London: Wednesday, 13 August 2014: Nutrition Science Partners Limited (“NSP”), a 50/50 joint venture between Chi-Med and Nestlé Health Science SA, today announces that a planned interim analysis was conducted on NATRUL-3, the global Phase III induction trial of HMPL-004 vs. placebo in ulcerative colitis. An independent Data Safety and Monitoring Committee (“DSMC”) evaluated the unblinded data of two doses of HMPL-004 vs. placebo, and has recommended that NSP terminate the study. No meaningful safety signals or risks for patients were identified, and further analysis and review of the data will be conducted. The NSP Board will continue to evaluate the potential opportunities of HMPL-004 in new indication areas and alternative regulatory pathways.
Christian Hogg, CEO
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|Panmure Gordon (UK) Limited
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|Citigate Dewe Rogerson
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NATRUL is the Phase III registration trial programme designed to evaluate the efficacy and safety of HMPL-004 in patients with mild-to-moderate UC. The first study, NATRUL-3, enrolled and treated its first patient in April 2013. Its primary endpoint is to evaluate treatments of HMPL-004 compared with placebo in patients with active UC who have an inadequate response to their current treatment with Mesalamine. The second study, NATRUL-4, is designed to evaluate HMPL-004 as a 52-week maintenance therapy. Subjects who have completed NATRUL-3 are eligible to enter NATRUL-4 directly.
Nutrition Science Partners (“NSP”) is focused on researching, developing, manufacturing and marketing worldwide novel medicines and nutritional products derived from botanical plant origins. NSP focuses on gastrointestinal indications, and may in the future expand into the metabolic disease and brain health areas. NSP is a 50/50 joint venture formed by Nestlé Health Science and Chi-Med.
Nestlé Health Science, a wholly-owned subsidiary of Nestlé, has an ever developing innovative portfolio of nutritional therapies, supported variously by proprietary diagnostics and devices, targeted towards the Vital Support areas of aging and critical/intensive care, as well as Gastrointestinal, Brain, Metabolic and Consumer Health, changing the way patients and healthcare professionals approach the management of health. Nestlé Health Science employs around 3,500 people worldwide and has its headquarters in Vevey, Switzerland. For more information, please visit www.nestlehealthscience.com.
HMP is a novel drug R&D company focusing on discovering, developing and commercialising innovative therapeutics in oncology and autoimmune diseases. With a team of around 200 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China.
HMP is majority owned by Chi-Med. For more information, please visit: www.hmplglobal.com.
Chi-Med is a China-based healthcare group focused on researching, developing, manufacturing and selling pharmaceuticals and health-related consumer products. Its China Healthcare Division manufactures, markets and distributes prescription and over-the-counter pharmaceuticals in China. Its Drug R&D Division focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases. Its emerging Consumer Products Division focuses on organic and natural consumer products in Asia.
Chi-Med is majority owned by the multinational conglomerate Hutchison Whampoa Limited (SEHK:13). For more information, please visit: www.chi-med.com.