Royalty Pharma and Syndax Pharmaceuticals Enter Into $350 Million Royalty Funding Agreement for Niktimvo
Royalty Pharma has entered into a $350 million synthetic royalty funding agreement with Syndax Pharmaceuticals based on U.S. net sales of Niktimvo. Under the agreement, Syndax will receive an upfront payment in exchange for a 13.8% royalty on U.S. net sales, with payments ceasing upon reaching a 2.35x multiple. The funding is expected to support Niktimvo's upcoming launches and development, with Syndax's proforma cash approaching $800 million as of June 30. Niktimvo is positioned as a first-in-class product targeting chronic graft-versus-host disease (GVHD) treatment.
Royalty Pharma ha stipulato un accordo di finanziamento per diritti sulle vendite sintetiche del valore di 350 milioni di dollari con Syndax Pharmaceuticals basato sulle vendite nette negli Stati Uniti di Niktimvo. In base all'accordo, Syndax riceverà un pagamento iniziale in cambio di una royalty del 13,8% sulle vendite nette negli Stati Uniti, con i pagamenti che cesseranno al raggiungimento di un multiplo di 2,35x. Si prevede che il finanziamento sosterrà i prossimi lanci e lo sviluppo di Niktimvo, con il cash proforma di Syndax che si avvicina a 800 milioni di dollari al 30 giugno. Niktimvo è posizionato come un prodotto di prima classe per il trattamento della malattia cronica da trapianto contro l'ospite (GVHD).
Royalty Pharma ha entrado en un acuerdo de financiamiento de regalías sintéticas por 350 millones de dólares con Syndax Pharmaceuticals basado en las ventas netas en EE. UU. de Niktimvo. Según el acuerdo, Syndax recibirá un pago inicial a cambio de una regalía del 13,8% sobre las ventas netas en EE. UU., con los pagos cesando al alcanzar un múltiplo de 2,35x. Se espera que el financiamiento apoye los próximos lanzamientos y el desarrollo de Niktimvo, con el efectivo proforma de Syndax acercándose a 800 millones de dólares al 30 de junio. Niktimvo está posicionado como un producto de primera clase destinado al tratamiento de la enfermedad injerto contra huésped crónica (GVHD).
Royalty Pharma는 350백만 달러 규모의 합성 로열티 자금 조달 계약을 Syndax Pharmaceuticals와 체결했으며, 이는 Niktimvo의 미국 순 매출을 기반으로 합니다. 계약에 따라 Syndax는 미국 순 매출에 대한 13.8% 로열티를 받는 대가로 선불금을 받게 되며, 2.35배에 도달하면 지급이 중단됩니다. 이 자금 조달은 Niktimvo의 향후 출시 및 개발을 지원할 것으로 예상되며, Syndax의 프로포르마 현금은 6월 30일 기준으로 8억 달러에 근접하고 있습니다. Niktimvo는 만성 이식편 대 숙주 질병(GVHD) 치료를 목표로 한 일류 제품으로 자리 잡고 있습니다.
Royalty Pharma a conclu un accord de financement de redevances synthétiques d'un montant de 350 millions de dollars avec Syndax Pharmaceuticals basé sur les ventes nettes aux États-Unis de Niktimvo. En vertu de l'accord, Syndax recevra un paiement initial en échange d'une redevance de 13,8% sur les ventes nettes aux États-Unis, les paiements cessant après avoir atteint un multiple de 2,35x. On s'attend à ce que le financement soutienne les futurs lancements et le développement de Niktimvo, avec une trésorerie pro forma de Syndax approchant 800 millions de dollars au 30 juin. Niktimvo est positionné comme un produit de première classe pour le traitement de la maladie chronique du greffon contre l'hôte (GVHD).
Royalty Pharma hat eine Vereinbarung über synthetische Lizenzgebühren in Höhe von 350 Millionen Dollar mit Syndax Pharmaceuticals abgeschlossen, die auf den Nettoumsätzen in den USA von Niktimvo basiert. Im Rahmen der Vereinbarung erhält Syndax eine Vorauszahlung im Austausch für eine Lizenzgebühr von 13,8% auf die Nettoumsätze in den USA, wobei die Zahlungen eingestellt werden, sobald ein Multiplikator von 2,35x erreicht wird. Die Finanzierung wird voraussichtlich die bevorstehenden Markteinführungen und die Entwicklung von Niktimvo unterstützen, wobei Syndaxs Proforma-Barvermögen zum 30. Juni 800 Millionen Dollar beträgt. Niktimvo ist als Produkt der ersten Klasse für die Behandlung der chronischen Graft-versus-Host-Erkrankung (GVHD) positioniert.
