The Company has developed a highly sensitive, user friendly, cost effective testing system for the detection and quantification of highly toxic environmental chemicals generally known as dioxin and dioxin-like compounds. It is called the Ah-IMMUNOASSAY® Kit(AH-1 Method). Since the discovery of the dioxin compounds, during the late 1950’s, extensive research has been undertaken into their chemical and biological properties. And as more information becomes available, it is now clear that the original and narrowly defined group of ‘dioxins’ is becoming more expansive to include many other highly toxic, chemically similar compounds. Dioxin, although singular in name, is actually comprised of at least 17 chemical variants or congeners of a larger dioxin family. These chemicals are highly toxic, with the most active congener (TCDD) being the most toxic chemical ever discovered. The number of chemicals with dioxin-like activity is even much larger still than the 17 original polychlorodibenzo-p-dioxin (PCDD) families, such as the polychlorodibenzofurans (PCDF), the polychlorinated biphenyls (PCBs), the polybrominated biphenyls (PBBs), the polycyclic aromatic hydrocarbons (PAHs), the heterocyclic amines (HAs), among others. Probably no other group of chemicals has invoked more public health concern and received more media attention than these dioxin and dioxin-like substances, both because of their widespread distribution and their capability for serious toxicity (e.g., cancer, birth defects, diabetes, hormone disruption, immunologic dysfunction, etc.). The Environmental Protection Agency (EPA) of the United States has concluded, for example, that more than 100 of these dioxins and dioxin-like chemicals are likely human carcinogens. Waste incineration is a major source of these chemicals. Paper mill bleaching and varied industrial syntheses also add significant amounts to the environment. Following release into the air, perhaps also into waste water or sludge, these chemicals then settle on plant material, soil, and water where they are likely to persist for very long periods of time. As a consequence, they tend to accumulate either onto particulate matter (such as found at the bottom of bodies of water), or into body fat reservoirs of animals and fishes which feed on the plants. And because of their stability and persistence, these chemicals accumulate to relatively high levels in animal based foods. A public service group in Japan, for example, has compared the relative contributions to human exposure of the original group of dioxins and furans in 4 countries, and showed that food contributes about 98% of the total exposure. Among the food residues, 80-88% of the total is consumed from seafood, milk, dairy products, meat and eggs; in Japan, the proportion of dioxin consumption from fish is much higher than for other countries. Investigating the distribution and toxicities of these chemicals has been challenging, both because of the ever-growing number of chemicals with dioxin-like activity and the difficulty of predicting toxicities. Because of these complexities, analysis of these chemicals has been very expensive, with the results being difficult to interpret. More recently, simpler analytical methods have been developed, such as the AH-1 Method, based on the use of biologically based concepts. Dioxins and dioxin-like chemicals (also called ligands), enter the cell and bind to a protein in the cytoplasm called Ah receptor (AhR), thus giving a ligand-AhR complex. This complex, by dropping and adding some smaller proteins (e.g., AhR translocator or ARNT, hsp-90 protein) is said to be ‘transformed’, thus enabling it to enter the nucleus to bind to a specific ‘dioxin receptor element’ (or enhancer) (DRE) of DNA. This interaction with DNA occurs ‘upstream’ of genes which then are activated to produce certain enzymes, some of which are highly correlated with the subsequent toxicity. The AH-I Method takes advantage of these facts. It is generally acknowledged, for example, that AhR binding appears to be essential for the development of toxicity by these chemicals. It is as if ligand binding of AhR is the main traffic intersection through which these chemicals pass on their way to produce their respective toxicities. In the AH-I Method, where an excess of AhR protein is provided, the amount of AhR-ligand complex that transforms is dependent on the amount of dioxin ligand present in the sample being assayed. The amount of the transformed complex is detected by using an antibody specific for the Ah-I protein component of the complex, thus giving the ‘IMMUNOASSAY’ name to the method. (For the scientifically minded reader, there really are two antibodies: the first interacts with the ARNT protein in the complex while the second, containing an enzyme that catalyzes the formation of the color reaction, binds to the first antibody. The color being produced in the reaction shows how much of the complex is present.). Dioxin is a toxic chemical group of widespread public health concern, and more information is needed, especially on the