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Roche (RHHBY) Announces Positive Data on Hemophilia Drug

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Roche (RHHBY - Free Report) announced full results from the phase III study, HAVEN 3, evaluating haemophilia A drug Hemlibra (emicizumab).

The randomized multicenter, open-label, phase III study evaluated the efficacy, safety and pharmacokinetics of Hemlibra prophylaxis versus no prophylaxis (episodic/on-demand factor VIII treatment) in patients with hemophilia A without factor VIII inhibitors.  

The trial results show that Hemlibra reduced treated bleeds by 96% compared to no prophylaxis in HAVEN 3 study in haemophilia A without factor VIII inhibitors. Moreover, in a subset of patients included in the study, who previously received factor VIII prophylaxis, which is the standard of care, Hemlibra reduced bleeds by 68% compared to their prior therapy.

Almost 55.6% of patients treated with Hemlibra every week and 60% of patients treated with Hemlibra every two weeks experienced zero treated bleeds, compared to none of patients treated with no prophylaxis.

Additionally, results from another phase III study, HAVEN 4, showed Hemlibra administered every four weeks provides clinically meaningful control of bleeding in people with or without factor VIII inhibitors.

We remind investors that the FDA granted Breakthrough Therapy Designation to Hemlibra in April 2018 for patients with hemophilia A without factor VIII inhibitors, based on data from the HAVEN 3 study. The drug is already approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.

Hemlibra was also approved by the European Commission in February 2018 for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors.

Roche’s hematology portfolio includes approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Tecentriq and Venclexta.

We note that Roche is developing Venclexta in collaboration with AbbVie (ABBV - Free Report) . Both companies are jointly commercializing the drug in the United States. AbbVie is commercializing the drug outside the United States as well.

Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Herceptin, MabThera are facing competition from biosimilars.

Roche’s stock has lost 7.3% in the last six months compared with industry’s gain of 0.5%.

 

Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) has also obtained FDA approval for a biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.

Zacks Rank

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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