-----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, Khpxsv5znkC/w2/YkbdnIrcp/lOG44srK46IzAo2IOzunLqDIGYJieQsmsbRywPO Tkpv5h6qkVKKzZGZcbuX1w== 0000891618-03-006430.txt : 20031224 0000891618-03-006430.hdr.sgml : 20031224 20031224110142 ACCESSION NUMBER: 0000891618-03-006430 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20031222 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031224 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: 031073049 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 f95303e8vk.htm FORM 8-K Connetics Corporation, Form 8-K, 12/22/03
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 22, 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)

 

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 22, 2003, Connetics Corporation announced that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Actiza ™, an investigational new drug formulation of 1% clindamycin delivered in the Company’s proprietary VersaFoam ™ delivery system, as a potential new topical treatment for acne.

     In September, Connetics announced positive results from its Phase III clinical trial with Actiza versus Clindagel® for the treatment of acne.

     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 22, 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/ Thomas G. Wiggans
       
         
        Thomas G. Wiggans
        President and Chief Executive Officer
         
         
Date: December 24, 2003        

 

Table of Contents

EXHIBIT INDEX

             
Exhibit            
Number   Description        
 
       
99.1   Press Release dated December 22, 2003.

  EX-99.1 3 f95303exv99w1.htm EXHIBIT 99.1 Exhibit 99.1

 

Exhibit – 99.1

(CONNETICS LOGO)

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

Connetics Announces Submission of a New Drug Application For Actiza
(Clindamycin Phosphate Foam, 1%)

PALO ALTO, Calif., December 22, 2003 — Connetics Corporation (Nasdaq: CNCT), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Actiza™, an investigational new drug formulation of 1% clindamycin delivered in the Company’s proprietary VersaFoam™ delivery system, as a potential new topical treatment for acne.

In September, Connetics announced positive results from its Phase III clinical trial with Actiza versus Clindagel® for the treatment of acne. Based on pre-NDA discussions, the FDA indicated that this 505(b)(2) application qualifies for exclusion from a user fee assessment.

According to the National Institute of Arthritis, Musculoskeletal and Skin Disorders (NIAMS), an estimated 17 million people in the U.S. are affected by acne, and an estimated 5.1 million people visit a physician for treatment per year. The prescription acne category is the largest segment of the dermatology market, and is estimated to be in excess of $1.5 billion annually in the U.S., not including oral antibiotics. Topical antibiotics, like clindamycin, are a major component of the prescription acne market and represent approximately one third of the market. Clindamycin is one of the most widely prescribed medications for acne.

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%. Connetics is also 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. Connetics has branded its innovative foam drug delivery vehicle, VersaFoam™. 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, in particular, statements about the market potential of Actiza. 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. Connetics faces risks and uncertainties that the filing of the NDA for Actiza may be delayed, that the FDA may not approve Actiza for sale, and that the expected market for Actiza 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-2 for the last fiscal year and Quarterly Report on Form 10-Q for the most recent fiscal quarter.

###

Clindagel® is a registered trademark of Galderma.

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