The Fast Track designation will enable Idenix Pharmaceuticals to shave precious time off their predicted timeline for a new drug application (NDA), and even increase interaction with the FDA to guarantee a quicker review and a shorter time to market.
HCV is a causative agent of chronic liver infections, which often leads to serious problems such as liver cirrhosis, liver failure or cancer. HCV infection is currently considered a worldwide problem with high incidence of infection attributed to improper injection practices and unsafe blood transfusions in low and high-income countries, alike. Estimates from the World Health Organization (WHO) indicate that the current disease burden is a staggering 3% of the world’s population. HCV causes an asymptomatic infection in most individuals, but almost 25% of infected persons eventually begin to display symptoms. Data also indicates that approximately 60-80% of symptomatic patients may develop a chronic infection resulting in chronic liver disease.
Currently, there exists no complete cure or prophylactic treatment for HCV infection. The global disease burden of HCV and the large unmet need for an effective HCV vaccine are the strongest drivers within this market today. Idenix’s IDX719, has a wide ranging in vitro activity profile across various HCV genotypes. Phase I trials indicate that the drug can be used against the most prevalent genotypes of HCV, 1, 2 and 3, which will increase the likely prescribed indication and use of IDX719 across the different HCV subtypes.
Idenix’s HCV pipeline is robust and promising. The company’s lead drug candidate, IDX184, is presently undergoing Phase IIb trials. IDX184, a nucleotide inhibitor, is designed to target the liver through a once-a-day orally administered pill, which will provide the patient and healthcare professionals with access to an easy dosing regimen and a convenient administration route.
Idenix stock prices have enjoyed a boost and the market has also seen an increase in the number of shares traded since the press release on Wednesday, 25 Julyk. While it is currently unclear if Idenix will choose to cultivate its commercial and manufacturing base or out-license this drug, the move to Fast Track the designation may also be seen as a reinforcement of the potential impact that these drugs may have on the HCV market. This virtually untapped blockbuster market is likely to change the face of Idenix, giving it the flexibility to diversify its portfolio beyond HCV and HIV.
The development of an antiviral in the HCV market is bound to provide relief to millions of infected individuals; however, most believe that the true silver bullet is an effective HCV vaccine. Until then, however, it is likely that we will see the antiviral market diversify, grow and even mature in the future. Idenix proposes that the HCV treatment paradigm favors the use of a combinatorial approach, where a cocktail of antiviral drugs will increase potency of the immune response and inhibit replication. For this reason, Idenix recognizes that it will require the contributions of other companies, such as Abbott, Bristol-Myers Squib and Gilead to collectively decrease infection prevalence.
As the HCV market matures, we begin to see similarities with the well-established influenza market. In addition to the different HCV genotypes, companies that enter this market will encounter antiviral resistance, akin to the phenomenon associated with influenza antiviral treatments today. Until then, however, Idenix can enjoy the luxury of a quicker FDA decision and continue to strive towards a potential lion’s share of a multi-billion dollar market.