Nature of the Business | 3 Months Ended |
Mar. 31, 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 was established to discover, develop and commercialize innovative anti-infective drug therapies. The Company is devoting substantially all of its efforts towards product research and development. |
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The Company incurred losses of $383,900 from inception through March 31, 2014 and had an accumulated deficit of $397,762 at March 31, 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. |
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The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to meet its projected operating requirements through at least March 31, 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 ACH-2684, and if the U.S. Food and Drug Administration’s, or FDA’s, clinical hold is removed, further clinical development of 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. |
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In June 2013, the FDA placed a clinical hold on sovaprevir after elevations in liver enzymes were noted in a phase I healthy subject drug-drug interaction study evaluating the effects of concomitant administration of sovaprevir with ritonavir-boosted atazanavir. In accordance with the clinical hold, the FDA provided that no new clinical trials that included dosing with sovaprevir could be initiated, however, the FDA allowed continued enrollment and treatment of patients in a then-on-going phase II clinical trial. In September 2013, the FDA requested, among other things, additional analysis to more fully characterize sovaprevir pharmacokinetics and the intrinsic and extrinsic factors that may lead to higher than anticipated exposures of sovaprevir or other potential toxicities in addition to the observed liver enzyme elevations. The FDA has approved the Company’s plan of analysis and additional clinical, non-clinical and pharmacokinetic data that the Company intends to submit shortly. The Company anticipates comment from the FDA during the second quarter of 2014. |