X4 Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize Mavorixafor in Europe, Australia, and New Zealand
X4 Pharmaceuticals (XFOR) has entered into an exclusive licensing agreement with Norgine for the commercialization of mavorixafor in Europe, Australia, and New Zealand. The deal includes a €28.5 million upfront payment and potential regulatory and commercial milestone payments of up to €226 million, plus tiered double-digit royalties up to mid-twenties on future net sales.
Mavorixafor, marketed as XOLREMDI® in the US, is an oral, once-daily treatment for WHIM syndrome patients aged 12 and older. X4 is preparing to submit a Marketing Authorization Application to the European Medicines Agency and is conducting a global Phase 3 trial for chronic neutropenia. Under the agreement, X4 will handle manufacturing and supply, while Norgine will manage market access and commercialization in the licensed territories.
X4 Pharmaceuticals (XFOR) ha stipulato un accordo di licenza esclusivo con Norgine per la commercializzazione di mavorixafor in Europa, Australia e Nuova Zelanda. L'accordo include un pagamento iniziale di 28,5 milioni di euro e pagamenti potenziali per traguardi normativi e commerciali fino a 226 milioni di euro, oltre a royalty a doppia cifra a scaglioni fino al venticinque per cento sulle vendite nette future.
Mavorixafor, commercializzato come XOLREMDI® negli Stati Uniti, è un trattamento orale, da assumere una volta al giorno, per pazienti con sindrome WHIM di età pari o superiore a 12 anni. X4 si sta preparando per presentare una Domanda di Autorizzazione al Commercializzazione all'Agenzia Europea dei Medicinali e sta conducendo una sperimentazione globale di Fase 3 per la neutropenia cronica. In base all'accordo, X4 si occuperà della produzione e della fornitura, mentre Norgine gestirà l'accesso al mercato e la commercializzazione nei territori concessi in licenza.
X4 Pharmaceuticals (XFOR) ha firmado un acuerdo de licencia exclusivo con Norgine para la comercialización de mavorixafor en Europa, Australia y Nueva Zelanda. El acuerdo incluye un pago inicial de 28,5 millones de euros y pagos potenciales por hitos regulatorios y comerciales de hasta 226 millones de euros, además de royalties en porcentaje de doble dígito de hasta mediados del veinte sobre las futuras ventas netas.
Mavorixafor, comercializado como XOLREMDI® en Estados Unidos, es un tratamiento oral, que se toma una vez al día, para pacientes con síndrome WHIM mayores de 12 años. X4 se está preparando para presentar una Solicitud de Autorización de Comercialización a la Agencia Europea de Medicamentos y está llevando a cabo un ensayo global de Fase 3 para la neutropenia crónica. Según el acuerdo, X4 se encargará de la fabricación y el suministro, mientras que Norgine gestionará el acceso al mercado y la comercialización en los territorios licenciados.
X4 제약 (XFOR)는 Norgine과 함께 유럽, 호주, 뉴질랜드에서 mavorixafor의 상용화를 위한 독점 라이센스 계약을 체결했습니다. 이 계약은 2,850만 유로의 선불 금액과 최대 2억 2,600만 유로의 규제 및 상업적 이정표 지급 가능성을 포함하고 있으며, 향후 순판매에 대해 중간 20대까지의 2자리수 로열티가 포함됩니다.
mavorixafor는 미국에서 XOLREMDI®로 판매되는 하루에 한 번 복용하는 경구 치료제로 WHIM 증후군 환자 12세 이상의 환자에 사용됩니다. X4는 유럽 의약품청에 마케팅 허가 신청서를 제출할 준비를 하고 있으며, 만성 호중구 감소증에 대한 글로벌 3상 임상을 진행하고 있습니다. 계약에 따라 X4는 제조 및 공급을 담당하고, Norgine은 면허가 부여된 지역에서 시장 접근 및 상용화를 관리합니다.
X4 Pharmaceuticals (XFOR) a conclu un accord de licence exclusif avec Norgine pour la commercialisation de mavorixafor en Europe, en Australie et en Nouvelle-Zélande. L'accord comprend un paiement initial de 28,5 millions d'euros et des paiements potentiels pour des jalons réglementaires et commerciaux pouvant atteindre 226 millions d'euros, ainsi que des redevances à deux chiffres progressives pouvant aller jusqu'à la vingtaine pour les ventes nettes futures.
