Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced further information related to infusion reactions and deaths for their Phase 3 clinical trials for Puricase(R) (pegloticase) being developed for treatment failure gout patients.
Our preliminary analysis indicated that 19 patients or 11% of pegloticase treated patients experienced an infusion reaction termed "serious" or "severe." Based on further information that has become available, we have determined that the number of patients who experienced a "severe" or "serious" infusion reaction is 18, a reduction of 1 due to a patient whose adverse event occurred after departing the clinical site post-infusion.
We also recently reported that 7 patients experienced a "severe" infusion reaction. Of the 18 patients who experienced a "serious" or "severe" infusion reaction, 5 had a "serious" infusion reaction that was also characterized as "severe" in an overlapping manner, whereas 7 patients had a "severe" infusion reaction that did not also carry the designation of "serious." Of the remaining 6 patients who had a "serious" infusion reaction, one was also reported as "mild" and five were reported also as "moderate."
Of the 212 patients in the Intent-To-Treat (ITT) population, 158 patients completed all visits. These 158 patients are included in the ITT analysis, including 3 patients who were assigned to pegloticase treatment who died during the trial; not drug related. One patient who was randomized to the placebo group died before the first placebo dose administration and is not included in the ITT population. Two patients who completed the study, but died after completion, are also included in the ITT analysis. We recently learned that one of these two patients was assigned to a pegloticase treatment arm and the other was assigned to the placebo. This last patient's death occurred 4 months after placebo administration.
It should be pointed out that the company does not seek out post-study follow-up information on patients who dropped out of the trial, or did not enroll in the Open Label Extension. However, if a patient's death is reported to the company after the patient has had a final visit (either a drop out or a completed patient), then this death will be included in accounting of patient dispositions in our regulatory submissions and reports. We are releasing this information at this time because we understand that a number of our stockholders and members of the analyst community are interested in better understanding these issues. However, we do not undertake any commitment to continue to disclose information of this sort.
The company is scheduled to release financial results for the fourth quarter and year-end 2007 following the close of the market on Tuesday, March 11, 2008 and will host an investment community conference call beginning at 10:00 a.m. Eastern Time on March 12, 2008.
Puricase is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials assessed the safety and efficacy of a six-month course of pegloticase therapy in patients with treatment-failure gout under the auspices of a Special Protocol Assessment from the U.S. Food and Drug Administration. Savient has licensed worldwide rights to the technology related to Puricase from Duke University and Mountain View Pharmaceuticals, Inc. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
Approximately three to five-million Americans suffer from gout, many of whom experience only limited success in the long term management of their painful symptoms. Within this group, we estimate that allopurinol, the mainstay of therapy for control of uric acid, is contraindicated or has failed to achieve therapeutic success at appropriate dosages in approximately 25,000 to 100,000 patients, meaning that today tens of thousands of gout patients have no effective treatment option. It is for these treatment-failure patients that pegloticase potentially offers a unique benefit and for which the product has been granted Orphan drug designation.
Savient Pharmaceuticals is a biopharmaceutical company engaged in developing and distributing pharmaceutical products that target unmet medical needs in both niche and broader markets. The company's product development candidate, Puricase (pegloticase) for treatment-failure gout, has reported positive Phase 1, 2 and 3 clinical data. Patient dosing in the Phase 3 clinical studies began in June 2006; patient enrollment was completed in March 2007; and the Phase 3 clinical studies were completed in October 2007. Pegloticase became the official generic name for Puricase assigned by the USAN Council replacing the previously used name of PEG-uricase. Savient's experienced management team is committed to advancing its pipeline and expanding its product portfolio by in-licensing late-stage compounds and exploring co-promotion and co-development opportunities that fit the Company's expertise in specialty pharmaceuticals and biopharmaceuticals with an initial focus in rheumatology. Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. Further information on Savient can be accessed by visiting: http://www.savient.com.
All statements other than statements of historical facts included in this press release regarding the expected safety or Puricase, our interpretation of the results and other developments (including adverse events) relating to our Phase 3 clinical trials for Puricase, regulatory approval for Puricase, and plans and objectives of management are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, further information that is identified in the continuing review of the results and other developments (including adverse events) relating to our Phase 3 clinical trials for Puricase, the risk that the FDA does not approve the marketing of Puricase, and other factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements which speak only as of the date of publication of this annual report to shareholders. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We do not have a policy of updating or revising forward-looking statements and, except as required by law, assume no obligation to update any forward-looking statements.
Pharmaceuticals, Savient. "Savient Provides Further Information On Top Line Phase 3 Trials Results For Puricase(R) (pegloticase)." Medical News Today. MediLexicon, Intl., 3 Mar. 2008. Web.