Launching Ampyra: What Drug Companies Can Learn From The Experience
Acorda Therapeutics Inc.'s risky regulatory strategy paid off at FDA, but it also has ramifications in the commercial world. As of September 30, seven months after Ampyra (dalfampridine) launched on March 1, the drug had generated sales of more than $85 million, well above the company's forecasts and most Wall Street analysts' expectations. But given the novelty of the drug and its clinical endpoints, its launch has also presented challenges. FDA approved Ampyra despite a mixed Advisory Committee reaction, and what some perceive to be poorly defined clinical endpoints, questionable responder rates, and a safety risk of seizures. As a result, doctors, payors, and patients must be educated about the science behind Ampyra. Some wonder if its stellar launch trajectory can continue, given what they perceive to be the drug's low efficacy for most people and lack of data correlating walking speed and improved quality of life or functionality. Furthermore, in the increasingly pressurized environment of reimbursement, payors are reviewing evidence on their own and may not come to the same conclusions as FDA.
You may also be interested in...
Several new drugs for multiple sclerosis could launch within the next two years, but amid escalating drug costs, payors are taking a harder look at the therapeutic category. New drugs will face increasing reimbursement hurdles, as payors implement the first prior authorization and step therapy protocols and look for ways to implement further cost reductions.
Lured by the success of Abbott in rheumatology, Novartis in oncology, and Genzyme in orphan/genetic diseases, pharmaceutical manufacturers have turned their collective sights on specialist-driven markets. But payor pressure is ballooning and as examples in these hotly competitive areas demonstrate, to truly succeed in specialist markets, companies cannot rely on a ‘follower’ strategy. Instead, careful selection of indications where true innovation is possible and fostering meaningful interaction with physicians and patient communities will allow pharmaceutical companies to grow specialty franchises alongside traditional strengths.
FDA new drug approvals are making a comeback, and a group of biopharma first-timers are leading the way. To understand the challenges they face in the transition from discovery to commercialization, IN VIVO looked at 50 companies spanning the past 10 years. Finally reaching the US market might be a biotech's defining moment, but for those who build to last, there could be more rewards beyond that first approval.