Mavorixafor, commercialisé sous le nom de XOLREMDI® aux États-Unis, est un traitement oral à prendre une fois par jour pour les patients atteints du syndrome WHIM âgés de 12 ans et plus. X4 se prépare à soumettre une demande d'autorisation de mise sur le marché à l'Agence européenne des médicaments et mène un essai mondial de phase 3 pour la neutropénie chronique. Dans le cadre de l'accord, X4 s'occupera de la fabrication et de l'approvisionnement, tandis que Norgine gérera l'accès au marché et la commercialisation dans les territoires sous licence.
X4 Pharmaceuticals (XFOR) hat einen exklusiven Lizenzvertrag mit Norgine über die Kommerzialisierung von mavorixafor in Europa, Australien und Neuseeland abgeschlossen. Der Deal umfasst eine Vorauszahlung von 28,5 Millionen Euro sowie potenzielle regulatorische und kommerzielle Meilensteinzahlungen von bis zu 226 Millionen Euro und gestaffelte zweistellige Tantiemen von bis zu mittleren zwanzig Prozent auf zukünftige Nettoumsätze.
Mavorixafor, in den USA als XOLREMDI® vermarktet, ist eine orale, einmal täglich einzunehmende Behandlung für Patienten mit WHIM-Syndrom ab 12 Jahren. X4 bereitet sich darauf vor, einen Antrag auf Marktzulassung bei der Europäischen Arzneimittel-Agentur einzureichen, und führt eine globale Phase-3-Studie zur chronischen Neutropenie durch. Im Rahmen des Vertrags übernimmt X4 die Herstellung und Lieferung, während Norgine den Marktzugang und die Kommerzialisierung in den lizenzierten Gebieten verwaltet.
- Secured €28.5 million upfront non-dilutive funding
- Potential for additional €226 million in milestone payments
- Double-digit royalties up to mid-twenties on future sales
- Strategic expansion into European and ANZ markets
- Strengthened balance sheet for Phase 3 trial funding
- None.
Insights
This licensing deal represents a transformative moment for X4 Pharmaceuticals, injecting critical non-dilutive capital of
The strategic value extends beyond immediate capital - Norgine's established European infrastructure provides efficient market access without X4 having to build out costly international operations. The agreement's timing aligns perfectly with their upcoming EMA submission for WHIM syndrome and ongoing Phase 3 trial in chronic neutropenia, providing runway for both programs.
For investors, this validates mavorixafor's commercial potential in key international markets while preserving significant value through the attractive royalty structure. The non-dilutive funding reduces near-term financing risk and supports the broader development program.
Breaking down the territorial scope, this deal covers high-value pharmaceutical markets including the EU5 (Germany, France, UK, Italy, Spain), other European nations, plus Australia and New Zealand. The combined rare disease market in these territories represents a substantial commercial opportunity, with favorable pricing and reimbursement dynamics for orphan drugs.
Norgine's specialty pharma expertise and established relationships with European payers will be important for market access. Their track record in successfully commercializing specialty products suggests strong execution capability for mavorixafor's launch. The partnership structure, maintaining X4's manufacturing role while leveraging Norgine's commercial infrastructure, optimizes the value chain for both parties.
In the rare disease space, WHIM syndrome represents an underserved market with significant unmet need. Mavorixafor's position as potentially the first approved therapy targeting a key disease mechanism creates a compelling value proposition for payers. The chronic neutropenia indication in development could substantially expand the commercial opportunity.
The deal's structure, with substantial milestone payments tied to both regulatory and commercial achievements, aligns incentives for successful market development. The high royalty rates of up to mid-twenties reflect both the asset's strategic value and the partners' shared confidence in its commercial potential. This partnership model is increasingly common in rare disease commercialization, allowing biotech innovators to maintain significant economic interest while leveraging established commercial infrastructure.
X4 to receive a
Upfront non-dilutive funds strengthen X4’s balance sheet as enrollment ramps up in the company’s global Phase 3 clinical trial in chronic neutropenia
Agreement underscores Norgine’s commitment to bring transformative therapies to patients in need in these key strategic territories
BOSTON and UXBRIDGE, United Kingdom, Jan. 13, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, and Norgine, a leading European specialist pharmaceutical company, today announced that they have entered into an exclusive licensing and supply agreement under which Norgine will commercialize mavorixafor in Europe, Australia, and New Zealand following regulatory approvals.
Mavorixafor is a selective CXCR4 receptor antagonist approved in the U.S. and marketed by X4 as XOLREMDI®, an oral, once-daily treatment for patients 12 years of age and older with WHIM syndrome, a rare primary immunodeficiency. X4 expects to announce shortly the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for mavorixafor in the treatment of WHIM syndrome, for which it has been granted Orphan Drug Designation by both the EMA and the U.S. Food and Drug Administration. X4 is also developing mavorixafor to treat chronic neutropenia (CN) and is currently conducting a global, pivotal Phase 3 clinical trial in certain CN disorders.
