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
June 21, 1999 (June 15, 1999)
Date of Report (Date of earliest event reported)
AVAX TECHNOLOGIES, INC.
(Exact name of Registrant as specified in its charter)
Delaware 000-29222 13-3575874
State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification Number)
4520 Main Street
Suite 930
Kansas City, MO 64111
(Address of principal executive offices)
(816) 960-1333
(Registrant's telephone number, including area code)
Page 1 of 5 Pages
Exhibit Index Appears at Page 3
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Item 5. Other Events
The sole purpose of this Form 8-K is to file a press release issued by
AVAX Technologies, Inc. on June 15, 1999 which announced the Company's
collaboration with NIHL for the commercialization of the Company's AC
Vaccine(TM) technology in Australia and New Zealand and announced that it will
begin to market its cancer vaccine, M-Vax(TM) in Australia, subject only to
licensure of a manufacturing facility by Australia's Therapeutic Goods
Administration (TGA).
Item 7. Financial Statements and Exhibits.
Exhibits: 99.7 Press Release dated June 15, 1999.
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.
AVAX TECHNOLOGIES, INC.
Date: June 21, 1999
By: /s/ Jeffrey M. Jonas
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Name: Jeffrey M. Jonas, M.D.
Title: President and Chief Executive Officer
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Exhibit Index
Exhibit Number Description
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99.7 Press Release dated June 15, 1999.
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EXHIBIT 99.7
Company Contact: Jeffrey M. Jonas, MD
AVAX Technologies, Inc.
(816) 960-1333
Investor Relations Contact: Olga Fleming/Sue Yeoh
CPR Financial Communications
(201) 641-2408
Media Contact: David Sassoon/Abenaa Hayes
The Rowland Company
(212) 527-7453
AVAX TECHNOLOGIES AND NEPTUNUS INTERNATIONAL HOLDINGS LIMITED ANNOUNCE JOINT
VENTURE AGREEMENT TO MARKET AC VACCINE(TM) TECHNOLOGY IN AUSTRALIA AND NEW
ZEALAND
- AVAX to Begin Marketing of M-Vax(TM) Melanoma Vaccine in Australia -
- AVAX To Receive Up To $10.0 Million (AUD) as Part of the Joint Venture
Agreement -
- Peter B. Simpson Appointed as General Manager of AVAX Australia -
Kansas City, MO, June 15, 1999 -- AVAX Technologies, Inc. (NASDAQ: AVXT) today
announced that it will begin to market its cancer vaccine, M-Vax(TM) in
Australia, subject only to licensure of a manufacturing facility by Australia's
Therapeutic Goods Administration (TGA). M-Vax, AVAX's lead cancer vaccine, is
currently in pivotal registration trials in the United States for patients with
stage 3 melanoma, a deadly form of skin cancer.
Consequently, AVAX will form a new subsidiary, AVAX Australia Pty. Ltd., and has
entered into a letter of intent for a joint venture with Neptunus International
Holdings Limited (NIHL) to manufacture and market its Autologous Cell Vaccine
(AC Vaccine(TM)) in Australia and New Zealand. Under the terms of the agreement,
NIHL will purchase $4.0 million (AUD) in shares and has the option to purchase
up to $10.0 million (AUD) in shares, or up to a 50% interest, in AVAX Australia
Pty. Ltd. AVAX will also be granted options to purchase common stock equivalent
to 5% of NIHL's fully diluted shares. The joint venture agreement is subject to
NIHL shareholder approval and final due diligence by both parties.
AVAX Australia will initiate the company's research, development, and
commercialization efforts of its Autologous Cell (AC) Vaccine(TM) technology in
Australia and New Zealand. AVAX Australia will be responsible for establishing
manufacturing, research, development, marketing and sales in these territories.
NIHL will also have options to participate in future commercialization in China,
Malaysia, the Philippines and Thailand. Peter Simpson will be appointed General
Manager and a director of the joint venture.
Jeffrey M. Jonas, M.D., President and CEO of AVAX Technologies, Inc., stated,
"This important event represents a tremendous milestone for both AVAX and
Australian patients. Australia and New Zealand have the highest incidence of
melanoma in the world, and we anticipate achieving sales in Australia by the
first half of 2000."
