Proceeds expected to support the upcoming
planned launches and fund the continued development of Niktimvo and
revumenib
Expected to fund Company through
profitability; proforma cash approaching $800 million as of June
30
WALTHAM,
Mass. and NEW YORK,
Nov. 4,
2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq:
SNDX) and Royalty Pharma plc (Nasdaq: RPRX) today announced that
Syndax has entered into a $350
million synthetic royalty funding agreement with Royalty
Pharma based on U.S. net sales of Niktimvo™
(axatilimab-csfr).
"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."
"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."
Under the terms of the agreement, Syndax received an upfront
payment of $350 million in exchange for a 13.8% royalty
on U.S. net sales of Niktimvo. Royalty payments
to Royalty Pharma will cease upon reaching a multiple of
2.35x.
Goldman Sachs & Co. LLC acted as exclusive financial advisor
and Cooley LLP acted as legal advisors to Syndax on the
transaction. Gibson, Dunn & Crutcher LLP and Dechert LLP
acted as legal advisors to Royalty Pharma.
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 18% of patients who
received Niktimvo in the clinical trial (AGAVE-201), with Grade 3
or 4 reactions in 1.3%.
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 44% of patients who received Niktimvo (N=79). Serious adverse
reactions in >2 patients included infection (pathogen
unspecified) (14%), viral infection (14%) and respiratory failure
(5.1%). Permanent discontinuation of Niktimvo due to an adverse
reaction occurred in 10% of patients and dose reduction due to
adverse reaction occurred in 8% of patients. Dose interruptions due
to an adverse reaction occurred in 44% of patients. The adverse
reactions leading to dose interruption in >2 patients were viral
infection, infection (pathogen unspecified), bacterial infection,
musculoskeletal pain, and pyrexia.
The most common (≥15%) adverse reactions, including laboratory
abnormalities, were increased aspartate aminotransferase (AST),
infection (pathogen unspecified), increased alanine
aminotransferase (ALT), decreased phosphate, decreased hemoglobin,
viral infection, increased gamma glutamyl transferase (GGT),
musculoskeletal pain, increased lipase, fatigue, increased amylase,
increased calcium, increased creatine phosphokinase (CPK),
increased alkaline phosphatase (ALP), nausea, headache, diarrhea,
cough, bacterial infection, pyrexia, and dyspnea.
Clinically relevant adverse reactions in <10% of patients who
received Niktimvo included:
- 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 26% (13/50) of patients with neutralizing antibodies
(NAb) and in 4% (2/45) of those without NAb.
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 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 or follow the Company on X
(formerly Twitter) and LinkedIn.
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.
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 Forward-Looking Statements
The information set forth herein does not purport to be complete
or to contain all of the information you may desire. Statements
contained herein are made as of the date of this document unless
stated otherwise, and neither the delivery of this document at any
time, nor any sale of securities, shall under any circumstances
create an implication that the information contained herein is
correct as of any time after such date or that information will be
updated or revised to reflect information that subsequently becomes
available or changes occurring after the date hereof.
This document contains statements that constitute
"forward-looking statements" as that term is defined in the
United States Private Securities Litigation Reform Act of
1995, including statements that express the company's opinions,
expectations, beliefs, plans, objectives, assumptions or
projections regarding future events or future results, in contrast
with statements that reflect historical facts. Examples include
discussion of Royalty Pharma's strategies, financing plans, growth
opportunities and market growth. In some cases, you can identify
such forward-looking statements by terminology such as
"anticipate," "intend," "believe," "estimate," "plan," "seek,"
"project," "expect," "may," "will," "would," "could" or "should,"
the negative of these terms or similar expressions. Forward-looking
statements are based on management's current beliefs and
assumptions and on information currently available to the company.
However, these forward-looking statements are not a guarantee of
Royalty Pharma's performance, and you should not place undue
reliance on such statements. Forward-looking statements are subject
to many risks, uncertainties and other variable circumstances, and
other factors. Such risks and uncertainties may cause the
statements to be inaccurate and readers are cautioned not to place
undue reliance on such statements. Many of these risks are outside
of the company's control and could cause its actual results to
differ materially from those it thought would occur. The
forward-looking statements included in this document are made only
as of the date hereof. The company does not undertake, and
specifically declines, any obligation to update any such statements
or to publicly announce the results of any revisions to any such
statements to reflect future events or developments, except as
required by law.
Certain information contained in this document relates to or is
based on studies, publications, surveys and other data obtained
from third-party sources and the company's own internal estimates
and research. While the company believes these third-party sources
to be reliable as of the date of this document, it has not
independently verified, and makes no representation as to the
adequacy, fairness, accuracy or completeness of, any information
obtained from third-party sources. In addition, all of the market
data included in this document involves a number of assumptions and
limitations, and there can be no guarantee as to the accuracy or
reliability of such assumptions. Finally, while the company
believes its own internal research is reliable, such research has
not been verified by any independent source.
For further information, please reference Royalty Pharma's
reports and documents filed with the U.S. Securities and
Exchange Commission ("SEC") by visiting EDGAR on
the SEC's website at www.sec.gov.
Syndax Contact:
Sharon
Klahre
sklahre@syndax.com
Tel 781.684.9827
Royalty Pharma Investor Contacts:
+1 (212) 883-6772
ir@royaltypharma.com
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.
