Meitheal Pharmaceuticals, Inc.

Meitheal Pharmaceuticals has secured North America rights to Nabriva Therapeutics’ intravenous broad-spectrum antibiotic Contepo (fosfomycin for injection), which has been stuck in regulatory limbo in the US since 2020. However, an FDA decision on the injectable for treating complicated urinary tract infections (cUTIs) is expected later this year. Dubbing it a “novel therapeutic with the potential to address a significant unmet need around increasing antibiotic resistance,” Tom Shea, chief executive of Meitheal, said the company is “uniquely positioned to advance Contepo through the final stages of the regulatory process and…deliver a…high-quality antibiotic to patients and providers.”As part of the deal, Meitheal gains licensing rights and all associated intellectual property, technology and know-how for Contepo, while Nabriva stands to receive an undisclosed payment at closing and royalties on US sales.While the oral form of fosfomycin – marketed as Monurol in the US by AbbVie – was cleared by the FDA in 1997 to treat uncomplicated UTIs in women, Nabriva’s injectable version has been rejected twice by the US regulator in 2019 and 2020. Both complete response letters cited deficiencies related to facility inspections and manufacturing processes at contract manufacturing sites in Europe.With this acquisition, Meitheal has added a second asset to its specialty portfolio, after bagging North America rights to Xentria’s anti-TNFα antibody XTMAB-16 last year. Meitheal’s buyouts align with the broader vision of its parent company Nanjing King-Friend Biochemical Pharmaceutical to focus on branded biopharmaceuticals.

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 Limitations of Use: The effectiveness of YUSIMRY has not been established in patients who have lost response to or were intolerant to TNF blockers. *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

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 biosimilar products, today announced recent progress for its generic injectables portfolio, underscoring the Company’s commitment to serve as a sustainable partner for generics development in the U.S. “Meitheal is pleased to further expand our portfolio of sustainably manufactured and priced generic injectables as we bring additional presentations of Bupivacaine Hydrochloride Injection to market during this time of product shortage. As we prepare to launch multiple new products in 2024, we are intently focused on expediting delivery of medicines in short supply,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “With over $100 million invested in generic R&D over the past six years, Meitheal is fully committed to pursuing efficient drug development and commercialization to simplify access to life-changing medicines for all patients.” Bupivacaine Hydrochloride Injection, USP is an anesthetic used for surgical, diagnostic, therapeutic, and obstetrical procedures. As of March 1, 2024, both the U.S. Food and Drug Administration (FDA) and the American Society of Health-System Pharmacists (ASHP) websites list multiple presentations of Bupivacaine Hydrochloride Injection on drug shortage. Capital investment of over $100 million by Meitheal’s parent company Nanjing King Friend Biochemical Pharmaceutical Co., Ltd. (NKF) for a brand new, state-of-the-art manufacturing workshop was completed in 2023 and inspected by the FDA in November of 2023 resulting in approval of five new lines. These approved lines add over 200 million units of capacity for vial and cartridge products that support current and future demand for generic injectables. These lines are expected to produce commercial products that will have an impact on drug shortages beginning in the second half of 2024. Meitheal is planning for the launch of multiple new products in 2024 across its core therapeutic areas of anti-infectives, anesthetics, critical care, fertility, and oncology by continuously evaluating new product opportunities and prioritizing those that address gaps in the current marketplace. ABOUT BUPIVACAINE HYDROCHOLORIDE FOR INJECTION, USP Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia. For full prescribing and safety information, please click on the following link. Learn more about Bupivacaine Hydrochloride Injection, USP 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 biosimilar products. Meitheal currently markets over 55 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of February 2024, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 20 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 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.