-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RAV/l1hsbIlUo5VVWsbx2oVypMXAacy8UcNMyh86h3+YM41atV0WGDpYTrj+6td0 CSsBif99M/jni9RfvnA3YQ== 0001193125-06-060893.txt : 20060322 0001193125-06-060893.hdr.sgml : 20060322 20060322162935 ACCESSION NUMBER: 0001193125-06-060893 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060317 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060322 DATE AS OF CHANGE: 20060322 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VIROPHARMA INC CENTRAL INDEX KEY: 0000946840 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232789550 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21699 FILM NUMBER: 06704044 BUSINESS ADDRESS: STREET 1: 397 EAGLEVIEW BLVD CITY: EXTON STATE: PA ZIP: 19341 BUSINESS PHONE: 6104587300 MAIL ADDRESS: STREET 1: 397 EAGLEVIEW BOULEVARD CITY: EXTON STATE: PA ZIP: 19341 8-K 1 d8k.htm FORM 8-K 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): March 17, 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 8.01. Other Events.

On March 17, 2006, ViroPharma Incorporated (the “Company”) issued two press releases in connection with a change in the approach of the Office of Generic Drugs, Center for Drug Evaluation and Research (“OGD”) regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in-vivo bioequivalence testing for Vancocin and the Company’s filing of a Petition for Stay of Action with the FDA regarding such requirements. A copy of each of the press releases is attached to this Current Report on Form 8-K as Exhibit 99.1 and 99.2.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

99.1    Press Release dated March 17, 2006 regarding OGD actions.
99.2    Press Release dated March 17, 2006 regarding 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: March 22, 2006   By:  

/s/ Thomas F. Doyle

    Thomas F. Doyle
    Vice President, General Counsel and
    Secretary


Exhibit Index

 

99.1    Press Release dated March 17, 2006 regarding OGD actions.
99.2    Press Release dated March 17, 2006 regarding Petition for Stay of Action.
EX-99.1 2 dex991.htm PRESS RELEASE DATED MARCH 17, 2006 REGARDING OGD ACTIONS. Press Release Dated March 17, 2006 Regarding OGD Actions.

Exhibit 99.1

 

LOGO    Contacts:   

William C. Roberts

Director, Corporate Communications

VIROPHARMA INCORPORATED

Phone (610) 321-6288

VIROPHARMA COMMENTS ON VANCOCIN

Exton, PA, March 17, 2006 ViroPharma Incorporated (Nasdaq: VPHM) today made the following statements about Vancocin®:

We were informed yesterday that the Office of Generic Drugs, Center for Drug Evaluation and Research (“OGD”), may have changed its approach regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in-vivo bioequivalence testing for Vancocin. Specifically, we were informed that a generic applicant may be able to request such a waiver provided that dissolution testing demonstrates that the test product is rapidly dissolving at certain specified conditions. This deviates from our understanding of OGD’s practices which would require, for a non-absorbed GI drug, a demonstration of bioequivalence through clinical studies or a demonstration of bioequivalence using an appropriately validated in vitro methodology.

We have attempted to contact OGD, but been unable to confirm this directly with it. Nonetheless, we feel that it is important to note that, if such a change in FDA’s approach has occurred:

 

    The change would have been made in the absence of any public discussion and, significantly, without seeking input from FDA’s own expert Advisory Committee on this important issue;

 

    We believe that there are important safety and scientific issues that the FDA must consider before making such an important change in its requirements for bioequivalence data; and

 

    We strongly disagree with both the manner in which this change in approach was developed, as well as the substance of the approach which ignores the need to demonstrate bioequivalence for a non-systemically absorbed drug. We will vigorously oppose at FDA this attempt to radically restrict the data on which FDA would make vancomycin capsule bioequivalence decisions. Vancocin combats a serious, and potentially life threatening, disease. In this context, we believe that the uncertainties of dissolution-only bioequivalence are simply unacceptable.


C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea, and the associated complications of disease. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the CDC, there are approximately 3,000,000 cases of antibiotic-associated diarrhea per year, of which 15 to 25 percent are caused by C. difficile.

About ViroPharma Incorporated

ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company’s website at www.viropharma.com.

Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including the Company’s plans to vigorously oppose changes to OGD practices regarding a generic applicant’s ability to request such a waiver of in-vivo bioequivalence testing for Vancocin provided that dissolution testing demonstrates that the test product is rapidly dissolving at certain specified conditions. There can be no assurance that ViroPharma’s efforts to oppose this change in OGD’s practices will be successful. If we are unable to change this approach at FDA, the threat of generic competition will become more acute. The entry of competing generic products will significantly affect our sales of Vancocin and our financial performance. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. These factors, and other factors, including, but not limited to those described in ViroPharma’s annual report on Form 10-K for the year ended December 31, 2005 filed with the Securities and Exchange Commission could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.

# # #

EX-99.2 3 dex992.htm PRESS RELEASE DATED MARCH 17, 2006 REGARDING PETITION FOR STAY OF ACTION. Press Release dated March 17, 2006 regarding Petition for Stay of Action.

Exhibit 99.2

 

LOGO    Contacts:  

William C. Roberts

Director, Corporate Communications

VIROPHARMA INCORPORATED

Phone (610) 321-6288

VIROPHARMA FURTHER COMMENTS ON VANCOCIN

Exton, PA, March 17, 2006 — ViroPharma Incorporated (Nasdaq: VPHM) today filed a Petition for Stay of Action with the FDA regarding the requirements for waivers of in-vivo bioequivalence testing for Vancocin. ViroPharma expects to make additional filings in support of its vigorous opposition to any approach that does not require rigorous scientific methods to demonstrate a rate and extent of drug release to the site of action consistent with good medicine and science. The company believes that, given the growing number of patients with severe, and possibility life threatening, C. difficile-associated disease, the appropriate expert advisory groups must validate the scientific and medical appropriateness of the approval standards for a generic locally acting vancomycin capsule product.

ViroPharma earlier today commented that it had been informed that the Office of Generic Drugs, Center for Drug Evaluation and Research (“OGD”), may have changed its approach regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in-vivo bioequivalence testing for Vancocin. In a discussion with the Company today, OGD has confirmed this change in approach.

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea, and the associated complications of disease, including death. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the CDC, there are approximately 3,000,000 cases of antibiotic-associated diarrhea per year, of which 15 to 25 percent are caused by C. difficile.

About ViroPharma Incorporated

ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company’s website at www.viropharma.com.

Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including the Company’s plans to vigorously oppose changes to OGD practices regarding a generic applicant’s ability to request such a waiver of in-vivo bioequivalence testing for Vancocin provided that dissolution testing demonstrates that the test product is rapidly dissolving at certain specified conditions. There can be no assurance


that ViroPharma’s efforts to oppose this change in OGD’s practices will be successful. If we are unable to change this approach at FDA, the threat of generic competition will become more acute. The entry of competing generic products will significantly affect our sales of Vancocin and our financial performance. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. These factors, and other factors, including, but not limited to those described in ViroPharma’s annual report on Form 10-K for the year ended December 31, 2005 filed with the Securities and Exchange Commission could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.

# # #

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