CRANFORD, N.J., Jan. 7, 2025
/PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or
the "Company") (Nasdaq: CTXR) and its oncology-focused subsidiary,
Citius Oncology (Nasdaq: CTOR), today announced significant
progress in preparations for the commercial launch of LYMPHIR™, an
innovative immunotherapy for the treatment of adults with relapsed
or refractory cutaneous T-cell lymphoma (CTCL). Management is
focused on making LYMPHIR available to patients as quickly as
possible, with preparations underway for launch in the first half
of 2025.
"Since LYMPHIR's approval in August
2024, we have worked diligently toward supporting its
successful launch. We are making significant progress to finalize
our manufacturing, marketing, reimbursement and sales efforts. This
is a pivotal inflection point as we transition from clinical
development to revenue generation. Our strategy not only focuses on
a successful U.S. market penetration, but also includes exploring
additional growth opportunities, including licensing partnerships
in key international markets, for which discussions are underway,
expanded indications for LYMPHIR, in addition to LYMPHIR's
potential as a combination immunotherapy. Our unwavering goal
remains to deliver substantial value to patients, healthcare
providers, and shareholders by bringing this innovative cancer
treatment to market," stated Leonard
Mazur, Chairman and CEO of Citius Pharmaceuticals and Citius
Oncology.
Key Launch Preparations and Activities:
- Manufacturing Scale-Up and Supply Chain
Optimization:
-
- Secured commercial supply agreements with leading contract
manufacturing organizations (CMOs).
- First Year Launch Supply has been produced.
- Healthcare Provider Engagement:
-
- Rolled out targeted education programs aimed at oncologists,
hematologists, and other key medical professionals.
- Launched an information platform that offers clinical data,
dosing guidelines, and safety information for healthcare
providers.
- Market Access and Reimbursement Efforts:
-
- Working closely with payers and healthcare providers to secure
reimbursement pathways that facilitate patient access.
- Submitted an application for a unique J-code under the
Healthcare Common Procedure Coding System (HCPCS) to streamline
reimbursement processes.
- Secured LYMPHIR's inclusion in the National Comprehensive
Cancer Network (NCCN) guidelines, a key factor in influencing
clinical decision-making and payer coverage in the U.S.
- Patient Support Initiatives:
-
- Designed a patient assistance program to help with financial
support and access to LYMPHIR.
- Developing a best-in-class patient services center to assist
LYMPHIR patients with administrative and prescribing needs.
- Marketing and Sales Initiatives:
-
- Launched a core marketing campaign to raise awareness among
healthcare providers, ensuring that top CTCL prescribers are
informed of LYMPHIR's availability.
- Building an experienced specialized field sales team to partner
with CTCL providers and office staff.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory
cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III
disease after at least one prior systemic therapy. It is a
recombinant fusion protein that combines the IL-2 receptor binding
domain with diphtheria toxin fragments. The agent specifically
binds to IL-2 receptors on the cell surface, causing diphtheria
toxin fragments that have entered cells to inhibit protein
synthesis. After uptake into the cell, the DT fragment is cleaved
and the free DT fragments inhibit protein synthesis, resulting in
cell death. Denileukin diftitox-cxdl demonstrated the ability to
deplete immunosuppressive regulatory T lymphocytes (Tregs) and
antitumor activity through a direct cytocidal action on
IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory approval in
Japan for the treatment of CTCL
and PTCL. Subsequently, in 2021, Citius acquired an exclusive
license with rights to develop and commercialize LYMPHIR in all
markets except for Japan and
certain parts of Asia. LYMPHIR was
approved by the FDA in August
2024.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin
lymphoma (NHL) that comes in a variety of forms and is the most
common type of cutaneous lymphoma. In CTCL, T-cells, a type of
lymphocyte that plays a role in the immune system, become cancerous
and develop into skin lesions, leading to a decrease in the quality
of life of patients with this disease due to severe pain and
pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise
the majority of CTCL cases. Depending on the type of CTCL,
the disease may progress slowly and can take anywhere from several
years to upwards of ten to potentially reach tumor stage. However,
once the disease reaches this stage, the cancer is highly malignant
and can spread to the lymph nodes and internal organs, resulting in
a poor prognosis. Given the duration of the disease, patients
typically cycle through multiple agents to control disease
progression. CTCL affects men twice as often as women and is
typically first diagnosed in patients between the ages of 50 and 60
years of age. Other than allogeneic stem cell transplantation, for
which only a small fraction of patients qualify, there is currently
no curative therapy for advanced CTCL.
INDICATION
LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the
treatment of adult patients with r/r Stage I-III cutaneous T-cell
lymphoma (CTCL) after at least one prior systemic therapy.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CAPILLARY LEAK SYNDROME
Capillary leak syndrome (CLS), including life-threatening or
fatal reactions, can occur in patients receiving LYMPHIR. Monitor
patients for signs and symptoms of CLS during treatment. Withhold
LYMPHIR until CLS resolves, or permanently discontinue based on
severity.
