- Meitheal, through parent company Hong Kong King-Friend, gains
exclusive U.S. rights to YUSIMRY® and responsibility for all
commercial activities nationally
- YUSIMRY® is currently approved by the U.S. FDA for nine
indications and is available at a lower cost compared to Humira®;
Meitheal expects additional indications, including a
high-concentration formulation, to be approved in 2025
- Agreement adds a fifth biosimilar to Meitheal’s growing
portfolio and supports the Company’s commitment to providing
sustainable access to critical medicines
Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated
biopharmaceutical company based in Chicago and focused on the
development and commercialization of generic injectables,
fertility, biologic, and branded products, today announced it has
gained exclusive commercial rights in the U.S. to YUSIMRY®
(adalimumab-aqvh), a biosimilar of Humira® (adalimumab), through an
exclusive license and supply agreement with its parent company,
Hong Kong King-Friend Industry Co., Ltd. (“HKF”).
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“The licensing of YUSIMRY® is a pivotal moment for Meitheal,
solidifying our foothold in the biosimilars market and providing us
with a high-value asset with the potential for robust growth in the
coming years,” said Tom Shea, Chief Executive Officer of Meitheal
Pharmaceuticals. “With our expertise across research,
manufacturing, and commercialization, Meitheal is well-positioned
to enhance patient access to high-quality biosimilars like YUSIMRY®
while continuing to advance its clinical and commercial
development.”
HKF has acquired worldwide rights to YUSIMRY® through an asset
purchase agreement with Coherus BioSciences, Inc. Under the
agreement, HKF gains substantially all assets related to YUSIMRY®,
including any results of development and regulatory activities, in
exchange for an upfront cash payment of $40,000,000. The closings
of both the asset purchase agreement and Meitheal’s exclusive
licensing agreement with HKF are effective immediately, subject to
standard conditions and approvals.
“Adalimumab is a critical medication for many Americans living
with autoimmune conditions, and we look forward to continuing to
deliver YUSIMRY®, a more affordable option to Humira®, to patients
at a fair and sustainable price,” said Brian McCarthy, Meitheal
Senior Vice President of Specialty. “With adalimumab biosimilars
recently gaining traction, YUSIMRY® is positioned to meet the
ongoing demand for accessible treatment options due to key macro
forces and the strategic investments being made in its production
and commercialization.”
In recent years, Meitheal and its parent company HKF have made
multiple investments to expand the Company’s biologics portfolio
and capabilities. This new, exclusive licensing agreement for
YUSIMRY® adds a fifth biosimilar and the first on-market biosimilar
to Meitheal’s portfolio. Meitheal’s parent company and related
entities have invested over $300 million in capital and R&D in
recent years to support sustainable product supply, including
investing $30 million in a monoclonal antibody drug substance
facility.
“We are pleased to have acquired the rights to this critical
option for patients and are confident that Meitheal is best
positioned to deliver fairly priced YUSIMRY® to U.S. patients in
need,” said Eric Tang, President of HKF. “We remain focused on
strategic investments in the important biosimilars market and we
look forward to a continued partnership with Meitheal to support
accessible healthcare solutions.”
YUSIMRY® is currently approved by the U.S. Food and Drug
Administration (“FDA”) in nine different indications as a
biosimilar of Humira®, including in both prefilled syringe (PFS)
and autoinjector presentations. As a top-selling pharmaceutical for
multiple inflammatory diseases, demand for adalimumab products
remains high. Meitheal will continue the development of both
pediatric presentations and a high concentration (100mg/mL)
formulation of YUSIMRY®.
Meitheal will work closely with Coherus to ensure a seamless
transition of existing YUSIMRY® operations, including the existing
and comprehensive support hub for patients and healthcare
providers.
ABOUT YUSIMRY®
YUSIMRY® (adalimumab-aqvh), a biosimilar of Humira®
(adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated
to reduce the signs and symptoms of rheumatoid arthritis, juvenile
idiopathic arthritis, psoriatic arthritis, and ankylosing
sponddylitis, and to treat Crohn’s disease, ulcerative colitis,
plaque psoriasis, hidradenitis suppurativa, and uveitis.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
YUSIMRY® (adalimumab-aqvh) is biosimilar* to Humira®
(adalimumab).