- Secured $350 million upfront funding through royalty agreement
- Expected to achieve profitability with current funding
- Proforma cash position approaching $800 million
- Retains significant profit participation in Niktimvo
- Multi-billion-dollar franchise potential for Niktimvo
- 13.8% royalty obligation on U.S. net sales of Niktimvo
- Funding comes with 2.35x return cap requirement
Insights
This
The transaction strengthens Syndax's balance sheet considerably, bringing their proforma cash position to approximately
Niktimvo (axatilimab-csfr) represents a significant advancement as a first-in-class therapy for chronic graft-versus-host disease (cGVHD). The unmet medical need in this space is substantial, as current treatments often have efficacy or significant side effects. The drug's novel mechanism targeting the CSF-1R pathway positions it uniquely in the treatment landscape.
The multi-billion-dollar market potential assessment appears reasonable given the therapeutic area's characteristics: chronic nature of the condition, competition and high unmet need. The planned expansion into additional indications could further enhance the commercial opportunity, making this a strategically sound investment for Royalty Pharma.
- Proceeds expected to support the upcoming planned launches and fund the continued development of Niktimvo and revumenib
- Expected to fund Syndax through profitability; proforma cash approaching
$800 million as of June 30
NEW YORK and WALTHAM, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that Royalty Pharma has entered into a
“We are excited to partner with Syndax, an innovative oncology company with an exciting pipeline” said Pablo Legorreta, founder and CEO of Royalty Pharma. “Niktimvo is a first-in-class product that has the potential to address the serious and devastating complications associated with chronic GVHD, where there is clear unmet need for additional treatment options. We look forward to Syndax and their partner Incyte launching Niktimvo soon and bringing this important medicine to GVHD patients.”
“We expect this transaction to fund us through profitability, while ensuring that we continue to participate in the profits from Niktimvo and retain the upside of its future growth. With this significant infusion of capital, we are well positioned to successfully launch two first-in-class medicines and expand their opportunity with additional indications,” said Michael A. Metzger, Chief Executive Officer of Syndax. “Royalty Pharma shares our belief that Niktimvo can create significant value as a new treatment option for patients with chronic graft-versus-host disease (GVHD) and recognizes its multi-billion-dollar franchise potential.”
Under the terms of the agreement, Syndax received an upfront payment of
Advisors
Gibson, Dunn & Crutcher LLP and Dechert LLP acted as legal advisors to Royalty Pharma. Goldman Sachs & Co. LLC acted as exclusive financial advisor and Cooley LLP acted as legal advisors to Syndax on the transaction.
About Niktimvo™ (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).
In the U.S., Niktimvo will be co-commercialized by Syndax and Incyte. Incyte has exclusive commercialization rights for Niktimvo outside of the U.S. Syndax anticipates that Niktimvo will be launched in the U.S. no later than early first quarter 2025.
In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.
Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) is underway and a Phase 3 combination trial with steroids is in preparation. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).
Niktimvo is a trademark of Incyte.
All other trademarks are the property of their respective owners.
Important Safety Information
Warnings and Precautions
Infusion-Related Reactions
Niktimvo™ (axatilimab-csfr) can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in
Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to Niktimvo. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue Niktimvo based on severity of the reaction.
Embryo-Fetal Toxicity
Based on its mechanism of action, Niktimvo may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose.
Adverse Reactions
Serious adverse reactions occurred in
The most common (≥
Clinically relevant adverse reactions in <
- Eye disorders: periorbital edema
- Skin and subcutaneous skin disorders: pruritus
- Vascular disorders: hypertension
Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions
Across treatment arms in patients with cGVHD who received Niktimvo in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in
Use in Specific Populations
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of Niktimvo.
Females and Males of Reproductive Potential
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose of Niktimvo.
Dosage and Administration
Dosage Modifications for Adverse Reactions
Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information for more recommendations. Please see the full Prescribing Information for Niktimvo.
About Royalty Pharma plc
Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly - directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta, GSK’s Trelegy, Roche’s Evrysdi, Johnson & Johnson’s Tremfya, Biogen’s Tysabri and Spinraza, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Novartis’ Promacta, Pfizer’s Nurtec ODT and Gilead’s Trodelvy, and 16 development-stage product candidates.
About Syndax
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib, a selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com.
Royalty Pharma Forward-Looking Statements
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Syndax Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the expected use of the upfront payment, including funding of the Company through profitability; the Company’s positioning to launch its products and expand opportunity; expectations of Niktimvo’s billion-dollar franchise potential by creating significant value as a new treatment option for patients with chronic GVHD; timing for commercialization of Niktimvo in the U.S.; and the progress, timing, clinical development and scope of clinical trials. Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Royalty Pharma Investor Relations and Communications
+1 (212) 883-6772
ir@royaltypharma.com
Syndax Contact
Sharon Klahre
+1 (781) 684-9827
sklahre@syndax.com
FAQ
What is the value of the royalty funding agreement between Royalty Pharma (RPRX) and Syndax?
What percentage royalty will Royalty Pharma (RPRX) receive from Niktimvo sales?
What is the return multiple cap for Royalty Pharma's (RPRX) investment in Niktimvo?
What therapeutic area does Niktimvo target under the Royalty Pharma (RPRX) agreement?