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
LYMPHIR can cause capillary leak syndrome (CLS), including
life-threatening or fatal reactions. CLS was defined in the
clinical trials as the occurrence of at least 2 of the following
symptoms at any time during LYMPHIR therapy: hypotension, edema,
and serum albumin <3 g/dL. These symptoms were not required to
occur simultaneously to be characterized as capillary leak
syndrome.
As defined, CLS occurred in 27% of patients in the pooled
population across 3 clinical trials, including 8% with Grade 3.
There was one (0.8%) fatal occurrence of CLS. Of the patients with
CLS, 22% had recurrence. The majority of CLS events (81%) occurred
within the first 2 cycles of treatment. The median time to onset
from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median
duration of CLS was 14 days (range: 2 to 40), and 75% of patients
had resolution. The most common symptoms included edema,
hypoalbuminemia, and hypotension. Pleural effusion, pericardial
effusion, and dehydration also occurred.
Regularly assess patients for weight gain, new onset or
worsening of edema, dyspnea, and hypotension (including orthostatic
changes). Monitor serum albumin levels prior to the initiation of
each cycle of therapy and more often as clinically indicated.
Withhold, reduce dose, or permanently discontinue based on
severity. If LYMPHIR is withheld, resume LYMPHIR following
resolution of CLS and when serum albumin is greater than or equal
to 3 g/dL.
Visual Impairment
LYMPHIR can cause serious visual impairment, including changes
in visual acuity and color vision. In the pooled population across
3 clinical trials, visual impairment occurred in 9%, with Grade 1
in 8% and Grade 2 in 1%. The most commonly reported symptom was
blurred vision. Of the patients with visual impairment, 67% had
resolution of their visual impairment.
Perform baseline ophthalmic examination and monitor as
clinically indicated. If patients experience symptoms of visual
impairment, such as changes in visual acuity, changes in color
vision, or blurred vision, refer for ophthalmologic evaluation.
Withhold LYMPHIR until visual impairment resolves or permanently
discontinue based on severity.
Infusion-Related Reactions
LYMPHIR can cause serious infusion-related reactions.
Infusion-related reactions were reported in 69% of patients in the
pooled population across 3 clinical trials of patients who received
LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see
Adverse Reactions (6.1)]. Eighty-three percent of infusion-related
reactions occurred in Cycles 1 and 2. The most common symptoms
included nausea, fatigue, chills, musculoskeletal pain, vomiting,
fever, and arthralgia.
Premedicate patients for the first three cycles prior to
starting a LYMPHIR infusion [see Dosage and Administration (2.3)].
Monitor patients frequently during infusion. For Grade 2 or higher
infusion reactions, premedicate at least 30 minutes prior to each
subsequent infusion with a systemic steroid for at least 3
cycles.
Interrupt or discontinue LYMPHIR based on severity [see Dosage
and Administration (2.4)]. Institute appropriate medical
management.
Hepatotoxicity
LYMPHIR can cause hepatotoxicity. In the pooled safety
population, elevated ALT occurred in 70% of patients, with Grade 3
ALT occurring in 22%; elevated AST occurred in 64% of patients,
with Grade 3 AST elevation occurring in 9%. For Grade 3 events,
median time to onset was 8 days (range: 1 to 15 days); median time
to resolution was 15 days (range: 7 to 50 days); all cases of Grade
3 ALT or AST elevations resolved [see Adverse Reactions (6.1)].
Elevated total bilirubin occurred in 5% of patients, with Grade 3
occurring in 0.9%.
Monitor liver enzymes and bilirubin at baseline and during
treatment as clinically indicated. Withhold, reduce dose, or
permanently discontinue LYMPHIR based on severity.
Embryo-Fetal Toxicity
Based on its mechanism of action, LYMPHIR can cause fetal harm
when administered to a pregnant woman. Verify the pregnancy status
of females of reproductive potential prior to the initiation of
LYMPHIR. Advise pregnant women of the potential risk to the fetus.
Advise females of reproductive potential to use effective
contraception during treatment and for 7 days following the last
dose of LYMPHIR.
ADVERSE REACTIONS
The most common adverse reactions (≥20%), including laboratory
abnormalities, are increased transaminases, albumin decreased,
nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain,
rash, chills, constipation, pyrexia, and capillary leak
syndrome
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Based on its mechanism of action, LYMPHIR can cause fetal harm when
administered to a pregnant woman. There are no available data on
the use of LYMPHIR in pregnant women to evaluate for a
drug-associated risk. No animal reproductive and developmental
toxicity studies have been conducted with denileukin diftitox.
