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Achillion Pharmaceuticals 2012 Annual Report

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Achillion Pharmaceuticals 2012 Annual Report Achillion Pharmaceuticals TO OUR SHAREHOLDERS, APRIL 2013 STABILITY 2012 Annual Report ribavirin for the treatment of genotype 1b HCV and is aimed at determining the safety, resistance profi le and potential for this simplifi ed regimen to cure genotype 1b HCV. This subset of genotype 1 represents a signifi cant portion of the overall HCV market and is present around the world, including a substan- tial portion of the United States, European and Asian markets. Michael Kishbauch It is important to note that the fi rst-in-human Phase 1 trials for President and Chief ACH-3102 were initiated in May 2012, followed by the dem- Executive Offi cer onstration of proof-of-concept results just a few months later 2012 was a year of signifi cant accomplishment and contin- in patients with genotype 1a HCV. ACH-3102 was then rapidly ued progress for Achillion’s portfolio of oral treatments for advanced into Phase 2 in a novel trial evaluating ACH-3102 as hepatitis C virus, or HCV. As has been our focus, Achillion is ACHILLION PHARMACEUTICALS, INC. PHARMACEUTICALS, ACHILLION the only directly-acting-antiviral agent in combination with singularly dedicated to its goal of discovering and advancing ribavirin for the treatment of genotype 1b HCV. Less than a potentially best-in-class compounds, including NS3/4A prote- year from initiation of clinical development, we have begun ase inhibitors and inhibitors of the NS5A protein that could be to show that ACH-3102 appears to be safe and well-tolerated used for the broad treatment of HCV. following 12 weeks of therapy, demonstrates potent antiviral HCV has emerged as a major public health crisis, not only in activity and viral suppression even in patients with up to the United States, but around the world. The viral disease is six baseline mutations that have been shown to be resistant estimated to affect nearly 170 million individuals worldwide, to fi rst-generation NS5A inhibitors, and, unlike other single including upwards of fi ve million or more infected patients direct-acting antiviral regimens, staves off viral rebound during here in the United States. HCV is frequently termed the silent therapy. Additional studies are required to determine the role epidemic since the virus doesn’t provide any visible signs of ACH-3102 and ribavirin can play in the treatment of genotype its presence but instead quietly replicates in the liver, leading 1b, although the profi le for ACH-3102 is supportive of lever- to fi brosis and scarring. After many years, if left undiagnosed aging this second-generation NS5A inhibitor as a potential and untreated, HCV can lead to liver cancer, cirrhosis and cornerstone agent in combination treatment regimens for HCV. potentially the need for liver transplantation. Fortunately for To that end, we are now keenly focused on initiating a Phase patients, there has been a rapid evolution in the understand- 2 clinical trial in the second quarter of 2013 that will evaluate ANNUAL REPORT 2012 REPORT ANNUAL ing of HCV which has translated into the development of sovaprevir and ACH-3102 with ribavirin as a 12-week treat- novel therapies that are advancing the ability to treat and cure ment regimen for genotype 1 HCV. This study is intended to HCV. Achillion is at the forefront of this research and has been set the foundation for an aggressive Phase 2 development pro- focused on discovering and advancing a number of potential gram in which we plan to evaluate sovaprevir and ACH-3102 oral treatments for this disease. Currently, Achillion is focused across a variety of patient subsets including those who are on conducting Phase 2 clinical trials to test combinations of treatment-naïve, treatment-experienced, co-infected with HIV, our internally discovered compounds and working to advance and patients with cirrhosis, as well as treatment arms that do optimal treatment approaches toward potential registration not include ribavirin. Looking forward to the third quarter and market approval. of 2014 and assuming the Phase 2 trials advance as planned, Achillion’s most advanced compounds include sovaprevir, we anticipate that approximately 500 patients will have been also referred to as ACH-1625, our second-generation, once- treated with the sovaprevir and ACH-3102 regimen, and the STABILITY ACUITY INGENUITY OPPORTUNITY daily protease inhibitor, and ACH-3102, a second-generation, results will enable the initiation of Phase 3 registrational pan-genotypic NS5A inhibitor. Sovaprevir has demonstrated development shortly thereafter. potent and pan-genotypic activity in early studies, and This is truly an exciting time at Achillion and for HCV patients achieved cures (defi ned as sustained viral response 12 weeks who are waiting for simpler, better tolerated, and highly effec- after the completion of therapy, or SVR12) of approximately tive