GSK: Professor Rob Horne discusses the MyAsthma programme

APP Pharmaceuticals : Approval and Launch of Topotecan for Injection

Nov 30, 2010 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

Topotecan for Injection is therapeutically equivalent to the reference-listed drug Hycamtin(R), which is currently marketed by the innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales of Hycamtin(R), in 2009 were $157.1 million.

Topotecanfor Injection is indicated for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is also indicated for use in combination therapy with Cisplatin for stage IV-B, and for recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. APP will market Topotecanfor Injection in 4 mg single dose vials; the product is bar-coded and preservative-free... APP Pharmaceuticals' Press Release -

Mylan Pharmaceuticals : Approval for Generic Version of Zyban(R)

May 4, 2010 - Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban(R)... Mylan's Press Release -

Ranbaxy & GSK : IND APPLICATION TO DCGI FOR RESPIRATORY INFLAMMATION CANDIDATE

October 13 , 2008 - Ranbaxy Laboratories Limited (Ranbaxy) announced that the Company has submitted an Investigational New Drug (IND) application to the Drug Controller General of India for permission to initiate Phase-I human clinical trials. The IND application is for the Respiratory Inflammation candidate that the Joint GSK-Ranbaxy steering committee had identified earlier last year.

Ranbaxy has successfully completed all the required regulatory safety and toxicity studies on the drug candidate and also plans to seek regulatory approval in other countries outside India in order to initiate Phase-I human clinical trials at the earliest... Ranbaxy Laboratories' Press Release -

Theravance : Clinical Results in the LAMA Respiratory Program for the Treatment of COPD

July 14, 2008 - Theravance, Inc. (NASDAQ: THRX) announced the results from a Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of an investigational inhaled long-acting muscarinic antagonist (LAMA), GSK1160724/TD-4208 (TD-4208), for the treatment of chronic obstructive pulmonary disease (COPD). In this study, TD-4208 was generally well tolerated at all doses tested. In addition, TD-4208 showed the potential for 24-hour bronchodilation in COPD patients.

Originally discovered by Theravance, TD-4208 was licensed to GlaxoSmithKline (GSK) in 2004 under the terms of the companies' Strategic Alliance Agreement. Recently, GSK informed Theravance that it intends to return the LAMA program to Theravance because the current formulation of TD-4208 is incompatible with GSK's proprietary inhaler device.

Both parties are currently discussing the transfer of information and materials back to Theravance... Theravance's Press Release -

Pharmacopeia and GlaxoSmithKline Collaboration : a New Lead Compound

Jun 04, 2008 - Pharmacopeia (NASDAQ: PCOP), an innovator in the discovery and development of novel small molecule therapeutics, announced that it has identified a new lead compound for advancement in its alliance with GlaxoSmithKline (NYSE: GSK), through its collaboration with the Center of Excellence for External Drug Discovery (CEEDD). This newly identified lead compound is the second from a program being evaluated as a potential treatment for respiratory disease.
As a result of this identification, Pharmacopeia received a $500,000 milestone payment from GSK... Pharmacopeia's Press Release -

GlaxoSmithKline : New data for pazopanib – GSK’s latest investigational anti-cancer agent – shows promise across multiple cancers

31 May 2008 - GlaxoSmithKline announced the results of two Phase II trials demonstrating the potential for pazopanib, an oral, investigational angiogenesis inhibitor, as a treatment for non-small cell lung cancer (NSCLC), [1] the most common form of lung cancer, [2] and renal cell carcinoma (RCC). [3] The data were presented at the 44^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Pazopanib is not approved in any market for any indication at this time.

