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M., Tagliaferro, A. and De Marchi, G.: "The Ligature of Two Internal Arteries in Disorders of Vascularization of the Myocardium, " Minerva Medica, 46: Part Two ; 1173, 1955. Langer, L.: "Die Foramina Thesesii im Herzen des Monschen, Sitzungsberichte Akad. Wissensch., " Mat h.-naturwissensch. Cl., Wien, 82: 25, 1880. Gross, L.: The Blood Supply to the Heart, New York, Hoeber, 1921. Hudson, C., Moritz, A. and Wearn, J.: "The Extracardiac Anastomoses of the Coronary Arteries, " J. Exper. Med., 56 : 919, 1932. Moritz, A., Hudson, C. and Orgain, E.: "Augmentation of the Extracardiac Anastomoses of the Coronary Arteries Through Pericardial Adhesions, " J. Exper. Med., 56: 927, 1932. Beck, C. S., Tichy, V. L. and Moritz, A. R.: "Production of Collateral Circulation to the Heart, " Proceeding8 of the Soc. Exper. Biol. and Med., 32: 759, 1935. Glover, R. P. and Davila, J. C. with Kyle, R. H., Beard, Jr., John C., Trout, R. G., and Kitchell, J. R.: "Ligation of the Internal Mammary Arteries as a Means of Increasing Blood Supply to the Myocardium, " J. Thoracic Surg. In press. Holman, E.: "Problems in the Dynamics of Blood Flow: 1. Conditions Controlling Collateral Circulation in the Presence of an Arteriovenous Fistula, Following the Ligation of an Artery, " Surgery, 26 : 889, 1949. Beck, C. S.: "Development of a New Blood Supply to the Heart by Operation, " Ann. Surg., 102 : 801, 1935. Beck, C. S.: "Revascularization of the Heart, " Ann. Surg., 128: 854, 1948. O'Shaughnessy, L.: "Surgical Treatment of Cardiac Ischemia, " Lancet, 1: 185, 1937. Fauteux, M.: "Pericoronary Neurectomy Associated with Ligature of Great Coronary Vein in Treatment of Some Forms of Coronary Disease, " Union Medicale du Canada, 74 : 424, 1945. Thompson, S. A. and Raisbeck, M. J.: "Cardio-cardiopexy: The Surgical Treatment of Coronary Arterial Disease by the Establishment of Adhesive Pericarditis, " Ann. mt. Med., 16: 495, 1942. Vineberg, A. M.: "Development of Anastomoses Between Coronary Vessels and Transplanted Internal Mammary Artery, " J.A.M.A., 55: 117, 1946. Brofman, B. L.: "Surgical Treatment of Coronary Artery Disease: Medical Management and Evaluation of Results, " Dis. Chest, 31: 253, 1957.
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RISK FACTORS This offering involves a high degree of risk. You should carefully consider the risks described below, in conjunction with the other information and financial statements and related notes included elsewhere in this prospectus, before making an investment decision. You should pay particular attention to the fact that we conduct our operations in Italy and are governed by a legal and regulatory environment that in some respects differs significantly from the environment that prevails in other countries with which you may be familiar. Our business, financial condition or results of operations could be affected materially and adversely by any or all of these risks. Risks Relating to Our Business We have generated limited revenue from commercial sales of our products to date, our revenues have declined significantly in 2004 compared to 2003, and we do not know whether we will ever generate significant revenues or achieve profitability. We are focused on product development and have generated limited revenue from commercial sales of our products to date. In 2003, we had revenues of 6.5 million, and in the first nine months of 2004, we had revenues of 2.0 million, primarily from sales of active pharmaceutical ingredients and existing products to Sirton, our sister company. We expect that our revenues in the year ending December 31, 2004 will be substantially less than our 2003 revenues because our plant was closed for a major upgrade in 2004 and because our affiliate, Sirton, has had a decrease in demand for the products we sell to them. In addition, our financial results reflect allocations of certain expenses, including centralized legal, accounting, treasury, information technology, purchasing and logistic, controlling and reporting, sales and marketing, and other corporate services and infrastructure costs provided by our majority shareholder, FinSirton, and affiliate, Sirton. We have determined the expense allocations based on what we consider to be a reasonable reflection of the utilization of services provided or the benefit received by us. However, our financial results may not be indicative of our operating results and cash flows in the future or what they would have been had we been a separate, stand-alone entity during the periods presented. After the offering, we plan to provide internally some of the services provided to us by FinSirton and Sirton, which may change our financial results in the future from what they would have otherwise been had the same existing inter-company services continued. We do not expect our revenues to materially increase unless we are able to sell our product candidates, and we will continue to incur significant expenses as we research, develop, test and seek regulatory approval for these product candidates. While we have been profitable in the past, we have incurred a loss of 2.6 million for the first nine months of 2004 and expect to incur a loss for the year ending December 31, 2004. We also expect that our general and administrative expenses will increase as we add additional personnel to support our operations in connection with our development of our product candidates. As a result, we anticipate incurring substantial and increasing losses for the foreseeable future. We cannot assure you that we will ever become profitable. If we fail to achieve profitability within the time frame expected by investors or securities analysts, the market price of our ordinary shares may decline. We currently have no product candidates for sale in the United States, and we cannot guarantee that we will ever have marketable products in the United States. We must demonstrate that our product candidates satisfy rigorous standards of safety and efficacy before the FDA, the European Commission and other regulatory authorities will approve the products for commercial marketing. We will need to conduct significant additional research, preclinical testing and clinical testing before we can file applications with the FDA and other regulatory authorities for 10 and isordil, for example, uso.