See full prescribing information for complete boxed
warning.
SERIOUS INFECTIONS
Patients treated with YUSIMRY are at increased risk for
developing serious infections that may lead to hospitalization or
death. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or
corticosteroids.
Discontinue YUSIMRY if a patient develops a serious infection
or sepsis. Reported infections include:
- Active tuberculosis (TB), including reactivation of latent
TB. Patients with TB have frequently presented with disseminated or
extrapulmonary disease. Test patients for latent TB before YUSIMRY
use and during therapy. Initiate treatment for latent TB prior to
YUSIMRY use.
- Invasive fungal infections, including histoplasmosis,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or other invasive
fungal infections may present with disseminated, rather than
localized, disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Consider
empiric anti-fungal therapy in patients at risk for invasive fungal
infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic
pathogens, including Legionella and Listeria.
Carefully consider the risks and benefits of treatment with
YUSIMRY prior to initiating therapy in patients: 1. with chronic or
recurrent infection; 2. who have been exposed to TB; 3. with a
history of opportunistic infection; 4. who resided in or traveled
in regions where mycoses are endemic; 5. with underlying conditions
that may predispose them to infection. Monitor patients closely for
the development of signs and symptoms of infection during and after
treatment with YUSIMRY, including the possible development of TB in
patients who tested negative for latent TB infection prior to
initiating therapy.
- Do not start YUSIMRY during an active infection, including
localized infections.
- Patients older than 65 years, patients with co-morbid
conditions, and/or patients taking concomitant immunosuppressants
may be at greater risk of infection.
- If an infection develops, monitor carefully and initiate
appropriate therapy.
- Drug interactions with biologic products: A higher rate of
serious infections has been observed in rheumatoid arthritis (RA)
patients treated with rituximab who received subsequent treatment
with a tumor necrosis factor (TNF) blocker. An increased risk of
serious infections has been seen with the combination of TNF
blockers with anakinra or abatacept, with no demonstrated added
benefit in patients with RA. Concomitant administration of YUSIMRY
with other biologic disease- modifying antirheumatic drugs (DMARDs)
(e.g., anakinra or abatacept) or other TNF blockers is not
recommended based on the possible increased risk for infections and
other potential pharmacological interactions as well as the lack of
demonstrated benefit of such combinations.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been
reported in children and adolescent patients treated with TNF
blockers, including adalimumab. Postmarketing cases of
hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell
lymphoma, have been reported in patients treated with TNF blockers,
including adalimumab. These cases have had a very aggressive
disease course and have been fatal. The majority of reported TNF
blocker cases have occurred in patients with Crohn’s disease or
ulcerative colitis and the majority were in adolescent and young
adult males. Almost all of these patients had received treatment
with azathioprine or 6-mercaptopurine concomitantly with a TNF
blocker at or prior to diagnosis. It is uncertain whether the
occurrence of HSTCL is related to use of a TNF blocker or a TNF
blocker in combination with these other immunosuppressants.
- Consider the risks and benefits of YUSIMRY treatment prior to
initiating or continuing therapy in a patient with known
malignancy.
- In clinical trials, more cases of malignancies were observed
among adalimumab-treated patients compared to control
patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical
trials for adalimumab-treated patients. Examine all patients,
particularly those with a history of prolonged immunosuppressant or
psoralen plus ultraviolet A light (PUVA) therapy, for the presence
of NMSC prior to and during treatment with YUSIMRY.
- In adalimumab clinical trials, there was an approximate 3-fold
higher rate of lymphoma than expected in the general U.S.
population. Patients with chronic inflammatory diseases,
particularly those with highly active disease and/or chronic
exposure to immunosuppressant therapies, may be at higher risk of
lymphoma than the general population, even in the absence of TNF
blockers.
- Postmarketing cases of acute and chronic leukemia were reported
with TNF blocker use. Approximately half of the postmarketing cases
of malignancies in children, adolescents, and young adults
receiving TNF blockers were lymphomas; other cases included rare
malignancies associated with immunosuppression and malignancies not
usually observed in children and adolescents.