distribution of this material in the environment. More survey data are needed not only to identify potential ‘hot spots’ but also to allay unwarranted concerns. Until now, such survey work has been prohibitively expensive, but with the introduction of simpler and much more cost effective bioassay methods, such as the AH-1 Method, it is now possible to gather far more information in order to make wiser decisions. The uses of the AH-1 Method are twofold: screening and monitoring. On screening, a sufficient number of samples taken from the site under investigation will need to be assayed in order to identify ‘hot spot’ areas with the highest contamination. This type of screening allows not only the setting aside of incorrectly suspected contamination areas, but also permits identification of areas of contamination needing more attention. Subsequent efforts and resources can then be focused on areas and samples most in need of attention and possible remediation. Monitoring refers to the assay of positive samples before and after treatment or remediation. In the case of fly ash, attempts are presently being made to destroy dioxin-like substances during the production process, thus the AH-I Method can be used to monitor the success of the intervention program. In the case of soil contaminated areas, there are new methods that are said to have the potential of degrading the dioxin-like substances already present. The herbal supplement market presents the opportunity to commercialize a quality assurance program that identifies the bioactivity present in herbal products, which are complex mixtures of substances. This product is a significant advance versus current practices for verifying the quality and the bioactivity of herbal products. This is the Company’s BioFIT™ Quality Assurance Certification Program. Typically, the Company will investigate the effect of a compound or mixture of compounds on a disease (such as cancer) or a symptom (such as depression). The Company scientists conduct in depth research of the scientific literature and review the results of successful clinical trials to establish the best scientific explanation for the positive results seen in such trials. Based on their review, they identify the biological mechanism which, if activated, would best explain the positive clinical results. By defining such mechanisms of action associated with a wide variety of biological effects the Company scientists can then test a wide variety of natural materials in "in vitro" models which demonstrate these effects for the purpose of either discovering or confirming these biological activities. Such discovery or confirmation provides the Company with the basis for its BioFIT™ Program. The Company is continuing to work with its Chinese colleagues, during the appropriate market conditions, to expand the scope of the BioFIT™ program to the rest of the world. The Company is engaged in an internet-based health exchange between the US and China and currently maintains the website www.newcenturynutrition.com. The Company has excellent relations with recognized health authorities and organizations within the People’s Republic of China. This website serves to provide a forum for the exchange of nutrition, health and related information. At its core is the New Century Nutrition website where renowned researchers, teachers and physicians from both countries can discuss their philosophies, research findings and health advice. Other components of the site include an herbal resource center featuring herbal databases from China, a nutrition resource center featuring healthy recipes and a technology center featuring the Ah-IMMUNOASSAY® Kit and the BioFIT™ Program. Our goal is to combine the best of Chinese medical practice with the best of Western practice creating new opportunities for information on health and disease prevention. The Company is selling its inventory of Andrographis Paniculata through the website. Andrographis is an annual plant that grows in much of Asia and has been used for centuries in India, China, Sri Lanka, and Indonesia. The herb is traditionally used to fight some viral infections and the associated symptoms, including fever, diarrhea, cough, and gastrointestinal problems. Modern research has been conducted over the past three decades, and much of this research has returned very promising results, supporting the traditional use of Andrographis over the past several hundred years. The Company owns an extract library of approximately 2,800 Traditional Chinese Medicines and other plant materials which it has screened using its proprietary screening technology. Through the screening process, the Company has identified the (10) extracts with potent in vitro activity against cancer cells as potential drug discovery and development candidates. The long term goal of the Company is to continue to pursue discussions and to partner with a major pharmaceutical partner to develop any potential drug candidates in the shortest possible time period. Future revenues are anticipated to be derived from the sale of the dioxin testing