Bayer (BAYRY) 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 precautionary measure.
Bayer already has Kogenate in its product portfolio for the treatment of haemophilia. We note that companies like Biogen Idec Inc. (BIIB) 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 Novo Nordisk (NVO) currently look more attractive with a Zacks Rank #2 (Buy). Other pharma stocks such as Jazz Pharmaceuticals (JAZZ) carry a Zacks Rank #1 (Strong Buy).
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