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Biomoda, Inc., is a biopharmaceutical company focusing on very
early cancer detection technology. Biomoda’s novel
cell-targeting technology is globally patented for the detection
of pre-cancerous and cancerous conditions in all human tissue.
This technology, originally called Tetrakis Carboxy Phenyl
Porphine (TCPP), was developed at Los Alamos National
Laboratories. Biomoda obtained a worldwide exclusive license to
the TCPP technology from the University of California in late
1995, and began new research broadening the scope of the
original patent and technology. In November 2000, Biomoda filed
a new U.S. provisional patent application defining the ability
of Biomoda’s version of the TCPP to detect pre-cancerous and
cancerous conditions in all human tissue.
Our diagnostic kit staining technique exploits the
unique cell-targeting characteristics of porphyrins–extremely
tiny, water-soluble biological pigments–that seek an
intracellular binding site in abnormal cells. When exposed to
certain wavelengths of fluorescent light, our diagnostic stain
causes abnormal cells to literally light up red/orange with a
degree of fluorescence proportional to the abnormality of the
cell. Biomoda’s first product will be a non-invasive test for
the extreme early detection of lung cancer.
Currently, there are no
commercially available methods of detecting lung cancer at the
pre-cancerous stage and there is no FDA approved screen for lung
cancer. We are preparing for additional clinical trials and
commercialization for extreme early lung cancer detection, thus
putting Biomoda on the leading edge of the research curve.
Before marketing any of its
products, the Company will need to complete one or more clinical
investigations of each product. There can be no assurance that
the results of such clinical investigations will be favorable to
the Company. During each investigative study and prior to its
completion, the results of the investigation will remain
“blinded” to ensure the integrity of the study. The Company will
not know the results of any study, favorable or unfavorable to
the Company, until after the study has been completed. Such data
must be submitted to the FDA as part of any regulatory filing
seeking approval to market the product. Even if the results are
favorable, the FDA may dispute the claims of safety, efficacy,
or clinical utility and not allow the product to be marketed.
General
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The Company’s present
strategy is to seek partners for commercializing its products in
foreign markets. There can be no assurance that the company will
be successful in finding suitable collaborative partners for any
of its technology, nor can there be any assurance as to the
timing or terms of any such collaborations. Such collaborative
arrangements, if entered into, may provide for the company to
receive a royalty for sales of its products by the licensee, as
well as up-front licensing fees and payments for development
work performed by the company. Royalties on sales, in any event,
will depend in part upon the efforts required of the licensee,
which may include the completion of product research and
development, performance of clinical investigations, obtaining
regulatory approvals, and manufacturing and marketing any
products. The amount and timing of resources devoted to these
activities may be controlled by the licensee. Should the
licensee fail to perform any essential functions, the company’s
business and results could be adversely affected. If the company
is unable to enter into favorable collaborative arrangements,
the company may not have sufficient resources to develop its
products. In addition, there can be no assurance that any of the
company’s collaborative partners would not pursue alternative
technologies or develop alternative products on their own or in
collaboration with others, including the company’s competitors.
Managed care organizations,
hospitals, ob/gyn specialists, and lung cancer specialists in
the region of Biomoda’s licensed cytopathology lab will be
alerted by direct mailings about the availability of improved
technology for detection of lung cancer in sputum samples and
cervical cancer from pap smears. A price list will be included.
A direct sales approach by telephone may be appropriate,
particularly since sales to clinical labs around the country
will have to be supported by Biomoda personnel with a knowledge
base similar to that of the decision makers.
Biomoda executives will
directly contact and negotiate national sales/operating
agreements (a National Account Approach). To the extent that
reagents are sold to small laboratories, these sales will be
accomplished through one or more major reagent distributors.
Sales support may be challenging, since the company anticipates
that sputum sample preparation will be particularly difficult in
inexperienced hands. Biomoda intends to support the customers
with technical support provided via phone, fax, and internet and
detailed procedural documentation.
Finalized plans for selling
Biomoda products and services will be developed during the first
eighteen months. The Marketing/Sales executive whom the Company
plans to hire during the second year will actively participate
in the consolidation and implementation of the selling program.
Manufacturing
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For the initial development
phase, no manufacturing facilities will be needed. However,
production and packaging facilities both for the cytopathology
reagents and for clinical trials materials will be required.
Since TCPP can be manufactured by total chemical synthesis,
Biomoda plans initially to contract out production of TCPP as a
fine chemical. Pharmaceutical companies may be particularly
attractive contract manufacturers. It is likely that when the
cytopatholgy product kits reach the market, Biomoda will invest
in the capital equipment for production and packaging, although
the decision may be made to continue to contract out these
functions so long as costs are competitive. All formulations
will be treated as confidential trade secrets, extending to all
contract manufacturers. Patents on formulations will be pursued
aggressively, minimizing the concerns attending contract
manufacturing.
Biomoda will investigate
contract manufacturing options with U.S., European and Asian
companies.
Quality assurance and quality
control will be maintained by an in-house QA/QC group, checking
conformance to requirements of outside contractors. A Total
Quality Management approach will be implemented, extending to
the suppliers of raw and finished materials.
Product Research and Development
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Initial research will be
conducted for the development of a method for early detection
and diagnosing of lung cancer. The first phase will be conducted
at a single site, with a control group known to have lung
disease and at a high risk for having cancer. The goal of this
additional clinical work will be to refine the preliminary
laboratory and contract lab results on scoring relative to
cellular anomalies. We intend to refine the protocol and further
develop a systematic and reproducible approach to accurately
defining sensitivity and specificity. The institution that will
be our strategic partner in this study will have a large sputum
bank with detailed information on the patients and samples. The
Company is currently in the process of reviewing several
candidates for use as strategic partners.
The second phase will be a
multi-site pilot study to gain further insight into
reproducibility and to evaluate the data with academic
collaborators. It is intended that the results will be published
in peer-review publications to further corroborate the data and
disclose the potential of the technology.
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