) revealed encouraging results of two clinical studies on the
Advate [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
Method] at the 24th Annual Congress of the International Society
on Thrombosis and Haemostasis (ISTH) in Amsterdam, the
Netherlands. Advate is meant for the avoidance or curtailment of
bleeding in victims of hemophilia A.
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A meta-analysis of post-authorization safety studies (PASS) of
the Advate demonstrated that the product lowers inhibitor rate
and is safe and effective for use in routine clinical practices.
The results were consistent with that of the trials conducted in
controlled, interventional settings. The large post-marketing
data included 1,200 patients from 15 countries.
Another integrated 10-year data from 12 interventional clinical
studies showed that the offering is safe for children and adults
with moderately severe or severe hemophilia A.
Positive data from the two clinical trials should boost sales of
Advate, which is a part of Baxter's Recombitants product category
under the BioScience segment. Revenues from the BioScience
business grew 5% in the first quarter of 2013, partly led by
higher demand for Advate.
Baxter is striving to grow its hemophilia business through the
international expansion of its product line. Advate is approved
in 58 countries across the globe, including the U.S., Canada, and
several countries in the European Union. Recently, the product
received regulatory approval in China for the control and
prophylaxis of bleeding episodes in individuals with hemophilia
A. We believe that Advate has a considerable scope to capture a
significant market share in the world's second largest economy.
In March, the company acquired the investigational hemophilia
compound OBI-1 from Inspiration BioPharmaceuticals, Inc. and
certain other OBI-1 related assets from Ipsen Pharma S.A.S. OBI-1
is a recombinant porcine factor VIII (rpFVIII) and is being
investigated for the treatment of bleeding episodes in people
with acquired hemophilia A and congenital hemophilia A patients
Although we believe that the recent developments including a
strong product line and several products in late stage clinical
development are encouraging, we are concerned about the relative
stagnation in sales, a difficult outlook for hospital spending
and tightening of reimbursement.
The stock currently carries a Zacks Rank #3 (Hold). While we
choose to remain on the sidelines for Baxter, medical device
stocks worth a look are
Wright Medical Group
). While WMGI carries a Zacks Rank #1 (Strong Buy), the other two
stocks carry a Zacks Rank #2 (Buy).