SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 28, 2013
Achillion Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| | | | |
| Delaware | | 001-33095 | | 52-2113479 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
| | | | |
300 George Street New Haven, CT | | 06511 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code:(203) 624-7000
N/A
(Former name or former address, if changed since last report)
Check the appropriate box if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
Item 8.01. Other Events
Achillion Pharmaceuticals, Inc. (the “Company”) announced today that the Company received notice from the U.S. Food and Drug Administration (“the FDA”) that a clinical hold has been placed on sovaprevir after elevations in liver enzymes associated with significantly higher than anticipated exposures to atazanivir and sovaprevir were noted in a Phase 1 healthy subject drug-drug interaction study evaluating the effects of concomitant administration of sovaprevir with ritonavir-boosted atazanavir. The FDA has allowed continued enrollment and treatment of patients in the Phase 2 -007 clinical trial evaluating 12-weeks of sovaprevir in combination with ACH-3102 and ribavirin for patients with treatment-naïve genotype 1 hepatitis C viral infection.
The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current report on Form 8-K.
Item 9.01. Financial Statements and Exhibits
The following exhibit relating to Item 8.01 shall be deemed to be furnished, and not filed:
| | 99.1 | Press Release dated July 1, 2013 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | | | ACHILLION PHARMACEUTICALS, INC. |
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| Date: July 1, 2013 | | | | By: | | /s/ Mary Kay Fenton |
| | | | | | | | Mary Kay Fenton Chief Financial Officer |
Exhibit Index
| 99.1 | Press Release dated July 1, 2013 |