product the Ah-IMMUNOASSAY® Kits and dioxin and dioxin-like chemical testing services, and ecommerce sales through the Internet. There can be no assurance that the Company will be able to attain such revenues in sufficient amounts to achieve profitable operations. Results of operations in the future will be influenced by numerous factors, including the ability of the Company to develop and manage the introduction of its products and services, market acceptance, competition and the ability to control costs. In 2001, the Company will continue to pursue the following strategies: (i) Identify and develop new markets in industries which will benefit from the adoption of the bioassay testing technologies and services; (ii) Form co-development, strategic partnerships and licensing partnerships in these new markets with the industry leaders; (iii) Structure development agreements that will provide up front licensing payments and on-going royalties from partnership revenues; (iv) Promote the bioassay technologies and services as the "Industry Benchmark"; and (v) Position the Company, via its internet websites, as a leading partner with China in the area of health and the trade of health related products and technologies. These strategies will be executed by focusing the Company’s primary activities on the Company’s patented AH-1 Method that detects potentially dioxins in the environment and provides quick, accurate and inexpensive results compared to traditional analytical techniques. MarketWorldwide, there is increasing awareness of the enormous health hazards of dioxins and dioxin-like chemicals. This awareness is derived from a combination of regulatory, economic and political pressures. Many governments, including those in North America, Western Europe and Japan, have set levels of dioxin pollution that will be allowed in the environment. In addition, international agencies, especially those associated with the United Nations and the World Trade Organization, have begun formal discussions that are leading to the establishment of similar international regulations in the future.The global pollution monitoring market is more than $10 billion annually. Andrew Jolin, owner of Government & Export Sales (GESS), developed the $10 billion estimate. GESS is a consulting firm that brings environmental technology to market around the world. There are at least 100,000 incinerators (small, medium and large size) operating in Asia. In the rest of the world there are probably another 150,000 incinerators, which brings the total to 250,000 (some estimate the number to be as high as 500,000). If each of the 250,000 incinerators had 10 dioxin tests/year @ $2,000 per test, that would create a $5 billion market for incinerators alone. This estimate is based on the number of incinerators currently in existence and it does not include any new additions. For example, there are 14 municipal waste incinerators in Britain and contracts have been awarded to build 60 new incinerators. It is also estimated that incineration capacity (28 to 138 extra incinerators) will be required by 2016. Another major market is industrial plant screening for dioxins. Paper mills, petroleum refineries, chemical manufacturers and others will create a $2.5 billion market for dioxin testing. With global annual growth forecast at 2.5%, these industries will increase dramatically within the next five to ten years and so will the market for the screening of dioxins. The food chain is an additional major market. From animal feed to mother’s milk, this market will develop into a $2.5 billion market, and will also increase due to global growth.Because the demand for pollution abatement is driven almost entirely by government regulation, Paracelsian is focusing its marketing efforts on those countries that already have set standards for dioxin pollution. In addition, we are introducing our technology to key government regulators and encouraging them to consider the kit for use as their government’s testing standard. The Company began to focus on the Japanese market for the following reasons: (1) Japan has a widely recognized dioxin pollution problem largely due to the greater use of waste incinerators for which the government has begun to enforce emission requirements, (2) Incinerators that do not meet government emission requirements are being shut down, causing disruption in many industries and, (3) The Japanese government has not yet imposed standards and types of tests to be used in monitoring pollution discharge and, as a result, companies are more open to new technologies which save money. On January 21, 2000, Paracelsian, Inc. and Kubota Corporation signed a License Agreement whereby Kubota will commercialize Paracelsian’s AH-1 Method in Japan. This agreement will provide both license fees ($150,000) and royalties. Kubota, a company with approximately $9 billion of revenue, is a leader in the control and resolution of environmental contamination problems in Japan. They have subsidiaries and affiliates that manufacture and/or market Kubota products in more than 130 countries. On