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

  * Agreement clears path for launch of Jubbonti(®) and Wyost(®) on May
    31, 2025 or earlier under certain circumstances
  * Jubbonti(®) and Wyost(®) are first and only FDA-approved biosimilars to and
    interchangeable with Prolia*(®) and Xgeva*(®)
  * Anticipated launch further strengthens Sandoz biosimilar portfolio and
    advances growth strategy

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(®) and Xgeva(®). Under the terms of the agreement,
Sandoz may enter the US market with a biosimilar version of Prolia(®) and
Xgeva(®) 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(® )and Wyost(®), on March 5, 2024. Jubbonti(® )and Wyost(®) are
interchangeable with and approved by FDA for all indications of reference
medicines Prolia(® )and Xgeva(®). 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(®) and Wyost(®) 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(®) (denosumab-bbdz)
Wyost(®) 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(®) 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(®) 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 Prescribing Information
(https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000WYOST.pdf)for
Wyost.
About Jubbonti(®) (denosumab-bbdz)
Jubbonti(®) 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(®) 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(®) 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
+------------------------------------------------------------------------------+
| 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. | +------------------------------------------------------------------------------+
CONTRAINDICATIONS
Hypocalcemia; pregnancy; and known hypersensitivity to denosumab products.
WARNINGS AND PRECAUTIONS
Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating
Jubbonti. Adequately supplement all patients with calcium and vitamin D.
Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk.
Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor
serum calcium. Same Active Ingredient: Patients receiving Jubbonti should not
receive other denosumab products concomitantly. Hypersensitivity including
anaphylactic reactions may occur. Discontinue permanently if a clinically
significant reaction occurs. Osteonecrosis of the jaw (ONJ): Has been reported
with denosumab products. Monitor for symptoms. Atypical femoral fractures: Have
been reported. Evaluate patients with thigh or groin pain to rule out a femoral
fracture. Multiple vertebral fractures have been reported following treatment
discontinuation. Patients should be transitioned to another antiresorptive agent
if Jubbonti is discontinued. Serious infections including skin infections: May
occur, including those leading to hospitalization. Advise patients to seek
prompt medical attention if they develop signs or symptoms of infection,
including cellulitis. Dermatologic reactions: Dermatitis, rashes, and eczema
have been reported. Consider discontinuing Jubbonti if severe symptoms develop.
Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms
develop. Suppression of bone turnover: Significant suppression has been
demonstrated. Monitor for consequences of bone over-suppression.
ADVERSE REACTIONS
Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common
than placebo) were: back pain, pain in extremity, hypercholesterolemia,
musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical
trials. Male osteoporosis: Most common adverse reactions (> 5% and more common
than placebo) were: back pain, arthralgia, and nasopharyngitis. Glucocorticoid-
induced osteoporosis: Most common adverse reactions (> 3% and more common than
active-control group) were: back pain, hypertension, bronchitis, and headache.
Bone loss due to hormone ablation for cancer: Most common adverse reactions (>=
10% and more common than placebo) were: arthralgia and back pain. Pain in
extremity and musculoskeletal pain have also been reported in clinical trials.
USE IN SPECIFIC POPULATIONS
Pregnant women and females of reproductive potential: Denosumab products may
cause fetal harm when administered to pregnant women. Advise females of
reproductive potential to use effective contraception during therapy, and for at
least 5 months after the last dose of Jubbonti. Pediatric patients: Denosumab
products are not approved for use in pediatric patients. Renal impairment: No
dose adjustment is necessary in patients with renal impairment. Patients with
advanced chronic kidney disease (eGFR Â