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Metabasis Therapeutics, Inc. (NASDAQ: MBRX Proposed) We are a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs principally to treat liver diseases and metabolic diseases linked to pathways in the liver. Examples of common metabolic diseases include diabetes, hyperlipidemia, a disease involving elevated levels of lipids such as cholesterol, and obesity. Since we became an independent company in 1999, we have established a broad and growing product pipeline targeting large markets with significant unmet medical needs. We currently have three internally discovered product candidates in clinical trials indicated for the treatment of type 2 diabetes, hepatitis B and primary liver cancer. Our three product candidates in clinical trials are: • CS-917, a product candidate for the treatment of type 2 diabetes that is currently in a Phase II clinical trial, • Hepavir B™, a product candidate for the treatment of hepatitis B that is currently in Phase I/II clinical trials, and • MB07133, a product candidate for the treatment of primary liver cancer that is currently in a Phase I/II clinical trial. In addition to our clinical stage programs, we have research programs focused on metabolic diseases linked to pathways in the liver such as type 2 diabetes, hyperlipidemia and obesity, as well as liver diseases such as hepatitis C and liver fibrosis. We believe our advanced research programs, which are research programs in which we have identified lead drug compounds and shown them to have efficacy in animal models, have the potential to yield additional clinical development candidates within the next two years. One of these advanced research programs recently yielded a compound, MB07803, that we recommended for clinical development. MB07803 is a clinical development candidate for the treatment of type 2 diabetes that works by the same mechanism as CS-917. Once recommended for clinical development, we test a candidate to determine manufacturing methods, to measure its toxicity in animal models and to develop a suitable dosage form. These processes are referred to as scale-up, toxicology and formulation development, respectively. A successful candidate would then be ready for human clinical testing. We have extensive expertise in liver diseases and in the pathways and proteins residing in the liver that significantly contribute to certain metabolic diseases or that are important for transporting drugs into the liver, acting upon them and expelling them from the body, processes referred to as drug uptake, metabolism and excretion, respectively. With this knowledge, we developed two proprietary technologies named NuMimetic™ and HepDirect®. We use our NuMimetic technology to discover molecules that bind effectively and specifically to certain regulatory sites, called nucleotide binding sites, residing on proteins called enzymes that control the output of cellular pathways involved in metabolic diseases, or metabolic pathways. We used our NuMimetic technology to discover CS-917, and we are also using it in certain of our advanced research programs. We use our HepDirect technology to target drugs to the liver, resulting in increased levels of the active forms of the drugs in the liver and decreased levels in non-liver tissues. We believe this technology will significantly improve drug efficacy and safety and result in new, proprietary drugs that may then be marketed by us or by companies we collaborate with that have compounds that would benefit from this approach. Hepavir B and MB07133 use our HepDirect technology, as do several of our advanced research programs. Our recent collaboration with Merck & Co., Inc. applies the HepDirect technology to certain compounds Merck has studied for the treatment of hepatitis C. Our Product Candidates in Clinical Trials CS-917 CS-917 is a product candidate in Phase II clinical trials for type 2 diabetes, a disease afflicting approximately 159 million people worldwide. Although many options exist for treating diabetes, there remains a substantial demand for new, more effective therapies. We believe CS-917, which we discovered using our NuMimetic technology, inhibits a metabolic pathway in the liver that is responsible for producing the sugar called glucose. In type 2 diabetics, this pathway produces excessive amounts of glucose, contributing to high blood glucose levels which may over time lead to morbidity and death. We believe that CS-917 is the first drug to reach the clinic that is designed to directly block this pathway. Results from an initial 14-day Phase II study in diabetics demonstrated that CS-917 is capable of significantly lowering blood glucose levels. An additional study designed to help identify a safe and effective dose is currently underway. We are developing CS-917 in collaboration with Sankyo Company, Ltd., and we retain co-promotion rights in North America. Hepavir B Hepavir B is a product candidate in Phase I/II clinical trials. Phase I/II trials are designed to evaluate safety and preliminary efficacy in a limited number of patients. Hepatitis B is a serious liver infection with over 350 million people chronically infected worldwide. Hepavir B uses our HepDirect technology to target adefovir, a proven anti-viral compound, specifically to the liver. Hepsera®, a marketed anti-viral drug indicated for the treatment of hepatitis B, also delivers adefovir but throughout the body, rather than specifically to the liver. We believe that Hepsera, while effective against hepatitis B, is used at a suboptimal dose due to an increased risk of kidney toxicity at higher doses. Because Hepavir B targets the active form of the drug to the liver while limiting the amount that reaches other organs, we expect it to be more effective than Hepsera without kidney toxicity. Hepavir B has completed two Phase I clinical trials in which it was well-tolerated and exhibited favorable pharmacokinetics, which is the way in which a drug compound is absorbed, distributed, metabolized and eliminated by the body. We are developing Hepavir B in collaboration with Valeant Pharmaceuticals International, formerly known as ICN Pharmaceuticals, Inc., to whom we have licensed worldwide commercialization rights. Although Valeant, in its regulatory filings with the FDA, refers to Hepavir B as currently in Phase I clinical trials, we believe these trials are more properly characterized as Phase I/II clinical trials because they are designed to evaluate both safety and preliminary