-----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, K1agLkPV+AGO2LvueODeh3Wqvcd3uGdTNT0ydhSMZxfNNfj58LPfXaWR/hr/YbDZ A6mac9bdDhnvjRcNifS79w== 0000950134-04-018183.txt : 20041124 0000950134-04-018183.hdr.sgml : 20041124 20041124134218 ACCESSION NUMBER: 0000950134-04-018183 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041123 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041124 DATE AS OF CHANGE: 20041124 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: 041166408 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 f03658e8vk.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

November 23, 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 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)

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 November 23, 2004, Connetics Corporation (“Connetics”) announced that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter (dated November 23, 2004) for Extina®, an investigational new drug formulation of 2% ketoconazole for the treatment of seborrheic dermatitis. The FDA concluded that Extina was not effective for the treatment of seborrheic dermatitis because it was not superior to placebo foam. A copy of the Connetics press release regarding Extina is attached as Exhibit 99.1 and is incorporated by reference in this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

  (c)   Exhibits

     
Exhibit    
Number
  Description
99.1
  Press Release dated November 23, 2004 regarding Extina.

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/ Sanjiv S. Dhawan
     
 
      Sanjiv S. Dhawan
      Vice President, Corporate Counsel

Date: November 24, 2004

 


Table of Contents

EXHIBIT INDEX

     
Exhibit    
Number
  Description
99.1
  Press Release issued November 23, 2004 regarding Extina.

 

EX-99.1 2 f03658exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1

(CONNETICS LOGO)

CONNETICS RECEIVES FDA NON-APPROVABLE LETTER FOR EXTINA

Conference Call to be held Wednesday, November 24th at 9:00 a.m. Eastern/6:00 a.m. Pacific

PALO ALTO, Calif. (November 23, 2004) – Connetics Corporation (Nasdaq: CNCT), a specialty pharmaceutical company focused on dermatology, today announced that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter (dated November 23, 2004) for Extina®, an investigational new drug formulation of 2% ketoconazole for the treatment of seborrheic dermatitis. The FDA concluded that Extina was not effective for the treatment of seborrheic dermatitis because it was not superior to placebo foam.

Connetics announced in April 2003 that results from its Phase III clinical trial with Extina demonstrated non-inferiority to Nizoral® (ketoconazole) 2% Cream as measured by the endpoint of the Investigator’s Static Global Assessment. Connetics also announced the results did not achieve statistical superiority versus placebo foam.

“The FDA’s decision is disappointing and surprising. Based on discussions with the FDA regarding the requirements for the Phase III trial, we believe Extina met the study endpoints and that the NDA was approvable,” said Thomas G. Wiggans, Connetics’ Chief Executive Officer. “We believe that Extina demonstrated efficacy and warranted approval. However, under the circumstances, we will evaluate all options for Extina.”

Commenting on the company’s near-term commercial prospects, Mr. Wiggans added “With our recently expanded and highly experienced sales force, we project continued growth from our core brands in 2005, and we are prepared for the commercial launch of Evoclin™, our new acne foam product, early next month. In addition, we have submitted an NDA for Velac® and have a robust pipeline of clinical and formulation-stage product candidates. We believe that any potential lost revenue for Extina in 2005 will be offset by expense savings as we will not be incurring the planned commercialization costs for Extina.”

As a result of today’s announcement, Connetics now expects product revenues and earnings per diluted share for the 2004 fourth quarter will come in at the low end of previous guidance ranges of $43 million to $46 million and $0.16 to $0.18, respectively.

Conference Call
Connetics will host a conference call to discuss Extina and the non-approvable letter received from the FDA on Wednesday, November 24th beginning at 9:00 a.m. Eastern Time/6:00 a.m. Pacific Time. To participate in the live call by telephone, domestic callers should dial (888) 328-2575, and international callers should dial (706) 643-0459. A telephone replay will be available for 48 hours beginning today at 6:30 p.m. Eastern Time/3:30 p.m. Pacific Time. To access the replay from the U.S., please dial (800) 642-1687; and from outside the U.S. please dial (706) 645-9291. The conference ID# is 2509680.

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 proprietary foam drug delivery vehicle VersaFoam®. The Company’s marketed products are OLUX® (clobetasol propionate) Foam, 0.05%, Luxíq® (betamethasone valerate) Foam, 0.12%, Soriatane®

- more -


 

(acitretin) capsules and Evoclin™ (clindamycin) Foam, 1%. Connetics is developing Velac® (a combination of 1% clindamycin and 0.025% tretinoin) Gel, for treating acne, and Desilux™ (desonide) Foam, 0.05% a low-potency topical steroid formulated to treat atopic dermatitis. Our product formulations aim to improve the management of dermatological diseases and provide significant product differentiation. In our marketed products, these formulations 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 impact of the non-approvable letter from the FDA to our business, revenues, expenses, and our future plans for Extina 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. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond Connetics’ control, and which could cause actual results or events to differ materially from those expressed in such forward-looking statements. 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 September 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.

     
Contacts:
   
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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