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We are a biopharmaceutical company focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate ion channel targets. Ions are charged particles, such as sodium, potassium, calcium and chloride. Ion channels are protein structures found in virtually every cell of the human body. Ion channels span the cell membrane and regulate the flow of ions into and out of cells. Ion channels represent an important and well-established class of molecular targets for drug development. There are currently over 35 drugs marketed by third parties for multiple therapeutic indications that modulate ion channels, representing over $6.5 billion in United States sales in 2003. Utilizing our proprietary know-how and integrated scientific and drug development capabilities, we have identified multiple drug candidates that modulate ion channels. Our four most advanced programs are: • ICA-17043 for sickle cell anemia, for which we recently completed a Phase II clinical trial and expect to initiate a Phase III clinical trial in the fourth quarter of 2004; • ICA-69673 for epilepsy and neuropathic pain, for which we are conducting Phase I clinical trials; • a compound for atrial fibrillation, which is being developed by our collaborator Bristol-Myers Squibb Company and is in Phase I clinical trials; and • compounds for dementia, including Alzheimer’s disease, which are being developed by our collaborator Yamanouchi Pharmaceutical Co., Ltd. and are undergoing preclinical testing. We are also conducting ongoing drug discovery programs focused on new therapeutics for pain disorders, inflammatory disorders and glaucoma. In each of these programs, we have validated multiple ion channel targets and identified small molecule compounds that have demonstrated in vitro and, in many cases, in vivo activity. In addition to our internal programs, we have established collaborations with Abbott Laboratories, Bristol-Myers Squibb and Yamanouchi to further capitalize on our ion channel capabilities. We have retained worldwide commercialization rights to ICA-17043 and ICA-69673. Our Lead Internal Clinical Programs Our most advanced drug candidate is ICA-17043, which we are developing for the chronic prophylactic treatment of sickle cell anemia. ICA-17043 is a small molecule that is dosed orally once a day. Sickle cell anemia is a serious blood disorder affecting at least 70,000 patients in the United States, primarily of African descent. Currently the only approved drug for the treatment of this disease is hydroxyurea, a drug primarily used as a cancer chemotherapeutic agent that is generally prescribed only for the most severely ill sickle cell patients as a result of its potentially serious side effects. Because hydroxyurea is not prescribed for the substantial majority of sickle cell anemia patients, there is a significant unmet medical need for sickle cell anemia treatment. We recently completed a randomized, double-blind, placebo-controlled Phase II clinical trial of ICA-17043 in 90 patients at 19 academic medical centers across the United States. We are in the process of completing our analysis of the data from this trial. We plan to initiate a pivotal Phase III trial of ICA-17043 for the chronic treatment of sickle cell anemia in the fourth quarter of 2004, subject to discussions with the U.S. Food and Drug Administration, or FDA. We are currently designing the protocol for this trial. Subject to satisfactorily completing clinical development and receiving required regulatory approvals, we intend to market and sell ICA-17043 in the United States directly to physicians who specialize in the treatment of sickle cell anemia patients. Because of the limited number of treatment centers and physicians who specialize in sickle cell anemia, we believe that we will be able to address this market with a relatively small, highly focused sales and marketing organization, either alone or with a collaborator. ICA-17043 has received fast track designation and orphan drug designation from the FDA. Our second most advanced drug candidate, ICA-69673, is a small molecule ion channel activator that targets a potassium channel located primarily on the membrane of nerve cells, or neurons, present in particular regions of the central and peripheral nervous system. We are developing ICA-69673 for the treatment of epilepsy and neuropathic pain. We have an effective Investigational New Drug application, or IND, for ICA-69673 for the treatment of epilepsy and plan to file a second IND for ICA-69673 for the treatment of neuropathic pain in the second half of 2004. In 2004, we initiated a Phase I single-dose escalation study of ICA-69673 in healthy volunteers. We expect to complete this initial Phase I clinical trial in mid-2004. ICA-69673 is taken orally and is being developed with the goal of achieving a once-a-day or twice-a-day dosing schedule. Our Drug Discovery Capabilities Since our inception in 1992, we have built significant capabilities for the discovery and development of drugs that act upon ion channel targets. We are applying the knowledge that we have obtained in our most advanced development programs across all of our drug discovery research and development efforts. Key elements of our capabilities include our: • cloning of over 300 human ion channel genes, which we believe represents substantially all of the human ion channel genome; • expertise in developing high throughput screens for ion channel targets; • ion channel focused chemistry library of over 200,000 compounds; • proprietary computational chemistry methods; • extensive ion channel database, which integrates substantial biological and chemistry information; • internal pharmacology and bioanalytic capabilities; and • ion channel drug discovery intellectual property. We believe that these core capabilities provide us with several important competitive advantages, including efficiencies in target identification and validation both within as well as across research programs. We further believe that by integrating a number of scientific and drug development disciplines we are able to discover and develop small molecule compounds that are more selective and specific for the medically relevant ion channel, thereby enabling us to identify and develop drug candidates that may have a reduced likelihood of adverse side effects and clinical failure. We pursue a target class approach to ion channel drug discovery. In this approach, we start with all potential ion channel targets and seek to identify applications to the treatment of various diseases. We believe that our approach provides for a more efficient drug discovery process, because our in-depth understanding of the targets and methods for finding small molecule modulators of these targets obviates the need to develop new research tools each time a new target is identified. Instead, we use our knowledge and skill to quickly find potential small molecule modulators of particular ion channel targets. We then use these small molecules to validate the particular target in a relevant animal model of disease. If a small molecule demonstrates activity in the animal model, it both validates the target and provides a starting point for further medicinal chemistry efforts. Our Strategy Our goal is to become a fully-integrated biopharmaceutical company and a leader in the discovery, development and commercialization of novel small molecule drugs that modulate ion channel targets and address disease areas with significant unmet medical need and commercial potential. Key elements of our strategy are to: • maximize the commercial potential of ICA-17043; • build and advance our product candidate pipeline, including ICA-69673; • strengthen and expand our core ion channel drug discovery technologies and development capabilities; • establish strategic alliances with leading pharmaceutical and biotechnology companies; and • establish specialized sales and marketing capabilities. Risks Associated with Our Business Our business is subject to numerous risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary. We have a limited operating history and have not yet commercialized any products. We have incurred substantial operating losses in each year since inception. As of December 31, 2003, we had an accumulated deficit of approximately $39.2 million. We expect to incur significant and increasing net losses for at least the next several years. All of our product candidates are undergoing clinical trials or are in early stages of development, and failure is common and can occur at any stage of development. None of our drug candidates has received regulatory approval for commercialization, and we do not expect that any drugs resulting from our or our collaborators’ research and development efforts will be commercially available for a number of years, if at all. We may never receive any product revenues or achieve profitability. Our Corporate Information We were incorporated under the laws of Delaware in November 1992. Our principal executive offices are located at 4222 Emperor Blvd, Suite 350, Durham, North Carolina 27703, and our telephone number is (919) 941-5206. Our website address is www.icagen.com. We do not intend for the information on our website to be a part of this prospectus. | ||||||||||||||
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