Accord BioPharma Announces Agreement by Intas Pharmaceuticals, Ltd. to Acquire UDENYCA® (pegfilgrastim-cbqv) Business from Coherus BioSciences, Inc., Unlocking Potential for Continued U.S. Growth

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Dec 03, 2024, 07:30 ET

Agreement demonstrates the expanding leadership of Accord BioPharma and Intas in the biosimilar market

RALEIGH, N.C., Dec. 3, 2024 /PRNewswire/ -- 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:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

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:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA^® in patients with ARDS.
Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA^® in patients with serious allergic reactions.
Allergies to Acrylics: The on-body injector (OBI) for UDENYCA uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.
Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA^® if sickle cell crisis occurs.
Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA^® if causality is likely.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA^® therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.
Potential Device failures: Missed or partial doses have been reported for products administered via on-body injectors due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended.
Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA^® if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

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.

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