On Tuesday, GlaxoSmithKline presented an updated overview of its R&D pipeline. The company has suggested that 20 new drugs could be filed by the end of the decade, but analysts suggest caution; further to a mixed track record in R&D over the past decade, GlaxoSmithKline's pipeline is heavily skewed towards early- and mid-stage products (ViewPoints: More promises, but it's time for GlaxoSmithKline to deliver).
However, there are a number of short-term opportunities, one of which – Nucala (mepolizumab) – was a point of considerable focus during Tuesday's presentation. Developed initially for the treatment of severe eosinophilic asthma, Nucala recently received a positive CHMP opinion in Europe and is likely to be approved by the FDA any day (its PDUFA date is actually November 4; it received unanimous backing from an advisory committee in June).
Nucala bridges the gap between GlaxoSmithKline's long-established presence in the small-molecule respiratory market and a new found opportunity in targeted and extended duration biologic therapies, suggested the company's head of pharmaceuticals' Patrick Valance on Tuesday.
Internal expectations for the product are high; although severe forms of the condition only account for between 5 percent and 10 percent of all asthma patients, GlaxoSmithKline estimates that these same patients account for some 60 percent of the cost burden associated with asthma in the developed markets. Asked directly about the company's ability to deliver value-enhancing therapies to market that are insulated from pricing pressure, Valance cited Nucala as an asset befitting such status.
In GlaxoSmithKline's favour, the company believes it is two years ahead of most competitors in this space including AstraZeneca (benralizumab and tralokinumab), Roche (lebrikizumab) and Sanofi/Regeneron Pharmaceuticals (dupilumab), each of which are developing biologic therapies for the treatment of asthma. Teva's competing anti-IL-5 antibody reslizumab provides likely nearer-term competition, with GlaxoSmithKline anticipating a late 2015/early 2016 approval, but has been developed in a less convenient intravenous formulation (versus Nucala's subcutaneous delivery).
Assessing the commercial opportunity for Nucala remains somewhat challenging, however. This is in part due to the relatively novel approach offered by this new generation of biologic therapies and also due to the number of competitors seeking to gain share of a relatively small proportion of the asthma market (albeit one that has grown by a third over the past 25 years, noted GlaxoSmithKline).
With Nucala positioned front and centre of GlaxoSmithKline's near-term pipeline aspirations in the respiratory and on the cusp of regulatory approval, we are polling US and EU5-based pulmonologists with the following questions…
In Phase III studies, Nucala was shown to reduce asthma exacerbations by 53 percent compared with placebo when administered every four weeks in addition to maintenance therapy in patients with severe eosinophilic asthma who experience frequent exacerbations despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. How impressive do you consider this data to be?
Among patients with severe eosinophilic asthma receiving regular treatment with oral corticosteroids, high-dose inhaled corticosteroids plus an additional controller medication, Nucala demonstrated a median overall reduction (from baseline) in oral corticosteroid dose of 50 percent during weeks 20-24 of a 24-week study. How impressive do you consider this data to be?
Nucala has also been shown to reduce hospitalisations by 61 percent versus placebo. Based on the totality of these data, how adequately do you think Nucala will satisfy unmet need in severe asthma?
After two years of availability, what proportion of eligible severe asthma patients would you expect to be prescribing Nucalabased on these data?
All patients enrolled in Phase III studies had peripheral blood eosinophil levels greater than or equal to 150 cells/μL at initiation of treatment or greater than or equal to 300 cells/μL within the past 12 months. By comparison, how do you think typical use of biomarker cut-off will shape usage of Nucala in the real-world setting?
You will be able to read the results and analysis later this week.
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