Denileukin diftitox-cxdl causes depletion of regulatory T
lymphocytes (Treg), immune activation, and capillary leak syndrome,
compromising pregnancy maintenance. Advise pregnant women of the
potential risk to a fetus.
In the U.S. general population, the estimated background risk of
major birth defects and miscarriage in clinically recognized
pregnancies are 2-4% and 15-20%, respectively.
Lactation
Risk Summary
No data are available regarding the presence of denileukin
diftitox-cxdl in human milk, the effects on the breastfed child, or
on milk production. Because of the potential for serious adverse
reactions in breastfed children, advise women not to breastfeed
during treatment with LYMPHIR and for 7 days after the last
dose.
Females and Males of Reproductive Potential
Based on its mechanism of action, LYMPHIR can cause fetal harm
when administered to a pregnant woman.
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential
prior to initiating LYMPHIR.
Contraception
Females
Advise females of reproductive potential to
use effective contraception during treatment with LYMPHIR and for 7
days after the last dose.
Infertility
Males
Based on findings in rats, male fertility may be
compromised by treatment with. The reversibility of the effect on
fertility is unknown.
Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric patients have not
been established.
Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR,
34 patients (49%) were 65 years of age and older and 10 patients
(14%) were 75 years of age and older. Clinical studies of LYMPHIR
did not include sufficient numbers of patients 65 years of age and
older to determine whether they respond differently from younger
adult patients.
You may report side effects to the FDA at 1-800-FDA-1088
or www.fda.gov/medwatch. You may also report side
effects to Citius Pharmaceuticals at 1-844-459-6744.
Please read Important Safety Information and full Prescribing
Information, including Boxed WARNING, for LYMPHIR™.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop
and commercialize novel targeted oncology therapies. In
August 2024, its primary asset,
LYMPHIR, was approved by the FDA for the treatment of adults with
relapsed or refractory CTCL who had had at least one prior systemic
therapy. Management estimates the initial market for LYMPHIR
currently exceeds $400 million, is
growing, and is underserved by existing therapies. Robust
intellectual property protections that span orphan drug
designation, complex technology, trade secrets and pending patents
for immuno-oncology use as a combination therapy with checkpoint
inhibitors would further support Citius Oncology's competitive
positioning. For more information, please visit
www.citiusonc.com.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a
biopharmaceutical company dedicated to the development and
commercialization of first-in-class critical care products. In
August 2024, the FDA approved
LYMPHIR, a targeted immunotherapy for an initial indication in the
treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage
pipeline also includes Mino-Lok®, an antibiotic lock
solution to salvage catheters in patients with catheter-related
bloodstream infections, and CITI-002 (Halo-Lido), a topical
formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial
for Mino-Lok and a Phase 2b trial for
Halo-Lido were completed in 2023. Mino-Lok met primary and
secondary endpoints of its Phase 3 Trial. Citius is actively
engaged with the FDA to outline next steps for both programs.
Citius Pharmaceuticals owns 92% of Citius Oncology. For more
information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements
are made based on our expectations and beliefs concerning future
events impacting Citius Pharma or Citius Oncology. You can identify
these statements by the fact that they use words such as "will,"
"anticipate," "estimate," "expect," "plan," "should," and "may" and
other words and terms of similar meaning or use of future dates.
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties that could
negatively affect our business, operating results, financial
condition and stock price. Factors that could cause actual
results to differ materially from those currently anticipated, and,
unless noted otherwise, that apply to Citius Pharma and Citius
Oncology, are: our ability to commercialize LYMPHIR and any of our
other product candidates that may be approved by the FDA; our need
for substantial additional funds; the estimated markets for our
product candidates and the acceptance thereof by any market; the
ability of our product candidates to impact the quality of life of
our target patient populations; risks relating to the results of
research and development activities, including those from our
existing and any new pipeline assets; our dependence on third-party
suppliers; our ability to procure cGMP commercial-scale supply; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; uncertainties relating to
preclinical and clinical testing; the early stage of products under
development; market and other conditions; risks related to our
growth strategy; patent and intellectual property matters; our
ability to identify, acquire, close and integrate product
candidates and companies successfully and on a timely basis;
government regulation; competition; as well as other risks
described in our SEC filings. These risks have been and may be
further impacted by any future public health risks. Accordingly,
these forward-looking statements do not constitute guarantees of
future performance, and you are cautioned not to place undue
reliance on these forward-looking statements. Risks regarding our
business are described in detail in our Securities and Exchange
Commission ("SEC") filings which are available on the SEC's website
at www.sec.gov, including in Citius Oncology's and Citius Pharma's
Annual Reports on Forms 10-K for the year ended September 30, 2024, filed with the SEC on
December 27, 2024, as updated by our
subsequent filings with the SEC. These forward-looking statements
speak only as of the date hereof, and we expressly disclaim any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in our expectations or any changes in events,
conditions or circumstances on which any such statement is based,
except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.