NOTE: Although the medications listed below in the "Addiction Treatments" section are specifically intended to be taken for prevention of relapse to dependence upon one or more drugs, none of them are habit-forming or addictive themselves, and should therefore be considered safe for recovering people to take. However, their proper use in the context of a recovery program requires monitoring by a health care professional, and it is for this reason that we place them in Class B.
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IN WTNEM WHEREOF, the Parties haft thmugh their th11y authorized mpromtafves have agreed tothis Sett a Amt, tlu ~ hwato, Rider A to this Setdement Agreet and the settlement embodied herein and theuin, on the date ft above heroin wrtn. AVENTLS PHARMACEUTICALS INC. BY R"N Esq. SHOOK, HARDY Bt BACON L.L.P. One xmsas City Place 1200 Main Street Kansas City, MO 64105-2118 Tel: 816 ; 474-6550 Fax 816 ; 421-4066.
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Men with mild, untreated type 2 diabetes were studied in a special diagnostic and treatment unit SDTU; similar to a clinical research center ; . All participants met the National Diabetes Data Group criteria for the diagnosis of type 2 diabetes 8 ; . Participant characteristics are given in Table 1. The study was approved by the Department of Veterans Affairs Medical Center and the University of Minnesota Committees on Human Subjects, and written informed consent was obtained from all participants. The participants did not have hematologic abnormalities, kidney disease, liver disease, macroalbuminuria 300 mg 24 h ; , congestive heart failure, or untreated thyroid disease. Before the study, all participants were interviewed to determine their physical activity profile and food aversions and to explain the study process and commitment in detail. Participants confirmed that they had been weight stable for at least 3 months. They were instructed to maintain their current activity level throughout the study. Two weeks before beginning the study, the participants completed a 3-day food frequency questionnaire, with one of the days being a Saturday or a Sunday. This information was used to calculate the total food energy necessary to maintain body weight. None of the participants were being treated with oral hypoglycemic agents or insulin at the time of enrollment in the study. A 5-week randomized, crossover study design was used with a 5-week washout period between diets. The control 15% protein ; diet was designed according to the recommendations of the American Heart Association 9 ; and the U.S. Department of Agriculture 10, 11 ; . The diet consisted of 55% carbohydrate, with an emphasis on starch-containing foods, 15% protein, and 30% fat 10% monounsaturated, 10% polyunsaturated, and 10% saturated fatty acid ; . A second diet was designed to consist of 20% carbohydrate, 30% protein, and 50% fat. The saturated fatty acid content of the test diet was 10% of total food energy; thus, the majority of the fat was mono- and polyunsaturated. This diet is referred to in the text as the LoBAG diet. The composition of the diets is given in Table 2. 2375, for example, vademecum.
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In late 2002, the Board of Directors undertook a comprehensive review of the Company's various incentive plans in the context of current best practices and the requirements of the Sarbanes-Oxley Act of 2002. As a result of this review, the Board of Directors decided to discontinue certain incentive plans of the Company effective December 4, 2002, subject to appropriate grandfathering provisions related to outstanding plan participation. There was no participation in these plans in 2003. The details of these plans are listed below. Stock Ownership Plan This plan was originally implemented in 1991, and subsequently amended in 1998 and in 2001, to provide an incentive to all employees of the Company by giving them a direct interest in the Company's growth and development. In 2002, the Board of Directors replaced this plan with a registered retirement savings program see "Employee Group Registered Retirement Savings Plan" ; . Equity Purchase Plan Eligible participants in this plan were entitled to purchase yearly common shares of the Company equal to not more than 40% of base salary, funded by an interest-bearing loan from the Company, with the common shares to be acquired by an open market purchase by a trustee on behalf of the participants. The purchase price was equal to the closing price of the common shares on the TSX or NASDAQ on December 31 of each year, based on a purchase commitment as of December 1 of the prior year. This plan was cancelled by the Board in 2002. Employee Participation Share Purchase Plan Each Participation Share is equal to a fraction of a common share depending on the performance of the common share from the date the Participation Share is issued to the date of conversion of the Participation Share. To minimize dilution to shareholders compared to a stock option plan, common shares are issued only to the extent that the stock price has appreciated since the date the Participation Shares are issued rather than on a per option exercise basis. The value and subscription price of such common shares is determined with the assistance of an independent valuator and the subscription amount is loaned to the participant on a non-recourse, interest-free basis by the Company. Certain restrictions on transferability apply and redemption rights are retained by the Company. Participation Shares generally vest over a four-year period. The loaned funds are repayable to the Company on conversion of vested Participation Shares. Participation Shares were viewed as advantageous over other forms of compensation for various reasons including mild dilution impact, lack of need for participants to sell shares to convert and favorable participant tax treatment. No further Participation Shares will be issued by the Company. The following table sets forth the 2003 financial year-end value of the named executive officers' unconverted Participation Shares, on an aggregated basis.
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References 1. Department of Health. Good practice guidelines for renal dialysis transplantation units: prevention and control of blood-borne virus infection. 2002.
Acknowledgment These articles were prepared by Anouska Feszczur and reviewed by the Pharmacy Department and Dr B Mathew. Comments are welcome at the e-mail address: DrugInformation.Graylands health.wa.gov.au.
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