WRAPUP 1-Genzyme, rivals battle for place in Gaucher market

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WRAPUP 1-Genzyme, rivals battle for place in Gaucher market

* Rivals present data at conference in Miami

* Drugs appear to show similar efficacy

* Genzyme hopes to keep grip on market with oral drug

By Toni Clarke

BOSTON, Feb 11 (Reuters) - Shire Plc (SHP.L) and Protalix Biotherapeutics Inc (PLX.A) released data from late-stage clinical trials of their experimental Gaucher disease drugs on Thursday that they hope will break Genzyme Corp's (GENZ.O) monopoly on the $1.2 billion market.

Genzyme, meanwhile, provided data from a trial of its experimental Gaucher disease pill that it hopes will succeed its intravenous drug Cerezyme, and maintain the company's dominance in the Gaucher market for years to come.

All three companies presented data at the Lysosomal Disease Network World Symposium in Miami.

Gaucher disease is a rare genetic disorder in which patients are deficient in an enzyme that breaks down certain fats in the body, leading to swollen, damaged organs and even death. It affects fewer than 10,000 people worldwide.

Genzyme's new drug, known as eliglustat tartrate (formerly GENZ-112638) is given in capsule form, making it more convenient to take and potentially giving the company an edge over Shire and Protalix, whose drugs are also infused.

But Genzyme's new drug will not be approved for several years, if at all. In the meantime, the company faces imminent competition. Shire and Protalix both hope to win approval for their drugs by the end of the year; Shire could potentially launch its drug as early as March.

"We maintain our thesis that Shire and Protalix will erode about one-third of Genzyme's Cerezyme market share over time," said Brian Abrahams, an analyst at Oppenheimer & Co, in a research note.

  Although the drugs were not pitted directly against each other, making comparisons unreliable, investors combed through the minutiae to gauge each drug's risks and benefits. For data see [ID:nN11177254]

  "Overall, we think the implications for Genzyme are mixed, where the competitor data look generally clean and efficacious, but the GENZ-112638 program looks promising," said Geoff Meacham, an analyst at J.P. Morgan.

Cambridge, Massachusetts- based Genzyme is struggling to rebuild its reputation with patients and with Wall Street after manufacturing problems last year lead to shortages of Cerezyme and Fabrazyme, its drug to treat Fabry disease.

Shire and Protalix hope to take advantage of Genzyme's troubles to loosen its stranglehold on the market.

"The world has changed a bit," said Suzanne Bruhn, senior vice president of strategic planning and program management at Shire. "2009 has changed the dynamic."

Some analysts expect Shire and Protalix to compete in part by pricing their drugs lower than Cerezyme, which can cost as much as $200,000 a year and is one of the most expensive in the world.

Protalix, with partner Pfizer Inc (PFE.N), the world's biggest drugmaker, is expected to be particularly aggressive, although it remains to be seen how well Pfizer, whose experience lies in marketing big-selling drugs to primary care physicians, adapts to a tiny niche market where success relies as much as anything on patient relationships.

"This is a patient community that requires a lot of support and services," said Bruhn, who declined to comment on Shire's likely pricing strategy.

"For us, it costs a lot of money to develop a drug. Price is one of many competitive levers, but it is about the whole package offering."   (Reporting by Toni Clarke; editing by Andre Grenon)

http://www.reuters. com/article/ idUSN11231275201 00211

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