FDA’s advisory panel voted 10 to 4 in favor of Pfizer’s Selzentry for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy. It remains to be seen whether the drug will pass muster at the FDA as data showed that Selzentry (maraviroc) along with Combivir® was as effective as Sustiva® plus Combivir at reducing viral load.

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Selzentry was granted accelerated approval in August 2007 and full approval in November 2008 by the FDA for use in treatment-experienced adult patients with only CCR5-tropic HIV-1 virus in combination with other antiretroviral therapies. The drug works by inhibiting viral entry into uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

Monogram Biosciences provides a companion diagnostic for Selzentry, called Trofile®. This assay identifies patients with CCR5-tropic HIV-1 virus.

FDA’s Antiviral Drugs Advisory Committee made its decision based on 48- and 96-week efficacy and safety data from an ongoing Phase III MERIT (maraviroc versus efavirenz regimens as initial therapy) trial and MERIT ES (analysis of the MERIT study with the enhanced sensitivity Trofile™ assay).

Results of MERIT at 48 weeks showed that Selzentry plus Combivir was as effective as Sustiva (efavirenz) plus Combivir at reducing viral load for the co-primary endpoint of less that 400 copies/mL. The combination, however, did not show noninferiority for the co-primary endpoint of less than 50 copies/mL at 48 weeks. Safety results at 96 weeks showed that among those patients who remained on therapy, less than half the number of malignancies were observed in patients taking Selzentry compared to those taking Sustiva.

MERIT ES is a retrospective analysis, which utilized Trofile in screening samples from the MERIT trial. Results of MERIT ES at 48 weeks showed that treatment-naïve patients with CCR5-tropic HIV-1 in the Selzentry combo arm experienced comparable virologic suppression to undetectable levels (< 50 copies/mL) as those in the Sustiva combo arm.

Source: GEN News

Popularity: 5% [?]

A U.S. Food and Drug Administration advisory panel on Thursday recommended Pfizer Inc’s <PFE.N> HIV drug Selzentry be approved for wider use in certain patients with the disease, despite concern from several panel members that they were underwhelmed by the data.

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Pfizer is seeking U.S. approval to market Selzentry for HIV patients who have a specific type of HIV-1 — one of two strains of the human immunodeficiency virus that causes AIDS — who have not tried any medications yet. It would be taken with other antiretroviral drugs.

In a 10-4 vote, panel members backed the wider use, saying it did offer doctors and patients another choice even if more data is needed.

“We’re not looking for the absolute best, we’re looking for an option,” said panelist Dr. Victoria Cargill, who heads minority research at the National Institutes of Health’s Office of AIDS Research, and voted for the drug.

FDA officials will weigh the panel’s vote before making its final approval decision. Pfizer said it expects a decision by Nov. 20.

Selzentry, also known as maraviroc, is already approved for use along with other drugs for HIV patients who have tried other antiretrovirals but have developed a resistance to them.

If approved, Selzentry would be expanded to adults with chemokine (c-c motif) receptor 5, or CCR5, tropic HIV-1 who have not yet begun treatment. Patients would need to first be tested for that particular strain before taking the medication, the company said.

But a number of panelists, even those who opted for the drug, said they were conflicted about backing the wider use given the company’s somewhat limited data.

Panelist Dr. Russell Van Dyke, professor at Tulane University School of Medicine, said he voted for the expanded use despite feeling some anxiety about it.

“I worry that it’s not quite as potent as we’d like it to be,” he said.

Pfizer officials said their trial, which compared Selzentry to efavirenz, showed its drug helped reduce viral load. Efavirenz is marketed as Sustiva by Bristol-Myers Squibb Co <BMY.N>.

But some panelists said that a number of other options have hit the U.S. market in recent years. Several panelists said the company’s data was underwhelming, especially given other available drugs.

They noted concerns about the number of patients in the study who stopped using the drug because of side effects like dizziness or rash as well as those who developed a resistance.

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“We have several first-line options available to us in 2009. I’m not convinced that this drug is my first choice” for patients who are new to HIV medications, said Dr. Barbara McGovern, a professor of medicine at Tufts University School of Medicine who voted against the drug.

Overall, panelists said they wanted Pfizer to gather more data on the effect of the drug in pregnant women as well as patients with hepatitis or tuberculosis. They also urged FDA officials to make the drug’s limitations clear on its label.

While the FDA does not factor costs into its approval decisions, some consumer advocates after the panel’s vote called on Pfizer to lower the price of Selzentry, which it says has risen 10 percent since its initial approval in 2007 to $13,767 per patient for a year’s worth of treatment.

“While any new HIV/AIDS drug is welcome, we urge Pfizer to use restraint and to lower the price of Selzentry immediately,” said AIDS Healthcare Foundation President Michael Weinstein, whose nonprofit groups provides health care to HIV and AIDS patients around the world.

Some panelists also mentioned the drug’s cost. Pfizer reported $46 million in Selzentry sales in 2008.

In a statement, Pfizer said it was pleased with the panel’s vote and would work with the FDA on the drug’s label.

Source: Reuters

Popularity: 7% [?]

GlaxoSmithKline and Pfizer announced Thursday that the drugmakers agreed to combine their HIV-drug segments into a new company focused on the research, development and commercialisation of HIV medicines. GlaxoSmithKline CEO Andrew Witty stated that “at the core of this specialist business is a broad portfolio of products and pipeline assets, which can be more effectively leveraged through the new company’s strong revenue base and dedicated research capability.”

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At the closing of the transaction, expected in the fourth quarter, GlaxoSmithKline will control 85 percent of the joint venture and Pfizer will hold 15 percent. According to the terms of the agreement, Pfizer’s interest could rise to as much as 30.5 percent in the event that certain sales and regulatory milestones are achieved. Dominique Limet, head of GlaxoSmithKline’s Personalised Medicine Strategy, was appointed CEO designate of the combined entity.

The new company will have 11 marketed products, including Combivir (lamivudine/zidovudine), Epzicom/Kivexa (abacavir/lamivudine), and Selzentry/Celsentri (maraviroc), and will hold a 19-percent share of the HIV market. The company will have 6 drugs in its pipeline, including 4 compounds in mid-stage development, as well as 17 molecules at its disposal to develop in fixed-dose combinations as possible new HIV treatments. Based on 2008 results, sales from the combined portfolio reached 1.6 billion pounds ($2.4 billion).

Commenting further on the deal, Witty remarked that “this is a new and unique way of incentivising research success and deciding how to allocate research and development capital.” He said the new company is “going to have two parents out there with, I think, a very rapid decision-making mechanism to allow it to be funded for what it needs to do.” The executive also explained that the new venture will not include GlaxoSmithKline’s vaccine programme. “Who knows down the road whether or not there would be a commercial collaboration opportunity if and when those vaccines make it to market, but they’re not currently scheduled to go into this business,” Witty noted.

In response to the news, analyst Navid Malik of Matrix Corporate Capital suggested that “GlaxoSmithKline is looking to consolidate its franchise through this tie-up with Pfizer, who are probably looking to exit HIV.” In addition, he suggested that “it’s quite a dramatic step, for two rival companies to put their pride aside and work together like this. But if they don’t there is a good chance that both their HIV businesses will fade away over time.” UBS analyst Gbola Amusa said the agreement could lead to more partnerships that result in company break ups and sales, and speculated that “we’ll look back in a few years and highlight this deal as being industry-shifting.”

Source: FirstWord

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