June 1, 2000, as part of the License Agreement, Paracelsian delivered an Assessment Plan to Kubota Corp., detailing the Kits functionality. Kubota reviewed and evaluated the Assessment Plan, and accepted the AH-1 Method. Kubota’s acceptance of the Assessment Plan, the Kit and our methodology is a milestone for Paracelsian. Kubota and Paracelsian are now focusing their efforts to market, sell and distribute the Kit throughout Japan. The present market for dioxin testing in Japan is $400 to $600 million yearly and the Japanese estimate that Paracelsian has the potential to capture 25% of that market over the next five years In May 2000, major newspapers across the USA reported that a draft Dioxin Reassessment Report by the Environmental Protection Agency(EPA) concluded for the first time that a large number dioxin-like compounds are "human carcinogens." This assessment, along with the numerous reports of many other serious ailments resulting from exposure to these chemicals, make this class of chemicals perhaps the most significant toxicity problem known in the world today. On November 2, 2000 the EPA held an open meeting for public comments on the Dioxin Reassessment Report. Approximately 50 people from around the US were scheduled to present their comments to the Science Advisory Board Dioxin Reassessment Review Committee. Dr. T Colin Campbell, President & CEO of Paracelsian, reported to the committee his concerns about including in the report all of the dioxin and dioxin-like chemicals because of their capability for serious toxicity. On December 7, 2000 the Company entered into a Strategic Partnership Agreement with Triangle Laboratories, Inc., based in the Research Triangle Park in North Carolina. Triangle Laboratories is a recognized world leader in High Resolution Mass Spectrometry and dioxin testing. They were formed in 1984, and are still led by the founding scientists. Triangle provides a wide range of testing services to a broad customer base, specializing in the most demanding testing, such as dioxins and related compounds. The Agreement contemplates a unified system wherein the Company’s AH-1 Method can be used by customers to screen large numbers of samples in a user friendly manner and on a cost effective basis. Samples that are positive can then be assessed with the Triangle high resolution gas chromatography/high resolution mass spectrometry assay system at the highest possible level of accuracy. The Partnership provides the basis for a more comprehensive agreement between the parties for the development and worldwide co-marketing of the multi-tiered testing system. The Companies specifically anticipate collaboration to make their combined capabilities available in the emerging Asian environmental markets, including China and Vietnam. The Company also has received inquiries on, or has provided demonstration of the AH-1 Method to several other countries around the world, including China, Thailand, Vietnam, South Korea, The Czech Republic, The Netherlands, Belgium, Israel, Canada and Germany; similar initiatives have also developed in the USA. A proposal also has been made to the U.S. State Department that they make use of the AH-1 Method in their proposed joint study with Vietnam on dioxin contamination caused by Agent Orange. The China partnership includes an agreement, which specifies development of a manufacturing and laboratory facility in China, arises from a long 20 year collaboration between Paracelsian’s CEO and President , Dr. T. Colin Campbell who has long held an endowed professorship at Cornell University. Moreover, Chinese and Paracelsian scientists are collaborating on the development of further improvements of the AH-1 Method. Paracelsian is implementing its marketing program through Government & Export Sales Specialists (GESS). GESS is a consulting/marketing company active in technology research, development, commercialization and marketing. Mr. NoriYoshi Inoue, formerly an International Marketing Manager with Kubota Corporation, will be collaborating with GESS to develop business opportunities for the Ah-IMMUNOASSAY® Kit. Orders have been placed, training has been requested, and/or inquiries have been made for possible licensing for the Ah-IMMUNOASSAY® Kit from the Kubota Corporation (Japan), Lockheed-Martin Corporation (U.S.), Scientific Supply Co. (for Thailand), ECOSOL (Israel), Cypress Diagnostics (Belgium), MCS Diagnostice BV (The Netherlands), Campo Scientific (The Netherlands), and Dynex Technologies, Inc. (The Czech Republic), among a few other individual customers CompetitionThere are companies who have been developing bioassay type methods, similar to that of the AH-1 Method of Paracelsian. Several approaches have been tried, with two being the more prominent. Unfortunately, one requires the use of radioactivity while the other requires the use of live cell cultures; both therefore require considerable technical expertise. Neither appears to be as cost effective as the Paracelsian AH-1 Method, as timely, and/or, according to our information, as patented protected. The