glaxosmithkline plc-spon adr (GSK) Key Developments
GlaxoSmithKline Submits U.S. Regulatory Application for Promacta (eltrombopag) for Severe Aplastic Anaemia
Feb 28 14
GlaxoSmithKline plc announced the submission of a supplemental new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Promacta(R) (eltrombopag) for the treatment of cytopenias (a reduction in blood cells) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST). SAA is a rare disorder in which the bone marrow fails to make enough new blood cells. There are no approved therapies available for SAA patients unresponsive to IST. Of those patients unresponsive to initial IST, approximately 40% die from infection or bleeding within 5 years of their diagnosis.
Robert W. Baird Eyes InterMune
Feb 25 14
Robert W. Baird & Co. Incorporated said InterMune Inc. (NasdaqGS:ITMN) is an ideal acquisition target following the bullish ASCEND data release. GlaxoSmithKline plc (LSE:GSK), Gilead Sciences Inc. (NasdaqGS:GILD) and Novartis AG (SWX:NOVN), among others, could be interested in InterMune's and that an acquisition price could be into the $60's.
Anoro (Umeclidinium / Vilanterol) Receives Positive Opinion from CHMP in Europe for the Treatment of Chronic Obstructive Pulmonary Disease
Feb 20 14
GlaxoSmithKline plc and Theravance Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)
has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol (UMEC/VI) under the proposed brand name Anoro as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Anoro is a combination of UMEC, a long-acting muscarinic antagonist (LAMA) and VI, a long-acting beta2 agonist (LABA) in a single inhaler, the Ellipta. The proposed strength is UMEC/VI 55mcg /22 mcg. CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. A final decision by the European Commission is anticipated during the second quarter of 2014. The phase III pivotal programme for UMEC/VI included seven clinical studies with almost 6,000 patients with COPD. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
GlaxoSmithKline plc Signs a Joint Drug Development Agreement with BioRap Technologies Ltd
Feb 17 14
GlaxoSmithKline plc has signed a joint drug development agreement with BioRap Technologies Ltd. GSK and BioRap will commercialize the Israeli company's molecule for the treatment of immune-system related diseases. In the first phase, GSK and BioRap will develop two product groups for the treatment of Graft-versus-host-disease (GVHD), a potentially lethal side-effect of bone marrow transplants. This is the same disease on which other Israeli companies Gamida Cell and Select Bio focus their activities. In the subsequent phase the product will be adapted to other diseases such as Crohn's and IBD. Details about the agreement have not been disclosed. However, it is believed to be similar to other agreements signed between pharmaceutical companies and research institutes for products in this phase (after proof of viability in animals), and which have yielded tens of millions and even hundreds of millions of dollars for research institutes.
GlaxoSmithKline Submits Regulatory Application to the China Food and Drug Administration for the Once-Daily Combination Medicine
Feb 10 14
On February 10, 2014, GlaxoSmithKline plc (GSK) submitted a regulatory application to the China Food and Drug Administration (CFDA) for the once-daily combination medicine of an inhaled corticosteroid, fluticasone furoate FF" and a long-acting beta2-agonist (LABA), vilanterol VI" (FF/VI) administered using the ELLIPTA, a new dry powder inhaler (DPI) for the following indications: Asthma (100/25mcg and 200/25mcg): The maintenance treatment of asthma. COPD (100/25mcg): The maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with an exacerbation history. FF/VI has been developed under the LABA collaboration agreement between Glaxo Group Limited and Theravance Inc.