CHICAGO--(BUSINESS WIRE)--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”).
“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.