Paracelsian product is the first receptor based system that works in a simple-to-use and cost effective form. Compared to the products of the closest competitors, the AH-1 Method is more user friendly, provides much faster turnaround time, is more cost-effective, requires less technical skills and sophisticated laboratory facilities, and is more meaningful of toxicological risk assessment because of its theoretical basis. The beauty of our system is its taking advantage of the observation that these chemicals travel through a common pathway in the cell according to their concentration and their relative toxicity. The AH-1 Method measures the central event in this pathway, one which shows the extent of activation of the receptor involved in the initiation of the myriad toxic events. That is, measurement of the central event is more meaningful than, say, measurement of a downstream outcome event which represents only one of many such events possibly involved in toxicological outcomes. PatentsWhere possible, the Company has applied for product and process patents. In the course of its research, the Company obtained 3 patents (#‘s 5,496,703, 5,529,899 and 5,833,994) prior to 2000 for the Dioxin Assay Systems which cover a wide range of commercial applications for the AH-1 Method and other assay technologies. During 2000, the Company was granted two additional patents. The US Patent & Trademark Office in October 2000 issued to the Company Patent # 6,127,136 for the detection of dioxin-like compounds. This patent relates to new, improved and user friendly methods of detecting dioxin-like compounds by detecting the transformed Ah receptor. This patent gives the Company the protection it needs to continue to strengthen its presence in the worldwide dioxin detection marketplace. In November 2000 the US Patent & Trademark Office issued to the Company Patent # 6,140,063, in vitro screening assay for the identification of compounds that inhibit destruction of cells due to viral infection. This patent represents a potential new screening pathway for anti-viral compounds. The Company is actively seeking partners to fully develop the market potential of these patents. Patents have a statutory duration of twenty years. The Company believes that patent protection of materials or processes it develops and any products that may result from the Company's research and development efforts are important to the possible commercialization of these products. However, there can be no assurance that the Company's patents will afford adequate protection to the Company or its licensees. Further, there can be no assurance that any patents that have been or may be issued will provide the Company with significant protection from competitors. Other private and public entities may file applications for patents and other proprietary rights to technology which could be harmful to the commercialization of the services and products developed by the Company. The ultimate scope and validity of patents which are now owned by or which may be granted to third parties in the future, the extent to which the Company may wish or be required to acquire rights under such patents, and the cost or availability of such rights cannot be determined by the Company at this time. The Company also relies on unpatented proprietary technology and no assurance can be given that others will not independently develop substantially equivalent proprietary information or otherwise gain access to the Company’s proprietary technology or that the Company can meaningfully protect its rights in such unpatented proprietary technology. In addition, although all of the Company's employees are parties to confidentiality agreements which are intended to protect the Company's proprietary technology, there can be no assurance that any of such employees will not compromise any of the Company's proprietary rights. Dependence on a Key Distributor and Certain Industries The Company has entered into an Agreement with the Kubota Corporation for the sale of the Company’s AH-1 Method in the Japanese market. The Licensing Agreement provides the Company with licensing fees and a royalty on sales in the Japanese market. In return, the Company provides Kubota with an exclusive license to manufacture and distribute the AH-1 Method in Japan. Future revenues from these licensing fees and royalties are dependent on market receptivity of the AH-1 Method. As with any new product, acceptance is not guaranteed, and future earnings could be negatively impacted. Government Regulation The dioxin and dioxin-like compound and the health care industries are the subject of significant proposed legislation. The Company cannot predict what new legislation might be enacted or what regulations might be adopted or amended, or if enacted, adopted or amended, the effect thereof on the Company’s operations. Any change in applicable law or regulation may have a material effect on the business of the Company. Funding of Research and Development The Company expended $744,143 in 1999 and $761,673 in 2000 on research and development. Costs