Re: NATAP: Merck Integrase 'Approval Expected Today'
Brian Mailman
about a cluster of cancers in the "drug" group vs. the placebo group in
testing? I vaguely remember that being a concern...
B/
> *Merck HIV drug 'Approval Expected Friday'
>
> *WASHINGTON http://www.businessweek.com
>
> Merck & Co. is expected to receive approval to market a first-of-kind
> HIV drug as early as Friday.
>
> The Food and Drug Administration is scheduled to make a decision on
> the company's drug Isentress to treat HIV patients who have developed
> a resistance to other medications. Physicians often prescribe a
> "cocktail" of several HIV drugs to fight the virus because it changes
> very rapidly.
>
> A panel of outside advisers unanimously recommended FDA rapidly
> approve the drug at a meeting last month.
>
> The Merck drug targets integrase, one of three enzymes used by the
> virus to reproduce and infect cells. The FDA previously has approved
> drugs that target the two other enzymes.
>
> Despite Isentress' innovative HIV-fighting mechanism, the drug could
> have trouble reaching blockbuster sales. Like most HIV therapies
> approved in recent years, Isentress will serve as a second-line
> therapy for patients who have stopped responding to older, more
> established drugs.
>
> BMO Capital Markets Robert Hazlett predicts sales of $400 million
> next year and peaking $950 million by 2010. By comparison, Gilead
> Science's market-leading drug Truvada posted sales of $1.1 billion
> last year. Gilead is also expected to have a drug similar to
> Isentress on the market by the end of the decade.
>
> *Merck's New AIDS Drug Has Promise -- if It Isn't Too Pricey
>
> *Wall St Jnl By SARAH RUBENSTEIN October 11, 2007; Page B1
>
> Merck & Co. could break new ground on the AIDS-fighting front this
> week with the Food and Drug Administration's expected approval of
> Isentress, a new type of drug that could be especially useful for
> patients who no longer respond to many existing treatments. Yet
> despite the continuing need and market for HIV treatments, and
> doctors' enthusiasm about the drug's prospects, it's no sure thing
> that Isentress will pay off for Merck.
>
>
> A major factor is pricing, yet to be determined and especially
> important because of the recent arrival of several other drugs to
> fight HIV, the virus that causes AIDS. Pfizer Inc.'s Selzentry, which
> won regulatory approval this summer, costs about $10,600 a year
> wholesale. Roche Holding AG's Fuzeon, which came out in 2003, costs
> about $24,500 a year wholesale, much higher than many other AIDS
> drugs. And Johnson & Johnson came out with Prezista last year and may
> win approval of another HIV drug in early 2008.
>
> Merck declines to discuss pricing ahead of an FDA decision. But if
> the company were to price Isentress at the high end of the range,
> "there's no way the system could handle that," says Lanny Cross, a
> former director of the New York AIDS Drug Assistance Program and a
> consultant for the National Alliance of State and Territorial AIDS
> Directors.
>
> Martin Delaney, a longtime AIDS activist, who has participated in
> price negotiations with Merck on behalf of a group called the Fair
> Pricing Coalition, says the company has shown sensitivity to
> patients' financial needs in the past. But he says Merck officials
> have been "arguing they need to get profitability." He says Merck has
> indicated it wants to price Isentress in the range of relatively new
> AIDS drugs such as Prezista and Bristol-Myers Squibb Co.'s Reyataz,
> both of which cost around $9,500 a year wholesale, according to their
> makers. He also says Merck has told him it has spent close to $2
> billion on HIV research.
>
> Isentress arrives at a time when Merck has just one other HIV drug in
> clinical trials, at the earliest stage of such testing. And it is
> just weeks after Merck's leading experimental AIDS vaccine collapsed
> in a clinical trial. Isentress represents a chance for Merck to show
> it is still a major player in this arena despite a years-long gap
> since it last brought a new drug to counter HIV to the market. Some
> doctors are excited by Isentress's potential, in particular because
> the pill represents a new way to attack a virus that has managed to
> develop resistance to many other drugs.
>
> An advisory panel of outside medical experts last month said the data
> support FDA approval of Isentress for patients who have failed
> treatment with other HIV drugs. The agency isn't required to follow
> such panels' advice, but usually does.
