals (RYTM) a annoncé la réacquisition des droits sur IMCIVREE® (setmelanotide) en Chine, à Hong Kong et à Macao, par la résiliation de son accord de licence de 2021 avec RareStone Group. L'entreprise remboursera 6,3 millions de dollars en espèces à RareStone et restituera toutes les actions précédemment acquises de RareStone sans considération supplémentaire.
Cette réacquisition s'inscrit dans la stratégie de Rhythm de développer setmelanotide et des agonistes MC4R de nouvelle génération à l'échelle mondiale. L'essai mondial de setmelanotide chez des patients souffrant d'obésité hypothalamique acquise progresse comme prévu, avec des données préliminaires attendues au deuxième trimestre 2025. L'essai est actuellement mené en Amérique du Nord, en Europe et au Japon.
Rhythm Pharmaceuticals (RYTM) hat die Rückerwerbung der Rechte an IMCIVREE® (setmelanotide) in China, Hongkong und Macau durch die Beendigung des Lizenzvertrags von 2021 mit der RareStone Group bekannt gegeben. Das Unternehmen wird 6,3 Millionen Dollar in bar an RareStone zurückzahlen und alle zuvor erworbenen RareStone-Aktien ohne zusätzliche Gegenleistung zurückgeben.
Die Rückerwerbung steht im Einklang mit der Strategie von Rhythm, setmelanotide und nächste Generation MC4R-Agonisten global zu entwickeln. Die globale Studie zu setmelanotide bei Patienten mit erworbener hypothalamischer Fettleibigkeit verläuft planmäßig, wobei die ersten Daten im 2. Quartal 2025 erwartet werden. Die Studie wird derzeit in Nordamerika, Europa und Japan durchgeführt.
- Complete global control of IMCIVREE franchise after reacquiring China rights
- On track for Q2 2025 topline data readout from global setmelanotide trial
- $6.3 million cash payment required for rights reacquisition
BOSTON, March 20, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it reacquired the rights to IMCIVREE® (setmelanotide) in China, including mainland China, Hong Kong and Macau, as the Company agreed to terminate its 2021 licensing agreement with RareStone Group Ltd.
“Rhythm continues to execute on our strategy of developing setmelanotide and the next generation of MC4R agonists with the goal of making these treatments available to patients from around the world who may benefit,” David Meeker, MD, Chairman, CEO and President of Rhythm, said. “Our global trial of setmelanotide in patients with acquired hypothalamic obesity – which is on track for topline data readout in the second quarter of 2025 – is being conducted in North America, Europe and Japan, and this reacquisition of rights for China, Hong Kong and Macau means Rhythm now owns the global franchise. I want to thank the current management of RareStone for their efforts in reaching a mutually acceptable agreement.”
Under the agreement, Rhythm has agreed to repay
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists LB54640 and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.
Setmelanotide Indication
In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.
Limitations of Use
Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:
- Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
- Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity
Contraindication
Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.
Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥
USE IN SPECIFIC POPULATIONS
Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.
Please see the full Prescribing Information for additional Important Safety Information.
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, without limitation, statements regarding the ability of setmelanotide to treat patients with hypothalamic obesity; the announcement of data from our clinical trials, including our Phase 3 trial evaluating setmelanotide for patients with acquired hypothalamic obesity; our plans and global strategy for commercialization of IMCIVREE, including in China, Hong Kong and Macau; and the timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks, uncertainties and other important factors, including, but not limited, to our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the ability to achieve necessary regulatory approvals, risks associated with data analysis and reporting, failure to identify and develop additional product candidates, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, the impact of competition, risks relating to product liability lawsuits, inability to maintain collaborations, or the failure of these collaborations, our reliance on third parties, risks relating to intellectual property, our ability to hire and retain necessary personnel, general economic conditions, risks related to internal control over financial reporting, and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.
Corporate Contact:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com
Media Contact:
Sheryl Seapy
Real Chemistry
(949) 903-4750
sseapy@realchemistry.com
FAQ
What territories did Rhythm Pharmaceuticals (RYTM) reacquire rights for IMCIVREE in March 2025?
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