Pharm Exec's 2012 Pipeline Report - Pharmaceutical Executive


Pharm Exec's 2012 Pipeline Report

Pharmaceutical Executive

Novel Antibiotics: Kryptonite for Superbugs

The market for hospital-treated infections—including nosocomial pneumonia, skin infections, and urinary tract infections, among others—will increase from $3.3 billion in 2010 to $4 billion in 2020, according to Decision Resources. In the case of pneumonia, for which a broad armamentarium of treatments exists, the infection remains the seventh-leading cause of death in the US.

Existing foils for the superbug include Cubist's Cubicin (daptomycin), a drug Cubist cannily licensed to Teva, in exchange for the resolution of a patent dispute; Cubicin will now resist generic challengers through June of 2017. Revenues will help support late-stage candidates like CXA-201, a Phase III drug acquired through Cubist's buyout of Calixa Therapeutics in 2009. CXA-201 is being tested for complicated urinary tract infections (cUTI), and as a first-line intravenous therapy for gram-negative bacterial infections, including multi-drug resistant pseudomonas aeruginosa. For cUTI, the company made the gutsy decision to test against levofloxacin, or generic Levaquin, as a comparator. Levaquin had blockbuster sales in 2010, but lost patent protection this year. "Cubist is banking very heavily on CXA-201," says Selvaraju.

Another class of antibiotics getting lots of attention is the oxazolidinones, of which Pfizer's Zyvox is a member. Despite some overzealous selling techniques—Pfizer acknowledged "certain improper actions" related to Zyvox promotion as part of the company's humongous $2.3 billion settlement over off-label Bextra marketing in 2009—the drug had blockbuster sales in 2010. Trius Therapeutics, a San Diego-based biopharma, is now in Phase III testing on a next-in-class oxazolidinone called tedizolid phosphate, or TR-701. If approved, Bayer will sell the drug outside the US. "Data [on TR-701] is coming in early 2012, and I'm very confident that it will be positive," says Selvaraju. "There's activity in this drug not only in skin infections, but also in bacterially associated pneumonia, so it's got a broad spectrum of activity, and I think it will become a very nice commercial opportunity for Trius going forward."

A third member of the oxazolidinones class is Rib-X's Radezolid, which is a little bit further behind TR-701, with Phase III data scheduled for early 2013. Rib-X formed a collaboration with Sanofi to explore bacterial ribosomes as a weapon against superbugs; Selvaraju says Rib-X has a "very unique discovery platform" based on in-depth knowledge of the bacterial ribosome.

Lastly, Cempra Pharmaceuticals is in Phase III with a next-gen oral and intravenous fluoroketolide called solithromycin, a member of the macrolides class of drugs. Macrolides include some of the most widely used agents for treating pneumonia and skin infection, such as Pfizer's Zithromax. Many of the macrolides have gone generic, and solithromycin "appears to have none of the side effect issues [of other macrolides], but does have a much greater activity against resistant organisms than any other member of its class," says Selvaraju.


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