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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):
SEPTEMBER 9, 1996
PROCEPT, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 0-21134 04-2893483
(State or other jurisdiction (Commission File (IRS Employer
of incorporation) Number) Identification No.)
840 MEMORIAL DRIVE, CAMBRIDGE, MASSACHUSETTS 02139
(Address of principal executive offices and zip code)
Registrant's telephone number, including area code:
(617) 491-1100
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ITEM 5. OTHER EVENTS.
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On September 9, 1996, Procept, Inc. ("Procept") announced that it
had restructured its research and development operations. Procept hereby
incorporates by reference the contents of its press release dated September 9,
1996, filed as Exhibit 99.1 to this report.
In addition, on September 10, 1996, Procept announced plans to
develop a topical microbicide women can use vaginally to help prevent HIV
infection and other sexually transmitted diseases. Procept hereby incorporates
by reference the contents of its press release dated September 10, 1996, filed
as Exhibit 99.2 to this report.
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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: September 18, 1996 PROCEPT, INC.
By: /s/ Michael J. Higgins
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Michael J. Higgins
Vice President, Finance
and Chief Financial Officer
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EXHIBIT INDEX
EXHIBIT SEQUENTIAL
NO. DESCRIPTION PAGE NO.
- ------- ----------- ----------
99.1 Press release dated September 9, 1996. Filed herewith. 5
99.2 Press release dated September 10, 1996. Filed herewith. 6
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EXHIBIT 99.1
PROCEPT
Procept, Inc.
840 Memorial Drive
Cambridge, MA 02139
Tel: 617-491-1100
Fax: 617-491-9019
Contact: Stanley C. Erck
President and Chief Executive Officer
Procept, Inc.
617-491-1100
For Immediate Release
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PROCEPT ANNOUNCES RESTRUCTURING
FOCUS ON CLINICAL DRUG CANDIDATES, CORPORATE PARTNERING PROGRAMS
CAMBRIDGE, MA, SEPTEMBER 9, 1996 -- Procept announced today that it has
restructured its research and development operations. The company will focus on
its pre-clinical and clinical drug candidates for the prevention of HIV
infection, on a drug development program for infectious diseases funded by
VacTex, Inc., and on two programs for immunosuppression for which it is seeking
corporate partners.
The company will continue its strategy to demonstrate the potential of its small
molecule immunosuppressives in in vivo disease models and to show safety and
efficacy in human clinical trials for its AIDS programs. Procept intends to
accomplish these goals by narrowing its earlier stage research efforts and
outsourcing other areas, while reducing its "cash burn" rate through a reduction
in staff to a level of 40 (representing a reduction of approximately one-third).
Procept will increase its efforts to attract corporate partners to help develop
and finance its drug discovery programs. Currently, the company is collaborating
with Sandoz Pharma Ltd. and VacTex to discover drugs useful in the treatment of
organ transplant rejection and tuberculosis, respectively. By securing partners
for its programs in AIDS, CD2 targeted drugs, and small molecule
immunosuppressives the Company hopes to further strengthen its financial
position.
Procept, Inc. is engaged in the research and development of small molecule
therapeutics for the prevention and treatment of chronic and life-threatening
immune system disorders. Procept is developing therapeutics for the treatment of
autoimmune diseases, organ transplant rejection, and infectious diseases such as
AIDS and tuberculosis. Founded in 1985 and traded on the Nasdaq National Market
System under the symbol PRCT, Procept is located in Cambridge, Massachusetts.
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EXHIBIT 99.2
PROCEPT
Procept, Inc.
840 Memorial Drive
Cambridge, MA 02139
Tel: 617-491-1100
Fax: 617-491-9019
Contact: Stanley C. Erck
President and Chief Executive Officer
Procept, Inc.
617-491-1100
Karen M. Goldman (media)
INFOCUS, Inc.
609-683-9055
For Immediate Release
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PROCEPT TO DEVELOP GEL TO PREVENT SEXUAL
TRANSMISSION OF HIV IN WOMEN
KEY PRECLINICAL RESULTS PRESENTED AT AIDS CONFERENCE
CAMBRIDGE, MA, SEPTEMBER 10, 1996 -- Procept, Inc. (NASDAQ: PRCT) announced
today plans to develop a topical microbicide women can use vaginally to help
prevent HIV infection and other sexually transmitted diseases (STDs).
Procept believes its PRO 2000 antiviral compound is well suited for development
as a female-controlled topical product to help prevent HIV infection.
Laboratory studies have shown that PRO 2000 is active against a wide range of
HIV strains from both the developed and developing world. It is also active
against other STD pathogens, such as herpes simplex virus type 2, a cause of
genital lesions which are believed to be a portal for HIV entry. Easily prepared
and stable, the company believes that it will be possible to manufacture
sufficient quantities of PRO 2000 to meet anticipated worldwide demand.
On September 7, Procept presented preclinical data on its PRO 2000 topical gel
formulation at the First Annual Meeting of Dr. Robert Gallo's Institute of Human
Virology in Baltimore. The gel was shown to be well tolerated in a rabbit
vaginal irritation study, and did not induce skin sensitization in guinea pigs.
PRO 2000 topical gel was also shown to be compatible with latex condoms. Procept
plans to begin Phase I clinical studies in healthy female volunteers by the end
of 1996.
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The World Health Organization predicts that by the year 2000, the rate of HIV
infection will be the same for men and women; currently more than 70% of new
infections worldwide are acquired through heterosexual intercourse. Donna E.
Shalala, U.S. Secretary of Health and Human Services, announced at the XI
International Conference on AIDS in Vancouver that the National Institutes of
Health and the Centers for Disease Control and Prevention will spend $100
million over the next four years to speed development of such products. "Today,
too often, women must rely solely on their male partner for protection from HIV.
And in too many cases that means no protection at all," she said. Development of
topical microbicides has also been endorsed by the British Medical Research
Council, and the Joint United Nations Programme on HIV/AIDS.
Procept, Inc. is engaged in the research and development of small molecule
therapeutics for the prevention and treatment of chronic and life-threatening
immune system disorders. Procept is developing therapeutics for the treatment of
autommune diseases, organ transplant rejection and infectious diseases, such as
AIDS and tuberculosis. Founded in 1985 and traded on the Nasdaq National Market
System under the symbol PRCT, Procept is located in Cambridge, Massachusetts.
