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HCV therapeutics is one of the fastest-developing markets in healthcare with a projected worth of $20 billion by 2020. Several companies are now positioning themselves to be the markets leaders including Gilead Sciences, Inc., Johnson & Johnson, AbbVie Inc, and Bristol-Myers Squibb Co.
What is Hepatitis C?
Hepatitis C is a liver infection caused by the HCV virus that results in inflammation, fatigue, joint pain, itchy skin, jaundice and long term complications including cirrhosis and liver cancer. The disease is now the leading cause of liver transplants. Left untreated, hepatitis C can ultimately lead to death; about 350,000 die annually around the world. Last year, the Centers for Disease Control and Prevention reported that HCV kills more Americans every year than HIV (HCV is more transmissible through blood than HIV) with most deaths occurring in middle-aged adults.
Reports estimate that about 170 million people or 3 percent of the global population are infected with HCV. Most disturbing, about half of those infected are not even aware they carry the virus; early screening is crucial in adequately treating the disease. HCV is contracted via contact with contaminated blood — 50 percent of cases are related to injection drug use — and more rarely through sex. Also at risk are patients receiving dialysis, injectable cancer and pain management treatments within outpatient clinics with poor infection control.
How is it treated?
A few years ago, the standard prescribed treatment for HCV was a six-month therapy with the antiviral ribavirin taken with a weekly injection of pegylated interferon, sold by Roche Holding Ltd. (OTCMKTS:RHHBY) and Merck & Co., Inc. (NYSE:MRK), according to Bloomberg. In 2011, Victrelis (Merck) and Incivek (Vertex Pharmaceuticals (NASDAQ:VRTX) and Johnson & Johnson) came on to the market, increasing cure rates from 50 percent to about 80 percent; however the side effects include life-threatening skin rashes and the risk of birth defects.
Next generation drugs and market outlook
A series of recent market reports by RnR Market Research show substantial growth for the HCV drug market in several regions across the globe including the United States, China, Brazil Japan and the United Kingdom.
“In United States, the projected drivers of HCV drug market growth include increased patient awareness of HCV, broader HCV screening recommendations, the shift in American medicine toward preventative care, and the launch of next-generation HCV therapies,” states the press release for the “PharmaPoint: Hepatitis C Virus — United States Drug Forecast and Market Analysis” report. Vertex’s Incivek leads the HCV market in the United States. However, the market research firm also notes that the possible side-effects associated with Incivek coupled with “the slow-progressing nature of HCV, has resulted in many patients deciding to forego treatment in order to wait for the launch of a more-tolerable HCV regimen.” According to other country-based reports, many other patients around the world are also waiting for “more-tolerable HCV regimen.
Companies with “more tolerable” HCV drugs in the pipeline
Several companies are now competing to offer hepatitis C treatments that don’t involve interferon injections, allowing patients to avoid the flu-like symptoms and other not-so-nice side effects. Some of the next generation drugs coming out of the pipeline are also showing a dramatic reduction in effective treatment duration as well as improved cure rates. The four highlighted below are seen as the emerging market leaders in a tight race for the top selling product.
Gilead Sciences
Gilead Sciences, the world’s largest maker of HIV medicines, is relatively new to this space but already standing out amongst the competition for new, improved HCV therapeutics. The promising clinical trial results for its drug, sofosbuvir — including improved cure rates, reduced therapy duration and fewer risks over the current treatment products — have pushed the stock to more than double its value over the past year.
In April of this year the company applied for regulatory clearance of the pill in combination with ribavirin for patients with two types of the virus, and with ribavirin and interferon for patients with other types of the infection who have not yet received treatment, according to Bloomberg. This month the company reported the drug will receive a priority marketing review by the FDA which has set a target review date of December 8 2013. The drug could become a top-selling product by 2015 with sales of $6.3 billion by 2016, reports Bloomberg.
In European markets, Gilead has had its marketing authorization application validated by the European Medicines Agency and was granted accelerated assessment, reports the Wall Street Journal.
Once approved, the drug could hit these markets in the first half of next year.
Johnson & Johnson
Janssen Research & Development, a division of Johnson & Johnson’s, applied in March of this year for clearance of simeprevir, an HCV treatment developed by Medivir AB (STO:MVIR-B). The drug is intended for use in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in patients with compensated liver damage. Simeprevir in combination with the current treatments has shown promising late stage Phase 3 clinical trial results including improved cure results and fewer risks.
In May, Janssen announced the FDA had granted priority review status for its new drug application. Analysts project approval by the end of this year.
Bristol-Myers Squibb Co.
Britsol-Myers Squibb is in Phase 2 trials for triple DAA treatment regimens of daclatasvir, asunaprevir and BMS-791325 in the hopes of bringing an interferon-free and ribavirin-free treatment option to patients with genotype 1 chronic hepatitis C infection. Phase 3 is expected to begin by late 2013. The company believes it could be the first to market in Japan as well as a major player in the US and other markets, reported Bloomberg.
AbbVie Inc.
AbbVie, a spinoff of Abbot Laboratories (NYSE:ABT), is in the late stage Phase 3 trials for its unnamed multidrug HCV oral therapy regimen. Phase 2 trial results showed the drug regimen cleared the virus in 90 percent of patients who completed the 8 week treatment. The company has seen its shares rally more than 25 percent since the start of 2013. Some analysts are predicting AbbVie’s HCV therapy may make it to market shortly after the market race favorite, Gilead meaning these two companies will be in stiff competition with each other for market share.
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.