Pazopanib targets vascular endothelial growth factor receptor (VEGFR), platelet derived growth factor receptor (PDGFR) and c-kit, key proteins that help with the growth of new blood vessels in the body. [4] This process, known as angiogenesis, plays a critical role in the growth and spread of tumors. [5]... GlaxoSmithKline's Press Release -

GlaxoSmithKline : New data on MAGE-A3 cancer immuno therapy support novel options of treating non-small cell lung cancer and melanoma

30 May 2008 - New data presented by GlaxoSmithKline (GSK) highlighted the potential of its investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) through results of three studies evaluating highly targeted immunotherapy as a treatment for metastatic melanoma and non-small cell lung cancer (NSCLC). These data were presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago[Abstract Nos: 9065^[i], 9045^[ii] and 7501^[iii].

A randomised, open label Phase II study designed to evaluate two different formulations of the MAGE-A3 ASCI in patients with metastatic melanoma has been conducted. In this study, the ASCI, which is a combination of MAGE-A3 recombinant protein and a GSK proprietary Adjuvant System, was evaluated and resultant data suggest a positive trend for clinical response... GlaxoSmithKline's Press Release -

Targacept : Designation of Lead Compound in Smoking Cessation Program, Milestone Payment from GlaxoSmithKline

May 05, 2008 - Targacept, Inc. (NASDAQ:TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), announced the designation of a lead compound in its smoking cessation program, triggering a $500,000 milestone payment under its alliance agreement with GlaxoSmithKline (GSK)...
... Neuronal nicotinic receptors (NNRs) are a class of proteins in the nervous system that modulate the levels of key chemical messengers, such as dopamine. Nicotine’s addictive effects have been linked to over-stimulation of dopamine release in brain regions involved in feelings of reward and pleasure. Various NNR subtypes modulate dopamine release in these pathways and represent optimal targets for therapeutic intervention. Compounds that can normalize the activity of these NNR subtypes have the potential to decrease the rewarding effects of nicotine and, as a result, the desire to smoke... Targacept's Press Release -

GlaxoSmithKline : further progress of oncology portfolio

22 April 2008 - GlaxoSmithKline Oncology will present a wide range of new data at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago starting Friday, May 30^th...
...
Non-Small Cell Lung Cancer : Preoperative treatment with pazopanib (GW786034) a multikinase angiogenesis inhibitor in early stage non-small cell lung cancer (NSCLC): a proof-of-concept phase II study...
Small Cell Lung Cancer : Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease - small cell lung cancer (ED-SCLC): final results of a randomised phase III trial... GlaxoSmithKline's Press release -

GlaxoSmithKline : Advair 250/50 for reduction of exacerbations in patients with COPD

April 30, 2008 - Advair 250/50 now the only treatment approved to both reduce exacerbations and improve lung function.
The U.S. Food and Drug Administration today approved Advair Diskus 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. With this approval, Advair becomes the only treatment FDA has approved to reduce COPD exacerbations. Treatment guidelines for COPD state that the reduction of exacerbations is a key goal in managing the disease... GlaxoSmithKline's Press Release -

Amira Pharmaceuticals and GSK, global agreement for FLAP inhibitor programme

4-February-2008: Amira Pharmaceuticals and GlaxoSmithKline enter global agreement for FLAP inhibitor program. Deal follows positive phase I data from novel product candidate AM103 for the oral treatment of respiratory diseaseAmira Pharmaceuticals and GlaxoSmithKline today announced they have entered into a worldwide exclusive agreement to develop, manufacture and commercialize FLAP (5-Lipoxygenase Activating Protein¬) inhibitors for the treatment of respiratory and cardiovascular disease... Amira Pharmaceuticals' Press Release - GlaxoSmithKline's Press Release -

GSK's Volibris (ambrisentan), EMEA positive opinion for approval to treat class II and II pulmonary arterial hypertension (PAH)

Thursday 21st February 2008 - GlaxoSmithKline (GSK) announced that Volibris^® (ambrisentan) has received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of Pulmonary Arterial Hypertension (PAH) in patients classified as World Health Organisation (WHO) Functional Class II and III, to improve exercise capacity¹. Approval by the European Commission and Marketing Authorisation is expected to be granted by the end of April 2008.
Ambrisentan, a non-sulphonamide class endothelin receptor antagonist (ERA), is the first PAH medicine indicated for WHO Functional Class II patients in Europe...GSK's Press Release-