of Environmental Compliance The Company believes it is in compliance with all applicable environmental laws and the cost of such compliance to the Company has been minimal. Employees and Board The Company employs 9 full time people and 1 part-time person. None of the Company’s employees are covered by a collective bargaining agreement. The Company considers its relationship with its employees to be excellent. All employees of the Company are signatories to confidentiality agreements that restrict proprietary right in, and commercial development of, all technology developed by the employees. On January 31, 2000 the Company announced that Dr. T. Colin Campbell was named Chairman, CEO & President. Dr. Campbell replaces Bernard M. Landes, who served as Chairman, CEO and President the previous two years. Dr. Campbell served on the Board of Directors of the Company for several years prior to taking this new position. On February 8, 2000 the Company announced that Dr. Mac Shaibe has accepted an invitation to serve on the Company’s Board. His appointment to the Board lasts until the annual meeting of shareholders’ in 2003. Dr. Shaibe’s background includes significant positions in academia, government and the private sector. Perhaps most noteworthy, Dr. Shaibe is a co-inventor of the Internet. On May 2, 2000 the Company announced that NoriYoshi Inoue has accepted an invitation to also become a Director on the Company. Mr. Inoue is a Senior Executive with over 25 years of Japanese and international management, marketing and sales experience. He has had significant success in creating and implementing profitable worldwide marketing programs and strategies. Mr. Inoue’s appointment to the Board lasts until the annual meeting of shareholders‘ in 2001. In addition, Gary G. Chabot has joined the Company as the Chief Financial Officer. Item 2. DESCRIPTION OF PROPERTIES The Company’s executive offices and research facilities are located at Langmuir Laboratories in Ithaca, New York, and occupy 6,210 square feet at that location. The Company occupies this space under a one-year lease from Cornell University, which expires in April 2001, and provides for automatic renewals. At this time, the Company believes that this space is sufficient for its administrative offices as well as the Internet operation, and the current manufacturing and research and development activities. Item 3. LEGAL PROCEEDINGS In addition to routine litigation that is incidental to its business, the Company is a party to the following litigation: Hadyk, et al. V. John G. Babish, et al.: This case was commenced in New York State Supreme Court (Onondaga County) in June 1993 by certain persons, individually and doing business as In Vitro Bioanalytic Systems, against the Company, Dr. John G. Babish, a former officer and director of the Company, and Edward Heslop, a founding shareholder of the Company, primarily as an action for money damages and injunctive relief against the Company for alleged misappropriation of proprietary information and unfair competition. The plaintiffs allege, among other things, that in 1990, prior to the Company’s incorporation, a partnership has been formed with Messrs. Babish and Heslop to commercialize products that the Company was developing. Damages, an accounting and an injunction are being sought against the Company. By decision dated September 14, 1994, the Court dismissed certain of the plaintiffs’ claims against the Company while permitting a claim alleging unfair competition to proceed. The case is in the pretrial motion phase as discovery is now closed and there are pending motions for summary judgment, including a motion for summary judgment by the Company. That motion, if successful, will fully resolve the case in favor of the company. A three-week trial has been scheduled to begin on March 26, 2001. If the case is not resolved by the pending motion, an appeal of the denial of the motion is contemplated, followed by the trial if necessary. The Company believes that the suit against it is without merit and intends to defend the case vigorously. Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. PART II Item 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company’s Common Stock, par value $0.01 per share (the "Common Stock"), commenced trading on February 11, 1992 on the over- the-counter market and was quoted on the National Association of Securities Dealers’ Automated Quotation System ("NASDAQ") until October 7, 1998 when it moved to the over-the-counter Bulletin Board, under the symbol PRLN.OB. The Company’s Redeemable Common Stock Purchase Warrants (the "Warrants") commenced trading on September 24, 1993 on the over-the-counter market and are no longer quoted under the symbol PRLNW, since the warrants expired on September 7, 2000. The following table sets forth the high and low bid prices for the Common Stock and Warrants during the periods indicated as reported by NASDAQ. The prices reported reflect inter-dealer quotations, may not represent actual transactions and do not include retail mark-ups, markdowns or commissions. |