Novartis's Research Experiment
Against the trend, Novartis has dramatically increased its discovery infrastructure because, unlike most of its competitors, it believes it can cut R&D attrition. Drug research fails, its R&D execs believe, because it oversimplifies heterogeneous diseases. Instead, Novartis is testing drugs early in rare diseases that might be models of broader conditions. The proof-of-concept idea isn't new, but Novartis is exploiting it more extensively than anyone else, in virtually all new programs.
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The EMA has given the nod to Novartis subsidiary Alcon’s vitreomacular traction drug Jetrea and agreed to an indication extension for its Ilaris product to treat gouty arthritis. EMA’s Committee for Medicinal Products for Human Use also confirmed a recommendation to suspend the marketing authorizations of three Merck Sharp & Dohme products used to treat adults with dyslipidemia.
Rare disease drug development has ballooned in just three years, powered by the success of independent biotechs like Alexion, Big Pharma’s entrée into the field, and pressure from regulators and payors that is dis-incentivizing development of traditional primary care drugs. The positive momentum has intensified dealmaking in the orphan drug space and is giving investors confidence to back rare disease-focused start-ups. Some have coined the resulting movement the “orphan drug bubble,” but interest isn’t likely to deflate soon – at least not as long as Big Pharma continues to invest in the area and industry is able to sustain a favorable reimbursement climate for ultra-premium-priced drugs.
Novartis' $440 million offer for cancer testing services lab Genoptix is another sign of the pharma giant's intent to build a full-blown molecular diagnostics business. The acquisition adds muscle to its existing Molecular Diagnostics unit. Coming just months after GE grabbed up Clarient, it is another example of the value of a specialty cancer services testing operation to an organization looking to bolster channel access to oncologists and pathologists.