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): November 22, 1999
CELLEGY PHARMACEUTICALS, INC.
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(Exact name of Registrant as specified in its charter)
California
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(State or other jurisdiction of incorporation)
0-26372 82-0429727
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(Commission (IRS Employer
File Number) Identification No.)
349 Oyster Point Boulevard, Suite 200
South San Francisco, CA 94080
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(Address of principal executive offices) (Zip Code)
(650) 616-2200
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(Registrant's telephone number, including area code)
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(Former name or former address, if changed since last report)
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ITEM 5: OTHER EVENTS.
Filed with this report as Exhibit 99.01 is a press release issued by
the Registrant on November 22, 1999, announcing:
o the unblinding and preliminary results of a pivotal Phase III
clinical trial for its product Anogesic(R)(nitroglycerin
ointment). In the analysis of the trial data, 44% of the patients
(35 out of 80) treated with the most effective dose of
Anogesic(R)experienced a complete resolution (cure) of their
condition. On the other hand, a similar unexpectedly high
percentage of the patients treated with placebo (vehicle ointment
containing no active drug) also were cured. However, at the most
effective dose of Anogesic(R), the rate of decrease in average
pain was significantly greater relative to the placebo vehicle, a
"p value" of less than 0.0002. While the secondary endpoint
result (pain reduction) is positive, the primary endpoint of the
trial (complete healing) was not met.
After the Registrant has completed further analysis of the data, the
Registrant plans to develop a potential follow-up clinical trial and discuss the
results with the U. S. Food and Drug Administration (FDA).
ITEM 7: FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
99.01 Press Release issued by the Registrant on November 22,
1999.
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SIGNATURE
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.
Date: November 29, 1999 CELLEGY PHARMACEUTICALS, INC.
By: /s/ K. MICHAEL FORREST
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K. Michael Forrest
President and Chief Executivel Officer
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EXHIBIT 99.01
Cellegy Announces Preliminary Results of
Phase III Clinical Trial with Anogesic(R)
Surprising Outcome Means Further Clinical Testing Required
South San Francisco, California, November 22, 1999 - Cellegy Pharmaceuticals,
Inc. (NASDAQ: CLGY) announced today the unblinding and preliminary results of a
pivotal Phase III clinical trial for its product Anogesic(R) (nitroglycerin
ointment). The product was studied in 304 patients to determine the optimum dose
and frequency required for the treatment of chronic anal fissures, a painful and
debilitating condition.
In the analysis of the trial data, forty-four percent (44%) of the patients
(35/80) treated with the most effective dose of Anogesic experienced a complete
resolution (cure) of their condition. On the other hand, a similar, inexplicably
high percentage of the patients treated with placebo (vehicle ointment
containing no active drug) were also cured. However, at the most effective dose
of Anogesic, the rate of decrease in average pain was significantly greater
relative to placebo, (p value less than 0.0002). While the secondary endpoint
result (pain reduction) is positive, the primary endpoint of the trial (complete
healing) was not met.
"We were completely surprised by the low efficacy outcome as well as the high
placebo response rate as both are inconsistent with results of several
previously reported clinical trials," commented K. Michael Forrest, president
and chief executive officer of Cellegy. In earlier trials on over 400 patients,
nitroglycerin ointment was shown to reduce pain, and, over an eight-week course
of therapy, cure most patients suffering from chronic anal fissures. In one such
study published in a leading peer reviewed journal, The Lancet, approximately
68% of patients who would otherwise have required surgery were cured, while only
8% of the patients responded to placebo.
"We will meet shortly with our expert consultants to analyze all aspects of the
trial data and to design the most appropriate clinical strategy," said Dr.
Daniel Azarnoff, Cellegy's senior vice president, clinical and regulatory
affairs. "We then plan to meet with the FDA to determine the next steps. We
continue to believe that Anogesic is effective and that it will ultimately be
recognized as a useful drug for the treatment of this serious, painful
condition."
"We are also proceeding with our plans to study the drug's effectiveness in
various hemorrhoid indications, which also offer a significant commercial
opportunity," added Forrest. "A pilot study in the treatment of pain following
hemorrhoid surgery is underway, and the Company is on target to commence a pilot
study in the use of Anogesic for the treatment of hemorrhoids within the next
few months."
Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the
development and commercialization of topically administered prescription drugs
and high performance cosmeceutical products. In addition to Anogesic ointment,
the Company is developing a transdermal testosterone gel for
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the treatment of male hypogonadism, a condition that can result in decreased
energy and libido in men, generally over the age of forty. Cellegy plans to
enter into advanced clinical trials with this product within the next few
months, pending protocol approval by the FDA. Cellegy has also developed a line
of high performance cosmeceutical products, which have been shown in clinical
tests to produce significant improvements in the appearance of photodamaged and
wrinkled skin.
This press release contains certain forward-looking statements by Cellegy.
Actual results could differ materially from those described, including but not
limited to the following: there can be no assurance that Anogesic or any product
in the Cellegy pipeline will be successfully developed, that final data will be
identical to the preliminary analysis, that final results will be supportive of
regulatory requirements necessary to obtain approval from the FDA or regulatory
authorities in other markets, that regulatory approval will be granted in a
timely manner or at all, that unforeseen patent or other intellectual property
disputes will not delay, impair or prevent marketing of Anogesic or other
products, or that physician and patient acceptance of Cellegy's products will be
achieved.
