Omegaven® is manufactured by German pharmaceutical company Fresenius Kabi. For some reason, the company decided to stay away from US market and this raised questions when announced back in 2006. Until patents held by FK are expired, no one in USA can sell Omegaven without license from FK.
Brief search in Clinical Trials registry gives 14 open clinical studies of Omegaven as Parenteral Nutrition in USA. I hope at least some of them don’t just pursue scientific goal of replicating earlier, but are compassionate attempts to provide an access to Omegaven by an Expanded Access Use program from FDA.
Several hundred saved children sadly is indeed too few for pharma to seriously care. The cost of clinical trial required for regulatory approval is ~ 100 M$ + about 100 M$ is required to set up manufacture, sales etc. With generous $ 100 000 per course of application (approx. a cost of life saved for pediatric anti-cancer drugs) and 200 patients/year, a company can generate $20 M revenue, so it has to wait 10 years just to cover the losses. And that without taking into account 30% IRR for VC, possible competitors undermining market share and so on.
Omegaven® is manufactured by German pharmaceutical company Fresenius Kabi. For some reason, the company decided to stay away from US market and this raised questions when announced back in 2006. Until patents held by FK are expired, no one in USA can sell Omegaven without license from FK.
Brief search in Clinical Trials registry gives 14 open clinical studies of Omegaven as Parenteral Nutrition in USA. I hope at least some of them don’t just pursue scientific goal of replicating earlier, but are compassionate attempts to provide an access to Omegaven by an Expanded Access Use program from FDA.
Several hundred saved children sadly is indeed too few for pharma to seriously care. The cost of clinical trial required for regulatory approval is ~ 100 M$ + about 100 M$ is required to set up manufacture, sales etc. With generous $ 100 000 per course of application (approx. a cost of life saved for pediatric anti-cancer drugs) and 200 patients/year, a company can generate $20 M revenue, so it has to wait 10 years just to cover the losses. And that without taking into account 30% IRR for VC, possible competitors undermining market share and so on.