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0404 - Summary/Objective
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040501 - Follow up ref SDS 2 DG36, ref SDS 1 IM9N.
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0408 - Progress
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040901 - Article published by Reuters News Service
040902 -
040903 - Reuters News Service
040905 - ..
040906 - Monthly shots of Amgen drug slash cholesterol 66 percent
040907 -
040908 - By Ransdell Pierson, Editing by Gary Crosse
040909 -
040910 - http://news.yahoo.com/monthly-shots-amgen-drug-slash-cholesterol-66-percent-165320912.html
040912 - ..
040913 - Published March 25, 2012
040915 - ..
040916 - 1. CHICAGO (Reuters) - Monthly injections of an experimental drug
040917 - from Amgen Inc slashed levels of cholesterol by up to an
040918 - additional 66 percent in patients already taking statins,
040919 - researchers said on Sunday, making it a potential strong rival
040920 - to a similar drug being developed by Regeneron Pharmaceuticals
040921 - Inc.
040923 - ..
040924 - 2. Amgen and Regeneron are racing to develop medicines that cut
040925 - cholesterol through a new strategy, by blocking a protein
040926 - called PCSK9.
040928 - ..
040929 - 3. In earlier studies, both drugs cut levels of "bad" LDL
040930 - cholesterol by up to two thirds, although Amgen's AMG 145 had
040931 - been tested in healthy volunteers taking no other cholesterol
040932 - medicines, while Regeneron's REGN 727 was tested in patients
040933 - with high cholesterol that also took statins.
040934 -
040935 - [On 120325 1950 reported continuing recent symptoms of
040936 - neuropathy in lower legs, possible side effects of
040937 - rosuvastatin. ref SDS 3 Z45I
040939 - ..
040940 - 4. Amgen on Sunday reported its first results from an early-stage
040941 - trial of AMG 145 in patients with high cholesterol also taking
040942 - statins, and impressive findings were seen in those getting
040943 - injections every two weeks or every month.
040945 - ..
040946 - 5. In the 51-patient study, patients receiving monthly injections
040947 - of AMG 145 and taking low to moderate doses of statins had up
040948 - to a two-thirds reduction in LDL cholesterol by the eighth week
040949 - of the study.
040951 - ..
040952 - 6. "We gave two doses four weeks apart and at the eighth week
040953 - there was minimal tapering off" of the drug's potency, Clapton
040954 - Dias, Amgen's medical services director, said in an interview.
040955 - "The 66-percent reduction of LDL was maintained."
040957 - ..
040958 - 7. In patients receiving injections of AMG 145 every two weeks in
040959 - combination with low to moderate doses of statins, LDL
040960 - reductions of up to 75 percent were seen after six weeks, Amgen
040961 - said.
040963 - ..
040964 - 8. Those taking the Amgen drug every two weeks in combination with
040965 - high doses of statins had LDL reductions of up to 63 percent.
040967 - ..
040968 - 9. Data from the Phase 1 study were presented at the annual
040969 - scientific sessions of the American College of Cardiology being
040970 - held in Chicago.
040972 - ..
040973 - 10. Researchers on Monday are slated to release the full data from
040974 - a Phase II study of REGN 727, and the findings will better
040975 - enable investors to size up the pros and cons of the rival
040976 - therapies.
040978 - ..
040979 - 11. Neither drug has shown any serious side effects so far in
040980 - clinical trials.
040982 - ..
040983 - 12. Dias said the ability of drugs like AMG 145 to slash LDL beyond
040984 - decreases attributed to statins such as Pfizer Inc's Lipitor
040985 - could help enable millions of heart patients to finally get
040986 - their cholesterol levels tightly controlled.
040988 - ..
040989 - 13. "A good 60 percent of high-risk patients in the United States
040990 - are unable to meet their aggressive goals of getting LDL levels
040991 - down" to target levels, Dias said, making them prime candidates
040992 - for AMG 145 if it continues to do well in trials and is
040993 - approved.
040994 -
040995 - 14. (Reporting by Ransdell Pierson, Editing by Gary Crosse)
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