The HealthCare segment at Bayer (BAYRY) announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) issued a positive feedback following the completion of review of hemophilia A treatment, Kogenate.
The EMA’s PRAC stated that recent evidence did not reveal an increased risk of developing antibodies (factor VIII inhibitors) to Kogenate compared to other recombinant or plasma-derived factor VIII products in previously untreated patients suffering from bleeding disorder haemophilia A. The PRAC concluded that the benefits associated with the product outweighed the risks involved.
However, the risk assessment committee believes further update of product information from recent studies is required in Europe. The PRAC’s recommendation will now be submitted to the Committee for Medicinal Products for Human Use (CHMP).
The CHMP will give an opinion on the product at its plenary meeting later in the month. The CHMP opinion will then be forwarded to the EU Commission for a final decision.
Kogenate is approved for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) suffering from hemophilia A. The drug is also approved for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in hemophilia A children with no pre-existing joint damage.
Bayer recorded Kogenate sales of €321 million in the third quarter of 2013. We note that the hemophilia market currently has players like Baxter International Inc. (BAX) and Pfizer Inc. (PFE).
Bayer, a large-cap pharma stock, presently carries a Zacks Rank #2 (Buy). Other players in the large-cap pharma space, which look attractive at current levels, include Allergan Inc. (AGN). Allergan carries the same Zacks Rank as Bayer.
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