Dive Brief:
- Strongbridge Biopharma plc has found early success relaunching a rare disease drug it bought from an Israeli drugmaker last year after that company was unable to find enough patients to support continued marketing of the treatment.
- Strongbridge rang up $1.5 million in net product sales for Keveyis (dichlorphenamide), a treatment for primary periodic paralysis which it relaunched commercially in the U.S. in April.
- The company says nearly 70 of the 80 pre-existing patients who were receiving Keveyis through compassionate use have been converted to Strongbridge's commercial supply and patient assistance program.
Dive Insight:
Taro Pharmaceutical Industries Ltd., which originally developed Keveyis, had been distributing the drug free of charge since last May after earning less than $1 million in sales following an August 2015 approval from the Food and Drug Administration.
Taro struggled to identify patients with the disease and its related variants, many of which frequently go undiagnosed. Primary periodic paralysis is an ultra-rare hereditary disorder that causes muscle weakness and paralysis.
Strongbridge bought U.S. rights to Keveyis in December for upfront and deferred payments totaling $8.5 million. Per deal terms, Taro agreed to continue to manufacture the drug for Strongbridge through Keveyis' period of orphan drug exclusivity.
Strongbridge seems to be making inroads where Taro couldn't. While Taro had failed to establish a market, Strongbridge says it has secured broad payer coverage and has generated 30 new patient start forms over the first 10 weeks its 12-person sales team has been in place.
The company also conducted a market analysis to gain a better understanding of the prevalence of the condition in the U.S. Information collected from a claims database suggested there may be up to 5,000 patients in the country with the disease, twice original estimates.
Identifying those patients will be critical as Strongbridge has already run out of existing patients to convert to commercial supply. Still, the company was enthusiastic about the early market signals and said it is looking at increasing its investment and expanding the sales team.