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fizer has acquired a global licence to develop and market Protalix Biotherapeutics of Israel’s investigational Gaucher’s disease treatment at a time when patients are facing up to a shortage of the only approved therapy, Genzyme Corp’s Cerezyme.

The pact involves Uplyso (taliglucerase alfa), which has completed Phase III trials and Protalix is preparing to complete a rolling New Drug Application with the US Food and Drug Administration. The agency has granted orphan drug and fast-track status for the enzyme replacement therapy and taliglucerase is currently being provided to Gaucher’s patients in the USA and in the European Union under a compassionate use protocol.

Protalix’ drug and Shire’s investigational therapy velaglucerase alfa, have been made available through pre-approval access programmes as a result of the global supply shortage caused by Genzyme temporarily shutting down its manufacturing facility in Boston in June after a bioreactor was contaminated with a virus which affected production of Cerezyme (imiglucerase).

Under the terms of the taliglucerase deal, Pfizer will cough up an upfront fee of $60 million, while Protalix will be eligible to receive a further $55 million in regulatory milestone payments. The companies will share future revenues and expenses for the development and commercialisation of the therapy on a 60%-40% basis in Pfizer’s favour.

David Aviezer, Protalix chief executive, said that “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.” A Pfizer/Protalix link-up has been rumoured since a delegation from the drugs giant visited the Israeli company’s facilities in Carmiel a month ago.

Pfizer to sell generics in Japan by 2011
Meantime, Pfizer says it is to sell generics in Japan by 2011 and is planning to expand its sales force there to market brand-name products.

Speaking at a news conference, Pfizer Japan director Hiroshi Matsumori said that the company and newly-acquired Wyeth will have completed the merger of their Japanese operations by September next year. It will then establish a new unit that will also sell 68 generic and off-patent drugs.

Mr Matsumori was quoted as saying that “Japan wants quality assurance and credibility for generic medicines and Pfizer has them”. He added that the firm’s contracts with suppliers outside the country “will help cut the costs of such medicines”.

It has also been reported that India’s Cipla is in talks with a number of drugmakers, including Pfizer, to supply generic products.