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Pfizer to market Gaucher disease treatment

Pfizer has entered into a deal with Protalix Biotherapeutics to develop and commercialise a potential treatment for Gaucher disease

Pfizer has entered into a deal with Israeli biotech company Protalix Biotherapeutics to develop and commercialise a potential treatment for the rare genetic disorder, Gaucher disease.

Under the terms of the agreement, Pfizer will gain worldwide licensing rights to commercialise the potential treatment – taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD), while Protalix will retain the exclusive commercialisation rights on their home territory in Israel. 

The deal will see Pfizer make an upfront payment to Protalix of $60m as well as potential milestone payments of up to $55m. Both future revenue and costs relating to taliglucerase alfa will be split between Pfizer and Protalix on a 60:40 basis respectively. 

Taliglucerase alfa is significant product for the pharmaceutical industry as it is the first enzyme replacement therapy derived from a proprietary plant cell-based expression platform using genetically engineered carrot cells. Current processes used by biotech companies involve genetically engineered hamster cells grown in stainless steel tanks, which is far more costly. 

"By joining our advances in biologics manufacturing and protein development with Pfizer's global strengths in patient services and reimbursement we expect to help make taliglucerase alfa an important and cost-effective treatment choice for Gaucher's patients throughout the world," said Dr David Aviezer, president and CEO of Protalix.  

The deal with Protalix is Pfizer's first step into the orphan drug market that often sees pharmaceutical companies developing highly expensive drugs for very rare diseases. 

Pfizer will now enter into direct competition with Genzyme, who market their own Gaucher disease treatment Cerezyme (imiglucerase). 

At the end of November, British pharmaceutical company, Shire, was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) following its European marketing authorisation application (MAA) for velaglucerase alfa to treat type 1 Gaucher disease.

Gaucher disease is an inherited condition affecting around 1 in 20,000 live births. The disease is an enzyme deficiency that can lead to enlargement of the liver and spleen, excessive bleeding and bruising, anemia, bone disease and other complications. 

2nd December 2009

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