SangStat announces positive results of CYCLOSPORINE pivotal trials; application for marketing approval to be filed by year end.MENLO PARK, Calif.--(HealthWire)--Sept. 30, 1996--SangStat, The Transplant Company(TM) (Nasdaq:SANG), announced today the results of its pivotal bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. trials showing that SangStat's proprietary CYCLOSPORINE cyclosporine /cy·clo·spor·ine/ (-spor´en) a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe formulation is bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to branded cyclosporine, as defined by 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. ) policy for generic drugs. Based on these results, SangStat intends to file for marketing clearance with the FDA by year end, earlier than previously forecast. Cyclosporine is the leading immunosuppressive drug immunosuppressive drug, any of a variety of substances used to prevent production of antibodies. They are commonly used to prevent rejection by a recipient's body of an organ transplanted from a donor. used in human organ transplantation The transfer of organs such as the kidneys, heart, or liver from one body to another. The transplantation of human organs has become a common medical procedure. Typical organs transplanted are the kidneys, heart, liver, pancreas, cornea, skin, bones, and lungs. to prevent graft rejection graft rejection Rejection Clinical immunology The constellation of defenses mounted by the immune system of the recipient of an allograft–eg kidney, liver, pancreas, etc, which compromise the continued viability of grafted tissue. Cf Graft. . It is currently marketed by Sandoz Ltd. in different formulations with 1995 worldwide sales reported at $1.2 billion. Two different formulations of the same drug are considered bioequivalent if the drug's absorption rate, blood concentration and persistence in the bloodstream are demonstrated to be equivalent according to defined regulatory policy. Two key pharmacokinetic parameters, area under the blood concentration vs. time curve (AUC AUC area under curve ) and the maximum drug concentration (Cmax) are measured in human bioequivalence trials. These parameters are calculated from drug levels measured in the blood over a defined time period following dosing. For AUC, AUC to a defined time point (AUC(0-t)) and AUC to infinity (AUC(0-oo)) are calculated separately. Among other factors, if the 90% confidence intervals (for the ratio of the log transformed parameters of SangStat's CYCLOSPORINE and Sandoz' cyclosporine (reference drug)) are contained within the range of 80% to 125%, then the formulations are considered bioequivalent under current FDA policy. SangStat's pivotal trial was a single-dose, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , cross-over bioequivalence trial in 36 healthy human volunteers comparing, under fasting conditions, SangStat's CYCLOSPORINE with the reference drug. Subjects had blood samples taken at defined time points over a 36-hour period and the cyclosporine blood levels were analyzed using a standardized, validated cyclosporine assay. Statistical comparisons of the key pharmacokinetic parameters for SangStat's CYCLOSPORINE and the reference drug yielded the following results: -0-
Least Squares Mean Ratio 90% Confidence
Parameter SangStat/Sandoz Interval(1) Power(2)
_________ ________________________ ______________ ________
Cmax 99.6 % 96.9 - 104 % 99.99 %
AUC (0-t) 99.8 % 97.3 - 103 % 99.99 %
AUC (0-oo) 99.4 % 97.0 - 103 % 99.99 %
(1) Based on log transformed parameters
(2) Power = Power (%) to detect 20% differences
between treatments (alpha = 0.05). For the study to be
statistically significant, the power should be at
least 80%.
A supporting trial in 21 subjects designed to assess food effect on cyclosporine bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. also demonstrated statistically significant bioequivalence between SangStat's and Sandoz' cyclosporine under fed conditions. None of the pilot or pivotal trials showed any serious or unexpected adverse events. Under current FDA regulations and policy, generic drugs can be approved based on a demonstration of bioequivalence to an FDA-approved reference drug without the need to duplicate the safety and efficacy trials conducted on the reference drug. If the FDA approves SangStat's CYCLOSPORINE based on bioequivalence to the reference drug, SangStat's formulation will receive an "AB" rating in the FDA's list of approved drugs. This rating would signify that SangStat's CYCLOSPORINE is therapeutically equivalent to, and interchangeable with, the reference drug. "The rapid completion and positive outcome of these pivotal bioequivalence trials will enable SangStat to move even faster in finalizing the preparation of its marketing application for filing by year end," according to Philippe Pouletty, MD, 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. , who will present the results to analysts and investors attending today's Montgomery Securities 26th Annual Investment Conference in San Francisco. "This is a major milestone for SangStat in that CYCLOSPORINE is one of the company's lead drug candidates addressing a significant market opportunity. Assuming market approval, we believe that SangStat as The Transplant Company(TM) will be well-positioned to compete in this growing market," said Dr. Pouletty. In the United States and Europe there are more than 200,000 transplant recipients requiring daily immunosuppressive therapy Immunosuppressive therapy Medical treatment in which the immune system is purposefully thwarted. Such treatment is necessary, for example, to prevent organ rejection in transplant cases. for the rest of their lives, the majority of whom take cyclosporine. SangStat is a biopharmaceutical company applying a disease management approach to improve the outcome of organ transplantation. The company has a total of 12 monitoring and therapeutic product and product candidates to address the pre-transplant, acute care and chronic phases of transplantation. Products in development include THYMOGLOBULIN(R) (exclusive marketing and development rights from Pasteur Merieux Serums et Vaccins "PMsv" for the U.S. and Canada) to treat graft rejection, CYCLOSPORINE and AZATHIOPRINE azathioprine: see metabolite. for chronic immunosuppressive therapy and ALLOTRAP(R) 2702 to promote graft acceptance following transplantation. Monitoring products include PRA-STAT(R) and CROSS-STAT(R) (both marketed in the U.S. and Europe), and product candidate TYP-STAT(TM), all designed to improve donor/recipient compatibility. Other monitoring products in development are intended to guide post-transplant therapy; CELSIOR(R) (exclusively licensed from PMsv) is an organ preservation solution; and drug candidate XE-9 is in early development for xenotransplantation xen·o·trans·plan·ta·tion n. The surgical transfer of cells, tissues, or especially whole organs from one species to another. xenotransplantation . XENOJECT(TM) platform technology also is in the discovery phase for replacing antibody therapy antibody therapy Clinical immunology Any therapeutic intervention in which a monoclonal or other concentrated antibody is used to manage a condition–eg, cancer or severe infection with small synthetic drugs. 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(TM), a comprehensive 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, XenoStat, Inc., in Menlo Park, California; SangStat Atlantique S.A. in Nantes, France and SangStat Canada, Ltd. in Mississauga, Ontario, Canada. This press release contains forward-looking statements that involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those risks associated with the company's ability to obtain regulatory approval for its CYCLOSPORINE, manufacturing of commercial quantities of CYCLOSPORINE on commercially favorable terms, and potential litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. associated with intellectual property claims of third parties. For a discussion of factors that might result in different outcomes, see the section under the caption "Risk Factors" beginning on page 30 of the 1995 Annual Report to Stockholders. EDITOR'S NOTE: The "oo" following "AUC" in the text and table in this release is an infinity symbol. In the name "Merieux Serums" above, the first "e" in both words should have accent symbols. In the e-mail address below, the "at" symbol following "maree" may not appear properly in some systems. CONTACT: SangStat, Maree Wall, V.P. Business Development & Investor Relations, 415/328-0300, x 131 E-Mail: maree_wall@sangstat.com |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion