HCV New Drugs

Achillion Pharmaceuticals moves up as a contender in the HCV market

Written by Dr. Ramya Kartikeyan, GlobalData's senior healthcare analyst covering infectious diseases.

GlobalData-  October 1 2012

On September 27, Achillion Pharmaceuticals released news of positive results surrounding Phase Ia trials testing ACH-3102, an NS5A inhibitor drug created to treat chronic Hepatitis C Virus (HCV) infections. In the past few months, developers in this space have faced serious concerns. Bristol-Myers Squibb’s HCV drug candidate BMS-986094, another NS5A inhibitor, recently caused the death of a patient during Phase IIb trials as a result of heart failure. The FDA, in response to this adverse event, moved to halt clinical trials on competitor Idenix Pharmaceuticals’ HCV NS5A inhibitor, IDX184.

 

Currently, the leading drugs on the market, Vertex’s Incivek (telaprevir) and Merck’s Victrelis (boceprevir) are only indicated with the use of Pegasys (pegylated interferon-alpha) and ribavirin, which fall short on multiple counts. Most important, however, are the toxicity issues associated with the use of ribavirin and Pegasys, and the fact these treatments do not intrinsically eliminate the virus, but instead stimulate the immune system to help deal with the viral infection. Both Incivek and Victrelis are NS5A inhibitors, which offer a glimpse into the market possibilities for a drug like Achillion’s ACH-3102. In contrast, Achillion has stated that further trials will test ACH-3102 in combination with ribavirin but not Pegasys. Nevertheless, this approach keeps in line with the trend of using NS5A inhibitors in combination with other Direct-Acting Antiviral (DAA) therapies.

 

In developing ACH-3102, Achillion focused on creating a drug that targets multiple genotypes of HCV. The different HCV genotypes pose a problem within the general population, where treatment towards a specific genotype of HCV is less likely to treat infections against other HCV genotypes.

 

Currently, there are 11 known genotypes of HCV, which makes the pan-genotypic treatment option of a drug like ACH-3102 very appealing to physicians and patients alike. Achillion’s research would appear to address the unmet need of drugs capable to treat multiple genotypes, in addition to creating drugs that deal with resistant strains of HCV. While seemingly a sound investment in research and development funds, it is interesting to note that many other players in this market still have active research programs focused upon treating HCV 1a.

 

The current HCV pipeline continues to be robust and growing. With most companies doubling down on their investments, research includes concurrent development in NS5A inhibitors, NS3 protease inhibitors, nucleotide inhibitors and polymerase inhibitors. With the pipeline leaning heavily in favor of polymerase and protease inhibitors, it would appear that the current marketed drugs have had a large role in determining the research focus of the newer products. More importantly, as products move to a fixed-dose combinatorial therapy, as seen in the HIV market, more companies are involved in expanding their pipeline to include different drug options and eliminate a split in potential drug revenue.

 

A growing population segment within the HCV therapeutics market is patients co-infected with HIV. This segment, largely seen as a growth market in countries with high prevalence of HIV, might allow companies to realize large profits within the seven major markets (US, UK, France, Italy, Germany, Spain and Japan), where prevalence of HIV is higher than its incidence. As companies such as Bristol-Myers Squibb, Gilead, Vertex and Abbott develop new HCV drugs, a likely secondary indication would be in patients infected with HIV.

 

With an early win, Achillion faces a long and turbulent path to the finish line. In the face of other bigger pharma players, Achillion might be seen as a potential acquisition or licensing opportunity, and given the debacle with Bristol-Myers Squibb’s HCV drug candidate, Achillion might not even think twice about offsetting some of the risk associated with the continued development of this drug. With a diverse HCV and antibacterial portfolio, Achillion is undoubtedly research-rich. Without assessing Achillion’s corporate strategy, the company will face important decisions with respect to marketing and commercialization approaches it chooses to adopt for their leading candidate drugs. However, as long as their drugs continue to trend positively, Achillion will enjoy the privilege of being courted by Big Pharma and seeking an alliance strongly in their favor.

 

http://www.globaldata.com/ExpertsInsightDetails.aspx?PRID=402&companyID=jpr/oAchillion