Savient Pharmaceuticals (FRA:BY7) GF Score : 0/100 (As of May. 15, 2024)

Savient Pharmaceuticals, Inc., was founded in 1980. It develops, manufactures and markets products through the application of genetic engineering and related biotechnologies. The Company, and its wholly-owned Subsidiaries, is a specialty biopharmaceutical company focused on commercializing KRYSTEXXA (pegloticase) in the United States and completing the development and seeking regulatory approval outside of the United States for KRYSTEXXA, particularly in the European Union. It completed a promotional launch of KRYSTEXXA in the United States during the first quarter of 2011 with its sales force commencing field promotion to health care providers on February 28, 2011. The Company also sells and distributes branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. The Company launched its authorized generic version of oxandrolone in December 2006 in response to the approval and launch of generic competition to Oxandrin. On January 1, 2012, KRYSTEXXA received a permanent J Code, which facilitates reimbursement to providers who treat patients suffering with RCG and who rely on Medicare and Medicaid. The manufacturing process for pegloticase, which is the drug substance of KRYSTEXXA, consists of the production through a recombinant process in which a genetically-engineered bacteria produces uricase, followed by its purification, PEGylation, further purification and formulation to produce the bulk pegloticase, which the company refers it as pegloticase drug substance. Pegloticase is aseptically filtered and filled into sterile, single dose vials to produce the KRYSTEXXA drug product. Its sales force targets rheumatologists and nephrologists with access to infusion centers and healthcare institutions, each of which treat adult patients suffering from RCG, as well as podiatrists who also treat patients with RCG. In March 2012, KRYSTEXXA was made available in the EU to healthcare professionals through a Named Patient Program. The Company sells its products to three drug wholesaler customers and various specialty distributors. Its research and development includes costs associated with the research and development of its KRYSTEXXA product prior to FDA approval and FDA-related post-marketing commitments for approved products (KRYSTEXXA post-approval). These costs mainly include pre-clinical and clinical studies and trials, personnel costs including compensation, consultants and contract research organizations, or CROs, quality control and assurance costs, regulatory costs and costs related to the development of commercial scale manufacturing capabilities for KRYSTEXXA, which also includes the costs of preparing Fujifilm to serve as its secondary source supplier of pegloticase drug substance for KRYSTEXXA in the United States. As of March 7, 2013, the company owned 14 issued U.S. patents and 154 issued foreign patents. It currently owns U.S. and several foreign registrations or applicat