MARKET WIRE
Mobius Therapeutics, Inc.™ has been
granted orphan drug designation for its platform product, Trabomycin™,
by the Office of Orphan Products Development of the U.S. Food and Drug
Administration. This approval grants seven years of U.S. market
exclusivity to Mobius, once its New Drug Application is approved.
"While the FDA had previously indicated that Trabomycin™ would be
eligible for orphan designation, this final approval represents a
significant step forward in the execution of our business plan," said Ed
Timm, President of Mobius Therapeutics. Orphan drug status is a
designation granted by the FDA to motivate innovation in therapies which
might normally be unprofitable endeavors due to the limited occurrence of a
specific medical condition. The grant allows Mobius Therapeutics the
exclusive marketing rights to this application in the U.S. for seven years
upon approval of its New Drug Application (NDA). "In addition to the
market exclusivity, millions of dollars associated with filing fees and
pediatric studies in our NDA are now waived, allowing us to focus our
resources on achieving our projected milestones and commercialization."
"Our focus remains certain," Timm continued. "We will provide precision
and convenience to the glaucoma surgeon, while providing glaucoma patients
an enhanced quality of care."
About Mobius Therapeutics™:
Mobius Therapeutics, Inc. ™ is an early stage venture focused on
solutions in glaucoma surgery. Its platform product, Trabomycin™, is a
system for delivering antifibrotic agents in glaucoma surgery. It is
awaiting regulatory approval, with additional product applications
pipelined. Mobius relocated from Atlanta to St. Louis beginning 1 July
2007.