-----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, Sd4xr4Mep2PrFK7Sk7dlkZILGaxjxq/uSyfJE5occxl1mHRVkq2ZBPCrnQfZEBhI Ou6vPaH5n3VtYwyxj5gh0w== 0000891618-03-006257.txt : 20031211 0000891618-03-006257.hdr.sgml : 20031211 20031211120921 ACCESSION NUMBER: 0000891618-03-006257 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20031210 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031211 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CONNETICS CORP CENTRAL INDEX KEY: 0001004960 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943173928 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27406 FILM NUMBER: 031048930 BUSINESS ADDRESS: STREET 1: 3400 W BAYSHORE RD CITY: PALO ALTO STATE: CA ZIP: 94303 BUSINESS PHONE: 4158432800 MAIL ADDRESS: STREET 1: 3400 W BAYSHORE RD CITY: PALO ALTO STATE: CA ZIP: 94303 FORMER COMPANY: FORMER CONFORMED NAME: CONNECTIVE THERAPEUTICS INC DATE OF NAME CHANGE: 19951214 8-K 1 f95147e8vk.htm FORM 8-K Connetics Corporation, Form 8-K, 12/10/03
Table of Contents

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

December 10, 2003


(Date of earliest event reported)

CONNETICS CORPORATION


(Exact name of Registrant as specified in its charter)
         
Delaware   0-27406   94-3173928

 
 
(State or Other
Jurisdiction of Incorporation)
  (Commission File No.)   (IRS Employer
Identification No.)

3290 West Bayshore Road, Palo Alto, California 94303


(Address of principal executive offices, including zip code)

(650) 843-2800


(Registrant’s telephone number, including area code)

 


TABLE OF CONTENTS

Item 5. Other Events.
Item 7. Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1


Table of Contents

Item 5. Other Events.

     On December 10, 2003, Connetics Corporation announced that it received notification from the FDA that no user fee is required for the new drug application (NDA) seeking marketing clearance for Extina™ (ketoconazole 2%) Foam. In April, Connetics announced positive results from its Phase III clinical trial with Extina versus Nizoral ™. Connetics submitted an NDA for Extina in July.

     A copy of the press release announcing this event is attached to this Report as Exhibit 99.1 and is incorporated into this report by this reference.

Item 7. Financial Statements and Exhibits.

     (c) Exhibits.

          99.1 Press Release dated December 10, 2003.

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.

             
    CONNETICS CORPORATION    
             
    By:   /s/ Katrina J. Church    
       
   
        Katrina J. Church
Executive Vice President, General Counsel and Secretary
   
             
Date:  December 11, 2003            

 


Table of Contents

EXHIBIT INDEX

     
Exhibit    
Number   Description

 
99.1   Press Release dated December 10, 2003

  EX-99.1 3 f95147exv99w1.htm EXHIBIT 99.1 Exhibit 99.1

 

Exhibit 99.1

(LOGO)

     
Company Contact
John Higgins
Chief Financial Officer
(650) 843-2800
  Investor Relations
Ina McGuinness or Bruce Voss
Lippert/Heilshorn & Associates
(310) 691-7100
     
jhiggins@connetics.com   imcguinness@lhai.com

Connetics Announces User Fee Not Required for Extina New Drug Application

PALO ALTO, Calif., December 10, 2003 — Connetics Corporation (Nasdaq: CNCT), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced that it received notification from the FDA that no user fee is required for the new drug application (NDA) seeking marketing clearance for ExtinaTM (ketoconazole 2%) Foam. In April, Connetics announced positive results from its Phase III clinical trial with Extina versus Nizoral™. Connetics submitted an NDA for Extina in July.

“We are pleased to have this matter resolved,” said Thomas G. Wiggans, President and Chief Executive Officer. “Consistent with our other NDA filings, we did not believe a user fee was due, and it is a positive development to have reached agreement with the FDA on this matter. Considering the time required to resolve the user fee issue, we now anticipate receiving marketing clearance for Extina by the end of 2004.”

About Connetics
Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. The Company’s marketed products are OLUX® (clobetasol propionate) Foam, 0.05% and Luxiq® (betamethasone valerate) Foam, 0.12%. The Company also is developing Extina™, a foam formulation of the antifungal drug ketoconazole, Actiza™, a foam formulation of clindamycin for treating acne, and Velac® Gel, a combination of clindamycin and tretinoin for treating acne. These formulations aim to improve the management of dermatological diseases and provide significant product differentiation. For more information about Connetics and its products, please visit www.connetics.com, or send an e-mail to ir@connetics.com.

This news release includes forward-looking statements, and predictions, including statements about the timing of potential future marketing clearance for Extina. These statements represent the Company’s judgment as of the date of this news release and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. In particular,

 


 

Connetics faces risks and uncertainties that the FDA may not approve Extina for sale, and that the expected market for Extina may not materialize. Factors that could cause or contribute to such differences include, but are not limited to, risks and other factors that are discussed in documents filed by Connetics with the Securities and Exchange Commission from time to time, including Connetics’ Annual Report on Form 10-K/A for the last fiscal year and Quarterly Report on Form 10-Q for the most recent fiscal quarter.

###

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