Drug repurposing is more efficient and produces higher success rates compared with traditional new chemical entity (NCE) drug development efforts

There are abundant commercial repurposing successes and studies show that repurposed drugs account for 25% of top pharma companies’ revenues. Examples include:

  • dimethyl fumarate, a psoriasis drug repurposed by Biogen Idec as an oral MS drug (Tecfidera) – now approaching $2B annual sales (~30% of 2013 revenues)
  • oxymetazoline (in Visine) repurposed as topical treatment for rosacea by Vicept, then acquired within 3 years by Allergan for $275M
  • thalidomide, the morning sickness drug of the 1950s that produced the infamous “thalidomide babies”, is now a $1.5B drug used for leprosy and multiple myeloma

Exclusivity Positions in Repurposing

RLS pursues two main avenues to secure commercially valuable exclusivity positions for its repurposed drugs:

Intellectual Property / Patents

  • Reformulation, dosing, delivery
  • Method of use
  • Combinations, salts, polymorphs
  • New method of synthesis
  • Pharmacokinetic profiles, clinical endpoints, personalization, etc.

Regulatory / Label

  • 7 year exclusivity in U.S. with orphan designation
  • 3 year exclusivity in U.S. with efficacy studies

In many cases the exclusivity position of a repurposed drug can rival that of new chemical entities (NCEs). Although the patent life of an NCE is ~20 years from the patent filing date, NCE development takes so long that by the time an NCE reaches the marketplace, only 5-10 years of patent life are left.