Pegfilgrastim (Amgen)

Agreement demonstrates the expanding leadership of Accord BioPharma and Intas in the biosimilar market RALEIGH, NC, USA I December 3, 2024 I Accord BioPharma , Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. (“Intas Pharmaceuticals”), focused on the development of oncology, immunology and critical care therapies, announced today that Intas Pharmaceuticals has signed an agreement to acquire the UDENYCA® (pegfilgrastim-cbqv) business from Coherus BioSciences, Inc. (“Coherus”). UDENYCA is a pegfilgrastim biosimilar to Neulasta® and is typically administered the day after chemotherapy to decrease the incidence of infection as caused by febrile neutropenia. During the 2023 fiscal year, sales of UDENYCA totaled $127.1 million. When final, the acquisition will expand Accord BioPharma’s product portfolio and is expected to position the company for accelerated growth in the biosimilar industry. UDENYCA is the only pegfilgrastim biosimilar approved in the United States currently available in three administration options — prefilled syringe (PFS), autoinjector (AI) and on-body injector (OBI) — providing patients and healthcare providers with choice, control and convenience. Since its launch in 2019, over 300,000 patients have been treated with UDENYCA. “By adding UDENYCA to our growing portfolio of biosimilars, we will strengthen our business footprint in the U.S.” said Chrys Kokino, U.S. President of Accord. “With an expanding presence in the market, we can fuel the internal innovation and external expansion needed to deliver more accessible treatment options to patients.” “In considering our strategic pathways to achieve future growth, acquiring the UDENYCA business in the U.S. is appealing for two reasons: the product’s impressive sales and uptake, and its range of administration options that give patients an opportunity to align their needs with a treatment plan,” said Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals. “Having an on-body injector within our portfolio will allow us to provide immune supportive care to patients in a variety of settings, including at home, a benefit to patients who live far away from their care center.” The sale is expected to close in the first quarter of 2025. As part of the acquisition, Accord BioPharma will be excited to welcome employees from Coherus to their team to help inform and expand work around UDENYCA. INDICATION UDENYCA ® is a leukocyte growth factor indicated to: Limitations of Use: UDENYCA ® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis. WARNINGS AND PRECAUTIONS: ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full Prescribing Information, including instructions for use, are available at www.UDENYCA.com . About Intas Pharmaceuticals Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas’ products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas’ Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas’ biosimilars are manufactured at Intas Pharmaceuticals’ state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at www.intaspharma.com . About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients’ perspective and develop high-quality therapies that impact patients’ lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com . About Coherus BioSciences Coherus BioSciences, Inc. 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. References: SOURCE: Accord BioPharma

Coherus BioSciences’ stock surged on Tuesday after the company announced plans to sell off the last biosimilar in its portfolio. Intas Pharmaceuticals has agreed to purchase Coherus’ Neulasta biosimilar, Udenyca, for up to $558.4 million. That includes $483.4 million upfront and $75 million in potential sales milestones. CEO Denny Lanfear told Endpoints News that the deal marks the completion of Coherus’ yearslong transformation from a biosimilar company into a “pure-play immuno-oncology company.” Coherus’ stock $CHRS was up 47% on Tuesday afternoon, trading at about $2 per share. Executives say the deal will fund the development of combination programs with Coherus’ currently approved PD-1 inhibitor Loqtorzi, and allow the company to pay off $230 million in debt taken on during the pandemic. The deal is expected to close in the first quarter of 2025. “One of the interesting things that we’re able to do with our portfolio is combine everything with Loqtorzi,” Lanfear said. “We’re really well-positioned with some great molecules.” Coherus is currently running a study combining its experimental IL-27 antagonist casdozokitug with Loqtorzi in non-small cell lung cancer, and expects “emerging data throughout 2025,” CMO Rosh Dias told Endpoints. The company is also on track to launch a trial in hepatocellular carcinoma combining three drugs: casdozokitug, Loqtorzi and bevacizumab, also known as Genentech’s Avastin. Coherus is also studying its monoclonal antibody CHS-114 in combination with Loqtorzi in head and neck cancer and gastric cancer. A study in gastric cancer is expected to kick off next quarter. Lanfear said Coherus’ “transformation” into an innovative oncology company was set in motion in 2021, when it in-licensed Loqtorzi from Junshi Biosciences. The company has since taken over Surface Oncology, which gave it both casdozokitug and CHS-114. “Our trajectory then was to use our biosimilars and monetize them to support our immuno-oncology franchise,” Lanfear said. Coherus sold three biosimilars this year, including its Humira biosimilar Yusimry to Hong Kong King-Friend Industrial Co. in June and its ophthalmology biosimilar Cimerli to Sandoz in March. Resizing ahead Lanfear said the company will be “resized” as it pivots away from biosimilars, but declined to provide further details. “I think that you have to right-size the company for the mission and the strategy,” he said. “You can expect us to say a little more about that in the first two weeks of January.” In March, Coherus announced plans to lay off 30% of its staff by the end of the year. In its news release on Tuesday, the company said it would transfer certain full-time employees to Intas to support Udenyca, while “eliminating Udenyca-related overhead and commercial expenses.”