OCTOPLUS\BIOLEX DEVELOPING LOCTERON.OctoPlus, a drug delivery and development company and Biolex, Inc., a protein therapeutics company, have entered into collaboration for co-development of a controlled release formulation of recombinant human alfa interferon. The product, named Locteron(TM), combines OctoPlus' proprietary biodegradable biodegradable /bio·de·grad·a·ble/ (-de-grad´ah-b'l) susceptible of degradation by biological processes, as by bacterial or other enzymatic action. bi·o·de·grad·a·ble adj. PolyActive(TM) drug delivery technology with Biolex' BLX-883, a recombinant alfa interferon produced in its proprietary LEX System(TM). Locteron is designed to be more convenient for patients than the current pegylated alfa interferon products on the market as it is expected to be administered every two weeks. Alfa interferon is a protein used to treat infectious diseases infectious diseases: see communicable diseases. , such as Hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. and B, and certain cancers. Worldwide sales for alfa interferon in 2004 exceeded US $3 billion. Locteron and BLX-883 are investigational drug candidates and have not been approved by the U.S. Food and Drug Administration or any other regulatory agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. . Under the terms of the agreement, OctoPlus and Biolex will co-develop Locteron, including the establishment of manufacturing capabilities to support clinical development and commercialization. Initial focus will be on the treatment of Hepatitis C. The companies expect Locteron to enter clinical trials in mid-2005. Financial terms of the collaboration have not been disclosed. In preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. , Biolex has shown that BLX-883 is comparable to commercially available alfa interferon and that it can be produced cost-effectively using Biolex' proprietary LEX System in the company's cGMP manufacturing facilities. Biolex recently announced the filing of an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration and the European equivalent, a Clinical Trial Application (CTA An abbreviation for cum testamento annexo, Latin for "with the will annexed." ), for the initiation of clinical trials of BLX-883, an immediate release formulation of Locteron. Dosing in the initial clinical study has commenced. OctoPlus has shown in preclinical studies that, when formulated with PolyActive, sustained alfa interferon levels in plasma can be achieved, for a period up to two weeks and longer, with a single injection. In contrast, all pegylated alfa interferon products currently on the market require weekly injections. OctoPlus has also demonstrated in these preclinical studies that alfa interferon, when formulated with PolyActive, is gradually released after injection, thus avoiding both high peak and low trough plasma levels. This key feature may result in an improved clinical profile for the drug candidate with possibly fewer side-effects. "We are very pleased to enter into this agreement with Biolex. Their innovative, cost-effective manufacturing platform allows for global commercialization of Locteron. Also, we are very impressed with their skills and expertise in the area of recombinant protein recombinant protein Molecular biology A protein encoded by recombinant DNA or generated from a recombinant gene. See Recombinant pharmacology. development," stated Joost Holthuis, Ph.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of OctoPlus. "This partnership exemplifies our increased focus on investing in the development of products based on our drug delivery technologies to an advanced clinical stage." "We looked at a number of drug delivery technologies and were impressed with the many benefits of PolyActive and the development capabilities of OctoPlus. Combining these benefits with the manufacturing advantages provided by the LEX System may result in a far superior and more cost-effective version of alfa interferon than what is currently commercially available," said Jan Turek, president and CEO of Biolex. "This collaboration builds on our business strategy to develop a pipeline of proprietary Biolex proteins. We are delighted to be working with OctoPlus to develop this product, and look forward to having Locteron, our second drug candidate, enter the clinic later this year." About OctoPlus OctoPlus is a product-oriented drug delivery company that focuses on the development of innovative drug delivery systems to build a pipeline of product candidates. OctoPlus is also an internationally established provider of pharmaceutical development services and GMP GMP (guanosine monophosphate): see guanine. manufacturing for pharmaceutical and biotechnology companies Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. . The company is located in Leiden, The Netherlands. More information can be found at http://www.octoplus.nl. About Biolex Biolex, Inc. is a private, venture capital-backed biopharmaceutical company. Biolex is developing recombinant human therapeutic proteins that, until now, have been impossible or very expensive to develop in existing expression systems. Biolex' proprietary LEX System(TM) has demonstrated speed, regulatory and economic benefits with hard-to-make proteins and monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). . Biolex has a pipeline of proprietary products in development and its lead candidate, BLX-883, is currently in a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I . Biolex also is partnering with pharmaceutical and biotechnology companies seeking the protein development and production benefits the LEX System offers. Biolex has entered into corporate partnerships with Centocor, Inc., Medarex, Inc., and other pharmaceutical/ biotechnology companies. The company's headquarters, research laboratories and clinical manufacturing facilities are based in Pittsboro, North Carolina Pittsboro is a town in Chatham County, North Carolina, United States. The population was 2,226 at the 2000 census. It is the county seat of Chatham CountyGR6. . For more information, visit http://www.biolex.com or call 919/542-9901. |
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