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As Of Filer Filing For·On·As Docs:Size Issuer Agent 7/03/06 Viropharma Inc 8-K:7,9 6/30/06 3:715K RR Donnelley/FA |
Document/Exhibit Description Pages Size 1: 8-K Viropharma Inc--Form 8-K HTML 16K 2: EX-99.1 Supplement to Petition for Stay of Action HTML 251K 3: EX-99.2 Press Release HTML 14K
| Viropharma Inc--Form 8-K |
UNITED STATES
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 30, 2006
VIROPHARMA INCORPORATED
(Exact Name of Registrant as Specified in its Charter)
| DELAWARE | 0-021699 | 23-2789550 | ||
| (State or Other Jurisdiction of Incorporation or Organization) |
(Commission File Number) | (I.R.S. Employer Identification Number) |
397 EAGLEVIEW BOULEVARD, EXTON, PENNSYLVANIA 19341
(Address of Principal Executive Offices including Zip Code)
(610) 458-7300
(Registrant’s Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing 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 (17CFR240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17CFR240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR240.13e-4(c)) |
Item 7.01 Regulation FD Disclosure
On June 30, 2006, ViroPharma Incorporated (the “Company”) filed a supplement to its Petition for Stay of Action with the U.S. Food and Drug Administration (FDA) regarding the bioequivalence requirements for abbreviated new drug applications that seek to copy Vancocin. The document sets forth scientific arguments supporting the Company’s strong belief that the decision of the FDA’s Office of Generic Drugs (OGD) to modify the bioequivalence standards for generic copies of Vancocin capsules is scientifically flawed. The Company believes that its latest submission demonstrates that the OGD’s proposal for demonstrating bioequivalence of a generic version of Vancocin capsules using only in vitro dissolution testing instead of human clinical trials is not applicable to Vancocin capsules, and presents an unacceptably high risk of approving a bioinequivalent product. A copy of the supplement to the Petition for Stay of Action and a press release announcing the filing are set forth as Exhibit 99.1 and 99.2 attached hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Supplement to Petition for Stay of Action. | |
| 99.2 | Press Release dated June 30, 2006 regarding supplement to Petition for Stay of Action. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| VIROPHARMA INCORPORATED | ||||
| Date: July 3, 2006 | By: | /s/ Thomas F. Doyle | ||
| Thomas F. Doyle | ||||
| Vice President, General Counsel and Secretary | ||||
| Exhibit No. | Description | |
| EX-99.1 | Supplement to Petition for Stay of Action. | |
| EX-99.2 | Press Release dated June 30, 2006 regarding supplement to a Petition for Stay of Action. | |
| This ‘8-K’ Filing | Date | Other Filings | ||
|---|---|---|---|---|
 | ||||
| Filed on: | 7/3/06 | |||
| For Period End: | 6/30/06 | 10-Q | ||
| List all Filings | ||||