Reconsidering Risk, Before It's Too Late
Drugmakers have always preferred to in-license late-phase product candidates over earlier-stage ones. This value equation rests on the theory that drug candidates steadily shed risk as they move through development. But that's not necessarily so. Phase III products may in fact be riskier than most marketing and business-development people commonly assume.
You may also be interested in...
Bristol-Myers Squibb's licensing arrangement for ImClone's Erbitux--both its upfront cash value and its subsequent level of disappointment--continues to define the industry's late-stage dealmaking. Genta's development and marketing alliance with Aventis for Genta's phase III anti-cancer chemosensitizer, Genasense, is no exception: the deal is both bigger, and smaller, than it might once have been had BMS and ImClone not stirred up the dealmaking pot. The Genta product was one of the only remaining unpartnered, important late-stage cancer projects available from a biotech company. It commanded a hefty price --at $135 million in upfront and near-term assured cash terms, and another $345 million in milestones. Before ImClone, Aventis says, it could have gotten this deal for less money. But if the ImClone transaction hadn't gone suddenly south (the FDA in December refused to accept ImClone's BLA submission for Erbitux), Aventis might also have had to pay far more.
Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics.
The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.