EU agency gives Baxalta green light to begin manufacturing two plasma-based therapies

Baxalta ($BXLT) has been given regulatory approval to begin manufacturing and distributing in Europe a pair of plasma-based therapies designed to treat specific types of primary immune deficiencies in humans.

The European Medicines Agency's Committee for Medicinal Products for Human Use provided a positive opinion, licensing production of Hyqvia (immune globulin infusion 10% with recombinant human hyaluronidase) and Gammagard liquid 10% (immune globulin infusion), which will be marketed in the EU as Kiovig.

The pair of treatments will be produced through Baxalta's manufacturing services agreement with Stichting Sanquin Bloedvoorziening of the Netherlands, the company said in a press release.

"The CHMP positive opinion enables Baxalta to provide additional supply of critical plasma-based therapies by leveraging our manufacturing network and regional partners to optimize our flexibility and capacity," John Furey, a Baxalta senior vice president, said in a statement.

The Illinois-based company said it will continue to supply the U.S. market from its FDA-approved manufacturing sites in the U.S., Austria and Italy. The agreement with Sanquin allows Baxalta to gradually ramp up to 1.6 million liters of incremental plasma fractionation capacity annually to meet the growing demand globally for plasma-based treatments.

The news likely makes Baxalta that more attractive (and expensive) to Shire ($SHPG), which has had the company in its acquisition sites for months. The Dublin drugmaker was recently reported to be readying a new takeover proposal for Baxalta after its previous offer of $30 billion was rejected as being a "lowball" valuation.

Baxalta's CEO, Ludwig Hantson, has expressed little interest in Shire's ovations, telling investors this summer that Baxalta is a brand-new company that hasn't had time to see its growth strategy play out.

- see Baxalta's release

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