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York Pharma (YRK.L) - York Pharma request approval for early Phase IIb trial of SabarepTM
YRK.L
Comment by Objective Capital , Oct 22, 2007
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York Pharma have announced that they have requested a pre-IND (Investigational New Drug) meeting with the US FDA with a view to initiating a Phase IIb trial for SabarepTM. Successful human studies have led to the selection of a final dosage and formulation and York are now integrating all of this into a GMP manufacturing process to be approved by regulatory authorities in advance of clinical studies in both Europe and the US. An earlier meeting with the MHRA has defined the clinical path that York will take to move the European approval forward.
Objective's view:
As indicated in our initiation report and subsequent writings our enthusiasm for a SabarepTM remains very high. Twenty five percent of children are afflicted with Atopic Dermatitis (a form of eczema) which is believed to be one of the triggering factors that can lead to the development of allergies and asthma later on in life. The product contains well known ingredients which have been combined to repair skin barrier defects that are the etiological basis of the disease. However, it is York's groundbreaking formulation that gives the product its skin barrier repair properties and proprietary position.
The US is a fertile market for this product concept. In the US the ingredients that make up SabarepTM are classified as GRAS or 'generally recognised as safe' substances which don't require clinical studies. However, to make therapeutic claims and to get the Derms to prescribe this proprietary formulation will require a full blown clinical trial.
York, in conjunction with a top regulatory consultant (a former FDA legal counsel), believes that it has found a legal way of accelerating its path to market and will attempt to persuade the FDA it should be allowed to do so. With the FDA, as with any regulatory agency, there are no guarantees that they will accept York's case. However, with GRAS substances, it is likely that York may have greater leeway in getting a positive view.
If successful in the current request, an accelerated path would enable a Phase IIb trial to commence as early as H2 of 2008 with a Phase III following in early 2009 and a submission of data by the end of 2009. That timetable could see SabarepTM approved in 2010.
York will still have to conduct a pivotal Phase III trial to demonstrate statistically significant efficacy although a phase IIb trial, which is usually a combination of a dose-ranging study and a randomised double blind efficacy test, should provide some indication in that regard.
In our Initiation report, we estimated the addressable market for SabarepTM at close to £3.9 billion and York's peak sales at around £200 million. Our estimates are based on what we believe to be conservative market penetration rates and conservative pricing (25% premium to generic products currently used) in this very large and highly emotional market. The actual out-turn could prove to be significantly higher depending on the result of upcoming trials and the partner that is ultimately selected to take this forward in that market.
