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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): August 27, 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: (650) 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 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
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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.
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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: August 27, 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 August 27, 1997 announcing
the results of a Phase III trial of gamma
interferon for the treatment of atopic dermatitis.
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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.
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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."
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