efficacy in a limited number of patients with hepatitis B over a 28-day period. MB07133 MB07133 is a product candidate in a Phase I/II clinical trial for primary liver cancer, which is cancer that originates in the liver. This disease causes over 500,000 deaths per year worldwide and has no currently approved drug treatment. MB07133 uses our HepDirect technology to target the active form of a marketed anti-cancer drug, called cytarabine or araC, to the liver. AraC is used to treat leukemia but is not effective in treating solid tumors, such as those that result from primary liver cancer, which we believe is due to poor conversion of the drug to its active form in the liver. MB07133 overcomes this poor conversion, and we expect that its administration will result in high levels of the active form of the drug in the liver and will provide an effective treatment of the cancer. In addition, we have demonstrated in multiple pre-clinical studies that this unique liver-targeting property also results in decreased drug levels in tissues outside of the liver, which in these studies eliminated or minimized toxicities normally associated with araC. We retain full worldwide commercialization rights to MB07133. Our Research Programs We believe that a broad product pipeline will provide strong growth potential and reduce our reliance on the success of any single product candidate. Our goal is to recommend at least one new drug compound per year for clinical development—a goal we have met in the past several years. Once recommended for clinical development, a candidate undergoes scale up, toxicology and formulation development. A successful candidate would then be ready for human clinical testing. We may also in-license technologies and products to complement these internal discovery efforts and further enhance our pipeline and market opportunities. We believe we have a strong intellectual property position in the U.S. and in foreign countries, including eight issued U.S. patents and 14 pending U.S. patent applications that cover proprietary technologies and compounds used in our current business. We retain worldwide commercialization rights for all product candidates developed in our current research programs, with the exception of hepatitis C product candidates covered by our collaboration with Merck. We have several advanced research programs that we believe have the potential to yield additional clinical development candidates within the next two years. From these advanced research programs, we recently recommended the clinical development of MB07803, a candidate for the treatment of type 2 diabetes that, like CS-917, is designed to block the metabolic pathway in the liver that is responsible for producing glucose. Assuming it successfully completes pre-clinical development, we intend to file an Investigational New Drug, or IND, application for MB07803 in late 2004 and once the IND becomes effective, begin clinical trials of MB07803 in 2005. Our advanced research programs include: • a program targeting hyperlipidemia and possibly obesity by controlling certain genes in the liver that are important for making or using cholesterol as well as genes involved in the control of energy expenditure, • programs using our HepDirect technology to identify drugs to treat hepatitis C infection including a collaboration with Merck to apply our HepDirect technology to certain compounds Merck has studied for the treatment of hepatitis C infection, • a program using our NuMimetic technology to treat metabolic diseases such as type 2 diabetes, hyperlipidemia and a disease associated with fatty livers known as non-alcoholic steatohepatitis, by inhibiting cholesterol and lipid production in the liver, and • a program using our HepDirect technology to treat liver fibrosis by inhibiting the overproduction of collagen in the liver. Our Business Strategy Our goal is to be a leading biopharmaceutical company developing and commercializing novel drugs. Important elements of our business strategy include: • advancing the development of our current product candidates, • continuing to develop a broad product pipeline, • continuing to enhance our liver-focused capabilities and intellectual property rights, • pursuing a diversified development and commercialization strategy for our product candidates, • establishing additional HepDirect partnerships with companies whose products would benefit from improved liver targeting, such as our collaboration with Merck, and • becoming a fully-integrated pharmaceutical company by building our internal development, regulatory and commercialization infrastructure as appropriate and when resources allow. Risks Affecting Us We are subject to a number of risks, which you should be aware of before you decide to buy our common stock. These risks are discussed more fully in "Risk Factors." We have not received regulatory approval for, or generated commercial revenues from, any of our product candidates. All of our current product candidates are in clinical development. If we do not successfully commercialize any of our product candidates, we will be unable to achieve our business objectives. As of December 31, 2003, we had an accumulated deficit of $36.4 million. We expect to continue to incur increasing losses over the next several years, and we may never become profitable. Corporate Information We were incorporated in Delaware in April 1997 as a wholly owned subsidiary of Gensia Sicor Inc., now Sicor Inc., which became an indirect wholly owned subsidiary of Teva Pharmaceutical Industries Limited in January 2004. In December 1997, Sicor assigned to us specified assets and liabilities relating to its then existing business of discovering and developing proprietary pharmaceutical products. Although we established a new business plan, pursued new opportunities and discovered new products and technologies following our inception, many of the assets we obtained in the transfer served as a foundation upon which we built our technologies and know-how. In June 1999, we completed a corporate restructuring and management stock purchase in which we became an independent company. We have a wholly owned subsidiary, Aramed, Inc., which was transferred to us by Sicor and does not conduct an active business. Our principal offices are located at 9390 Towne Centre Drive, Building 300, San Diego, CA 92121, and our telephone number is (858) 587-2770. Our website address is mbasis.com. | ||||||||||||||
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