The biopharmaceuticals division of Baxter International Inc. BAX is firing on all cylinders, just ahead of its scheduled spin-off on July 1.
On Jun 25, 2015, PharmaEngine announced that its sublicense partner, Baxter, has received the acceptance of Market Authorization Application (MAA) from the European Medicines Agency (EMA) for MM-398.
In May 2011, PharmaEngine and Merrimack Pharmaceuticals MACK had inked an exclusive license agreement. Under the terms of the deal, Merrimack was granted the rights to develop, manufacture, and sell PEP02 (designated as MM-398 by Merrimack) in Asia and Europe. In Sep 2014, Merrimack had licensed the rights to MM-398 outside the U.S. and Taiwan to Baxter's BioScience business.
The acceptance of MAA implies that Baxter can now successfully bring MM-398 to the markets where it has been granted rights. Once sales of the product gains accretion, it should prove incremental to the company’s top-line growth.
Merrimack has also received the notification from the US Food and Drug Administration (FDA) for the acceptance and the grant of the priority review designation for their New Drug Application (NDA).
Also recently, Baxter provided a positive update on an ongoing trial that intends to evaluate the safety and optimal dosing level of BAX 335 – an investigational factor IX (FIX) gene therapy used to treat hemophilia B. The oral presentation was conducted at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress in Toronto, Canada.
We believe successful completion of the clinical trial and the subsequent launch of the therapy will help Baxter gain better market traction in a growing gene therapy market. This will duly propel growth of its biopharmaceuticals business.
Earlier this month, Baxter got the approval of its board of directors for the planned split of the company’s biopharmaceuticals business into a separate company to be called Baxalta Incorporated.
Notably, Baxalta is going to formally debut as an independent Baxter drug spin-off on Jul 1, 2015. Baxalta will emphasize on the development and marketing of innovative biopharmaceuticals. Baxter’s board of directors has approved the spin-off, which had been announced in Mar 2014.
Zacks Rank
Currently, Baxter has a Zacks Rank #3 (Hold). Better-ranked medical stocks at the moment include AMN Healthcare Services AHS and INC Research Holdings INCR. Both the three stocks sport a Zacks Rank #1 (Strong Buy).
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