glaxosmithkline plc-spon adr (GSK) Key Developments
Merck & Co. Inc. Enters into Collaboration with Glaxosmithkline plc on Renal Cell Carcinoma Treatment
Dec 20 13
Merck & Co. Inc. has entered into collaboration with GlaxoSmithKline plc evaluating the former's investigational anti-PD-1 immunotherapy MK-3475 and the latter's orally administered kinase inhibitor, pazopanib, in advanced renal cell carcinoma. A Phase I/II trial has therefore been initiated evaluating the safety and efficacy of MK-3475 and pazopanib combination in treatment naïve patients with renal cell carcinoma. The collaboration allows the study of MK-3475 with pazopanib and other agents in the UK company's portfolio in the future.
GlaxoSmithKline plc & Theravance Inc Partnership Wins US FDA's Approval for ANORO ELLIPTA for the Treatment of COPD
Dec 19 13
GlaxoSmithKline plc and Theravance Inc. announced jointly on December 18, 2013 the receipt of approval from the US Food and Drug Administration (FDA) for ANORO ELLIPTA for treating chronic obstructive pulmonary disease (COPD). ANORO ELLIPTA is a combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The companies added that Anoro Ellipta (umeclidinium and vilanterol inhalation powder) is the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg. Theravance is obligated to make a milestone payment of USD 30 million to GSK following FDA approval of Anoro Ellipta as well as another USD 30 million payment to GSK upon the expected launch of Anoro Ellipta in the US in the first quarter of 2014. This phase III pivotal programme for Anoro Ellipta reportedly included seven clinical studies with almost 6,000 patients with COPD, a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing, concluded the companies.
Glaxosmithkline plc and Genmab A/S Receive Priority Review from FDA for Arzerra(R) (Ofatumumab) as First Linetreatment for Chronic Lymphocytic Leukemia (CLL)
Dec 17 13
GlaxoSmithKline plc and Genmab A/S announced that the US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental Biologics License Application (sBLA) for the use of Arzerra(r) (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 19, 2014 for the sBLA for Arzerra(r).
Inserm Transfert and GlaxoSmithKline Signs License Agreement on Immuno-Oncology
Dec 13 13
Inserm Transfert and GlaxoSmithKline announced the signing of an exclusive worldwide licence agreement aimed at developing therapeutic antibodies targeting an immune checkpoint molecule in the immuno-oncology area of research. however, Inserm is entitled to milestone payments from GSK linked to the development of the products, as well as royalties on sales. Furthermore, according to the terms agreed by the companies, Inserm Transfert has given GSK exclusive worldwide rights to develop and commercialise monoclonal antibodies that modulate the Inducible T-cell COStimulator (ICOS) on the surface of T lymphocytes and enhance immune responses. In return, GSK will pay Inserm Transfert a lump sum, milestone payments related to product development, and royalties from the commercialisation of products resulting from the collaboration between the companies.
GSK to Invest GBP 200 Million in UK Manufacturing Sites
Dec 12 13
GlaxoSmithKline announced that it will be investing around GBP 200 million in two of its manufacturing sites in the United Kingdom as well as for the building of a new centre for pharmaceutical manufacturing innovation. In particular, the company intends to invest in new manufacturing facilities in Ware for the Relvar Ellipta inhaler and also in Worthing, for building a sterile building and filling line for antibiotic Augmentin (amoxicillin + clavulanate). The company will also be creating a new centre for manufacturing innovation focussed on "transforming emerging science and technologies into practical manufacturing applications". The GBP 200 million investment follows the GBP 500 million investment by GSK announced last year in March, focused towards building a new production site in Cumbria as well as upgrading two its sites in Scotland, and also in Hertfordshire and Durham. In particular, the investments follow the establishing of the "patent box" scheme, which reduced the corporation tax on profits generated from UK-owned intellectual property, from 24% to 22%.