SangStat and Pasteur Merieux Connaught Receive THYMOGLOBULIN -- anti-thymocyte globulin, rabbit -- PLA Complete Review Letter From FDA; Pre-Approval Site Inspection Completed.MENLO PARK, Calif., and LYON, France--(BW HealthWire)--Jan. 28, 1998--SangStat, The Transplant Company(R), (Nasdaq: SANG), and Pasteur Merieux Connaught, IMTIX Division (Rhone-Poulenc group), announced that they have received a Product License Application (PLA (Programmable Logic Array) A type of programmable logic chip (PLD) that contained arrays of programmable AND and OR gates. PLAs are no longer used. See PLD. (language, music) Pla - A high-level music programming language, written in SAIL. ) 'Complete Review' letter from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for THYMOGLOBULIN. The pre-approval site inspection of the Pasteur Merieux Connaught manufacturing facility has also been completed. The PLA was submitted in January, 1997 with a proposed indication for the treatment of acute allograft allograft: see transplantation, medical. rejection and for prevention of recurrent acute rejection in renal transplant renal transplant Transplantation of a kidney from a living donor or cadaver to a recipient with ESRD Indications–children Congenital kidney/GU tract malformations–42%; focal segmental glomerulosclerosis-12% and others; 31% of children were ≤ age 5 patients. The receipt of this action letter indicates that the FDA has completed its review of the THYMOGLOBULIN PLA within the twelve-month review target suggested in the 1992 Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. (PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) ). In line with the FDA Modernization Act (PDUFA II), the FDA's Center For Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. (CBER CB·er n. One that uses a CB radio. ) is now issuing 'complete review' letters rather than 'approvable' or 'not approvable' letters for biologics applications. A complete review letter has been received for the THYMOGLOBULIN PLA, and FDA action on THYMOGLOBULIN's Establishment License Application (ELA Noun 1. ELA - an extreme leftist terrorist group formed in Greece in 1971 to oppose the military junta that ruled Greece from 1967 to 1974; a revolutionary group opposed to capitalism and imperialism and the United States Revolutionary People's Struggle ) is expected soon. Prior to final potential product approval, CBER's 'complete review' letter for the THYMOGLOBULIN PLA requires responses to questions related to the PLA. Following the completion of the manufacturing facility pre-approval inspection the FDA has provided a separate list of observations. SangStat and Pasteur Merieux Connaught intend to provide responses to all of the questions on the PLA and observations from the inspection within the next 2-3 weeks. Philippe Pouletty, M.D., SangStat's Chairman and 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. said, "We are very pleased that the FDA has completed its review of the PLA and issued this key action letter for THYMOGLOBULIN. Achieving this milestone with our lead therapeutic product candidate is a significant accomplishment for SangStat." He continued, "Subject to providing satisfactory responses to all questions FDA may have, we look forward to receiving US market clearance for THYMOGLOBULIN for the treatment of acute graft rejection in kidney transplant recipients." "We are very pleased that the FDA has completed its pre-approval site inspection of our new, dedicated facility for manufacturing THYMOGLOBULIN," said Gilles Alberici, Ph.D., Head of IMTIX, the Pasteur Merieux Connaught Transplant Division. "We intend to submit our responses to the FDA within 2-3 weeks and, subject to final potential approval, we look forward to meeting SangStat's anticipated commercial needs for THYMOGLOBULIN." THYMOGLOBULIN is currently marketed in 44 countries and has been used in more than 40,000 patients worldwide for the treatment and prevention of acute graft rejection episodes in transplant recipients. SangStat acquired an exclusive license from Pasteur Merieux Connaught to market this drug in the United States and Canada. Subject to marketing clearance and scaling up of production, Pasteur Merieux Connaught will manufacture commercial supplies of THYMOGLOBULIN for marketing and distribution by SangStat in the United States. THYMOGLOBULIN is manufactured and marketed outside North America by IMTIX, the Pasteur Merieux Connaught transplantation division. THYMOGLOBULIN is a pasteurized pas·teur·ize tr.v. pas·teur·ized, pas·teur·iz·ing, pas·teur·iz·es To subject (a beverage or other food) to pasteurization. pas , rabbit anti-human thymocyte thymocyte /thy·mo·cyte/ (thi´mo-sit) a lymphocyte arising in the thymus. thy·mo·cyte n. A lymphocyte that develops in the thymus and is the precursor of a T cell. immunoglobulin which induces immunosuppression immunosuppression Suppression of immunity with drugs, usually to prevent rejection of an organ transplant. Its aim is to allow the recipient to accept the organ permanently with no unpleasant side effects. as a result of T-cell depletion. Common side effects of polyclonal antibody therapy include, among others, fever, infections, leukopenia leukopenia /leu·ko·pe·nia/ (-pe´ne-ah) reduction of the number of leukocytes in the blood below about 5000 per cubic mm.leukope´nic basophilic leukopenia basophilopenia. and thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. . These side effects are often transient. THYMOGLOBULIN is contraindicated in patients with an allergy to rabbit proteins. SangStat is a specialty pharmaceutical company applying a disease management approach to improve the outcome of organ transplantation. The Company has a total of 12 monitoring and therapeutic products and product candidates to address the pre-transplant, acute care and chronic phases of transplantation. SangStat is located in Menlo Park, California Menlo Park is a city in San Mateo County, California in the United States of America. It is located at latitude 37°29' North, longitude 122°9' East. Menlo Park had 30,785 inhabitants as of the 2000 U.S. Census. , and operates The Transplant Pharmacy(R), a comprehensive pilot pharmacotherapy pharmacotherapy /phar·ma·co·ther·a·py/ (-ther´ah-pe) treatment of disease with medicines. phar·ma·co·ther·a·py n. Treatment of disease through the use of drugs. management program, and wholly-owned subsidiaries, SangStat Atlantique S.A., SangStat's European base of operations Noun 1. base of operations - installation from which a military force initiates operations; "the attack wiped out our forward bases" base air base, air station - a base for military aircraft army base - a large base of operations for an army in Nantes, France, SangStat Canada, Ltd. in Mississauga, Ontario, Canada and XenoStat, Inc., in Menlo Park, California. IMTIX was established in 1995 as a specific division of Pasteur Merieux Connaught dedicated to biologicals for transplantation and hematology. Its products are distributed in more than 60 countries including the EU countries, Canada, Brazil, South Africa and Japan. IMTIX also has an active development program of therapeutics for acute care. IMTIX takes part fully in the mission of Pasteur Merieux Connaught: to contribute as a global leader to the protection and maintenance of human health by creating superior immunological products. Pasteur Merieux Connaught is part of the Rhone-Poulenc group and refers to Pasteur Merieux Serums & Vaccins of Lyon, France and its subsidiaries, including Connaught Laboratories, Ltd., in Toronto, Canada and Connaught Laboratories, Inc. in Swiftwater, Pennsylvania. This press release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements reflect SangStat and Pasteur Merieux Connaught's current views with respect to future events. Actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. Important factors common to the FDA drug review and clearance process could cause actual results to differ materially with regard to the approvability and possible market acceptance of THYMOGLOBULIN. These factors include, without limitation: (1) that data obtained from clinical trials are subject to varying interpretations, and there can be no assurance that the FDA (or an FDA panel of experts) will agree with SangStat's assessment of clinical trial results; (2) that there can be no assurance that the agency will not issue new guidelines, guidance documents, policies, or regulations or otherwise have new, different or previously unknown requirements that may materially affect the approvability of the product; (3) that there can be no assurance that final labeling can be agreed upon in a timely manner; (4) that there can be no assurance that any manufacturing or control issues will be adequately resolved to the FDA's satisfaction; (5) that there can be no assurance that any current or future questions relating to the FDA's review of the PLA or ELA applications or to the inspection of the manufacturing facility can be adequately answered to FDA's satisfaction; and (6) that there can be no assurance of FDA clearance of the product. Other factors that could cause actual results to differ materially include, without limitation, uncertainty related to the current or future manufacturing of commercial quantities of product on commercially favorable terms, market size, market acceptance, profitability and competition. For a discussion of factors that might result in different outcomes, see page 30 of SangStat's 1996 Annual Report and SangStat's 10-K and 10-Q reports filed with the Securities and Exchange Commission. -0- You can find copies of our latest press releases on the web at www.biospace.com/sangstat CONTACT: SangStat Medical Corporation Maree Wall, 650/688-2331 or Pasteur Merieux Connaught, IMTIX - France Ariane Mansouri, 33.4.72.73.79.76 or Media: Brad Miles, 212/477-9007 x17 |
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