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【drug-news】默克可望07年获得美国对HIV药物的批准
13 December 2006
NEW YORK: Merck & Co expects to seek US approval in 2007 for drugs to treat HIV, cholesterol and insomnia, and it aims to have another four products in late-stage trials by mid-year, the company said on Tuesday.
The products due to be in late-stage trials are MK-524B, which raises "good" HDL cholesterol; weight loss drug MK-364, which works through the same mechanism as Sanofi-Aventis' Acomplia; MK-974 for migraine headaches; and MK-822, which treats osteoporosis by blocking a protein called Cathepsin K.
Merck also described enthusiasm for its drugs in earlier stages of testing, as the company aims to restore double-digit earnings growth by 2010 following recent patent expirations on several of its older medicines and the withdrawal two years ago of its Vioxx arthritis treatment.
The US drugmaker laid out its hopes and plans in a 4-hour meeting with industry analysts and money managers, but Merck shares slipped about 1 per cent amid a perceived lack of excitement at the annual event.
"There really wasn't much surprise," Natexis Bleichroeder analyst Jon LeCroy said of the main portion of the meeting on drug research. "It's a relatively uneventful meeting."
OrbiMed Advisors analyst Trevor Polischuk said he took a "negative" overall view of the presentations on Merck's experimental drugs because side effects or disadvantages were seen among many of them.
"Every sort of compound you can come up with has some negative baggage," Polischuk said, referring to the highlighted Merck drugs.
AdvertisementAdvertisementFor example, Polischuk said Merck predicted its insomnia drug, gaboxadol, would be a controlled substance because of its abuse potential, eliminating a potential advantage over other sleep drugs.
Merck research chief Peter Kim said one of the company's most promising experimental drugs is its HIV medicine MK-518, which blocks an enzyme called integrase. It was well tolerated in clinical trials and worked faster than perhaps any other class of medicines to reduce levels of the virus that causes Aids, he said.
"The speed in knocking down HIV. . . and its ability to inhibit (drug) resistant HIV is very impressive," Kim said at the meeting, held at company headquarters in Whitehouse Station, New Jersey.
Kim also put the spotlight on MK-364, but noted that the weight-shedding drug was associated with psychiatric side effects in clinical trials. He noted that Sanofi's Acomplia had been associated with depression and other psychiatric problems in its own trials.
The research chief expressed enthusiasm for MK-859, another of Merck's HDL-raising drugs, which works the same way as Pfizer Inc's torcetrapib, a highly potent medicine for which trials were halted early this month due to safety concerns.
He said MK-859 raised levels of HDL by more than 50 per cent in clinical trials and cut levels of "bad" LDL cholesterol by more than 20 per cent, without raising blood pressure or causing serious cardiovascular side effects.
Torcetrapib, by contrast, was discontinued after it was linked to elevated blood pressure and a worrisome number of deaths.
Merck also singled out cancer drug, MK-457, now in mid-stage trials against a wide variety of tumors. It is designed to stimulate the body's natural process of destroying aberrant cells by blocking a protein called Aurora kinase.
Merck, which last week maintained its forecast for flat earnings for 2006 and slightly higher 2007 results, largely pegged its financial goals to revenue from three recently launched new vaccines and a new diabetes drug called Januvia.
Company officials on Tuesday also stressed the importance of a continuing cost-cutting programme meant to produce cumulative savings of $US4.5 billion ($NZ6.6 billion) to $US5 billion in the period 2006 through 2010.
Shares of Merck were down US40 cents to $US43.61 in afternoon trading on the New York Stock Exchange.
http://www.stuff.co.nz/stuff/0,2106,3898506a6026,00.html NEW YORK: Merck & Co expects to seek US approval in 2007 for drugs to treat HIV, cholesterol and insomnia, and it aims to have another four products in late-stage trials by mid-year, the company said on Tuesday.
纽约：默克公司打算2007年在美国寻求治疗HIV，胆固醇和失眠药物的批准，其目的是在年中获得另外四个产品的最后一阶段的试验
The products due to be in late-stage trials are MK-524B, which raises "good" HDL cholesterol; weight loss drug MK-364, which works through the same mechanism as Sanofi-Aventis' Acomplia; MK-974 for migraine headaches; and MK-822, which treats osteoporosis by blocking a protein called Cathepsin K.
处于最后一阶段试验的产品有，MK-524B，可提高“好”高密度脂蛋白胆固醇；减肥药MK-364，作用机制与Sanofi-Aventis公司的Acomplia相同；MK-974治疗偏头痛；MK-822通过阻断Cathepsin K蛋白治疗骨质疏松症。
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作者:admin@医学,生命科学 2011-05-06 05:14
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