- 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
CHICAGO, IL, USA I June 27, 2024 I 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.
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).
SOURCE: Meitheal Pharmaceuticals
Post Views: 292
- 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
CHICAGO, IL, USA I June 27, 2024 I 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.
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).
SOURCE: Meitheal Pharmaceuticals
Post Views: 292
