|Sucampo Announces Acceptance of New Drug Submission for AMITIZA; Auinox Reports Initiation of Patient Dosing of AQX-1125|
|By William Kent|
|Tuesday, 30 December 2014 20:32|
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), a global biopharmaceutical company, today announced that Health Canada has accepted the company's New Drug Submission (NDS) for AMITIZA® (lubiprostone), 24 mcg capsules, for the treatment of chronic idiopathic constipation in adults and opioid induced constipation in adults with chronic non-cancer pain.
"AMITIZA has been available to patients in the U.S., Japan, U.K. and Switzerland, with over nine million prescriptions written in the US alone and continued year over year growth in sales," said Peter Greenleaf, Chief Executive Officer of Sucampo. "Together with our partner Takeda, we are now focused on making AMITIZA available to patients in new markets worldwide, and this new drug submission in Canada is another important step in this process."
Sucampo is responsible for all regulatory interactions and for negotiating approval of AMITIZA in Canada, and Takeda Canada Inc. will have responsibility for product commercialization in that market. Takeda will now be exclusively marketing AMITIZA in all global markets, except Japan and the People's Republic of China.
Aquinox Pharmaceuticals, Inc. (NASDAQ: AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced today that it has initiated dosing in a Phase 2 clinical trial of AQX-1125 for the treatment of atopic dermatitis (AD).
The KINSHIP clinical trial is being conducted at clinical research centers in Canada as a randomized, double-blind, multicenter, placebo-controlled Phase 2 trial evaluating the efficacy and safety of AQX-1125 in approximately 50 adult patients with mild to moderate AD. The KINSHIP trial's primary endpoint is change from baseline in Total Lesion Symptom Score (TLSS) after 12 weeks of treatment. The TLSS is a comprehensive assessment of AD symptoms where AQX-1125 may have a beneficial effect. Secondary endpoints include safety, pharmacokinetics and additional parameters for assessing AD.
"We believe AQX-1125's ease of administration as a once daily, oral, anti-inflammatory medicine, and its ability to reduce immune cell migration to inflamed surfaces, could provide a clinically meaningful benefit to AD patients," said Dr. Stephen Shrewsbury, Senior Vice President of Clinical Development and Chief Medical Officer of Aquinox. "The KINSHIP trial has been designed to first evaluate AQX-1125's safety and efficacy in mild to moderate AD patients. Our eventual interest is AQX-1125's potential as an effective, oral therapy for moderate to severe AD patients."
The prevalence of AD ranges from 1%-20% worldwide. An estimated 17.8 million Americans are affected by AD, which is considered underdiagnosed by physicians. Approximately two-thirds of Americans with AD suffer from the moderate to severe form of the disease, where existing therapies are often ineffective or unsuitable for long-term treatment.
Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing cancer immunotherapies, announced that its Lm-LLO immunotherapy technology was highlighted on FOX News Channel's Sunday Housecall.
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Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP), a global biopharmaceutical company, today announced that Health Canada has accepted the company's New Drug Submission (NDS) for AMITIZA® (lubiprostone), 24 mcg capsules, for the treatment of chronic idiopathic constipation in adults and opioid induced constipation in adults with chronic non-cancer pain.
TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime® Abdominal Stent Graft System, today announced that its management will be presenting at the J.P. Morgan 33rd Annual Healthcare Conference on January 13, 2015 in San Francisco.
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL), a clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of unmet clinical needs, today announced that the Company's shareholders approved the appointment of two new members to the Board of Directors, Doron Turgeman and Shlomo Shalev.