Nature of the Business | 9 Months Ended |
Sep. 30, 2013 |
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 $354,462 from inception through September 30, 2013 and had an accumulated deficit of $368,324 at September 30, 2013, 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 support its current operating plan through at least September 30, 2014. However, the Company’s operating plan may change as a result of many factors, including but not limited to: |
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| • | | the costs involved in the clinical development, manufacturing and formulation of ACH-3102, ACH-2684, ACH-3422, and if the 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, or 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 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 the phase II -007 clinical trial evaluating 12-weeks of sovaprevir in combination with ACH-3102 and ribavirin for patients with treatment-naive genotype 1 HCV. In September 2013, after reviewing our response, the FDA stated that although all issues identified in the June 2013 letter had been addressed, it had concluded that the removal of the clinical hold was not warranted. 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 also requested the Company’s proposed plan for future clinical trials in combination with other directly-acting antivirals. At the request of the FDA, the Company plans to submit its proposed plan for analyzing the additional clinical, non-clinical and pharmacokinetic data requested before year-end, and if that analysis plan is approved by the FDA, submit a complete response during the first half of 2014. |