-----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, Ph8N4YSo3c1t8LoKvUYGzCpRpCq4RY/dS6J6msi0PLW8DoZ1YvAfcrxOkePzSnED ETYUsETbGZWdqEDFh1jgyA== 0000950134-04-014229.txt : 20040928 0000950134-04-014229.hdr.sgml : 20040928 20040928144148 ACCESSION NUMBER: 0000950134-04-014229 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040927 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20040928 DATE AS OF CHANGE: 20040928 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: 041049569 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 f02063e8vk.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 27, 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 (see General Instruction A.2. below):

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 27, 2004, Connetics Corporation announced that it commenced the Phase III clinical program for Desilux™, a low-potency topical steroid, formulated with 0.05% desonide in the Company’s proprietary emollient foam delivery vehicle. The clinical program will focus on atopic dermatitis and is designed to include infants from three months of age and children up to 17 years of age.

Item 9.01 Financial Statements and Exhibits.

     (c) Exhibits

99.1 Press Release dated September 27, 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 28, 2004

 


Table of Contents

EXHIBIT INDEX

     
Exhibit    
Number
  Description
99.1
  Press Release dated September 27, 2004

 

EX-99.1 2 f02063exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1

(Connetics Logo)

CONNETICS COMMENCES PHASE III CLINICAL TRIAL FOR DESILUX

First Drug Program to Include Connetics’ Patented Emollient Foam Technology

PALO ALTO, Calif. (September 27, 2004) — Connetics Corporation (Nasdaq: CNCT), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced it has commenced the Phase III clinical program for Desilux™, a low-potency topical steroid, formulated with 0.05% desonide in the Company’s proprietary emollient foam delivery vehicle. The clinical program will focus on atopic dermatitis and is designed to include infants from three months of age and children up to 17 years old. Subject to a successful Phase III trial outcome, Connetics intends to submit a New Drug Application to the U.S. Food and Drug Administration by the end of 2005.

Desonide currently is the leading topical steroid prescribed by dermatologists in the low-potency dermatoses market. The low-potency steroid market has annual U.S. sales exceeding $150 million. A Desilux approval would provide Connetics with its first low-potency steroid product and will expand the Company’s topical steroid product offerings into all three of the market segments of the $1.0 billion topical steroid market. In addition to offering a low-potency topical steroid, Desilux will also be the Company’s first product with a pediatric indication.

The emollient foam delivery vehicle is an important advancement in topical steroid therapy. The vehicle, which recevied a patent in May 2004 was developed by Connetics as a cosmetically and functionally elegant formulation to displace emollient-based and ointment-based treatments. The market opportunity for emollient-based and ointment-based products currently exceeds $280 million in U.S. topical steroid sales annually.

“The commencement of our Phase III clinical program involving our patented emollient foam delivery vehicle is an exciting advancement for Connetics,” said Lincoln Krochmal, M.D., Executive Vice President of Research and Product Development for Connetics. “We believe that incorporating a strong moisturizing benefit into our proprietary foam will provide a novel product in the market.” Dr. Krochmal continued, “We have established the leading brands in the mid- and super-high potency steroid categories with Luxíq and OLUX. With this low-potency foam steroid in development, we look forward to being able to offer dermatologists a complete line of topical steroids with enhanced cosmetic elegance, which we believe leads to greater patient compliance and increased patient satisfaction.”

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.

-More-

 


 

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Securities Litigation Reform Act. Statements about the planned timing of an NDA filing for Desilux and similar statements projecting a positive outcome of the Phase III clinical program for Desilux. 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
Director, Investor Relations
(650) 739-2950
pobrien@connetics.com
  Ina McGuinness or Bruce Voss
Lippert/Heilshorn & Associates
(310) 691-7100
imcguinness@lhai.com

# # #

 

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