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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
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Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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DATE OF REPORT: November 2, 1999
(Date of earliest event reported)
PHOTOGEN TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
NEVADA 0-23553 36-4010347
(State or other jurisdiction (Commission File Number) (I.R.S. Employer
of incorporation or Identification No.)
organization)
7327 OAK RIDGE HIGHWAY, SUITE B
KNOXVILLE, TENNESSEE 37931
(Address of principal executive offices) (Zip Code)
(423) 769-4011
(Registrant's telephone number including area code)
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ITEM 5. OTHER EVENTS.
Photogen Technologies, Inc. (the "Company") issued a press release
announcing that the Company had formed a joint venture with Elan. The Press
Release, dated November 2, 1999, is attached as Exhibit 99 hereto.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) The following exhibit is filed with this report:
99 Press release of the Company, dated November 2, 1999, announcing
that the Company had formed a joint venture with Elan.
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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.
Photogen Technologies, Inc.
By: /s/ John Smolik
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John Smolik, President
Date: November 2, 1999
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EXHIBIT INDEX
Exhibit Description
No.
99 Press release of the Company, dated November 2, 1999, announcing
that the Company had formed a joint venture with Elan.
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Exhibit 99
FOR IMMEDIATE RELEASE
PHOTOGEN TECHNOLOGIES FORMS JOINT VENTURE WITH ELAN TO
ADVANCE COMPREHENSIVE, NON-SURGICAL APPROACH TO DETECTION AND
TREATMENT OF CANCER IN THE LYMPH NODES
PHOTOCHEMICAL TECHNIQUES MAY OFFER NON-INVASIVE ALTERNATIVE FOR DETECTION,
DIAGNOSIS AND TREATMENT; PHASE II HUMAN TRIALS SET FOR NEXT YEAR
KNOXVILLE, Tenn., Nov. 2, 1999 -- Photogen Technologies Inc. (OTC BB: PHGN)
today announced a joint venture with Elan Corporation, plc ("Elan") to develop
and commercialize nanoparticulate diagnostic imaging agents for the detection
and treatment of cancer that has spread to patients' lymph nodes.
The goal of the joint venture is to develop a treatment that would more than
halve the number of lymph node surgeries by precisely locating the nodes where
cancer has spread and at the same time, if necessary, treating the affected
lymph nodes in one all-inclusive, non-invasive procedure.
Each company is contributing significant intellectual property and know-how to
the venture. Photogen's contribution includes knowledge relating to lymphography
accessed through recent acquisition and licensing agreements with Alliance
Pharmaceuticals and Massachusetts General Hospital (see Photogen press release
dated Oct. 26, 1999). Elan, through its drug delivery division Elan
Pharmaceutical Technologies, is contributing its NanoCrystal-TM- stabilized
nanoparticulate formulation technology to develop the diagnostic imaging agents.
Phase II human trials with the venture's lead candidate are expected to begin in
2000. Elan will provide Photogen with a credit facility to fund its share of the
development costs of the joint venture. In addition, Elan has purchased $6
million of Photogen's common stock as part of the agreement.
"This corporate venture with Elan in the field of lymphography will enable us to
redouble our efforts in bringing to market non-invasive methods for determining
how much cancer a patient has and how far it has spread," said John Smolik,
president and CEO of the Knoxville, Tenn.-based biotech firm.
"With our approach, we believe we can significantly reduce the number of lymph
node surgeries used to determine the spread of cancers, including melanoma and
cancers of the breast, prostate, lung, and head and neck."
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Eugene Cooper, Executive Vice President Research and Development at Elan
Pharmaceutical Technologies added, "Elan's NanoCrystal-TM- technology has
significant application in the field of diagnostic imaging. We are delighted to
have the opportunity to combine this technology with the know-how and expertise
of Photogen, a leader in the emerging field of photodynamic therapy, to help
advance the detection and treatment of diseases of the lymph node."
Background on Lymphography
Lymphography is a procedure following the diagnosis of cancer that is used to
determine if a patient's cancer has spread to the lymph nodes. The presence or
absence of cancer in the sentinel lymph node, is an indication of the
seriousness of a cancer and the ability to cure it. Under current treatment
programs, a malignant node or a node that is suspected of containing cancerous
cells must be surgically removed.
Early lymphography methods required injecting relatively unsafe oily contrast
agents into surgically isolated lymphatic vessels. More recent technologies
involve injecting blue dye and radioactive particles near the tumor and tracking
the materials to the general area of the sentinel node, which can then be
biopsied for evaluation and if needed, surgically removed.
Using the venture's technology, sentinel nodes will be precisely and safely
located by injecting a small amount of nanoparticulate contrast material. Due to
the particular physicochemical properties of these materials, they concentrate
within the lymph nodes, and reveal affected areas where cancer has spread using
computed tomography (CT) or magnetic resonance imaging (MRI). In most cases, the
image may provide enough information to determine the advancement of the cancer
and in the future, may also be used to monitor the results of cancer treatment
and detect recurrence.
The venture expects to take its technology one step further by combining the
contrast materials with a safe radiosensitizer that dramatically reduces tumor
cells when exposed to low-level radiation. Combining the two non-invasive
activities may provide an "all inclusive" treatment that would locate, diagnose
and treat the lymph nodes in one simple procedure -- including those nodes that
contain only a few cancerous cells that might otherwise escape detection.
Photogen Technologies, Inc. is a development-stage company focused on creating
photodynamic-related healthcare products based on its proprietary multi-photon
excitation and other related technologies. The company has discovered new
methods for using light energy from lasers and X-rays to activate photoactive
agents within deep tissue sufficient to produce a range of beneficial
therapeutic and diagnostic outcomes.
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These technologies involve methods, materials and devices that may be used to
produce light and photoactive agents that will destroy diseased cells, remove
tissue or identify and diagnose disease. Photogen's proprietary technology is
covered under existing U.S. patents and additional pending applications in the
U.S. and worldwide. The company has no products or operating revenues at this
time.
Statements in this release that are not strictly historical are
"forward-looking" statements that are made pursuant to the safe harbor provision
of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks, which may cause the company's actual
results in the future to differ materially from expected results. These risks
and uncertainties include: the ability of the company to develop a product and
obtain regulatory approval for its use; the ability of the company to
successfully market and sell any products and equipment; the company's ability
to manufacture products in sufficient quantities; the company's ability to
maintain intellectual property protection for its proprietary products, to
defend its existing intellectual property rights from challenges by third
parties, and to avoid infringing intellectual property rights of third parties;
unforeseen operating risks; the company's ability to secure collaborative
agreements with third parties for various research, development, manufacturing,
marketing and other functions; competition; risks associated with the dependence
on manufacturers of the company's proposed products; the availability of capital
to finance planned activities; and the extent to which the clinicians performing
the procedures are able to obtain third-party reimbursement. These risks are
qualified in their entirety by cautionary language and risk factors set forth in
the company's filings with the Securities and Exchange Commission.
Media Contacts: Hilary Kaye or Joan Murray at Hilary Kaye Associates (714)
426-0444 (PST)
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