-----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, FFvUUgY8kvFEHsjwUr0NI0i9xKDlMrZxuwTsPRKpSVfEUJKtywca6uWQ9Q2q5koQ y3zNPNP6MoS0JsOzc+GKTw== 0000891618-97-003643.txt : 19970912 0000891618-97-003643.hdr.sgml : 19970912 ACCESSION NUMBER: 0000891618-97-003643 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970827 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19970902 SROS: NASD 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: SEC FILE NUMBER: 000-27406 FILM NUMBER: 97673802 BUSINESS ADDRESS: STREET 1: 3400 W BAYSHORE RD CITY: PALO ALTO STATE: CA ZIP: 94303 BUSINESS PHONE: 4158432800 FORMER COMPANY: FORMER CONFORMED NAME: CONNECTIVE THERAPEUTICS INC DATE OF NAME CHANGE: 19951214 8-K 1 FORM 8-K DATE OF REPORT AUGUST 27, 1997 1 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 Date of Report (Date of earliest event reported): August 27, 1997 CONNETICS CORPORATION - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware - -------------------------------------------------------------------------------- (State or other jurisdiction of incorporation) 0-27406 94-3173928 - -------------------------------------------------------------------------------- (Commission File Number) (IRS Employer Identification No.) 3400 West Bayshore Road, Palo Alto, CA 94303 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (650) 843-2800 -------------------------- - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report) 2 ITEM 5. OTHER EVENTS On August 27, 1997, Connetics Corporation (the "Company") announced the results from its Phase III clinical trial of gamma interferon for the treatment of atopic dermatitis. Analysis of the trial did not show an acceptable therapeutic response with respect to the primary clinical endpoint--a composite clinical severity index based upon erythema (redness of the skin), papulation (swelling) and excoriation (scratch marks). As a result, the Company (which has one product on the market and three other compounds in late-stage clinical trials) announced that it has suspended plans to submit a Biological License Application (BLA) for gamma interferon for the treatment of atopic dermatitis. The Company's press release with regard to this development is attached hereto as Exhibit 99.1. ITEM 7. FINANCIAL STATEMENT AND EXHIBITS. (c) EXHIBITS -------- Exhibit 99.1 Press Release dated August 27, 1997 announcing the results of a Phase III trial of gamma interferon for the treatment of atopic dermatitis. -2- 3 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 thereunto duly authorized. CONNETICS CORPORATION (Registrant) Dated: August 27, 1997 By: /s/ Cynthia M. Butitta ------------------------------------------ Cynthia M. Butitta Vice President, Finance and Administration and Chief Financial Officer -3- 4 INDEX TO EXHIBITS EXHIBITS -------- Exhibit 99.1 Press Release dated August 27, 1997 announcing the results of a Phase III trial of gamma interferon for the treatment of atopic dermatitis. EX-99.1 2 PRESS RELEASE DATED AUGUST 27, 1997 1 EXHIBIT 99.1 Contacts: Connetics Corporation Burns McClellan Cynthia M. Butitta Audra Nass - Media VP, Finance & Administration 650-352-6262 Chief Financial Officer Reagan Codner - Investors 650-843-2800 212-213-0006 FOR IMMEDIATE RELEASE CONNETICS ANNOUNCES PHASE III RESULTS OF GAMMA INTERFERON FOR ATOPIC DERMATITIS PALO ALTO, CA -- August 27, 1997 -- Connetics Corporation (NASDAQ: CNCT) announced today that based on the results of a 555 patient Phase III trial, it has suspended plans to submit a Biological License Application (BLA) for gamma interferon for the treatment of atopic dermatitis. The Company, which has one product on the market and three compounds in late-stage clinical trials, stated analysis of the study did not show an acceptable therapeutic response with respect to the primary clinical endpoint - a composite clinical severity index based upon erythema (redness of the skin), papulation (swelling) and excoriation (scratch marks). "Naturally, we are disappointed with these results, but this program was conducted quickly and efficiently to evaluate gamma interferon's viability as a therapeutic option for atopic dermatitis," stated Thomas G. Wiggans, president and chief executive officer of Connetics. "We are committed to meeting our objectives with our late-stage programs, including the evaluation of the Phase II gamma interferon keloid trial." Connetics has recently reported positive clinical results on two of its product candidates, including Phase III data on a novel mousse formulation of betamethasone for the treatment of psoriasis, for which the Company expects to file a new Drug Application in the first quarter of 1998. In addition, Connetics reported positive Phase II results on ConXno (relaxin) for scleroderma, a life-threatening condition that affects over 300,000 Americans and for which there is currently no marketed treatment available. 2 Gamma Interferon - Phase III August 27, 1997 Page Two Connetics Corporation, headquartered in Palo Alto, California, is focused on the acquisition, development and marketing of products in the areas of rheumatology and dermatology. The Company currently markets Ridaura(R) (auranofin), a treatment for rheumatoid arthritis, acquired from SmithKline Beecham. Several products are under development: betamethasone mousse for the treatment of scalp psoriasis and other dermatoses; gamma interferon for the treatment of keloids; ConXn(TM) (relaxin) for the treatment of scleroderma and other fibrotic conditions; and TCR vaccines for the treatment of rheumatoid arthritis and multiple sclerosis. Special Note: The second and third paragraphs of this news release contain forward-looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, the unpredictability of clinical trials, potential delays in filing its planned NDA, and risks associated with product development. These and other factors are discussed in more depth in Connetics' Form 10-K for the year ended December 31, 1996 under the heading "Additional Factors That May Affect Future Results." ### -----END PRIVACY-ENHANCED MESSAGE-----