Trading in shares of Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) has been heavy in recent weeks, ahead of a decision by US Food and Drug Administration (FDA) whether to approve the company's treatment for Gaucher's disease Uplyso.
Meanwhile, Protalix has been benefiting from troubles at rival Shire Plc (LSE: SHP; Nasdaq: SHPGY), which received from the US Food and Drug Administration (FDA) a complete response letter, which will delay the start of production of the company's Gaucher's treatment at a second plant in the US.
Shire beat Protalix to market last year, with the launch of Vpriv for treating Gaucher's disease, which Shire produces at a plant in Massachusetts. Shire reported $72 million in Vpriv sales for the first quarter of 2012. In 2011, Shire's main competitor in the market, Sanofi SA (Euronext: SNY; NYSE: SNY) subsidiary Genzyme, reported €149 million ($197 million) in sales for its Gaucher's treatment, Cerezyme.
Shire has been seeking to boost its manufacturing capacity by building a second plant in Lexington, Kentucky. The European Medicines Agency (EMEA) approved the plant, but the FDA still has outstanding issues which must be resolved before it will give its approval. Shire can produce Vpriv for customers in Europe, but it can only supply the drug for US customers from the company's FDA approved plant.
In its announcement, Shire said that the delay should not affect Vpriv sales in the US in the near term, but that it would affect the accumulation of inventory for the US market.
For Protalix, the issue could slow Shire's penetration of the US market, which has been quite successful so far. Shire previously benefited from Protalix's delay into the market, after the FDA refused marketing approval for Uplyso last February, and asked the company to respond to questions about its manufacturing process and about its plant.
Protalix expects to begin marketing Uplyso through its partnership with Pfizer Inc. (NYSE: PFE; LSE: PFZ) as soon as FDA approval is obtained. Most analysts believe that Protalix will receive the approval this time, but that was also true last year, when the approval was not granted.
The delay in approval of Shire's second US plant may increase Protalix's chances of obtaining FDA approval for Uplyso, because the FDA does not want a shortage of treatment for Gaucher's disease. Two years ago, when Genyzme had a contamination problem at its plant, the FDA accelerated the regulatory process for Protalix. When Genzyme solved its problems, the FDA tightened its oversight of Protalix.
In a recent interview with Israeli biomed investor site BioHolder.com, Protalix CEO David Aviezer said that the company was ready to meet expected demand for Uplyso from its Israeli plant, and that it did not have the production capacity limitations facing Shire. Protalix also hopes that, at the same time as, or shortly after, it obtains FDA approval, it will obtain EMEA and Israeli Ministry of Health approval for the drug, and that it will also sign a distribution contract in Brazil worth tens of millions of dollars.
In a separate matter, Protalix expects to submit by the end of June its application to begin a clinical trial for its treatment for Fabry's disease, a genetic disorder. The trial will test the drug's safety and provide initial indications of its effectiveness.
Protalix's share price fell 0.2% in early trading on the TASE today to NIS 26.84, after falling 1% on the American Stock Exchange on Friday to $6.99, giving a market cap of $634 million. The share price earlier rose 12% in expectation of the FDA decision on May 1.
Published by Globes [online], Israel business news - www.globes-online.com - on April 29, 2012
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