History

Lantibio, Inc., formerly known as MoliChem Medicines, Inc., began operations in 1997 when the Company obtained assignment and licensing agreements from Glaxo Wellcome and the University of North Carolina at Chapel Hill for a compound commonly referred to as “duramycin,” which was known then as “2622U90” and later designated as “Moli1901,” to be studied for the treatment of respiratory indications. In early 2008, the compound was assigned the International Non-proprietary Name (INN), "lancovotide," by the World Health Organization.

For five years, the Company developed lancovutide (then known as "Moli1901") into Phase 2 clinical trials in the United States for the treatment of cystic fibrosis. Operations were funded initially through a federal grant and support from the Cystic Fibrosis Foundation as well as private financing from venture capitalists and other investors.

In April 2003, the Company re-focused its development efforts for lancovutide on dry eye disease and changed its name to Lantibio, Inc. The Company conducted animal studies in rabbits and a preliminary human safety trial in Europe as a proof of concept for the dry eye indication.  The development program in the US is conducted under an IND.

Lantibio out-licensed development and commercialization of lancovutide for the treatment of cystic fibrosis in the European Union and Eastern Europe to AOP Orphan Pharmaceuticals AG in Austria. Currently, AOP is sponsoring a late Phase 2 multi-center, dose regimen finding clinical trial in centers throughout Europe, which is slated to be complete by end 2009.

In August 2005, Lantibio entered into a development, manufacturing, and supply agreement with Apotex Fermentation, Inc. (AFI) in Winnipeg, Mannitoba, Canada.  The agreement with AFI provides access to the drug substance, method development, clinical batches, regulatory support, and supply of commercial batches at an advantageous overall cost.

In December 2005, Lantibio obtained U.S. development and marketing rights for a proprietary ophthalmic formulation containing sodium hyaluronate 0.18% through a licensing and supply manufacturing agreement with TRB Chemedica. The product, known as Vismed®, is marketed in territories in Europe and Asia as a lubricant eye drop and an adjunct to contact lens wear.  A proprietary name, Rejena®, has been granted for use in the U.S.  The product is the subject of an NDA submitted in January 2009 for which an approvable letter was received July 21, 2009.  Lantibio is evaluating the request by FDA to conduct an additional clinical study.