Filgrastim (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

FORT LAUDERDALE, FL / ACCESSWIRE / December 2, 2024 / Sunshine Biopharma Inc. (NASDAQ:"SBFM") (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has completed mouse model studies providing proof-of-concept for the Company's K1.1 mRNA product as a novel therapeutic agent for human hepatocellular carcinoma.Human hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwide and the most common type of primary liver cancers in adults. In recent years, several systematic treatment options were available to HCC patients either as first-line or second-line treatment. Yet, the five-year survival rate of HCC patients remains at only 18-21%.When transfected into cultured human HCC cell lines and patient-derived HCC cells, K1.1 mRNA exhibited dose-dependent anti-proliferative activity in vitro. Following encapsulation in specifically engineered lipids, the resulting K1.1 mRNA-Lipid Nanoparticles (K1.1/LNP) were efficiently delivered to livers of mice in a dose-dependent manner in vivo. K1.1/LNP, under repeated systemic dosing, was found to reduce growth of two different types of human HCC tumors orthotopically grafted into the livers of immunodeficient mice. The pharmacodynamics of K1.1/LNP in intrahepatic tumors was well correlated with antitumor efficacy in mice.We are excited about these findings which show the feasibility of K1.1 mRNA technology to not only enter malignant liver cells in a dose dependent fashion, but also in a manner that inhibits growth of these same cells" said Dr. Steve Slilaty, CEO of Sunshine Biopharma and inventor of the Company's K1.1 mRNA technology. "We are currently conducting additional animal studies to delineate the therapeutic window and optimize dosing of our K1.1/LNP for use as a single agent in future treatment of HCC patients," he added.About Sunshine Biopharma Inc.Sunshine Biopharma currently has 63 generic prescription drugs on the market in Canada and 31 additional drugs scheduled to be launched in the remainder of 2024 and in 2025. Among the new drugs to be launched is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy.In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.All registered trademarks are the property of their respective owners.Safe Harbor Forward-Looking StatementsThis press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma, Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.For Additional Information:Sunshine Biopharma Contact:Camille Sebaaly, CFODirect Line: 514-814-0464[email protected]SOURCE: Sunshine Biopharma, Inc.