The Next Wave: Pharm Exec's 2011 Pipeline Report - Pharmaceutical Executive


The Next Wave: Pharm Exec's 2011 Pipeline Report

Pharmaceutical Executive

HIV: Better Combos and Classes Keep Coming

The Holy Grail of the HIV community is a cure, while pharma persists in turning out new drugs—a critical need because with lifelong multidrug treatment the standard of care, many people with HIV risk running out of options due to resistance, toxicity, or price. The new class of integrase inhibitors is the main event on the calendar, as Gilead's elvitegravir and ViiV Healthcare's GSK 1349572 come online in 2013 and 2014, respectively. Along with Merck's first-in-class Isentress, these molecules, which thwart the virus' effort to integrate its genome into the host cell's DNA, have the potential to disrupt the $10 billion market currently in the hands of Gilead's megablockbuster fixed-dose combinations.

"Most of industry's focus right now is on second-generation integrase inhibitors," says McGill University's Matthias Gotte. "It's the only new target that is panning out, and coming up with new and better versions of protease inhibitors and the other classes is generally viewed as not cost-effective."

With no better efficacy than Isentress, and also sharing the same resistance profile, elvitegravir suffers from "too little, too late" syndrome. But Gilead has shrewdly bundled it in a new adherence-friendly four-in-one pill dubbed the Quad, which, along with the biotech's upcoming Truvada/riplivirine fixed-dose duo, will establish the one-pill cocktail as the gold standard. By contrast, the integrase blocker in development at ViiV, the GSK/Pfizer HIV joint venture, has gained "next big thing" status for its superior potency and unique resistance pattern. ViiV is already behind schedule to meet its stated goal of one new drug a year, but its investment in HIV R&D has the potential to revitalize this formerly on-a-mission field as it tests new non-nucleosides and new CCR5 inhibitors—classes of dwindling interest to competitors.

Depression: A Not-So-Rosy Outlook

"Depression is going through a challenging time," says Datamonitor analyst Ben Greener. "It's a mature market and reaching the patent cliff." Led by Prozac and Effexor, the market has been flooded with molecules that treat depression and anxiety by targeting two neurotransmitters, serotonin and norepinephrine. French pharma Servier took a very different approach with Valdoxan, a dual action molecule that combines a melanotergic receptor agonist and a 5HT2C antagonist, targeting the neurotransmitters dopamine and noradrenaline.

Already marketed in the EU, where uptake has been slow, its main selling points have been that it is fact-acting, free of the sexual side effects common to the serotonin-reuptake inhibitors, and a sleep promoter. But a recent analysis of pooled data from four head-to-head trials showed that Valdoxan beat Prozac and Effexor by a small but significant margin. With a growing need for boosters that jump-start a failing regimen, blockbuster sales are predicted for Valdoxan, according to Datamonitor.

Nicotine Addiction: What Lights Up the Field

The market for anti-smoking products exceeds $2 billion, but their superiority over cold-turkey quitting remains controversial. The first vaccines are set to offer a new weapon in the fight against nicotine addiction. Long-lasting single injections, these new vaccines remove the hurdle of daily adherence while sparking the immune system to produce nicotine-specific antibodies that aggregate nicotine in the bloodstream, resulting in a nicotine complex too large to cross the blood-brain barrier where the reward system awaits. Denying the pleasure of the fix may indirectly help minimize the craving that accompanies quitting smoking.


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