-----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, G519iWEiylzMP/n8S0v4IL3s7DyadaL5z+DGK1tv0IL9O05xWiU1zSDZ3EvfjSgM vlaQj4UCXX0G4N2XDhKU4A== 0000950134-04-013232.txt : 20040907 0000950134-04-013232.hdr.sgml : 20040906 20040907142029 ACCESSION NUMBER: 0000950134-04-013232 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040902 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20040907 DATE AS OF CHANGE: 20040907 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: 041018513 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 f01672e8vk.htm FORM 8-K e8vk
Table of Contents



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

September 2, 2004


Date of Report (Date of earliest event reported)

CONNETICS CORPORATION


(Exact name of Registrant as specified in its charter)
         
Delaware
  0-27406   94-3173928
(State or Other
  (Commission File   (IRS Employer
Jurisdiction of
  No.)   Identification No.)
Incorporation)
       

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)

     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:

  o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
  o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
  o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
  o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))



 


TABLE OF CONTENTS

Item 8.01. Other Events.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1


Table of Contents

Item 8.01. Other Events.

     On September 2, 2004, Connetics Corporation announced that the U.S. Food and Drug Administration (FDA) has advised the Company that the FDA made an administrative error when assigning the original user fee goal date for Extina ® (2% ketoconazole). During the course of the ongoing review of the Extina New Drug Application, the FDA acknowledged on September 2, 2004 that the original user fee goal date of September 24, 2004 was assigned in error and that the correct date is November 26, 2004.

Item 9.01 Financial Statements and Exhibits.

     (c) Exhibits

          99.1 Press Release dated September 2, 2004.

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: September 7, 2004 

 


Table of Contents

EXHIBIT INDEX

     
Exhibit    
Number   Description
99.1
  Press Release dated September 2, 2004

 

EX-99.1 2 f01672exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1

(CONNETICS LOGO)

EXTINA USER FEE GOAL DATE IS NOVEMBER 26, 2004

PALO ALTO, Calif. (September 2, 2004) – Connetics Corporation (Nasdaq: CNCT), announced that the U.S. Food and Drug Administration (FDA) has advised the Company that the FDA made an administrative error when assigning the original user fee goal date for Extina® (2% ketoconazole). During the course of the ongoing review of the Extina New Drug Application, the FDA today acknowledged that the original user fee goal date of September 24, 2004 was assigned in error and that the correct date is November 26, 2004. Extina is an investigational new drug formulation and a potential new treatment for seborrheic dermatitis.

Commercial planning for Extina, as well as the Company’s previously announced sales force expansion plans and financial guidance for 2004, are unchanged.

About Connetics

Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. Connetics has branded its innovative foam drug delivery vehicle VersaFoam®. The Company’s marketed products are OLUX® (clobetasol propionate) Foam, 0.05%, Luxíq® (betamethasone valerate) Foam, 0.12%, and Soriatane® (acitretin) capsules, 10 mg and 25 mg. Connetics is developing Extina®, a foam formulation of the antifungal drug ketoconazole, Actiza™, a foam formulation of clindamycin for treating acne, and Velac®, a combination of clindamycin and tretinoin for treating acne. These formulations aim to improve the management of dermatological diseases and provide significant product differentiation, and have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information about Connetics and its products, please visit www.connetics.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Securities Litigation Reform Act. Statements about the commercial planning activities for Extina, planned sales force expansion; and financial guidance for 2004 are forward-looking statements. These statements are based on certain assumptions made by Connetics’ management based on experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. 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 filed for the year ending December 31, 2003 and form 10-Q for the quarter ended June 30, 2004. Forward-looking statements represent the judgment of the Company’s management as of the date of this release, and Connetics disclaims any intent or obligation to update any forward-looking statements.
     
Company Contact:   Investor Relations:
Patrick O’Brien
  Ina McGuinness or Bruce Voss
Director, Investor Relations
  Lippert/Heilshorn & Associates
(650) 739-2950
  (310) 691-7100
pobrien@connetics.com
  imcguinness@lhai.com

# # #

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