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FORM 8-K.--CURRENT REPORT
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 7, 1999
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OPHIDIAN PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
Delaware 333-33219 39-1661164
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(State, or other jurisdiction (Commission (IRS Employer of
incorporation) File Number) Identification No.)
5445 East Cheryl Parkway, Madison, Wisconsin 53711
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (608)271-0878
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(Former name or Former Address, if changed since last report.)
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INFORMATION TO BE INCLUDED IN THE REPORT
Item:
1. Changes in Control of Registrant.
2. Acquisition or Disposition of Assets. SEE EXHIBIT 1
3. Bankruptcy or Receivership.
4. Changes in Registrant's Certifying Accountant.
5. Other Events. SEE EXHIBIT 1
6. Resignations of Registrant's Directors.
7. Financial Statements and Exhibits.
8. Change in Fiscal Year.
9. Sales of Equity Securities Pursuant to Regulation S.
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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.
OPHIDIAN Pharmaceuticals, Inc.
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(Registrant)
Date June 23, 1999 /s/Donald L. Nevins
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(Signature)
Donald L. Nevins
Vice President-Finance
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EXHIBIT 1
Contact: Donald L. Nevins, CFO
FOR RELEASE 12:00 PM CDST Ophidian Pharmaceuticals, Inc.
Phone 608.271.0878
Fax 608.277.2395
E-mail [email protected]
$2 MILLION NEW FINANCING FOR OPHIDIAN PILOT PLANT
June 7, 1999 -- MADISON, Wisconsin - Ophidian Pharmaceuticals, Inc. ("Ophidian")
(NASDAQ SmallCap: OPHD and Pacific Exchange, Inc.: OPD), a biotechnology company
developing innovative antibody-based drugs announced today that it has secured
$2,000,000 in a new senior note financing. The funds are being provided by one
of the company's directors, Rex J. Bates, and a shareholder, Davis U. Merwin, in
a private transaction.
These new funds will be used primarily to outfit a pilot manufacturing facility
for the production of experimental drug to be used in Ophidian's human clinical
trials and other research programs. The company's lead development drug, named
OPHD001 a new non-antibiotic product for the treatment of serious infections due
to the bacterium Clostridium difficile, is about to enter Phase II clinical
trials. The drug is a novel formulation of antibodies from hen eggs that
neutralize toxins produced by the disease-causing organism. The company's second
drug based on this technology is named OPHD002 and is an oral formulation
designed to treat intestinal inflammation arising in inflammatory bowel disease.
The company expects to submit an Investigational New Drug application to the
Food & Drug Administration by the end of the first quarter of 2000 for approval
to begin clinical trials of OPHD002.
"This pilot manufacturing capability will enhance our ability to support ongoing
clinical development based on our proprietary antibody technology," stated
Douglas Stafford, Ophidian's President and Chief Executive Officer. He added,
"This financing comes at a critical time as greater amounts of test drug are
needed to support expanding clinical development objectives."
The funds are provided under ten-year, 10%, senior notes with warrants. The
assets of the Company secure the notes. Interest on the notes for the first
three years is payable in common shares of the Company at the then current
market value and thereafter in cash. 1,000,000 five-year warrants, exercisable
at $2.00 were issued separately. The notes can be applied to the exercise of the
warrants. The notes also carry certain subordination features.
Messrs. Bates and Merwin are, before this transaction, beneficial owners of
502,878 [5.5%] and 437,650 [4.7%] respectively of the Company's 9,223,018 common
shares outstanding and 9,150 each [less than 1% each] of the Company's 1,933,088
outstanding publicly traded warrants.
This document may contain certain forward-looking statements based on current
management expectations. There are certain key factors that could cause future
results to differ from those anticipated by management. Such factors include,
but are not limited to, technical risks associated with the development of new
products, the continued progress of clinical trials of the company, the
company's ability to continue to establish collaborative agreements with third
parties, the competitive environment of the biotechnology and pharmaceutical
industries, and general economic conditions. Additional information on potential
factors that could affect the company's financial results are included in the
company's prospectus dated 7 May 1998, and other reports filed with the
Securities and Exchange Commission.
