Nature of the Business | 6 Months Ended |
Jun. 30, 2014 |
Nature of the Business | ' |
1. Nature of the Business |
Achillion Pharmaceuticals, Inc. (the “Company”) was incorporated on August 17, 1998 in Delaware. The Company is seeking to discover, develop and commercialize innovative drug therapies. The Company is devoting substantially all of its efforts towards product research and development. |
The Company incurred losses of $399,557 from inception through June 30, 2014 and had an accumulated deficit of $413,419 at June 30, 2014, which includes preferred stock dividends recognized until the Company’s initial public offering in 2006. The Company has funded its operations primarily through the sale of equity securities. |
The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to meet its projected operating requirements through at least June 30, 2015. However, the Company’s future capital requirements may change and will depend upon numerous factors, including but not limited to: |
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| • | | the costs involved in the clinical development, manufacturing and formulation of ACH-3422, ACH-3102 and sovaprevir; |
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| • | | the scope of and costs associated with entering into cooperative study arrangements, CSAs, if any, for the collaborative development of its drug candidates in combination with others’ drug candidates; |
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| • | | the costs involved in obtaining regulatory approvals for the Company’s drug candidates; |
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| • | | the scope, prioritization and number of programs the Company pursues; |
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| • | | the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent and other intellectual property claims; |
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| • | | the Company’s ability to raise incremental debt or equity capital, including any changes in the credit or equity markets that may impact its ability to obtain capital in the future; |
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| • | | the costs associated with, and the outcome of, lawsuits against the Company, if any; |
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| • | | the Company’s acquisition and development of new technologies and drug candidates; and |
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| • | | competing technological and market developments currently unknown to the Company. |
In June 2013, the U.S. Food and Drug Administration (the “FDA”) placed a clinical hold on sovaprevir after elevations in liver enzymes were noted in a phase I healthy subjects drug-drug interaction study evaluating the effects of concomitant administration of sovaprevir with ritonavir-boosted atazanavir. In June 2014, the FDA removed the clinical hold on sovaprevir, allowing the Company to conduct therapeutic trials of sovaprevir in HCV patients with a maximum dose of 200 mg once daily and in single dose studies in healthy volunteers, but the FDA maintained a partial clinical hold on sovaprevir for multiple dose studies that the Company may conduct in healthy volunteers. The Company expects to continue to work collaboratively with the FDA on the continued clinical development of sovaprevir. Following an internal assessment of the Company’s protease inhibitor drug candidates, sovaprevir and ACH-2684, the Company has determined to advance sovaprevir in future clinical trials with ACH-3422 and ACH-3102, rather than ACH-2684. |