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Merck Stops Development of Odanacatib for Osteoporosis
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Merck & Co., Inc. (MRK - Free Report) announced that it is discontinuing the clinical development of its osteoporosis pipeline drug, odanacatib as its overall benefit-risk profile does not support filing or further development.
Odanacatib or MK-0822 was being developed as an oral, once-weekly treatment of osteoporosis in post-menopausal women.
In Sep 2014, Merck presented positive results from a pivotal phase III fracture outcomes study evaluating the use of odanacatib in postmenopausal women suffering from osteoporosis. However, though the study showed that treatment through odanacatib did reduce the risk of osteoporotic fractures, it also found that a higher number of adjudicated stroke events occurred in the odanacatib arm.
Additional analyses of data from the study, including an independent re-adjudication of major adverse cardiovascular events (MACE), confirmed an increased risk of stroke, which does not support further development.
The data will be presented at the upcoming Annual Meeting of American Society for Bone Mineral Research (ASBMR) in Atlanta in September.
We remind investors that in Jul 2012, the Data Monitoring Committee (DMC) had raised concerns regarding certain safety issues related to the candidate and recommended that these be followed up.
We note that Merck has had its share of pipeline and regulatory setbacks. The company received a complete response letter (CRL) for sugammadex (neuromuscular reversal agent) in 2015. Other setbacks include the discontinuation of vicriviroc (HIV), the termination of the development of acadesine (ischemia reperfusion injury in patients undergoing heart bypass surgery), as well as the discontinuation of the development of phase III candidates telcagepant (acute migraine), V710 (vaccine), preladenant (Parkinson’s) and MK-0431C (diabetes). Repetition of such pipeline failures can weigh heavily on the stock.
The latest news to discontinue the development of odanacatib did not impact the share price much, thereby indicating that the market was anticipating a negative finding.
Zacks Rank and Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).
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Merck Stops Development of Odanacatib for Osteoporosis
Merck & Co., Inc. (MRK - Free Report) announced that it is discontinuing the clinical development of its osteoporosis pipeline drug, odanacatib as its overall benefit-risk profile does not support filing or further development.
Odanacatib or MK-0822 was being developed as an oral, once-weekly treatment of osteoporosis in post-menopausal women.
In Sep 2014, Merck presented positive results from a pivotal phase III fracture outcomes study evaluating the use of odanacatib in postmenopausal women suffering from osteoporosis. However, though the study showed that treatment through odanacatib did reduce the risk of osteoporotic fractures, it also found that a higher number of adjudicated stroke events occurred in the odanacatib arm.
Additional analyses of data from the study, including an independent re-adjudication of major adverse cardiovascular events (MACE), confirmed an increased risk of stroke, which does not support further development.
The data will be presented at the upcoming Annual Meeting of American Society for Bone Mineral Research (ASBMR) in Atlanta in September.
MERCK & CO INC Price and Consensus
MERCK & CO INC Price and Consensus | MERCK & CO INC Quote
We remind investors that in Jul 2012, the Data Monitoring Committee (DMC) had raised concerns regarding certain safety issues related to the candidate and recommended that these be followed up.
We note that Merck has had its share of pipeline and regulatory setbacks. The company received a complete response letter (CRL) for sugammadex (neuromuscular reversal agent) in 2015. Other setbacks include the discontinuation of vicriviroc (HIV), the termination of the development of acadesine (ischemia reperfusion injury in patients undergoing heart bypass surgery), as well as the discontinuation of the development of phase III candidates telcagepant (acute migraine), V710 (vaccine), preladenant (Parkinson’s) and MK-0431C (diabetes). Repetition of such pipeline failures can weigh heavily on the stock.
The latest news to discontinue the development of odanacatib did not impact the share price much, thereby indicating that the market was anticipating a negative finding.
Zacks Rank and Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>