Roche RHHBY announced positive top-line results from the late-stage study, PEMPHIX.
The study evaluated the efficacy and safety of MabThera/Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV).
The primary endpoint was the percentage of participants who achieved sustained complete remission off corticosteroid therapy (no disease activity, as evaluated by Pemphigus Disease Area Index, without the use of steroids for 16 consecutive weeks or more) at week 52. The study met the primary endpoint and demonstrated MabThera to be superior to MMF in achieving sustained complete remission.
MabThera/Rituxan also met the secondary endpoints, including cumulative corticosteroid dose, number of flares, time to sustained remission and time to disease flare.
We remind investors that in June 2018, MabThera/Rituxan became the first biologic therapy approved by the FDA and the European Commission for PV, an autoimmune, blistering disease. This approval was based on the Ritux 3 study. The PEMPHIX study provided additional clinical evidence on the effectiveness of MabThera/Rituxan for PV. Data from the PEMPHIX study will be presented at an upcoming medical congress.
The stock has gained 11.4% in the year so far compared with the industry's 3.1% growth.
Recently, the FDA accepted Roche’s supplemental biologics license application (sBLA) and granted Priority Review status to Rituxan in children with two rare blood vessel disorders. The sBLA is for the use of the drug in combination with glucocorticoids (GCC) for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children aged two years or older. If approved, this would be the first pediatric indication for MabThera/Rituxan.
Rituxan is currently approved for the treatment of four autoimmune indications.
The FDA approved the drug for rheumatoid arthritis (RA) in 2006, GPA and MPA in 2011, and pemphigus vulgaris in 2018.
Roche is currently looking to diversify its portfolio in wake of stiff competition from biosimilars for key drugs such as Avastin, Rituxan and Herceptin from Novartis NVS and Amgen AMGN. Apart from Rituxan, the company’s rheumatology portfolio has a first-in-class anti-IL-6 receptor therapy, Actemra/RoActemra, which is approved for rheumatoid arthritis (RA), polyarticular and systemic juvenile idiopathic arthritis, giant cell arteritis, and chimeric antigen receptor T-cell-induced cytokine release syndrome.
Zacks Rank & Another Stock to Consider
Roche currently carries a Zacks Rank #2 (Buy).
Another top-ranked stock worth considering is Bristol-Myers Squibb Company BMY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates increased from $4.79 to $5.03 for 2020 over the past 60 days.
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