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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): June 5, 1997
CONNETICS CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware
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(State or other jurisdiction of incorporation)
0-27406 94-3173928
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(Commission File Number) (IRS Employer Identification No.)
3400 West Bayshore Road, Palo Alto, CA 94303
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (415) 843-2800
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(Former name or former address, if changed since last report)
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Item 5. Other Events
On June 5, 1997, Connetics Corporation (the "Company") announced the
results from its Phase II clinical trial of ConXn(TM) (recombinant human relaxin
H2). 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
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Exhibit 99.1 Press Release dated June 5, 1997 announcing Phase
II trial of ConXn(TM)in Schleroderma.
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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: June 5, 1997 By: /s/ Cynthia M. Butitta
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Cynthia M. Butitta
Vice President, Finance and Administration
and Chief Financial Officer
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INDEX TO EXHIBITS
Exhibits
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Exhibit 99.1 Press Release dated June 5, 1997 announcing Phase
II trial of ConXn(TM)in Schleroderma.
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EXHIBIT 99.1
Contacts:
Sher Hoff Burns McClellan
Shareholder Relations Reagan Codner - Investors
Connetics Corporation 212-505-1919
415-843-2800 Audra Nass - Media
415-352-6262
For Immediate Release
CONNETICS ANNOUNCES RESULTS OF PHASE II TRIAL OF
CONXN(TM) IN SCLERODERMA
PALO ALTO, Calif. -- June 5, 1997 -- Connetics Corporation (Nasdaq: CNCT)
announced today positive results of Phase II data which suggest ConXn(TM)
(recombinant human relaxin H2) may be an effective treatment for scleroderma, a
life threatening connective tissue disorder for which there is currently no
treatment. This represents the first controlled clinical study to show positive
results in the treatment of scleroderma.
The double-blind, placebo-controlled study involved 64 patients randomized into
one of two treatment groups (25 or 100 ug/kg/day), or placebo. In the group
receiving a dose of 25 ug/kg/day statistical significance was found in skin
score improvement, the primary clinical endpoint, and positive trends were seen
in all other parameters. As suggested by previous studies, the higher dose had
no effect on the treatment group compared to placebo.
"We are encouraged by these results, which corroborate earlier dose response
trials of ConXn's effect on connective tissue turnover via its effects on
collagen and collagenase production," stated Scott Harkonen, M.D., Senior Vice
President, Product Development and Operations, of Connetics. "Based on these
data, we are committed to the continued development of ConXn for scleroderma, a
devastating and currently untreatable disease."
Connetics is continuing its analysis of the data and will meet with clinical
investigators and the Food and Drug Administration (FDA) to finalize its plans
for continued development, leading to product approval, of ConXn. The Phase II
data has been submitted for presentation at the American Academy of Rheumatology
Annual Meeting in November.
"This is the first ever prospective, controlled trial of a potentially
disease-modifying agent for scleroderma that has produced positive results. This
offers a real ray of hope for the tens of thousands of Americans with this
disease," stated Dr. James R. Seibold, M.D., University of Medicine & Dentistry
of New Jersey, Robert Wood Johnson Medical School.
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Scleroderma is a serious connective tissue disease resulting from an excessive
production of collagen. The disease afflicts approximately 300,000 patients in
the U.S. alone, 80 percent of whom are women. In its severe form (which affects
approximately 60,000 patients), the disease results in hardening of the skin and
internal organs, and is fatal in 50 to 70 percent of cases within five years.
Connetics Corporation, headquartered in Palo Alto, California, is focused on the
acquisition, development and marketing of products in the areas of rheumatology
and dermatology. Ridaura(R) (auranofin) is a treatment for rheumatoid arthritis
that Connetics acquired from SmithKline Beecham. Several other products are
under development: gamma interferon for the treatment of severe atopic
dermatitis and keloids; betamethasone mousse for the treatment of scalp
psoriasis and other scalp dermatoses; ConXn(TM) (relaxin) for the treatment of
scleroderma and other fibrotic conditions; and TCR vaccines for the treatment of
rheumatoid arthritis and multiple sclerosis. In March 1997, the Company's board
of directors approved a change in the Company's name from Connective
Therapeutics, Inc. to Connetics Corporation, which was approved by the Company's
stockholders at its annual meeting on May 14, 1997.
Special Note: The third and fifth 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 and risks associated with product
development. These and other factors are discussed in more depth in Connective's
(also known as Connetics) Form 10-K for the year ended December 31, 1996 under
the heading Additional Factors That May Affect Future Results.
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