GSK raises stake in Amicus for Fabry drug
pharmafile | July 18, 2012 | News story | Research and Development, Sales and Marketing | Amicus, Fabry, GSK, R&D
GlaxoSmithKline is to increase ownership in Amicus Therapeutics as the firms extend their collaboration to find a new drug for Fabry disease.
GSK’s $18.6 million investment will bring its stake in the US company to 19.9% per cent. The original deal to develop and commercialise the investigational pharmacological chaperone migalastat HCl was signed in 2010.
While it affects only 5,000 to 10,000 people across the world, Fabry sufferers can experience pain, kidney failure and increased risk of heart attack.
GSK’s deep pockets mean that the programme will now encompass the joint development of enzyme replacement therapy (ERT) for Fabry disease co-formulated with chaperone migalastat HCl.
The two firms will use Japan-based JCR’s proprietary recombinant human alpha-Gal A enzyme (JR-051), which is licensed to GSK for all markets outside Japan.
Pre-clinical studies suggest this combined product may give greater alpha-Gal A enzyme uptake into tissue, reducing levels of GL-3 in Fabry disease-relevant tissues compared to recombinant enzyme alone.
Clinical studies could begin in 2013 and GSK will have commercial rights to all Fabry products outside the US, with Amicus – which could net up to $200 million – taking charge of them in the US.
Currently, they face two rivals: Shire’s Replagal and Sanofi subsidiary Genzyme’s Fabrazyme, both of which are subcutaneous ERTs.
“We have strengthened our relationship with Amicus through the expanded Fabry collaboration and additional equity investment in the company,” said Marc Dunoyer, global head of GSK Rare Diseases.
“Amicus has a very successful track record as our development partner and long-standing relationships with the Fabry community and we look forward to their leadership in the US commercialisation of several potential new medicines for patients with Fabry disease,” he added.
The pair will share R&D costs, with Amicus paying 25% and GSK 75% for the rest of this year: the proportions will switch to 40% and 60% for co-formulation work immediately and for all products from 2013 onwards.
Amicus chief executive John Crowley praised GSK for adding “significant value to the Fabry programme through its global scale and capabilities as well as the dedicated focus of GSK Rare Diseases”.
The extended deal means Amicus is transforming itself into a “commercial-stage biopharmaceutical company”, Crowley added.
Aside from the nascent investigation into the combination medicine, the project has two other arms which are much further advanced.
Migalastat HCl on its own is being looked at in Phase III global studies (011 and 012) in patients with genetic mutations that are amenable to monotherapy.
Results from 011 should be available by September to support a New Drug Application to the FDA. And a Phase II study (013) looking at the drug co-administered with ERT for Fabry disease is ongoing.
Adam Hill
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