The HealthCare segment at
) 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
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
Baxter International Inc.
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 carries the same Zacks Rank as Bayer.
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