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June 27, 2014
14:25 EDTGSKGlaxo, Genmab report Phase III ofatumumab study did not meet primary endpoint
GlaxoSmithKline (GSK) and Genmab (GNSMF) announced that the Phase III study of ofatumumab versus physicians' choice in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia did not meet its primary endpoint of progression free survival. The median PFS, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians' choice. The result reported today is headline data; the full analysis of safety and efficacy data is underway and will be completed in the coming months. "It was our priority to share this result with the scientific community as soon it became available. We will now work to further analyse the data and to better understand the totality of the efficacy and safety findings," said Dr. Rafael Amado, Head of Oncology R&D at GSK. "Although ofatumumab performed broadly in-line with previous data, today's result is disappointing. Based on this result, we do not anticipate applying for a label expansion for ofatumumab in this specific refractory CLL population," said Jan van de Winkel, Ph.D., CEO of Genmab.
News For GSK From The Last 14 Days
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April 27, 2015
10:04 EDTGSKHigh option volume stocks
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08:46 EDTGSKAgenus data positive, says JMP Securities
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08:41 EDTGSKTelegraph discusses potential takeover of GSK by Pfizer
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06:19 EDTGSKPharmceutical companies buy drugs and raises prices, WSJ reports
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April 24, 2015
07:11 EDTGSKAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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April 20, 2015
07:20 EDTGSKAmerican Association for Cancer Research to hold annual meeting
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07:01 EDTGSKPernix Therapeutics obtains six months U.S. pediatric exclusivity for Treximet
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April 16, 2015
09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
April 15, 2015
11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale

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