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From the (latest) preliminary S-1: PROSPECTUS SUMMARY This summary highlights information contained elsewhere in this prospectus. You should read the entire prospectus carefully, especially the risks of investing in our common stock, which we discuss under "Risk Factors," and our consolidated financial statements and related notes. OVERVIEW We are a biopharmaceutical company engaged in developing small molecule drugs to treat central nervous system, cardiovascular and inflammatory conditions. We currently have four product candidates in development for six indications. Rotigotine CDS, our lead product candidate, is being developed by Schwarz Pharma AG. Rotigotine CDS is completing Phase III clinical trials for the treatment of Parkinson's disease and is in a Phase IIb clinical trial for Restless Legs Syndrome. King Pharmaceuticals Research and Development, Inc., a subsidiary of King Pharmaceuticals, Inc., has completed Phase II clinical trials with binodenoson as a pharmacologic stress agent for cardiac imaging and is expected to start Phase III clinical trials in the fourth quarter of 2003. King is also developing MRE-0094 as a treatment for chronic diabetic foot ulcers. The intravenous dosage form of selodenoson is being developed by Fujisawa Healthcare, Inc. Intravenous selodenoson is in Phase II clinical trials for heart rate control in atrial fibrillation and has demonstrated slowing of heart rate. We retain rights to the intravenous formulation outside the United States and Canada and the worldwide rights to the oral formulations of selodenoson. We have completed a Phase I clinical trial for an oral dosage form of selodenoson. We focus on small molecule drug candidates that act to selectively modify the activity of certain receptors, such as receptors for adenosine and dopamine. By targeting receptor subtypes responsible for specific effects, our goal is to produce therapeutic results while minimizing side effects. To limit stimulation of receptor subtypes in other tissues, we have developed molecules to target tissues where receptor subtypes may be sensitive to lower levels of drugs. In addition, to avoid side effects, we have designed molecules that may not enter certain organs. Small molecule medications are more easily formulated, have greater potential for absorption and utilization by the body, are more efficiently manufactured than large molecule therapies and generally offer greater dosing flexibility so that patients can comply with prescribed dosing schedules. OUR PRODUCT CANDIDATES We currently have four product candidates in development for six indications. - Rotigotine CDS, our most advanced product candidate, is being developed by Schwarz Pharma. Rotigotine is a proprietary dopamine receptor agonist formulated in a once-daily transdermal patch. Rotigotine CDS is completing Phase III clinical trials as both a first-line treatment of early stage and a combination therapy for late stage Parkinson's disease. Parkinson's disease is an age-related, neurodegenerative disorder that affects approximately one million people in the United States. Approximately $2 billion is spent annually on drug therapy worldwide to treat this disease. Rotigotine CDS is designed to provide a constant blood level of the drug over a 24-hour period, thereby minimizing daily symptoms and side effects. We have licensed to Schwarz Pharma the worldwide development and commercialization rights to rotigotine CDS for Parkinson's disease. Rotigotine was administered to approximately 1,000 patients and healthy subjects before it entered Phase III clinical trials. Schwarz Pharma performed a randomized, double-blind, placebo- controlled, Phase IIb clinical trial in early stage Parkinson's disease patients that demonstrated a statistically significant improvement in patient's symptoms compared to placebo (p-value at two highest doses <0.0001). Schwarz Pharma also performed a Phase II clinical trial in 310 late stage patients. The primary endpoint of this trial measured the reduction in patient "off" time. Although this trial demonstrated a reduction in "off" time compared to baseline, the results were not statistically significant compared to placebo as a result of an unexpectedly large placebo effect. Schwarz Pharma plans to enroll approximately 1,200 patients with early stage and late stage Parkinson's disease into pivotal Phase III clinical trials using the same primary endpoints used in the Phase II clinical trials. Two of these trials have been completed. The initial results from the Phase III clinical trials are expected to be released in the first quarter of 2004. Schwarz Pharma has announced that it intends to submit a new drug application, or NDA, for rotigotine CDS by the end of 2004. 1 - Rotigotine CDS is also being developed in lower-dose transdermal patches which are currently in a Phase IIb clinical trial for the treatment of Restless Legs Syndrome. Restless Legs Syndrome is a common neurologic movement disorder in which patients suffer an almost irresistible urge to move their legs that often results in sleep disturbances. Studies reported by the American Academy of Family Physicians have indicated that up to 15% of the population in the United States may have Restless Legs Syndrome. There are currently no medications approved for the treatment of Restless Legs Syndrome in the United States. A once-daily transdermal medication may provide continuous therapeutic blood levels of the drug and symptomatic relief throughout the night and into the daytime. We have licensed to Schwarz Pharma the worldwide development and commercialization rights to rotigotine CDS for Restless Legs Syndrome. A Phase II safety and efficacy pilot trial performed in Europe was completed in April 2002 and revealed a statistically significant improvement in symptoms (p-value = 0.04). Schwarz Pharma is currently conducting a randomized, placebo-controlled, dose-ranging Phase IIb trial in Europe under a US investigational new drug application, or IND. Schwarz Pharma expects the results of this trial will be available in the third quarter of 2004. - Binodenoson is an adenosine A(2A) agonist that is being developed by King. King has completed Phase II clinical trials and is expected to begin Phase III clinical trials during the fourth quarter of 2003. Binodenoson is being developed as an alternative to exercise prior to cardiac perfusion imaging for the diagnosis of coronary artery disease. Many