HYPERSENSITIVITY
- Anaphylaxis and angioneurotic edema have been reported
following adalimumab administration. If a serious allergic reaction
occurs, stop YUSIMRY and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
- Use of TNF blockers, including adalimumab, may increase the
risk of reactivation of hepatitis B virus (HBV) in patients who are
chronic carriers. Some cases have been fatal.
- Evaluate patients at risk for HBV infection for prior evidence
of HBV infection before initiating TNF blocker therapy.
- Exercise caution in patients who are carriers of HBV and
monitor them during and after YUSIMRY treatment.
- Discontinue YUSIMRY and begin antiviral therapy in patients who
develop HBV reactivation. Exercise caution when resuming YUSIMRY
after HBV treatment.
NEUROLOGIC REACTIONS
- TNF blockers, including adalimumab, have been associated with
rare cases of new onset or exacerbation of central nervous system
and peripheral demyelinating diseases, including multiple
sclerosis, optic neuritis, and Guillain-Barré syndrome.
- Exercise caution when considering YUSIMRY for patients with
these disorders; discontinuation of YUSIMRY should be considered if
any of these disorders develop.
- There is a known association between intermediate uveitis and
central demyelinating disorders.
HEMATOLOGIC REACTIONS
- Rare reports of pancytopenia, including aplastic anemia, have
been reported with TNF blockers. Medically significant cytopenia
has been infrequently reported with adalimumab.
- Consider stopping YUSIMRY if significant hematologic
abnormalities occur.
CONGESTIVE HEART FAILURE
- Worsening and new onset congestive heart failure (CHF) has been
reported with TNF blockers. Cases of worsening CHF have been
observed with adalimumab; exercise caution and monitor
carefully.
AUTOIMMUNITY
- Treatment with YUSIMRY may result in the formation of
autoantibodies and, rarely, in development of a lupus-like
syndrome. Discontinue treatment if symptoms of a lupus-like
syndrome develop.
IMMUNIZATIONS
- Patients on YUSIMRY should not receive live vaccines.
- Pediatric patients, if possible, should be brought up to date
with all immunizations before initiating YUSIMRY therapy.
- Adalimumab is actively transferred across the placenta during
the third trimester of pregnancy and may affect immune response in
the in utero exposed infant. The safety of administering live or
live-attenuated vaccines in infants exposed to YUSIMRY in utero is
unknown. Risks and benefits should be considered prior to
vaccinating (live or live-attenuated) exposed infants.
ADVERSE REACTIONS
- The most common adverse reactions in adalimumab clinical trials
(>10%) were: infections (e.g., upper respiratory, sinusitis),
injection site reactions, headache, and rash.
INDICATIONS
- Rheumatoid Arthritis: YUSIMRY is indicated, alone or in
combination with methotrexate or other non-biologic DMARDs, for
reducing signs and symptoms, inducing major clinical response,
inhibiting the progression of structural damage, and improving
physical function in adult patients with moderately to severely
active rheumatoid arthritis.
- Juvenile Idiopathic Arthritis: YUSIMRY is indicated,
alone or in combination with methotrexate, for reducing signs and
symptoms of moderately to severely active polyarticular juvenile
idiopathic arthritis in patients 2 years of age and older.
- Psoriatic Arthritis: YUSIMRY is indicated, alone or in
combination with non-biologic DMARDs, for reducing signs and
symptoms, inhibiting the progression of structural damage, and
improving physical function in adult patients with active psoriatic
arthritis.
- Ankylosing Spondylitis: YUSIMRY is indicated for
reducing signs and symptoms in adult patients with active
ankylosing spondylitis.
- Crohn’s Disease: YUSIMRY is indicated for the treatment
of moderately to severely active Crohn’s disease in adults and
pediatric patients 6 years of age and older.
- Ulcerative Colitis: YUSIMRY is indicated for the
treatment of moderately to severely active ulcerative colitis in
adult patients.
Limitations of Use:
The effectiveness of YUSIMRY has not been established in
patients who have lost response to or were intolerant to TNF
blockers.
- Plaque Psoriasis: YUSIMRY is indicated for the treatment
of adult patients with moderate to severe chronic plaque psoriasis
who are candidates for systemic therapy or phototherapy, and when
other systemic therapies are medically less appropriate. YUSIMRY
should only be administered to patients who will be closely
monitored and have regular follow-up visits with a physician.
