Baxter International Inc. (NYSE:BAX) notched a pair of wins over the past 24 hours, acquiring Archemix Corp.’s hemophilia assets and winning an investigational device exemption for a home hemodialysis system from the Food & Drug Administration.
The acquisition deal with Archemix included an exclusive license of the Cambridge, Mass.-based company’s anti-TFPI aptamer technology, which includes the product ARC19499, a potential subcutaneous hemophilia therapy that’s in clinical trial in the United Kingdom, Baxter announced today.
The Deerfield, Ill.-based company yesterday announced that the FDA granted its home hemodialysis system an investigational device exemption.
The system is being developed in collaboration with DEKA Research and Development Corp. and HHD LLC, which owns patent rights to some of the technology. The IDE allows the company to begin a clinical study in patients undergoing hemodialysis treatment.
Baxter and DEKA expect to begin the study in mid-2011 in the U.S., aiming for regulatory approval in 2013. The companies said they’re also planning an additional clinical study in Canada that will focus on the device’s performance in a "nocturnal setting," and if successful, the study should support a CE Mark application in Europe in 2012, according to the companies.
“We are gratified to achieve this milestone in support of this new home hemodialysis device,” said Dean Kamen, founder of Manchester, N.H.-based DEKA.
