) recently initiated a phase III study on BAY 94-9027 in children
(up to 12 years of age) for the treatment of hemophilia A.
The phase III PROTECT VIII study (PROphylaxis in hemophilia A
patienTs via directly pEgylated long-aCTing rFVIII) will evaluate
whether the candidate can be used prophylactically to prolong the
duration of protection from bleeding for up to one week, while
also being used to treat acute bleeds.
The study will be a multicenter, multinational, partially
randomized, open-label trial. Bayer intends to enroll around 50
previously treated children from across the world for the phase
III study. These children suffering from severe hemophilia A have
a history of at least 50 exposure days (ED) with any FVIII
product. These children will also be given an option to
participate in an optional extension study.
Bayer is also conducting the PROTECT VIII study in adults
suffering from hemophilia A. The company has already completed
enrolment in this trial.
We remind investors that in May 2013, Bayer had discontinued the
phase II/III TRUST (TReatment with Unique recombinant rFVIIa
STudy) study on BAY 86-6150. The study was evaluating the
efficacy and safety of the candidate in patients suffering from
hemophilia A or hemophilia B with inhibitors.
A neutralizing antibody was detected during the course of the
study. Since patient safety was the primary objective of the
study, Bayer discontinued the BAY 86-6150 trial as a
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Bayer already has Kogenate in its product portfolio for the
treatment of haemophilia. We note that companies like
Biogen Idec Inc.
) are also developing therapies targeting the hemophilia market.
Bayer, a large-cap pharma company, presently carries a Zacks Rank
#4 (Sell). Meanwhile, other large-cap stocks such as
) currently look more attractive with a Zacks Rank #2 (Buy).
Other pharma stocks such as
) carry a Zacks Rank #1 (Strong Buy).