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Amgen/Allergan's Rituxan Biosimilar Meets Goal in Phase III
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Amgen Inc. (AMGN - Free Report) and partner Allergan plc announced positive top-line results from a phase I/III study on the duo’s biosimilar candidate, ABP 798. Both companies are developing ABP 798 as a biosimilar version of Roche’s (RHHBY - Free Report) drug, Rituxan (rituximab).
The phase I/III study evaluated the pharmacokinetics (PK), efficacy and safety of ABP 798 as compared to Rituxan for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA). The study met the primary endpoint of PK similarity and also demonstrated an equivalent efficacy and a similar safety profile of the branded drug. The primary objective of the program was to compare the PK similarity of ABP 798 with Rituxan.
This study is one of the two analyses that will support global regulatory submissions of ABP 798. The second one is being conducted on patients with non-Hodgkin's lymphoma.
Notably, Rituxan is approved for treating adult patients with moderate-to-severe RA, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Amgen has collaborated with Allergan for the worldwide development and commercialization of four oncology antibody biosimilar medicines. Among them, a biosimilar version of Roche's Avastin — Mvasi — is already approved in the United States and the EU while a biosimilar version of Herceptin — Kanjinti — is under review in the United States and launched in the EU. Amgen is also developing biosimilar version of Johnson and Johnson/Merck's (MRK - Free Report) Remicade — ABP 710 — which is currently under review in the United States.
Currently, Amgen has 10 biosimilar products in its portfolio. Several of Amgen's own drugs are facing biosimilar competition. Biosimilars are already adversely impacting key products like Neupogen and Neulasta.
Shares of Amgen have increased 2.5% in the past year versus the industry's decline of 25%.
In a separate press release, Amgen stated that China's National Medical Products Administration (NMPA) has given an approval to include the cardiovascular indication on the label of its PCSK9 inhibitor, Repatha (evolocumab). Repatha has been approved in China for adult patients with established atherosclerotic cardiovascular disease to reduce the risk of myocardial infarction, stroke and coronary revascularization.
Last July, Repatha was approved in China for addressing adults and adolescents (aged 12 years and above) afflicted with homozygous familial hypercholesterolemia (HoFH).
The approval of this new indication in China will help high-risk patients, who are unable to control their low-density lipoprotein cholesterol (LDL-C) levels with statin therapy alone, with a new treatment option to prevent heart attacks and strokes.
We would like to remind investors that Repatha was approved by the FDA in 2015 for the same indication.
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Amgen/Allergan's Rituxan Biosimilar Meets Goal in Phase III
Amgen Inc. (AMGN - Free Report) and partner Allergan plc announced positive top-line results from a phase I/III study on the duo’s biosimilar candidate, ABP 798. Both companies are developing ABP 798 as a biosimilar version of Roche’s (RHHBY - Free Report) drug, Rituxan (rituximab).
The phase I/III study evaluated the pharmacokinetics (PK), efficacy and safety of ABP 798 as compared to Rituxan for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA). The study met the primary endpoint of PK similarity and also demonstrated an equivalent efficacy and a similar safety profile of the branded drug. The primary objective of the program was to compare the PK similarity of ABP 798 with Rituxan.
This study is one of the two analyses that will support global regulatory submissions of ABP 798. The second one is being conducted on patients with non-Hodgkin's lymphoma.
Notably, Rituxan is approved for treating adult patients with moderate-to-severe RA, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Amgen has collaborated with Allergan for the worldwide development and commercialization of four oncology antibody biosimilar medicines. Among them, a biosimilar version of Roche's Avastin — Mvasi — is already approved in the United States and the EU while a biosimilar version of Herceptin — Kanjinti — is under review in the United States and launched in the EU. Amgen is also developing biosimilar version of Johnson and Johnson/Merck's (MRK - Free Report) Remicade — ABP 710 — which is currently under review in the United States.
Currently, Amgen has 10 biosimilar products in its portfolio. Several of Amgen's own drugs are facing biosimilar competition. Biosimilars are already adversely impacting key products like Neupogen and Neulasta.
Shares of Amgen have increased 2.5% in the past year versus the industry's decline of 25%.
In a separate press release, Amgen stated that China's National Medical Products Administration (NMPA) has given an approval to include the cardiovascular indication on the label of its PCSK9 inhibitor, Repatha (evolocumab). Repatha has been approved in China for adult patients with established atherosclerotic cardiovascular disease to reduce the risk of myocardial infarction, stroke and coronary revascularization.
Last July, Repatha was approved in China for addressing adults and adolescents (aged 12 years and above) afflicted with homozygous familial hypercholesterolemia (HoFH).
The approval of this new indication in China will help high-risk patients, who are unable to control their low-density lipoprotein cholesterol (LDL-C) levels with statin therapy alone, with a new treatment option to prevent heart attacks and strokes.
We would like to remind investors that Repatha was approved by the FDA in 2015 for the same indication.
Zacks Rank
Amgen currently carries Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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