Pharming gets FDA approval for new facility to make HAE drug Ruconest 

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The FDA has signed off on a new facility for Pharming Group to produce its hereditary angioedema drug Ruconest. (FDA)

Pharming Group last year took back control of Ruconest, its treatment for protein deficiency hereditary angioedema (HAE). Now, it has gained approvals for a new manufacturing facility that will ensure it has sufficient supplies for the drug. 

The Leiden, Netherlands-based company today said with the FDA approval of the biologics facility, it is able to release product that is manufactured with starting material from the facility for sale in the U.S. In January, the European Medicines Agency, approved the facility. 

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“Following on from the EMA approval announced earlier this year in January, this gives us sufficient capacity for current demands as we continue to build for the future,” Pharming CEO Sijmen de Vries said in a statement. 

In December, Pharming agreed to pay Swedish Orphan Biovitrum €7.5 million to reacquire the sales rights to Ruconest, which Sobi had licensed in 36 countries, including some EU markets. 

Pharming followed that in January with a €125 million offering it says will be used to expand manufacturing. Last year, Pharming also invested about €4.1 million for new equity in its BioConnection BV, which handles filling and finishing for its product. 

The company for several years benefited from additional sales stemming from shortages of competitor drugs like Cinryze, now owned by Takeda, but those shortages have since been resolved. 

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