Pfizer submits Gaucher drug to EMA
pharmafile | November 29, 2010 | News story | Sales and Marketing | Cerezyme, EMA, Gaucher disease, Genzyme, Pfizer, Protalix BioTherapeutics, Shire, Vpriv, taliglucerase alfa
Pfizer and partner Protalix BioTherapeutics have submitted a marketing application to European regulator the EMA for their Gaucher disease candidate taliglucerase alfa.
The drug was granted orphan designation by the European Commission for the treatment of Gaucher disease on 23 March 2010 and if approved would compete with treatments from Genzyme and Shire.
Pfizer’s taliglucerase alfa has also been accepted for review by the FDA, which is due to pass judgement on it by 25 February 2011.
Taliglucerase alfa is currently available to patients with Gaucher disease in the US under an ‘expanded access protocol’ as well as to patients in several member states of the EU, Israel and other countries under Named Patient provisions.
Under the terms of their agreement, Pfizer will receive exclusive worldwide licensing rights for the commercialisation of taliglucerase alfa (known as Uplyso in the US), while Protalix will retain the exclusive commercialisation rights in Israel where the company is based.
Gaucher disease is an inherited disorder that is caused by a deficiency in an enzyme called glucocerebrosidas.
Taliglucerase alfa is a plant-cell expressed form of glucocerebrosidase and works as an enzyme replacement therapy.
Pfizer will hope the drug will help bolster its rare disease portfolio and its plans to further diversify in the wake of the imminent patent expiry for its biggest seller Lipitor.
Genzyme getting back up to speed with its Gaucher drug
If approved taliglucerase alfa will compete with Shire’s Vpriv, which won approval in August to treat Gaucher disease.
Pfizer will also be competing with Genzyme’s own Gaucher disease drug Cerezyme, but sales of its drug have taken a knock as manufacturing woes have continued to beset the specialist US biotech firm.
However, Genzyme has said that it has ended fill/finish operations within its Allston plant for products sold in the US, as required by the FDA consent decree in May.
All fill/finish activities for all of its rare disease drugs, including Cerezyme, Myozyme for Pompe disease, Fabrazyme for Fabry disease and Thyrogen, for post-operative thyroid cancer patients, for the US market will now take place at Genzyme’s Waterford, Ireland plant, and at an external contract manufacturer.
In a statement Genzyme said that with this move, all previous restrictions on the marketing and distribution of Thyrogen within the US have been lifted.
Cerezyme logged sales of $793.02 million in 2009 and $497.66 million for the nine-month period of 2010. Meanwhile, Vpriv generated sales of $84 million for the nine-month period ending September 30, 2010.
Ben Adams
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