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 3, 1997
Cellegy Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)
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California 0-26372 82-0429727
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
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1065 East Hillsdale Boulevard, Suite 418, Foster City, California 94404
(Address of principal executive offices, including zip code)
(650) 524-1600
(Registrant's telephone number, including area code)
This report on Form 8-K consists of 6 sequentially numbered pages.
The exhibit index is located at sequentially numbered page 4.
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Item 5: Other Events.
On November 3, 1997, the Company signed a letter of intent (the
"Anogesic Agreement") with Neptune Pharmaceutical Corporation ("Neptune") to
acquire all patent and other intellectual property rights relating to "Anogesic"
(the "Anogesic Acquisition"), a topical product candidate for the treatment of
anal fissures and hemorrhoids.
The closing of the Anogesic Acquisition is subject to certain
conditions, including, without limitation, the satisfactory completion of the
Company's due diligence of Neptune, the absence of material adverse changes in
Neptune's or the Company's business between the date of the Anogesic Agreement
and the closing date, the approval of the transaction by Neptune's shareholders
and the absence of litigation or claims relating to the transaction or Anogesic.
There can be no assurance that the Company will complete the Anogesic
Acquisition. Failure to complete the Anogesic Acquisition may have an adverse
effect on the market price of the Common Stock but would not, the Company
believes, have a material adverse effect on its financial or business condition.
The Company issued 33,057 shares of Common Stock to Neptune upon
signing the Anogesic Agreement. The Company currently expects to conclude the
Anogesic Acquisition by December 31, 1997, although there can be no assurance
that the acquisition will be completed by this date, if at all. At the closing,
the Company will deliver to Neptune additional shares of Common Stock. In
addition, the Anogesic Agreement calls for a series of additional payments,
payable in shares of Common Stock, upon successful completion of various
milestones which, if achieved, would occur over the next several years. The
Anogesic Agreement does not provide for the payment by the Company of any future
product royalties in connection with sales of Anogesic.
Item 7: Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits.
The following exhibits are filed herewith:
99.01 Press Release dated November 5, 1997
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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 hereunto duly authorized.
Date: November 12, 1997 By: /s/ A. Richard Juelis
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A. Richard Juelis
Vice President, Finance &
Chief Financial Officer
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INDEX TO EXHIBITS
Sequentially
Exhibit Number Description of Exhibit Numbered Page
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99.01 Press Release dated November 5, 1997 5
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EXHIBIT 99.01
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Cellegy Announces Agreement to Acquire Unique Product
for Treatment of Anal Fissures and Hemorrhoids
Foster City, California, November 5, 1997 - Cellegy Pharmaceuticals,
Inc. (Nasdaq SmallCap: CLGY) announced today that it has signed a legally
binding letter of intent to acquire Anogesic(R) from Neptune Pharmaceutical
Corporation of New York City. Anogesic is a nitroglycerin based product which,
based on published studies on over 400 patients, appears to effectively heal
anal fissures and hemorrhoids. These commonly occurring conditions are only
partially treated by existing products and frequently require surgery.
Under the terms of the agreement, Cellegy would acquire rights to
Neptune's issued and allowed U.S. patents as well as related foreign patent
applications which cover the use of any nitric oxide donors for the treatment of
anal fissures, hemorrhoids and other conditions of the anorectum. The Company
plans to initiate Phase III clinical trials of Anogesic in 1998.
"Anogesic fits well within Cellegy's strategy of bringing innovative
new therapies to markets where significant unmet medical needs exist and
development times are relatively short," commented K. Michael Forrest, President
and CEO of Cellegy. "With the addition of Anogesic, this brings to three the
number of Cellegy products that are in late stage clinical development.
Glylorin(TM), our lead product for the treatment of ichthyosis, has been
licensed to Glaxo Wellcome and is now nearing completion of Phase III trials.
Our transdermal testosterone gel for the treatment of testosterone deficiency in
men over the age of 40 is expected to enter Phase III testing in 1998."
Each year in the U.S. alone, some 9 million patients seek treatment
from physicians for hemorrhoids. Of the approximately 200,000 new cases of anal
fissures per year, over half require painful and expensive surgical intervention
to effectively treat these conditions. Both conditions are principally a result
of increased anal pressure generated by involuntary contraction of the anal
sphincter, leading to extreme pain and bleeding. Despite the fact that existing
treatments provide only partial symptomatic relief, sales of products currently
used to treat fissures and hemorrhoids are estimated to be more than $500
million in the U.S., Europe and Japan.
Anogesic, once administered, is rapidly metabolized to nitric oxide, a
key neurotransmitter responsible for the relaxation of the anal sphincter.
Anogesic will incorporate Cellegy's proprietary CELLEDIRM technology to assist
in mitigating the inflammation usually present in these conditions. Clinical
studies published in the New England Journal of Medicine and The Lancet have
shown that nitroglycerin promotes healing and is capable of rapidly relieving
intense anal pain. In the Lancet study, 80 patients with anal fissures were
randomized to receive treatments with topical 0.2% nitroglycerin ointment or
placebo. After 8 weeks, healing was observed in 26/38 (68%) patients treated
with nitroglycerin and in 3/39 (8%) patients treated with placebo (p less than
0.0001).
Neptune Pharmaceutical was founded by Dr. Stephen R. Gorfine, a
prominent colorectal surgeon, whose pioneering work led to the discovery of
Anogesic. Dr. Gorfine is an Assistant Clinical Professor of Surgery at Mt. Sinai
Medical School in New York City and is board certified in colon and rectal
surgery, general surgery and internal medicine. He will serve as a Cellegy
consultant during the completion of the Phase III clinical trials.
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Upon signing of the agreement, Cellegy issued approximately 33,100
shares of common stock to Neptune and will, at the closing of the product
acquisition, issue to Neptune another approximately 430,000 shares. The
agreement calls for future payments to be made in shares of Cellegy common stock
upon the achievement of various milestones. No future royalties on sales will be
payable to Neptune.
Consummation of the Anogesic acquisition is subject to a number of
terms and conditions, including completion of due diligence by Cellegy and other
customary closing conditions. The Company currently expects the transaction to
be concluded before December 31, 1997.
Cellegy has filed a registration statement with the Securities and
Exchange Commission relating to a proposed public offering of 2,250,000 shares
of common stock. Oppenheimer & Co., Inc. will act as the underwriter of the
offering. This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sales of these
securities in any state which an offer, solicitation or sale would be unlawful
prior to registration or qualification under the securities laws of any such
state. The offering may only be made by means of a prospectus. A copy of the
prospectus may be obtained from Oppenheimer & Co., Inc., Oppenheimer Tower, One
World Financial Center, 200 Liberty Street, 39th Floor, New York, NY 10281,
telephone number (212) 667-7000.
This press release contains forward-looking statements. There are
certain important factors that could cause actual results to differ materially
from those anticipated by the forward-looking statements made in this press
release. Among, but not limited to these, are unexpected regulatory delays or
difficulties relating to Anogesic or other products of Cellegy and the outcomes
of future clinical trials relating to the acquired product. Additional
information that could affect Cellegy's business and financial results are
included in Registration Statement number 333-38179 filed with the Securities
and Exchange Commission on October 17, 1997 and in Cellegy's annual and
quarterly reports and other documents on file with the Securities and Exchange
Commission.
For More Information:
Company Contacts: (650) 524-1600
Richard Juelis K. Michael Forrest
Vice President, Finance & CFO President & CEO
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