Dr. Jonas continued, "Our joint venture agreement with NIHL will be our first
international initiative to commercialize our unique AC Vaccine technology
outside of the United States. We are pursuing additional near-term product
opportunities in other important geographic markets, as well as expanding the
application of
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our AC Vaccine technology to other cancer indications through further research
and development. Our recently announced collaboration in the area of breast
cancer with the University of Tokyo is an example of our expanding R&D
commitment overseas."
"NIHL's familiarity with Australia will prove invaluable as we further our
efforts to bring our products to market internationally and to demonstrate the
commercial feasibility of delivering custom made vaccines to patients in a
cost-effective manner. In addition, the NIHL agreement will provide AVAX with
access to significant funding, allowing us to expand our research, development,
and commercial efforts in Australia while we enroll patients in our
multi-center, pivotal registration trial of M-Vax in the United States.
"To aid AVAX in achieving its international objectives, we are extremely pleased
to have Peter Simpson join our organization," Dr. Jonas added. "His extensive
background in international marketing, negotiations and partnering, coupled with
his regional market expertise, is very impressive, and we look forward to his
contributions."
Peter B. Simpson was formerly managing director of Biota Holdings Limited
(Australian Stock Exchange:BTA) of Melbourne. While at Biota, Mr. Simpson was
responsible for negotiating and successfully completing an agreement with Glaxo
(U.K.), under which Glaxo was granted license to Biota's products. Zanamovir,
for the treatment of Influenza, has recently been approved in Australia and
Europe as a direct result of that collaboration. Prior to Biota, Mr. Simpson was
the director of research and development of David Bull Laboratories Pty. Ltd.,
one of the world's largest manufacturers and suppliers of small-volume
injectable drug products. Mr. Simpson currently serves on the board of directors
of NIHL, Novogen Limited, Gradipore Limited, Inovax Limited and Zenex plc.
Mr. Simpson stated, "Results from previous clinical trials of AVAX's unique
vaccine technology are very compelling, and I look forward to working with AVAX
management to bring about the commercial success of M-Vax for patients with
malignant melanoma. It is our primary objective to actively develop additional
opportunities for the company's AC Vaccine technology in other markets
throughout the Pacific Rim."
Neptunus International Holdings Limited (NIHL) of Hong Kong is a pharmaceutical
group first listed on the Australian Stock Exchange in 1994. The AVAX joint
venture will represent its single focused new activity. Interests associated
with NIHL's major shareholder maintain significant pharmaceutical and
technological interests in the People's Republic of China.
AVAX Technologies, Inc. specializes in the development and commercialization
of novel biotechnologies, immunotherapies and pharmaceuticals for cancer and
other life-threatening diseases using three core technologies: the AC Vaccine
technology, topoisomerase inhibitors and anti-estrogens.
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Except for statements that are historical, the statements in this release are
"forward-looking" statements that are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995 and Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934. Forward-looking statements involve significant risks and uncertainties,
and in light of the significant uncertainties inherent in such statements, the
inclusion of such information should not be regarded as a representation by AVAX
that the objectives and plans of the company will be achieved; in fact, actual
results could differ materially from those contemplated by such forward-looking
statements. Many important factors affect the company's ability to achieve the
stated outcomes and to successfully develop and commercialize its product
candidates, including, among other things, the ability to obtain substantial
additional funds, obtain and maintain all necessary patents or licenses, to
demonstrate the safety and efficacy of product candidates at each stage of
development, to meet applicable regulatory standards and receive required
regulatory approvals, to meet obligations and required milestones under its
license agreements, to be capable of producing drug candidates in commercial
quantities at reasonable costs, to compete successfully against other products,
and to market products in a profitable manner, as well as other risks detailed
from time to time in AVAX's public disclosure filings with the Securities and
Exchange Commission, including, without limitation, its Annual Report on Form
10-KSB for the fiscal year ended December 31,1998. AVAX does not undertake any
obligation to publicly release any revisions to these forward-looking statements
or to reflect the occurrence of unanticipated events.
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