New drug re­duces heart at­tacks, but is that enough?

Miami Herald - - FRONT PAGE -

TREN­TON, N.J. — Soso re­sults for a new type of choles­terol drug have left Merck in a quandary: Does the com­pany try to bring it to mar­ket or scrap it?

A large, long-term study of the drug showed that it pre­vents heart at­tacks and re­duces the need for heart pro­ce­dures, while three sim­i­lar drugs de­vel­oped by ri­vals failed. But the drug, anace­trapib, only re­duced those com­pli­ca­tions by 9 per­cent.

Now Merck, which has spent 13 years and likely hun­dreds of mil­lions of dol­lars test­ing the drug, has to de­cide whether to spend even more to seek ap­proval from reg­u­la­tors and con­vince peo­ple to buy it in a mar­ket full of choles­terol drugs.

The re­sults of the 30,450pa­tient study were an­nounced Tues­day at a con­fer­ence of heart spe­cial­ists in Barcelona, Spain and pub­lished in the New Eng­land Jour­nal of Medicine. The study found that anace­trapib is safe and some­what ef­fec­tive.

That kind of re­sult is nor­mally enough to seek ap­proval to mar­ket a new medicine, es­pe­cially for heart dis­ease, which is the top killer in many de­vel­oped coun­tries. Yet even af­ter see­ing the re­sults weeks ago, Merck says its ex­ec­u­tives are still con­sult­ing with med­i­cal ex­perts and reg­u­la­tors on whether to go through the costly process of ap­ply­ing for ap­proval.

An­a­lyst Steve Brozak, pres­i­dent of WBB Se­cu­ri­ties, pre­dicts Merck will do so, given anace­trapib’s safety, the huge pool of po­ten­tial pa­tients and all the re­sources Merck has poured into the drug.

“This will get used,” Brozak said.

Merck would likely price the bill some­where be­tween the two ex­tremes that now de­fine the mar­ket for choles­terol drugs.

Generic ver­sions of brand-name statin choles­terol pills in­clud­ing Lip­i­tor, Crestor and Merck’s own Zo­cor now cost $10 to $20 a month. Repatha and Pralu­ent, two new in­jected medicines in a dif­fer­ent drug cat­e­gory that have been shown to dra­mat­i­cally re­duce choles­terol, cost $14,000 a year.

Ge­orge­town Univer­sity car­di­ol­o­gist Dr. Allen J. Taylor said he thinks the drug would be ap­proved by the Food and Drug Ad­min­is­tra­tion de­spite its “rel­a­tively weak ben­e­fit.”

“If you were dis­cussing this with pa­tients,” Taylor said, “you would have to tell them that when you start this, you’ll have to take it for four years to have a 1 per­cent chance of pre­vent­ing an event,” mean­ing a heart at­tack or a pro­ce­dure such as by­pass surgery or im­plant­ing a stent to keep an artery open.

Taylor said it’s still un­clear how anace­trapib con­trols choles­terol, which would make it hard for doc­tors to de­ter­mine which pa­tients would ben­e­fit much from it. But he and Brozak praised the com­pany for do­ing such an ex­haus­tive, ex­pen­sive study in an era when many stud­ies are quick and rel­a­tively small, some­times pro­duc­ing un­clear re­sults.

In the study, pa­tients get­ting anace­trapib plus a statin for four years had, on av­er­age, lower lev­els of bad choles­terol and other fats, and higher lev­els of good choles­terol, com­pared to a group get­ting a statin and a dummy pill. But Merck’s drug didn’t pre­vent any deaths from heart at­tacks or other car­diac prob­lems.

Anace­trapib’s only wor­ri­some side ef­fect was a longterm ac­cu­mu­la­tion of the drug in pa­tients’ fatty tis­sue. It’s un­known if that will cause prob­lems, so Merck plans to study that by fol­low­ing some par­tic­i­pants for two years af­ter they stop tak­ing the drug.

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