13th Dec 2007 14:30
GlaxoSmithKline PLC13 December 2007 GlaxoSmithKline Presents Innovative Neuroscience Pipeline GlaxoSmithKline (GSK) plc today presented an overview of its neuroscienceportfolio and the company's disease area strategy to investors and analysts at ameeting in New York. Highlights • Innovative neuroscience pipeline spans 13 different disease areas including Alzheimer's disease, depression, schizophrenia, and multiple sclerosis (MS): - More than 25 innovative compounds currently in development with 15 new mechanisms of action • New "proof of concept" data presented on promising phase II compounds 773812 for schizophrenia and 742457 for Alzheimer's disease: - Both assets to progress to large-scale phase IIb trials assessing efficacy and safety compared to leading marketed therapies • Phase II programme for use of ofatumumab in multiple sclerosis announced, with trials involving approximately 300 patients starting in 2008: • Phase III treatment, 1838262, profiled: - Filing for restless legs syndrome (RLS) expected in third quarter of 2008 - New phase III programme for migraine prophylaxis planned - New phase II studies in neuropathic pain announced • Four CNS products with potential to be launched or approved in 2008: - Trexima potential "new gold standard" for migraine; - Lamictal XR new once daily treatment for epilepsy; - Lunivia, a successful treatment for insomnia in the US, expected to be launched in Europe; - Requip XL the first non-ergot once daily dopamine agonist for the treatment of Parkinson's disease **************************************** • Overall pipeline progress continues: - 8 approvals, 8 filings and 9 key assets starting phase III trials so far in 2007 - GSK confirms FDA filing of Promacta, a new oral treatment for short-term idiopathic thrombocytopaenic purpura, to be submitted shortly - Synflorix, a paediatric conjugate vaccine designed to provide protection against pneumococcal disease and otitis media linked to non-typeable Haemophilus influenzae (NTHi) remains on track to file with European and International regulatory authorities before year-end Moncef Slaoui, Chairman Research and Development, GlaxoSmithKline said: "GSKcontinues to make good progress with its pipeline and today we have set out ourvision in the area of neuroscience. Alongside vaccines, oncology andbiopharmaceuticals, this is a key area for additional R&D investment and futuregrowth for GSK. "Diseases such as schizophrenia, Alzheimer's and Parkinson's disease present achronic and ever expanding burden to patients, care givers and healthcaresystems across the world. Every 72 seconds, a person is diagnosed withAlzheimer's disease. The urgency to provide medical solutions for this and otherneurological diseases has never been greater," Slaoui said. GSK will be increasing its focus in neurosciences with a significant investmentin China. GSK is building a fully integrated, end-to-end R&D center that willemploy more than 1,000 staff by 2010. China's growing talent pool of scientificexpertise is leading to the rapid development of excellence in life sciences ingeneral and neuroscience in particular. GSK's R&D expansion in China will buildon ongoing work in neural stem cell research and natural product compoundlibraries, and will focus on neurodegeneration (Alzheimer's and Parkinson'sdisease) and neuroinflammation (MS). Slaoui said: "Neuroscience is one of the most complex and challenging areas ofresearch and development. At GSK, we are moving ever closer to deliveringmedicines that can alter the course of these debilitating neurological diseasesand radically change the lives of patients." ******************************************** GSK neuroscience portfolio has more than 25 compounds in clinical developmentand spans a wide variety of central nervous system (CNS) diseases. Many of thesecompounds have novel mechanisms of action, with the potential to offersignificant benefits to patients. GSK presented new data and development plans for several compounds during theseminar, including: 773812 - A potential major new treatment for schizophrenia: Schizophrenia is a chronic psychiatric disorder. People with the disease oftensuffer terrifying symptoms such as delusions, hallucinations, and jumbled orillogical thoughts. 773812 is from the atypical antipsychotic class of medicines, and has thepotential to become a major new treatment. Current atypical antipsychoticmedicines work by blocking receptors for a variety of neurotransmitters in thebrain. However, they have variable receptor binding affinity resulting indifferent efficacy and safety profiles. GSK has developed '812 as a compoundwith selectivity towards those receptors that are associated with efficacy, suchas the dopamine D2 and serotonin 5HT2 receptors, whilst having minimal activityon receptors believed to be responsible for side-effects, such as dopamine D1,histamine H1, muscarinic M1, alpha and beta adrenergic receptors. This profilehas the potential to deliver efficacy similar to the present antipsychoticswithout troublesome tolerability problems such as sedation, metabolicdisturbance, impaired cognition and orthostatic hypotension. Two studies to assess the efficacy and safety of '812 compared to placebo andolanzapine, a commonly used atypical antipsychotic, in patients with acuteschizophrenia have been completed. In these studies, '812 produced astatistically significant improvement in patients compared to placebo (pRelated Shares:
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