Orphan Drug Status Granted to Telormedix´ lead product

Please login or
register
08.12.2014

Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Vesimune for the treatment of carcinoma in situ (CIS) in the bladder.

The FDA grants orphan drug status to products for rare diseases and defines a rare disease as one with a prevalence of less than 200,000 cases in the USA. As there are approximately 60.000 cases of non-muscle invasive CIS of the bladder, it is clearly a rare disease meaning that the orphan designation was extended to Vesimune.

Vesimune is Telormedix’ lead product, a TLR-7 agonist, that has successfully completed a Phase II trial in CIS of the bladder. The product is a unique sterile liquid formulation of a marketed immune modulatory compound, designed on innovative technology principles to carrier drug delivery systems in order to increase solubility, bio-adhesiveness and stability. These properties mean that the product can be used in therapeutic settings that the original product could not.

Johanna Holldack, CEO of Telormedix, commented: "This is fantastic news that vindicates our development strategy. With Vesimune having completed Phase II and with this orphan drug designation, we are now in a pivotal position for discussions with potential license partners.”

0Comments

More news about

Telormedix SA

Company profiles on startup.ch

Telormedix SA

rss