Baxalta Incorporated BXLT announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion licensing the production of HyQvia and Gammagard Liquid 10% (marketed as Kiovig outside the U.S. and Canada) in the EU through the company’s manufacturing services agreement with Netherlands-based Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation).
With the CHMP issuing a favorable opinion, Sanquin will now be able to process plasma supplied by Baxalta into bulk material for HyQvia and Gammagard Liquid 10% for the markets in the EU, Iceland and Norway. Moreover, these additional manufacturing capabilities will let Baxalta optimize capacity at other facilities so that it can cater to other regions. The company will continue to deliver the products to the U.S. market from its FDA-approved manufacturing facilities in the U.S., Austria and Italy.
Both HyQvia and Gammagard Liquid 10% are approved for the treatment of specific types of patients suffering from primary immune deficiency.
We note that Baxalta had entered into a manufacturing services agreement with Sanquin in Jul 2012. Under the agreement, Baxalta can gradually ramp up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-based treatments.
We are encouraged by Baxalta’s efforts to boost global supply in order to meet long-term consumer demand for its immunoglobulin therapies and other plasma-based therapies. Apart from a contract manufacturing services agreement with Sanquin, the company is also expanding its capacity through ongoing yield improvements and construction of a new greenfield site in Covington, GA.
Baxalta is a Zacks Rank #1 (Strong Buy) stock. Some of the other favorably ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Actelion Ltd. ALIOF and Anika Therapeutics Inc. ANIK.
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