“This strategic agreement is a significant milestone for X4 as we seek to maximize the global potential of mavorixafor and bring in funding for our ongoing global, Phase 3 trial in chronic neutropenia,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. “We believe Norgine to be the ideal partner due to their impressive infrastructure and successful commercialization track record in specialty pharmaceuticals, as well as a shared focus on putting patients first. We look forward to expanding access to mavorixafor and continuing to address the unmet needs of those with rare immune disorders.”
Janneke van der Kamp, Chief Executive Officer of Norgine, commented on the announcement: “We are very pleased to partner with X4 in this underserved, rare disease space and expand access to mavorixafor to patients in Europe, Australia, and New Zealand. If approved by the respective regulatory bodies, mavorixafor would be the first treatment targeting a key underlying cause of WHIM syndrome, a disease characterized by low white blood cell counts and frequent and/or serious infections. Through this agreement, we continue to expand our innovative portfolio of products and our expertise across rare diseases and specialty markets. This important milestone for our company further underscores Norgine’s position as a partner of choice across Europe and ANZ.”
Under the terms of the license and supply agreement, X4 will receive
About X4 Pharmaceuticals
X4 is delivering progress for patients by developing and commercializing innovative therapies for those with rare diseases of the immune system and significant unmet needs. Leveraging expertise in CXCR4 and immune system biology, X4 has successfully developed mavorixafor, an orally available CXCR4 antagonist that is currently being marketed in the U.S. as XOLREMDI® in its first indication. The company is also evaluating additional uses of mavorixafor and is conducting a global, pivotal Phase 3 clinical trial (4WARD) in people with certain chronic neutropenic disorders. X4 is headquartered in Boston, Massachusetts and operates a research center of excellence in Vienna, Austria. For more information, please visit www.x4pharma.com.
About Norgine
Norgine is a uniquely positioned, specialty pharmaceutical and consumer healthcare company, with more than
Forward Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” or other similar terms or expressions that concern X4's expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, implied or express statements regarding the initiation, timing, progress, and results of X4’s current and future preclinical studies and clinical trials and related preparatory work and the period during which the results of trials will become available, as well as X4’s research and development programs; the timing and anticipated interactions with regulatory authorities and any related approvals for mavorixafor in Europe, Australia, and New Zealand; the potential market opportunity for mavorixafor; the anticipated strategic benefits of X4’s exclusive licensing agreement with Norgine and of any current or future collaborations; and the mission and goals for X4’s business. Any forward-looking statements in this press release are based on management's current expectations and beliefs. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond X4’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: X4 may have difficulty establishing and maintaining an effective sales and marketing organization or suitable third-party alternatives for any approved products; X4 may not be able to obtain or maintain orphan drug designation or exclusivity for X4’s drug candidates, which could limit the potential profitability of X4’s product candidates; X4 may not be able to obtain regulatory approval for, or successfully commercialize, mavorixafor or any other product candidate for other chronic neutropenic disorders or any other potential indication; the expected availability, content, and timing of clinical data from X4's ongoing clinical trials of mavorixafor may be delayed or unavailable, including X4’s ongoing Phase 3 clinical trial; the design and rate of enrollment for clinical trials, including the current design of a Phase 3 clinical trial evaluating mavorixafor in certain chronic neutropenic disorders may not enable successful completion of the trial(s); the commercial opportunity for mavorixafor in chronic neutropenic disorders may be smaller than anticipated; X4 may be unable to obtain and maintain regulatory approvals; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development; the regulatory review and approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if X4 is ultimately unable to obtain regulatory approval for X4’s product candidates, including additional indications for mavorixafor, X4’s business will be substantially harmed; initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials, including assessing the ability of mavorixafor monotherapy to durably increase absolute neutrophil count in patients with chronic neutropenia; adverse safety effects arise from the testing or use of X4’s product and product candidates; the need to align with X4’s collaborators may hamper or delay X4’s development and commercialization efforts or increase X4’s costs; X4’s business may be adversely affected and their costs may increase if any of X4’s key collaborators fails to perform its obligations or terminates the collaboration; the internal and external costs required for X4’s ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause the company to use cash more quickly than expected or to change or curtail some of X4’s plans or both; and other risks and uncertainties, including those described in the section entitled “Risk Factors” in X4’s Quarterly Report on X4’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 13, 2024, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.
X4 Company Contact:
José Juves
Head of Corporate & Patient Affairs
jose.juves@x4pharma.com
X4 Investor Contact:
Daniel Ferry
Managing Director, LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
Norgine Media Contact
Neha Bhimbat
contact@norgine.com
FAQ
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