Baxter International Inc. BAX recently submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the approval of BAX 855. The NDA filing in Japan follows Baxter’s biologics license application (BLA) with the FDA, which the company filed in late 2014.

Developed in partnership with Nektar Therapeutics NKTR, longer-acting BAX 855 is expected to be a new treatment option for Hemophilia A patients. In the phase 3 study that involved 137 previously treated patients, BAX 855 demonstrated its effectiveness by controlling 96% bleeding episodes in 1 or 2 infusions in patients aged 12 years and above.

In Feb this year, Baxter provided additional efficacy and safety data at the 8th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Helsinki, Finland. BAX 855 used in prophylactic treatment reduced median annualized bleeding rate (ABR) by 95% as compared to on-demand therapy.

Baxter is also continuing with its pediatric studies on BAX 855, upon completion of which, it expects to file for marketing authorization with the European Medicines Agency in 2016.

Baxter is expanding its international business by winning approvals for new drugs and products as well as through partnerships. A Japanese approval of BAX 855 will be significantly positive in driving the adoption rate of the drug in Asia-Pacific over the long run.

Recently, Baxter entered into a licensing and distribution partnership with France-based Laboratoire Aguettant SAS, which expands the company’s parenteral nutrition (PN) therapy portfolio.

Baxter also received CE marking approval in Europe for HOMECHOICE CLARIA — its automated peritoneal dialysis (APD) system integrated with the SHARESOURCE web-based connectivity platform. The company plans to initiate the commercial launch of the system in select European and Asian countries in the first half of 2015.

Although an innovative product pipeline is the key growth catalyst for Baxter, we believe that intense competition in each of its segments and lackluster hospital spending are the major concerns. Moreover, foreign currency volatility is another factor which is expected to significantly hurt the company’s overall results, particularly in 2015.

Stocks to Consider

Currently, Baxter carries a Zacks Rank #4 (Sell). Better-ranked stocks include LeMaitre Vascular LMAT and SurModics SRDX. Both LeMaitre Vascular and SurModics sport a Zacks Rank #1 (Strong Buy).

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