30.04.2024 07:00:32 - Press Release: Sandoz reaches agreement with Amgen resolving all patent litigation related to its US denosumab biosimilars

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules

Sandoz reaches agreement with Amgen resolving all patent litigation related to its US denosumab biosimilars

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-- Agreement clears path for launch of Jubbonti(R) and Wyost(R) on May 31,
2025 or earlier under certain circumstances

-- Jubbonti(R) and Wyost(R) are first and only FDA-approved biosimilars to
and interchangeable with Prolia*(R) and Xgeva*(R)

-- Anticipated launch further strengthens Sandoz biosimilar portfolio and
advances growth strategy
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Basel, April 30, 2024 -- Sandoz, the global leader in generic and biosimilar medicines, today announced that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz denosumab biosimilars.

Patent infringement proceedings were initially filed by Amgen in the US Federal District Court for the District of New Jersey in May of 2023 pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Amgen that the company infringed up to 21 patents expiring as late as 2037, protecting reference medicines Prolia(R) and Xgeva(R) . Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Prolia(R) and Xgeva(R) on May 31, 2025, or earlier under certain circumstances if customary acceleration provisions are triggered.

Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti(R) and Wyost(R) , on March 5, 2024. Jubbonti(R) and Wyost(R) are interchangeable with and approved by FDA for all indications of reference medicines Prolia(R) and Xgeva(R) . They have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.

The settlement clears the path to bring both Jubbonti(R) and Wyost(R) to the US market on May 31, 2025, or earlier under certain circumstances. Bringing denosumab to market allows us to further our Purpose of pioneering access for patients, by providing them with affordable high-quality medicines.

The terms of the agreement will not impact our previously disclosed 2024 guidance.

About Wyost(R) (denosumab-bbdz)

Wyost(R) is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.(1)

Bone is the third most frequent site for metastatic tumors.(2) Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate.(3)

Wyost(R) 120 mg/1.7 mL (70 mg/mL) injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).(8,9) Wyost(R) is indicated in the US to prevent SREs in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.(1)

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Hypocalcemia and known clinically significant hypersensitivity to denosumab products.

WARNINGS AND PRECAUTIONS

Same Active Ingredient: Patients receiving Wyost should not receive other denosumab products concomitantly. Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs. Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Wyost. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Wyost. Monitor for symptoms. Avoid invasive dental procedures during treatment with Wyost. Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule out a femoral fracture. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: When Wyost treatment is discontinued, evaluate the individual patient's risk for vertebral fractures. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.

ADVERSE REACTIONS

Bone Metastasis from Solid Tumors: Most common adverse reactions (>= 25%) were fatigue/asthenia, hypophosphatemia, and nausea. Multiple Myeloma: Most common adverse reactions (>= 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. Giant Cell Tumor of Bone: Most common adverse reactions (>= 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy: Most common adverse reactions (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

USE IN SPECIFIC POPULATIONS

Pediatric patients: Recommended only for treatment of skeletally mature adolescents with giant cell tumor of bone. Renal impairment: Patients with creatinine clearance less than 30 mL/min or receiving dialysis are at risk for hypocalcemia. Adequately supplement with calcium and vitamin D.

This is not the complete list of all the safety information for Wyost. Please click to see full https://www.globenewswire.com/Tracker?data=_u_nw0OLF994uCdvWgrMzpan8aKZlKumjgQMN8cy2QQoqcFrk0lWIJAXnh5DO5nGhEURmSoWyphNuoi-2AZe670EbGZ1Y7Mc4lUCoGvBpSTl53OLXiW7ocgQ866JE8Ll0pGnIDWSwkpo1MVIOZJPmtNDtgi_BI89AY_RCYRSH9U= Prescribing Information for Wyost.

About Jubbonti(R) (denosumab-bbdz)

Jubbonti(R) is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.(4)

Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease or when bone strength and structure change. People living with osteoporosis typically do not have symptoms and might not know they have the disease until they experience a fracture. More than 10 million US adults aged 50 and over live with osteoporosis, a major cause of fractures in postmenopausal women and in older men.(5,6) Half of all women over the age of 50 will experience an osteoporotic fracture during their lifetime.(7)

Jubbonti(R) 60 mg/1 mL injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).(8,9) Jubbonti(R) is indicated in the US to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.(4)

SELECT IMPORTANT SAFETY INFORMATION

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WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY
DISEASE
See full prescribing information for complete boxed warning.

-- Patients with advanced chronic kidney disease are at
risk of severe hypocalcemia following denosumab
products administration. Severe hypocalcemia
requiring hospitalization, life-threatening events
and fatal cases have been reported.

-- The presence of chronic kidney disease-mineral bone
disorder (CKD-MBD) markedly increases the risk of
hypocalcemia.

-- Prior to initiating Jubbonti in patients with
advanced chronic kidney disease, evaluate for the
presence of CKD-MBD. Treatment with Jubbonti in these
patients should be supervised by a healthcare
provider with expertise in the diagnosis and
management of CKD-MBD.
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CONTRAINDICATIONS

Hypocalcemia; pregnancy; and known hypersensitivity to denosumab products.

WARNINGS AND PRECAUTIONS

MORE TO FOLLOW) Dow Jones Newswires

April 30, 2024 01:00 ET (05:00 GMT)
Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
SANDOZ GROUP N A3ETYB Schweiz 32,450 01.07.24 17:50:00 -0,090 -0,28% 0,000 0,000 32,810 32,540

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