Discovery Laboratories has announced that the FDA has approved the Afectair device for marketing in the US, and the company plans a launch later this year. The company describes Afectair as “a proprietary patient interface technology that simplifies delivery of aerosolized medications to patients requiring ventilator support” and estimates that it could bring in $50-75 million.
Discovery Labs Chairman and CEO W. Thomas Amick commented, “We are pleased to have Afectair registered with the FDA and we are eager to move this proprietary technology to commercialization in the latter part of 2012. Our ability to bring Afectair to market is a testament to our commitment to advancing a new standard in respiratory critical care.”
The company’s Senior VP and COO Thomas Miller said, “In preparation for this milestone, we identified a number of operational and commercial options intended to support the commercial introduction of Afectair. We are now focused on implementing a commercial plan that includes the establishment of key strategic manufacturing and distribution relationships.”
According to Discovery Labs, it expects to receive a European Conformity (CE) marking for commercialization of Afectair in the EU in time to launch the products in Europe by the end of 2012 as well. Last fall, the EU granted orphan designation to Discovery’s Aerosurf aerosolized KL4 surfactant; the Afectair was originally developed for the delivery of Aerosurf.
Read the Discovery Labs press release.
