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% [?]

Drug makers have touted the importance of expanding in emerging markets like Russia, China and India to drive growth outside the slowing U.S. market. But one challenge is figuring out how to price drugs in those markets.

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A continuing dispute between GlaxoSmithKline and the Russian government over the pricing of HIV medicines illustrates the conundrum for companies of maintaining an acceptable profit margin vs. gaining market share, according to the WSJ.

Russia wants GSK to lower the price of its anti-retroviral medication Combivir by 15%. GSK refuses, saying that such a price wouldn’t be able to support a “viable business model,” according to Glaxo’s general manager in Russia, Fabio Landazabal, reports the WSJ. “Pricing of this level is clearly not sustainable nor appropriate if applied to middle-income countries.”

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GSK recently made a different decision in parts of Asia, cutting prices on some products by as much as 50% to make prices more affordable — and to increase increase sales.

“We’re ready to be flexible in our business model to be sure [Glaxo] is suited to the markets where we’re working,” GSK chief Andrew Witty told the WSJ.

Emerging markets have also been hit by the recession — IMS Health’s recent drug forecast said that expectations for growth in 2009 would be 3% to 4% lower than previously believed. Still, the top seven emerging markets “will contribute more than half of global market growth in 2009 and sustain an average 40% contribution through 2013,” according to IMS.

Source: The Wall Street Journal

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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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