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Expert View
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Solanezumab, Eli Lilly's experimental Alzheimer's antibody, is to be tested in another Phase III trial, targeting mild patients only. Discussions with the FDA have dissuaded Lilly from seeking immediate approval, although the path to market for the much-maligned drug now appears relatively straightforward, albeit 4 years later than scheduled.
Published By Datamonitor
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13 Dec 2012 |
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Expert View
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Zytiga's indication expansion for the treatment of pre-chemotherapy castration-resistant metastatic prostate cancer significantly increases its commercial potential. However, potential competition from Xtandi may restrict sales.
Published By Datamonitor
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13 Dec 2012 |
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Expert View
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Pfizer has announced positive Phase II trial data for its ER+/HER2-negative breast cancer drug PD-991. If the strong efficacy is repeated in the planned Phase III pivotal study, PD-991 is likely to generate considerable revenue in the lucrative first-line advanced and metastatic ER+/HER2-negative breast cancer treatment setting, and is well positioned to become the first-in-class CDK inhibitor.
Published By Datamonitor
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07 Dec 2012 |
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Expert View
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Eisai's Fycompa has become the first AMPA receptor antagonist to gain FDA approval for the adjunctive treatment of partial-onset seizures. While underwhelming clinical trial data, DEA scheduling, and a boxed warning will hinder revenues, Fycompa's novel class, convenient dosing regimen, and preferable side-effect profile will support its uptake in the drug-resistant patient population.
Published By Datamonitor
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25 Oct 2012 |
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Expert View
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While both EXPEDITION studies missed their primary endpoints, a pooled analysis of solanezumab data has revealed a significant reduction in cognitive decline in mild Alzheimer's disease. The drug's commercial potential in this indication should ensure that Lilly conducts further studies, despite the inherent high risk of failure.
Published By Datamonitor
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09 Oct 2012 |
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CommentWire
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Following the announcement of positive Phase III data in June 2012, the FDA has granted approval of Aubagio for the oral treatment of relapsing multiple sclerosis (MS). Sanofi is competitively pricing Aubagio in the face of strong competition, but will nevertheless achieve only modest sales for the drug in the MS market.
Published By Datamonitor
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14 Sep 2012 |
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Expert View
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Merck & Co. has announced positive Phase III data for its insomnia candidate suvorexant, renewing hope in the novel orexin receptor antagonist drug class after speculation about class-wide safety issues. Although suvorexant has the potential to address key unmet needs in the treatment of insomnia, demonstration of superiority over zolpidem and lack of scheduling will be key to commercial success.
Published By Datamonitor
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12 Sep 2012 |
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Expert View
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COPD therapy Spiriva has celebrated its 10th anniversary with the presentation of additional data at the 2012 annual meeting of the European Respiratory Society in Vienna, Austria. New data were presented for both COPD, for which the drug is widely established, and for asthma, for which it is in Phase III studies with the aim of providing an alternative treatment option for uncontrolled patients.
Published By Datamonitor
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06 Sep 2012 |
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Expert View
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At the 2012 annual meeting of the European Respiratory Society in Vienna, Austria, Novartis presented considerable data for its candidate QVA149 (a combination of indacaterol and glycopyrrolate) in chronic obstructive pulmonary disease. The data add to mounting evidence of the potential for this dual bronchodilator to provide an improved treatment option for patients.
Published By Datamonitor
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05 Sep 2012 |
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Expert View
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Development of Lilly's pipeline glutamate receptor agonist, pomaglumetad methionil, has been discontinued following a confirmed lack of efficacy. Disappointingly, this promising new mechanism fails to translate into a viable drug, although Roche's commitment to its own novel schizophrenia candidate, RG1678, shows that drug developers are not yet ready to move away from psychiatry.
Published By Datamonitor
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30 Aug 2012 |
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