>
> Merck may find it difficult to sell Isentress at the highest price
> possible when many public-assistance programs that help pay for HIV
> treatments are experiencing fiscal strain. In the 2006 fiscal year,
> 20 out of nearly 60 AIDS Drug Assistance Programs saw their budgets
> decrease, according to the Kaiser Family Foundation, a nonprofit
> health-policy research group in Menlo Park, Calif. Such programs
> bought drugs for nearly 100,000 HIV patients in 2006 and provided
> insurance coverage for thousands more, according to Kaiser.
>
> Merck declines to specify how much it spent to develop Isentress or
> to research other HIV drugs, beyond saying it has spent "hundreds of
> millions of dollars" on such work. "We believe [HIV research] is the
> right thing to do," says Robin Isaacs, the Whitehouse Station, N.J.,
> company's executive director of infectious-disease clinical
> research. "We are hopeful that will translate into return on
> investment for our shareholders."
>
> While Merck is viewed by many in the AIDS community as one of the
> major drug makers most committed to HIV research, revenue from such
> products currently represents a modicum of Merck's total revenue,
> which amounted to $22.64 billion last year. The company drew a
> combined $327 million from sales of Crixivan, an HIV drug from the
> mid-1990s that is no longer used widely, and Stocrin, which Merck
> sells overseas.
>
> Isentress could provide a bottom-line boost, though it doesn't carry
> the potential of some major Merck products such as asthma-drug
> Singulair, which had $3.58 billion of sales last year. Credit Suisse
> drug analyst Catherine Arnold estimates Merck's annual sales of
> Isentress could be $500 million world-wide by 2012, and likely more
> if used in a broad swath of patients. Merck is an investment-banking
> client of Credit Suisse.
>
>
> Another factor influencing Isentress's prospects is whether doctors
> will prescribe it for patients in early stages of HIV treatment. The
> FDA advisory panel debated how early in a patient's treatment to
> approve Isentress use, given that most patients in Merck's trials had
> used a number of drugs already. It will be up to the FDA to make that
> determination -- though doctors would be permitted to prescribe
> Isentress "off label" at any point in treatment.
>
> About two-dozen HIV drugs are now available, most of which block two
> enzymes that HIV uses to replicate in the body: protease and reverse
> transcriptase. Isentress, known generically as raltegravir, would be
> the first drug on the market to target a third enzyme -- integrase --
> that helps the virus insert its DNA into that of human cells.
>
> Because HIV mutates quickly to outwit drugs, cocktails of three
> medications are typically used to simultaneously attack the virus in
> different spots. Patients tend to change drugs as their virus
> adapts. Isentress would be taken along with other drugs.
>
> Merck's late-stage studies of Isentress involved patients who had
> been receiving HIV treatment for a median of 10 years, had virus
> resistant to at least one drug in each of three major classes of HIV
> drugs and showed evidence the virus was continuing to replicate in
> their bodies. In other words, they were already sick or in danger of
> becoming sick soon.
>
> "Since this drug seems to be very effective and pretty well
> tolerated, I think [there is] potential for it to move in and take
> territory" from some older drugs, says Judith Feinberg, a leader of
> the AIDS clinical-trials unit at the University of Cincinnati College
> of Medicine who served on the advisory panel.
>
> However, she said some doctors may be uncomfortable prescribing
> Isentress more broadly until further studies are complete. Merck is
> currently conducting late-stage Isentress studies in patients who are
> new to HIV treatment. The company expects to have the results toward
> the end of 2008. Dr. Feinberg says she had no ties to Merck at the
> time of the panel hearing but has since agreed to give talks
> sponsored by the company.
>
> Isentress will be used principally in "patients who have tried a
> whole raft of drugs," says Daniel Kuritzkes, director of AIDS
> research at Brigham and Women's Hospital in Boston, who consults for
> Merck and other HIV-drug makers. However, "for patients who have
> earlier stages of disease, there will be some tendency to hold off
> because it's so useful in patients with extensive treatment
> experience."
>
>
> Another potential complication is that Isentress is taken twice a
> day, while some new patients take a once-a-day pill called Atripla
> that combines three drugs. That could make it tougher to get patients
> to take Isentress from the beginning.
>
> While Merck has little else for HIV in clinical trials,
> research-and-development chief Peter Kim says the company is
> committed to pursuing HIV treatments, and continues to do research
> related to the integrase enzyme.
>
> "We really do think that this drug-resistance issue is going to
> continue to be a significant unmet medical need," Dr. Kim says.
>
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