SOURCE: Mobius Therapeutics, Inc.

January 23, 2008 10:28 ET

Mobius Therapeutics™ Granted Orphan Drug Designation

ST. LOUIS, MO--(Marketwire - January 23, 2008) - 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.

Contact Information

  • For more information, contact:
    Ed Timm
    Mobius Therapeutics, Inc.™
    743 Spirit 40 Park Drive
    Unit 111
    Chesterfield, MO 63005
    Phone: +1 636-519-4860
    Fax: +1 636-519-4859
    Mobile: +1 404-775-5910
    Email Contact
    www.MobiusTherapeutics.com