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Amgen Files for Approval of Osteoporosis Drug in Japan
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Amgen Inc. (AMGN - Free Report) and partner UCB SA (UCBJF - Free Report) announced that they have submitted an application seeking marketing approval for its investigational monoclonal antibody romosozumab to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The companies are looking to get romosozumab approved for the treatment of osteoporosis in postmenopausal women at an increased risk of fracture.
Amgen’s share price has gained 1.5% in the past one month, outperforming the 4.5% fall witnessed by the Zacks classified Medical-Biomedical and Genetics industry.
Per the latest release, romosozumab works by binding and inhibiting the activity of the protein sclerostin, and leads to increased bone formation and lower bone resorption. The drug has been co-developed by Amgen and UCB worldwide, while in Japan, it was developed by Amgen Astellas BioPharma, a joint venture between Amgen and Japanese pharmaceutical company Astellas Pharma. The Japanse regulatory submission was based on two pivotal phase III studies – FRAME and BRIDGE.
Amgen has already filed for an approval of romosozumab in the U.S. and Canada for this indication.
Osteoporosis is a major public health issue among the aging population of Japan, with about 12 million people suffering from the disease. The rate of incidence of hip fracture is increasing in the older population of the country. Hence, the regulatory filing for the drug calls seeks to address massive unmet need for osteoporosis patients at a high risk of fracture.
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Cambrex Corporation and Heska Corporation Both Cambrex and Heska sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 83.8% year to date.
Cambrex’s earnings estimates increased 3.7% for 2016 and 5.2% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 13% year to date.
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Amgen Files for Approval of Osteoporosis Drug in Japan
Amgen Inc. (AMGN - Free Report) and partner UCB SA (UCBJF - Free Report) announced that they have submitted an application seeking marketing approval for its investigational monoclonal antibody romosozumab to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The companies are looking to get romosozumab approved for the treatment of osteoporosis in postmenopausal women at an increased risk of fracture.
Amgen’s share price has gained 1.5% in the past one month, outperforming the 4.5% fall witnessed by the Zacks classified Medical-Biomedical and Genetics industry.
Per the latest release, romosozumab works by binding and inhibiting the activity of the protein sclerostin, and leads to increased bone formation and lower bone resorption. The drug has been co-developed by Amgen and UCB worldwide, while in Japan, it was developed by Amgen Astellas BioPharma, a joint venture between Amgen and Japanese pharmaceutical company Astellas Pharma. The Japanse regulatory submission was based on two pivotal phase III studies – FRAME and BRIDGE.
Amgen has already filed for an approval of romosozumab in the U.S. and Canada for this indication.
Osteoporosis is a major public health issue among the aging population of Japan, with about 12 million people suffering from the disease. The rate of incidence of hip fracture is increasing in the older population of the country. Hence, the regulatory filing for the drug calls seeks to address massive unmet need for osteoporosis patients at a high risk of fracture.
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Cambrex Corporation and Heska Corporation Both Cambrex and Heska sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 83.8% year to date.
Cambrex’s earnings estimates increased 3.7% for 2016 and 5.2% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 13% year to date.
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