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Grifols –the Catalan group of 26 companies operating in the healthcare sector– has obtained approval from the Food and Drug Administration (FDA) to market a new generation of 10% concentration intravenous immunoglobulin (IVIG) in the United States. With this authorization, they are the first company to offer two concentrations of liquid IVIG (5% and 10%) on the US market. This new product is scheduled to go on sale at the end of this year.

Thanks to this news, the company’s stock has risen 5.11%, to 10.035 euros, recovering ground lost at the end of April.

Grifols has distributed their 5% concentrate hemoderivative in the US since 2007 and in Europe since 2008. The group has already begun the process to obtain approval from the European Medicine Agency (EMA) to market the 10% concentration IVIG in Europe and estimates they will gain approval by the fourth quarter of 2010.

This new product is manufactured in the Grifols plant in Parets del Vallès (Barcelona), which has the capacity to produce 13 million grams per year. However, starting in 2013, once their new plant in Los Angeles has received approval, they plan to produce all supplies in the US.

Additionally, Palau Pharma has recovered the license to their start anti-inflammatory drug UR-13870 (in Phase I), which they had released to multinational Schering-Plough. According to information from the La Vanguardia newspaper, Schering’s return of the license has given Palau Pharma the opportunity to negotiate licensing of their drugs to other pharmaceutical groups, which they hope to reach agreements with in 2010.

Palau Pharma's pipeline is currently made up of ten innovative projects in different stages of development to treat diseases like osteoarthritis, fungal infections, depression and asthma, among others. Palau Pharma is working on some of these projects with partners, for example they are developing a new osteoarthritis drug with Neogenius Pharma.

 

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