GlaxoSmithKline, EMEA positive opinion for the approval of Hycamtin® (topotecan) hard capsules for the treatment of relapsed small cell lung cancer

04 February 2008 - GlaxoSmithKline (GSK) announced that oral Hycamtin^™ (topotecan hard capsules) has received a positive opinion from the European Medicines Agency (EMEA) recommending marketing authorisation. GSK expects final approval by the European Commission and Marketing Authorisation for this indication in approximately two months. Topotecan capsules will be indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate...GlaxoSmithKline's Press Release-

GlaxoSmithKline and TB Alliance, Tuberculosis Drug Discovery Program

January 24, 2008 - GlaxoSmithKline (GSK) and the Global Alliance for TB Drug Development (TB Alliance) have renewed their joint research program with the goal to improve the treatment of tuberculosis (TB), which is caused by the bacillus Mycobacterium tuberculosis (M.tb). The research collaboration, initiated in 2004, currently includes a portfolio of early projects which may ultimately yield new medicines that attack M.tb, including drug-resistance strains... TB Alliance's Press Release-

GlaxoSmithKline and Theravance, 642444 and 685698 advance in clinical development for the treatment of asthma

Jan. 03, 2008 - GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced the start of large Phase 2b asthma dose-optimisation studies with both the lead inhaled corticosteroid (ICS) GW685698 ('698) and the lead long-acting beta agonist (LABA) GW642444 ('444) assets in the 'Horizon' programme to develop a next-generation combination product. GSK began enrolling patients with mild to severe asthma in the '698 Phase 2b clinical programme on 21st December 2007 and began enrolling patients with persistent asthma in the '444 Phase 2b clinical programme on 29th December 2007. These clinical programmes will determine the most effective doses to be taken into Phase 3 combination studies. The Phase 2b COPD programme with '444 is also on schedule to commence in 1H 2008... GSK's Press Release - Theravance's Press Release-

Theravance, GSK1160724, Phase 1 Clinical Study With Investigational Medicine For Respiratory Disease

December 12, 2007 - Theravance, Inc. (NASDAQ: THRX) announced that GlaxoSmithKline plc (GSK) initiated subject screening in a Phase 1 clinical study designed to assess the safety, tolerability, and pharmacokinetics of an investigational, inhaled bronchodilator, GSK1160724, for the treatment of chronic obstructive pulmonary disease (COPD)...GSK1160724 is an inhaled, long-acting muscarinic antagonist (LAMA) discovered by Theravance through the application of multivalent drug design in a drug discovery program dedicated to finding new medicines for respiratory diseases such as COPD and asthma... Theravance's Press Release -

Theravance, Initiation of Phase 2 Clinical Program with its MABA Compound in COPD

October 31, 2007 - Theravance, Inc. (NASDAQ: THRX) announced that GSK has initiated a Phase 2 clinical study of GSK961081, an investigational bifunctional muscarinic antagonist-beta₂ agonist compound for the treatment of chronic obstructive pulmonary disease (COPD)... Theravance's Press Release -

Exelixis Submits XL880 Diligence Report to GlaxoSmithKline

Sept. 14, 2007- Exelixis, Inc. (Nasdaq: EXEL) announced that the company has submitted a comprehensive data report relating to XL880 to GlaxoSmithKline (GSK)...

XL880 has attractive pharmaceutical properties, with high solubility and oral bioavailability. In preclinical studies, XL880 inhibited its targets with nanomolar potency, and retained potent activity against mutationally activated forms of MET found in hereditary papillary renal cell carcinomas. The compound also demonstrated dose-dependent tumor growth inhibition in models of breast cancer, colorectal cancer, non-small cell lung cancer, and glioblastoma, and has been shown to cause substantial tumor regression in all models tested...

Exelixis' Press Release -