Protalix Biotherapeutics Inc. (NYSE MKT:PLX; TASE: PLX) predicts in its first-ever guidance that its Brazilian partner will order $39 million worth of Elelyso, the company's treatment for Gaucher's disease, through July 2015, and that 25% of adult patients in Israel will be treated with the drug in 2014. Elelyso has been included in the basket of healthcare services and is given to almost all new patients.
The Israeli market is small, but especially profitable for Protalix, because it is the only market in which the company does not share revenue with its distribution partner, Pfizer Inc. (NYSE: PFE; LSE: PFZ). The agreement has been a disappointment for Protalix to date, generating just $1.1 million revenue in the third quarter of 2013. The company provided no numbers in the statement, saying only, "The company anticipates that its collaboration with Pfizer Inc. will continue to be profitable in 2014, with the Company's share in the collaboration to continually increase."
In the US, Protalix recently signed several agreements with insurance companies, which have selected Elelyso as the treatment of choice. More agreements are due. "We assume that our marketing expenses in the joint venture will fall in the coming year," Protalix president and CEO Dr. David Aviezer told "Globes".
Aviezer added that, under a government decision, all Gaucher patients were switched to Elelyso in the fourth quarter. "This is an excellent example of the processes that we seek," he said. Elelyso is already sold in the US, Israel, Brazil, Chile and Mexico, with approvals pending in Canada, Australia, and Argentina.
Protalix has filed with the US Food and Drug Administration (FDA) to approve Elelyso for treating children. This is a market with a larger proportion of naive patients - patients who have never been treated by an alternative drug. Protalix, which only recently entered the market, has a better chance in the children's market than in the adult market, where most patients are treated by other drugs. Aviezer says that the FDA's response is due in early 2014, after which the company will be able to file applications in other countries.
In 2014, Protalix expects interim results from the Phase I/II clinical trial of PRX-102 in Fabry patients during the second half the year and full results during the first half of 2015; completion of a Phase I clinical trial for its oral GCD treatment for Gaucher's disease and the initiation of the next phase of the trial in the second half; initiation of a Phase I clinical trial Oral PRX-106 anti TNF for the oral treatment of autoimmune diseases; and to file an investigational new drug application (IND) with the FDA for a Phase I clinical trial of PRX-110 for the treatment of cystic fibrosis.
Published by Globes [online], Israel business news - www.globes-online.com - on January 13, 2014
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