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Launched in 2006, TPIAO is a recombinant human thrombopoietin productapproved in China for the treatment of chemotherapy induced thrombocytopenia,or platelet deficiency. The aim of this filing is to extend the label ofTPIAO for use in the treatment of ITP. ITP is characterized by an immunesystem malfunction that perceives the body's platelets as foreign and destroysthem, potentially resulting in dangerously low platelet counts. There aretoday approximately eighty thousand patients diagnosed with ITP in China, withmore than half of these patients resistant to conventional steroid treatment.
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TPIAO represents a new approach for the treatment of ITP, by stimulatingthe TPO receptor, which is intended to have the effect of directly increasingplatelet production to outpace platelet destruction by the immune system. Theregistration trial examined the safety and efficacy of a 14-day subcutaneousinjection of TPIAO on ITP patients who are resistant to steroid treatment,followed by a 14-day observation period. The results showed an overallpatient response rate to TPIAO treatment of 60.27%, significantly higher thanthe Danazol control group response rate of 36.51%. Patients administeredTPIAO also reached effective platelet counts in 7 days, compared to 10 daysfor patients within the control group.
Dr. Jing Lou, Chief Executive Officer of 3SBio, commented, "The filing ofTPIAO for ITP successfully caps our development initiatives for 2008 and wenow have three new product candidates in the approval pipeline. As withNuLeusin and high dosage EPIAO, TPIAO for ITP represents a logical extensionof an existing product franchise, in-line with our therapeutic focus andgrowth strategy. The successful completion of our three Phase III trialsdemonstrates the strength of our research and development platform andhighlights our operational excellence. Upon approval, TPIAO for ITP wouldprovide a new treatment option for patients and will further enhance ourfootprint within China's growing pharmaceutical market."
About the Phase III Study
The Phase III study that 3SBio conducted was a multi-center, randomized,placebo-controlled study in ITP patients who failed to respond toglucocorticoid treatment. All patients were administered Danazol, a syntheticsteroid hormone drug routinely used to treat ITP. The treatment group wasadministered an additional 1.0 microgram/kg TPIAO subcutaneously daily for 14days. The primary endpoint of the trial was the measurement of effectiveplatelet counts, in which maximum counts reached >50x109/L or increased>30x109/L over the baseline, during the 14-day treatment.
The results of the Phase III study demonstrated TPIAO to be an effectivetreatment for ITP with tolerable mild adverse effects. The overall responserate in the treatment group and the control group was 60.27% and 36.51%,respectively (p=0.0104). The platelet response time, characterized by thetime required for platelet counts to reach >50x109/L or increase >30x109/Lover the baseline, for the first 25% of patients in the TPIAO treatment andcontrol group was 7 and 10 days, respectively. A 14-day TPIAO treatment wassubsequently applied to patients in the control group whose platelet countsremained < 20x109/L. The overall response rate to the TPIAO treatment was67%. The overall adverse events rate in the treatment and control group was34.25% and 26.15%, respectively; the rate of TPIAO-related adverse events forthe two groups, including mild sleepiness, mild dizziness, fatigue, mildallergic reaction, and paroxysmal visual field defect, was 15.07% and 4.08%,respectively.
About 3SBio Inc.
3SBio Inc. is a leading, fully integrated biotechnology company focused onresearching, developing, manufacturing and marketing biopharmaceuticalproducts, primarily in China. For more information, please visit 3SBio on theweb at: http://www.3sbio.com .
Safe Harbor Statement
Statements in this release may contain "forward-looking" statements withinthe meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended, and as definedin the Private Securities Litigation Reform Act of 1995. These statements arebased upon 3SBio management's current expectations, and actual results coulddiffer materially. Among the factors that could cause 3SBio's actual resultsto differ from what the company currently anticipates may include competitionfrom other domestic and foreign pharmaceutical companies; the expected marketgrowth for pharmaceutical products in China; market acceptance of 3SBioproducts; expected hospital or patient demand for our products; the completionof 3SBio's ongoing clinical trials as planned; receipt and timing ofregulatory approvals for 3SBio's new products and uses; 3SBio's ability toexpand its production, sales and distribution network and other aspects of itsoperations; its ability to effectively protect its intellectual property;changes in the healthcare industry in China, including changes in thehealthcare policies and regulations of the PRC government and changes in thehealthcare insurance sector in the PRC; and fluctuations in general economicand business conditions in China. For additional information on these andother factors that may affect the 3SBio's financial results, please refer tothe company's filings with the Securities and Exchange Commission athttp://www.sec.gov . 3SBio undertakes no obligation to update or revise theseforward-looking statements, whether as a result of new information, futureevents or otherwise, after the date of this press release.For more information, please contact: Investor Contact: David Chen, COO 3SBio Inc. Tel: +86-24-2581-1820 Investor Relations (US): Mahmoud Siddig Taylor Rafferty Tel: +1-212-889-4350 Investor Relations (HK): Ruby Yim Taylor Rafferty Tel: +852-3196-3712 Media Contact: Jason Marshall Taylor Rafferty Tel: +1-212-889-4350
SOURCE 3SBio Inc.