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Contact: Donald L. Nevins, CFO
FOR RELEASE 12:00 PM CDST Ophidian Pharmaceuticals, Inc.
Phone 608.271.0878
Fax 608.277.2395
E-mail [email protected]
OPHIDIAN EXPANDING CLINICAL DEVELOPMENT AND DRUG APPLICATIONS
OF ITS CORE ANTIBODY TECHNOLOGY
June 7, 1999 -- SAN FRANCISCO, California - Ophidian Pharmaceuticals, Inc.
(Ophidian) (NASDAQ SmallCap: OPHD and Pacific Exchange, Inc.: OPD), disclosed
today that it is moving ahead with its plans to begin Phase II clinical testing
of its lead drug, OPHD001, for Clostridium difficile-associated disease. This
trial is planned to begin this summer. The company also disclosed its plan to
submit an Investigational New Drug to the Food & Drug Administration by the end
of the first quarter of 2000 for approval to begin clinical trials for a second
gastrointestinal product, OPHD002. OPHD002 is an oral anti-cytokine antibody
formulation designed for the treatment of inflammatory bowel disease. Douglas
Stafford, Ophidian's President and Chief Executive Officer, made these
statements at the 11th Annual International Life Sciences Partnering Conference
hosted in San Francisco. This conference is an international forum to promote
strategic partnerships among biotechnology and pharmaceutical firms for the
development and commercialization of new drug products.
Mr. Stafford said, "We have learned a great deal about orally-delivered
antibodies through the development of OPHD001. From this knowledge and extensive
new laboratory studies, we have found that the oral delivery of our avian
antibodies is effective in treating inflammatory intestinal diseases in animals.
This creates a new significant therapeutic application for our core technology
in the area of inflammatory bowel diseases." The company's technology allows for
topical delivery of therapeutic antibodies to diseased regions of the intestinal
tract with oral dosing techniques. "The topical delivery is a unique strategy to
localize the drug effect to the intestinal tract without side effects associated
with systemic administration," he added.
This document may contain certain forward-looking statements based on current
management expectations. There are certain key factors that could cause future
results to differ from those anticipated by management. Such factors include,
but are not limited to, technical risks associated with the development of new
products, the continued progress of clinical trials of the company, the
company's ability to continue to establish collaborative agreements with third
parties, the competitive environment of the biotechnology and pharmaceutical
industries, and general economic conditions. Additional information on potential
factors that could affect the company's financial results are included in the
company's prospectus dated 7 May 1998, and other reports filed with the
Securities and Exchange Commission.
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Contact: Donald L. Nevins, CFO
FOR IMMEDIATE RELEASE Ophidian Pharmaceuticals, Inc.
Phone 608.271.0878
Fax 608.277.2395
E-mail [email protected]
OPHIDIAN TO LOCATE MANUFACTURING FACILITY IN MADISON, WI
10 June 1999 -- MADISON, Wisconsin - Ophidian Pharmaceuticals, Inc. ("Ophidian")
(NASDAQ SmallCap: OPHD and Pacific Exchange, Inc.: OPD), a biotechnology company
developing pharmaceuticals from avian antibodies announced late yesterday that
it entered into a five year lease for a facility to house its pilot
manufacturing plant. Ophidian expects to move approximately $1 million of
currently owned equipment into this facility after completing approximately $.4
million in leasehold improvements. Approximately $1.4 million of additional
production equipment will be purchased for this new facility. The facility would
provide drug materials for basic research and clinical development needs.
