Baxter International (BAX) recently revealed that the Committee for Medicinal Products for Human Use (“CHMP”) belonging to the European Medicines Agency (“EMA”) has given a favorable opinion for extending the therapeutic indications of Kiovig to encompass a new indication for multifocal motor neuropathy (“MMN”), a debilitating disorder needing life-time therapy.
Following acceptance by the European Commission, Baxter will be granted marketing authorization for the Kiovig MMN indication across all European Union (“EU”) nations.
MMN is an uncommon autoimmune disorder marked by gradual weakening of the limbs. The victim faces difficulty performing simple tasks. If left untreated, MMN may degenerate into muscle atrophy or involuntary twitching.
The favorable opinion for Kiovig MMN is underpinned by a couple of open-label, investigator-initiated prospective clinical efficacy studies on victims of MMN, both of which demonstrated upkeep of muscular strength and better functionality. Negative events were transient in nature and in line with those seen with other Kiovig indications.
Earlier, Baxter launched a phase 3 trial, in 2008, in Canada and the U.S., for Gammagard Liquid (known as Kiovig overseas) for the treatment of MMN. Following its conclusion later this year, Baxter plans to obtain Food and Drug Administration (“FDA”) approval. The company has received Orphan Drug Designation for this indication in the U.S.
Kiovig originally received approval, in Europe, in 2006 and the drug has been obtainable in the U.S. since 2005. It is sold as Gammagard Liquid – Immune Globulin Intravenous (Human). Kiovig is a human normal immunoglobulin (“IVIG”), 10% solution used for multiple indications such as treatment of Primary Immunodeficiency Syndromes and recurrent bacterial infections in patients with chronic lymphocytic leukemia.
Baxter reported first quarter adjusted (excluding one-time items) earnings per share of 98 cents, beating the Zacks Consensus Estimate of 93 cents, and surpassing the year-ago results of 93 cents. Total revenues were $3,284 million, up 12% year over year, also beating the Zacks Consensus Estimate. Among the positive factors, Baxter retains a strong product pipeline with several products in late-stage clinical development.
Improved execution has improved sentiment toward Baxter. The company remains a good bet for value investors willing to wait as fundamentals improve. Among others, it competes with Becton, Dickinson and Company (BDX) in certain niches. We have a Neutral recommendation on the stock.
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