Biovitrum Wins Contract to Manufacture Pharmaceutical Substance For Resistentia's clinical Phase III Trials of New Protein-Based Drug Candidate for the Treatment of Allergy.STOCKHOLM, Sweden -- Biopharma company Biovitrum (STO:BVT BVT Bouvet Island (ISO Country code) BVT Brevet BVT Bournville Village Trust (UK) BVT Build Verification Test (Software testing process) ), listed on the Stockholm Stock Exchange The Stockholm Stock Exchange (Swedish: Stockholmsbörsen) is a stock exchange located in Stockholm, Sweden. Founded in 1863 [1] it is the primary securities exchange of the Nordic Countries. since September 15, 2006, has entered an agreement with the Uppsala-based biotech company Resistentia Pharmaceuticals AB for process development and manufacturing of the biopharmaceutical substance RES 08 intended for use in clinical phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials of Resistentia's new protein-based drug candidate for the treatment of allergy. With the onset of an allergic reaction allergic reaction n. A local or generalized reaction of an organism to internal or external contact with a specific allergen to which the organism has been previously sensitized. , allergy antibodies (IgE, immunoglobulin E immunoglobulin E n. Abbr. IgE The class of antibodies produced in the lungs, skin, and mucous membranes and responsible for allergic reactions. , a specific protein in our immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. ) are formed against a specific substance, for example pollen, dust, etc. Resistentia has developed a protein drug candidate (RES 08) that blocks the effect of IgE preventing an allergic reaction. RES 08 is a recombinant fusion protein A fusion protein is a protein created through genetic engineering from two or more proteins/peptides. This is achieved by creating a fusion gene: removing the stop codon from the DNA sequence of the first protein, then appending the DNA sequence of the second protein in frame. (a protein with a compound structure produced by biotechnical methods) that initially is intended for the treatment of IgE-mediated allergies. Biovitrum's assignment is to develop the existing process for the biotechnical manufacturing of RES 08 to a standard that meets the high demands of a clinical phase III trial, and furthermore to manufacture sufficient amounts of the substance for the trial. The project will run for more than two years beginning in November 2006. "We are very pleased with our partnership with the Swedish company Resistentia. This is a complex and extensive assignment which further emphasizes Biovitrum's role as a leading company in the Nordic biopharma industry," says Mats Pettersson, President of Biovitrum. "The agreement which involves both process development and manufacturing of the biopharmaceutical drug substance for this clinical phase III trial, means that we will utilize our extensive expertise and broad experience in protein pharmaceuticals to the full extent," says Hans EurstrEm, SVP SVP S'il Vous Plaît (French: Please) SVP Senior Vice President SVP Schweizerische Volkspartei (Swiss People~s Party) SVP Society of Vertebrate Paleontology SVP Social Venture Partners SVP St Vincent de Paul Biovitrum Biopharmaceuticals and Marketing & Sales. Marcus Bosson, President of Resistentia, says: " Biovitrum's long experience and expertise in the development and manufacturing of phase III processes is of vital importance at this stage to efficiently advance our project one step closer towards the market". Facts to the editor Biovitrum Biovitrum is one of the largest biopharma companies in Europe. With operations in Sweden and in the UK Biovitrum conducts research and develops pharmaceuticals for unmet medical needs both for common diseases and conditions that affect smaller patient populations. Biovitrum has a broad and balanced R&D portfolio with several projects in clinical and preclinical phases for the treatment of obesity, diabetes, inflammation and eye and blood diseases as well as a number of well defined niche indications. Biovitrum develops and produces protein-based drugs on a contractual basis and markets a range of specialist pharmaceuticals primarily in the Nordic countries. Biovitrum has approximately revenues of USD USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 119 million and 550 employees. Biovitrum is listed on the Stockholm Stock Exchange since September 15, 2006. For more information see www.biovitrum.com/. Resistentia Resistentia Pharmaceuticals AB is a Swedish privately held biotech company developing innovative immunotherapies that target allergy and asthma as well as inflammatory disorders. Founded in 1998, the company has developed an industrial organization with experiences ranging from molecular immunology, pre-clinical and clinical drug development to industrial biopharmaceutical production. In addition to its lead anti-IgE immunotherapeutic, Resistentia has initiated pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. of an immunotherapeutic against complement factor C5a for the treatment of rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and other autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . Clinical phase III development The manufacturing of protein pharmaceuticals for later clinical phases (phase III) imposes higher demands on both process and manufacturer than production of clinical materials for earlier phases (phase I/II). When phase III processes are developed, focus is directed toward manufacturing costs, process robustness and industrial scalability. After development and characterization, these processes are finalized for validation and can subsequently be utilized when a product is registered with the medical products agency. Process characterization involves identification of critical parameters of a manufacturing process in a laboratory environment in order to assess and adjust the process so that manufacturing meets the high demands for reproducibility and consistency during validation. Process validation involves investigating through a number of consecutive manufacturing batches whether the product meets the pre-specified requirements. This information was brought to you by Waymaker http://www.waymaker.net |
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