patients cannot perform the level of exercise necessary for an adequate diagnostic test and require a pharmacologic stress agent in lieu of exercise. We estimate that approximately 2.6 million cardiac perfusion imaging procedures are performed annually in the United States using a pharmacologic stress agent. Binodenoson is designed to minimize the side effects associated with the most commonly used agents, adenosine and dipyridamole. Binodenoson is formulated to be dosed as an injection for ease of administration rather than the continuous infusion with an intravenous pump required with adenosine and dipyridamole. We have licensed to King the worldwide development and commercialization rights to binodenoson as a pharmacologic stress agent. Binodenoson has been administered to 440 patients and healthy volunteers in six clinical trials. King completed a multi-center, single-blind, two-arm crossover Phase IIb clinical trial in patients who received pharmacologic stress tests with both adenosine and binodenoson. Results from the trial indicated that binodenoson was comparable to adenosine for detecting the extent of coronary disease. In addition, this clinical trial demonstrated that binodenoson had fewer and less severe side effects than adenosine with a statistically significant p-value of <0.01 in each case. King intends to initiate Phase III clinical trials in the fourth quarter of 2003 in the United States and internationally. - Selodenoson is currently being developed in intravenous and oral formulations for the treatment of atrial fibrillation. The intravenous dosage form of selodenoson, an adenosine A(1) agonist, is being developed by Fujisawa Healthcare. Intravenous selodenoson is in Phase II clinical trials for heart rate control in atrial fibrillation and has demonstrated slowing of heart rate. An oral formulation of selodenoson has completed a Phase I clinical trial. In addition to the clinical trials discussed below, clinical trials are ongoing to evaluate the side effects from A(1) receptor stimulation on other parts of the body. Selodenoson is designed to control heart rate in atrial fibrillation by slowing conduction through the atrioventricular node. Atrial fibrillation is the most common sustained cardiac arrhythmia, or abnormal heart rhythm, and currently affects approximately two million people in the United States. Selodenoson is being developed as both an intravenous formulation for acute rate control and as a modified release oral formulation for chronic rate control. We have licensed to Fujisawa Healthcare the rights to develop and commercialize the intravenous formulation of selodenoson in the United States and Canada. We retain rights to develop and commercialize the intravenous formulation in all other countries and worldwide rights for all oral formulations. We and Fujisawa Healthcare have performed a total of 11 Phase I and Phase II clinical trials in which a total of 453 patients and healthy volunteers received selodenoson. One of these Phase II clinical trials examined the effect on heart rate of infusions of escalating doses of selodenoson in patients with atrial fibrillation. The data from this trial demonstrated a statistically significant decrease (p-value < 0.05) in heart rate compared to baseline in patients who received the drug, but there was no change from baseline in patients who received 2 placebo. This data has been accepted to be presented at the American Heart Association's Scientific Sessions in November 2003. Two more of these Phase II clinical trials have been completed and we anticipate the release of these results in early 2004. - MRE-0094 is an adenosine A(2A) agonist formulated as a topical treatment currently in development for the treatment of chronic diabetic foot ulcers. Approximately 15% of the estimated 16 million diabetics in the United States develop foot ulcers. It is estimated that of the more than 50,000 annual amputations of a lower extremity in diabetics, 85% result from foot ulcers. MRE-0094 appears to promote wound healing. King filed an investigational new drug application, or IND, in May 2002 for MRE-0094. We have licensed to King the worldwide development and commercialization rights for MRE-0094. We believe there may be additional therapeutic indications for our portfolio of product candidates. None of our product candidates have been approved by the Food and Drug Administration or European regulators for commercialization. We have a history of operating losses and, as of June 30, 2003, we had an accumulated deficit of approximately $44.8 million. In addition, we are dependent upon third parties, especially our collaborators, for the successful commercialization of our clinical product candidates. We are at an early stage of development and face significant challenges in achieving our business objectives, including successful completion of clinical trials, obtaining regulatory approvals, market acceptance of our products and competition from companies with greater resources. OUR BUSINESS STRATEGY We intend to develop and commercialize therapies for central nervous system, cardiovascular and inflammatory conditions. To achieve this objective, we intend to concentrate on the following key strategies: - continue to invest to support our corporate collaborators in their development and commercialization of our advanced product candidates; - expand our product candidate portfolio by acquiring or in-licensing product candidates and programs that are 18-24 months from human clinical trials; - retain development responsibility for and marketing rights to selected drug candidates through late stage development to maximize product value; and - maintain balanced in-house expertise and capabilities in synthetic chemistry, pharmacology and key elements of clinical development while outsourcing routine drug development activities. CORPORATE INFORMATION We were incorporated as Discovery Therapeutics, Inc. in Delaware in 1994 and changed our name to Aderis Pharmaceuticals, Inc. in January 2002. Our principal executive offices are located at 85 Main Street, Hopkinton, Massachusetts 01748, and our telephone number is (508) 497-2300. References in this prospectus to "Aderis," "we," "our" and "us" refer to Aderis Pharmaceuticals, Inc. Our web site is located at www.aderis.com. Information contained in our web site is not incorporated by reference into and does not form any part of this prospectus. | ||||||||||||||
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