Hepatitis C: Significant unmet need fuels pharma development and deals
| Jul 26, 2012
The World Health Organization estimates hepatitis C (HCV) affects up to 170 million people worldwide. Though it can remain dormant for decades, HCV can lead to severe liver damage, including cirrhosis and liver cancer.
Despite increased awareness and medical advances, significant unmet medical needs still exist. The current standard treatment does not work for everyone and can result in significant side effects, which at times may result in stopping treatment. In 2011, a new class of drugs for HCV – protease inhibitors – were approved in the US and Europe; they are considered a significant advance in the fight against the disease despite the fact they’re used in combination with pegylated interferon and ribavirin and only approved for genotype 1. Hepatitis has 11 genotypes, with genotypes 1 and 2 being most prevalent in the US and Europe.
With typically less than 20% of patients treated globally, a large population remains “warehoused” waiting for new treatment options. The current treatments are contraindicated for some patients as they have a compromised liver, severe depression, alcohol or drug abuse or are pregnant. Other patients are “warehoused” by physicians until better, more effective treatments are available.
According to Kantar Health’s 2011 National Health and Wellness Survey, only 11% of US patients and 18% of Europeans are currently treated. It’s worth noting that these treated patients have higher levels of comorbid depression, anxiety, work productivity loss, activity impairment, and worse mental and physical quality of life than untreated patients (for more information see our infographic, Hepatitis C: The Ticking Time Bomb).
A third significant unmet medical need is the large undiagnosed population. It’s believed approximately 80% of people with HCV remain asymptomatic for years, with the unintended consequence of the further spread of HCV. In the US the Centers for Disease Control started a campaign urging baby boomers – everyone born between 1945 and 1965 – to get tested, which may provide a sudden increase in the diagnosed population, inconsistent with the decrease recently observed.
The many unmet needs in HCV have led to a boom in companies attempting to develop this market and initiated a surge in licensing and acquisition activity. In October 2011, Roche paid $230 million for Anadys Pharmaceuticals, and one month later Gilead paid $11 billion for Pharmasset. BMS also added to their HCV portfolio by acquiring Inhibitex for $2.5 billion in January 2012, and other companies developing products in hepatitis have been the subject of acquisition rumors.
In terms of product development two treatments were approved last year (Incivek and Victrelis), and the pipeline (according to Thomson Pharma) has 55 candidates in Phase II and 12 products in Phase III. New classes of drugs, absent of concomitant pegylated interferon and ribavirin, are being investigated and offer oral administration rather than intravenous. Companies including Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Medivir/Tibotec and Vertex are racing to get these new products approved.
And it’s no wonder so much attention has been focused on HCV. Analysts expect the market’s value to skyrocket by the end of the decade, with one source estimating it could grow from $1.7 billion in 2010 to $16 billion in 2015.
All of this activity is making hepatitis C one of the most watched segments in the pharmaceutical industry. The product launches are expected to continue, changing the way this debilitating disease is treated and vastly improving the lives of patients.