therapies to treat their disease. As our programs continue 80% when combined with the current standard of care, to mature and produce data throughout 2013 and 2014, we pegylated-interferon and ribavirin, for the treatment of geno- remain confi dent that Achillion can successfully navigate the type 1 HCV. Sovaprevir was shown in Phase 2 studies to be path forward for our potentially best-in-class compounds and safe and well-tolerated, and based upon drug-drug interaction ultimately see them compete in this dynamic HCV market. studies conducted to date, is believed to have a low potential Thank you to all our shareholders for your continued support for interactions compared to other protease inhibitors and encouragement and I look forward to sharing all of the Achillion Pharmaceuticals, Inc. approved for treating HCV. Furthermore, sovaprevir appears progress made with our exciting programs in the year to come. to have an improved barrier to resistance based upon the lack 300 George Street • New Haven, CT 06511 Sincerely, of virologic breakthrough during treatment. www.achillion.com Combining Elements for Success ACH-3102, with what we believe to be a differentiated profi le compared to fi rst-generation NS5A inhibitors, is a truly inno- vative compound with a potentially higher barrier to resis- Michael D. Kishbauch tance. Our ongoing Phase 2a trial is evaluating ACH-3102 with President and Chief Executive Offi cer 84699_ACHILLION_Covers.indd 1 4/6/13 4:07 PM Achillion Pharmaceuticals TO OUR SHAREHOLDERS, APRIL 2013 STABILITY 2012 Annual Report ribavirin for the treatment of genotype 1b HCV and is aimed at determining the safety, resistance profi le and potential for this simplifi ed regimen to cure genotype 1b HCV. This subset of genotype 1 represents a signifi cant portion of the overall HCV market and is present around the world, including a substan- tial portion of the United States, European and Asian markets. Michael Kishbauch It is important to note that the fi rst-in-human Phase 1 trials for President and Chief ACH-3102 were initiated in May 2012, followed by the dem- Executive Offi cer onstration of proof-of-concept results just a few months later 2012 was a year of signifi cant accomplishment and contin- in patients with genotype 1a HCV. ACH-3102 was then rapidly ued progress for Achillion’s portfolio of oral treatments for advanced into Phase 2 in a novel trial evaluating ACH-3102 as hepatitis C virus, or HCV. As has been our focus, Achillion is ACHILLION PHARMACEUTICALS, INC. PHARMACEUTICALS, ACHILLION the only directly-acting-antiviral agent in combination with singularly dedicated to its goal of discovering and advancing ribavirin for the treatment of genotype 1b HCV. Less than a potentially best-in-class compounds, including NS3/4A prote- year from initiation of clinical development, we have begun ase inhibitors and inhibitors of the NS5A protein that could be to show that ACH-3102 appears to be safe and well-tolerated used for the broad treatment of HCV. following 12 weeks of therapy, demonstrates potent antiviral HCV has emerged as a major public health crisis, not only in activity and viral suppression even in patients with up to the United States, but around the world. The viral disease is six baseline mutations that have been shown to be resistant estimated to affect nearly 170 million individuals worldwide, to fi rst-generation NS5A inhibitors, and, unlike other single including upwards of fi ve million or more infected patients direct-acting antiviral regimens, staves off viral rebound during here in the United States. HCV is frequently termed the silent therapy. Additional studies are required to determine the role epidemic since the virus doesn’t provide any visible signs of ACH-3102 and ribavirin can play in the treatment of genotype its presence but instead quietly replicates in the liver, leading 1b, although the profi le for ACH-3102 is supportive of lever- to fi brosis and scarring. After many years, if left undiagnosed aging this second-generation NS5A inhibitor as a potential and untreated, HCV can lead to liver cancer, cirrhosis and cornerstone agent in combination treatment regimens for HCV. potentially the need for liver transplantation. Fortunately for To that end, we are now keenly focused on initiating a Phase patients, there has been a rapid evolution in the understand- 2 clinical trial in the second quarter of 2013 that will evaluate ANNUAL REPORT 2012 REPORT ANNUAL ing of HCV which has translated into the development of sovaprevir and ACH-3102 with ribavirin as a 12-week treat- novel therapies that are advancing the ability to treat and cure ment regimen for genotype 1 HCV. This study is intended to HCV. Achillion is at the forefront of this research and has been set the foundation for an aggressive Phase 2 development pro- focused on discovering and advancing a number of potential gram in which we plan to evaluate sovaprevir and ACH-3102 oral treatments for this disease.
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