Douglas Stafford, President and Chief Executive Officer said, "This space will
allow us to support our growing clinical development platform and enhance our
ability to attract commercial partners for our technology." "Operating our own
facility will allow us to use our equipment assets and know-how more
productively," he added. Ophidian has developed proprietary processes for the
manufacture of therapeutic antibodies from the eggs of specially immunized hens.
The lead product in clinical development is OPHD001, an oral formulation of
antibodies to treat intestinal infections due to Clostridium difficile, a major
cause of antibiotic-associated colitis. The company's second product using the
avian antibody technology is OPHD002, an oral drug for the treatment of
inflammatory bowel disease. The new pilot facility will contain clean rooms and
critical systems to support the egg antibody processing as well as fermentation
and recombinant protein purification under FDA regulations.
The location of the facility is at 2617 Progress Road, Madison, Wisconsin. The
initial lease will cover 4,870 square feet of office space and 19,559 square
feet of production space. The company has options to expand the lease to a total
of 42,458 square feet and to purchase the facility. The facility provides space
for future expansion for commercial production capacity. The company's lease
obligation for the first five years is approximately $0.8 million.
This document may contain certain forward-looking statements based on current
management expectations. There are certain key factors that could cause future
results to differ from those anticipated by management. Such factors include,
but are not limited to, technical risks associated with the development of new
products, the continued progress of clinical trials of the company, the
company's ability to continue to establish collaborative agreements with third
parties, the competitive environment of the biotechnology and pharmaceutical
industries, and general economic conditions. Additional information on potential
factors that could affect the company's financial results are included in the
company's prospectus dated May 7, 1998, and other reports filed with the
Securities and Exchange Commission.
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Contact: Donald L. Nevins, CFO
FOR IMMEDIATE RELEASE Ophidian Pharmaceuticals, Inc.
Phone 608.271.0878
Fax 608.277.2395
E-mail [email protected]
OPHIDIAN EXPANDS PROGRAM FOR INFLAMMATORY BOWEL DISEASES
June 11, 1999 - MADISON, Wisconsin - Ophidian Pharmaceuticals, Inc. (Ophidian)
(NASDAQ SmallCap: OPHD and Pacific Exchange, Inc.: OPD), a biotechnology company
developing pharmaceuticals from avian antibodies announced today that Terrence
Barrett, M.D. has joined its Scientific Advisory Board. Dr. Barrett, a
gastroenterologist specializing in the treatment of inflammatory bowel disease,
is on the faculty of Northwestern University Medical School. In addition to his
clinical practice he is carrying out an extensive basic research program in
intestinal immunology.
Douglas Stafford, Ophidian's President and Chief Executive Officer said, "We are
pleased to gain the medical and scientific guidance of Dr. Barrett as our
inflammatory bowel disease program gains momentum." "This program builds on our
growing knowledge of the health benefits of the topical application of
therapeutic antibodies to the intestinal tract," he added. The company is
developing an oral formulation of avian antibodies, named OPHD002, for the
treatment of inflammation associated with inflammatory bowel disease, such as
Crohn's disease. Ophidian has shown that the oral delivery of avian antibodies
is an effective treatment of inflammatory intestinal disease in animal disease
models. The company expects to complete the filing of an Investigational New
Drug application for OPHD002 for initial clinical trials by the end of the first
quarter of 2000.
The reader is referred to the company's press releases of June 7,1999 and June
10, 1999 which detail additional financing and a new pilot manufacturing
facility to support its antibody processing technology.
This document may contain certain forward-looking statements based on current
management expectations. There are certain key factors that could cause future
results to differ from those anticipated by management. Such factors include,
but are not limited to, technical risks associated with the development of new
products, the continued progress of clinical trials of the company, the
company's ability to continue to establish collaborative agreements with third
parties, the competitive environment of the biotechnology and pharmaceutical
industries, and general economic conditions. Additional information on potential
factors that could affect the company's financial results are included in the
company's prospectus dated May 7, 1998, and other reports filed with the
Securities and Exchange Commission.
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