- Hidradenitis Suppurativa: YUSIMRY is indicated for the
treatment of moderate to severe hidradenitis suppurativa in adult
patients.
- Uveitis: YUSIMRY is indicated for the treatment of
non-infectious intermediate, posterior, and panuveitis in adult
patients.
*Biosimilar means that the biological product is approved based
on data demonstrating that it is highly similar to an FDA-approved
biological product, known as a reference product, and that there
are no clinically meaningful differences between the biosimilar
product and the reference product. Biosimilarity of YUSIMRY has
been demonstrated for the condition(s) of use (e.g., indication(s),
dosing regimen(s)), strength(s), dosage form(s), and route(s) of
administration described in its Full Prescribing Information.
Please see Full Prescribing Information,
including Boxed Warning and Medication guide
ABOUT MEITHEAL PHARMACEUTICALS
Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals
is focused on the development and commercialization of generic
injectable medications and, as of 2022, has expanded its focus to
include fertility, biologic, and branded products. Meitheal
currently markets over 55 US Food and Drug Administration
(FDA)-approved products across numerous therapeutic areas including
anti-infectives, oncolytics, intensive care, and fertility. As of
the end of May 2024, Meitheal, directly or through its partners,
has over 20 products in the research and development phase, 14
products planned for launch in 2024, and an additional 19 products
under review by the FDA. Meitheal’s mission is to provide easy
access to fairly priced products through robust manufacturing,
consistent supply, and rapid response to our customers’ needs.
Ranked among the top 100 Crain’s Best Places to Work in Chicago,
Meitheal emulates the traditional Irish guiding principle we are
named for — Meitheal (Mee·hall): working together toward a common
goal, for the greater good.
Learn more about who we are and what we do at
www.meithealpharma.com.
ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF)
Hong Kong King-Friend Industrial Company is a wholly owned
subsidiary of NKF, founded in 2010.
ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY
(NKF)
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF)
is a China-based company principally engaged in the research and
development, production and sales of Active Pharmaceutical
Ingredients (API) and Finished Dosage Form (FDF). Established in
1986 as one of world leading manufacturers of heparin related APIs,
NKF has grown into a fully integrated API and FDF manufacturer in
multiple therapeutic areas including critical care and oncology.
With three U.S. FDA approved manufacturing sites in China and more
than 500 employees, including more than 100 dedicated research and
development experts, NKF strives to meet patient needs globally
with market presence in the U.S., China, EU and across the world.
The Company is publicly listed on Shanghai Stock Exchange with a
market capitalization over U.S. $3.0 billion.
ABOUT COHERUS BIOSCIENCES
Coherus is a commercial-stage biopharmaceutical company focused
on the research, development and commercialization of innovative
immunotherapies to treat cancer. Coherus is developing an
innovative immuno-oncology pipeline that is expected to be
synergistic with its proven commercial capabilities in
oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody
immunotherapy candidates focused on enhancing the innate and
adaptive immune responses to enable a robust antitumor immunologic
response and enhance outcomes for patients with cancer.
Casdozokitug is a novel IL-27 antagonistic antibody currently being
evaluated in two ongoing clinical studies: a Phase 1/2 study in
advanced solid tumors and a Phase 2 study in hepatocellular
carcinoma. CHS-114 is a highly selective, competitively positioned,
cytolytic anti-CCR8 antibody currently in a Phase 1 study in
patients with advanced solid tumors. CHS-1000 is a preclinical
candidate targeting immune-suppressive mechanisms via the novel
pathway ILT4.
Coherus markets LOQTORZI® (toripalimab-tpzi), a novel
next-generation PD-1 inhibitor and UDENYCA® (pegfilgrastim-cbqv), a
biosimilar of Neulasta® (pegfilgrastim).
Neulasta® is a registered trademark of Amgen, Inc.
Humira® is a registered trademark of AbbVie Inc.
LOQTORZI® and UDENYCA® are registered trademarks of Coherus
BioSciences, Inc.
YUSIMRY® is a registered trademark of Hong Kong King-Friend
Industry Co., Ltd. (assignment pending) and licensed to Meitheal
Pharmaceuticals, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20240627526326/en/
Meitheal Pharmaceuticals, Inc. John Spilman, VP of Corporate
Strategy 773 899 5910 info@meithealpharma.com