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Roche Announces Positive Late-Stage Data on Rituxan in PV

Zacks Equity Research

Roche RHHBY announced that the late-stage study, PEMPHIX, on its rheumatoid arthritis (RA) drug, MabThera/Rituxan for the indication of pemphigus vulgaris (PV) was successful.

We note that Rituxan became the first biologic therapy for PV after being approved by the FDA in June 2018 and the European Commission in March 2019.

The phase III study was designed to evaluate the efficacy and safety of Rituxan compared with mycophenolate mofetil (MMF) in patients with moderate to severe active PV requiring 60-120 mg/day oral prednisone (or equivalent).

The study met the primary endpoint at week 52 and demonstrated that Rituxan is superior to MMF. In the study, 40.3% of patients treated with Rituxan achieved sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more compared to 9.5% in the MMF arm.

The PEMPHIX study provided additional clinical evidence of the effectiveness of Rituxan for PV, a rare autoimmune condition characterized by blistering of the skin and mucous membranes.

Meanwhile, the study is ongoing, with patients participating in a 48-week safety follow-up period after treatment completion or discontinuation.

Notably, the drug is indicated for the treatment of four autoimmune conditions. Rituxan in combination with glucocorticoids is also indicated for the treatment of granulomatosis with polyangiitis (Wegener’s granulomatosis, GPA) and microscopic polyangiitis (MPA) in adults.

In fact, MabThera/Rituxan is one of Roche’s legacy drugs. However, the drug is facing biosimilar competition in Europe, which is adversely impacting sales.

Apart from Rituxan, Roche’s rheumatology portfolio has a first-in-class anti-IL-6 receptor therapy, Actemra/RoActemra. It is approved for RA, polyarticular and systemic juvenile idiopathic arthritis, giant cell arteritis and chimeric antigen receptor T-cell-induced cytokine release syndrome.

Roche’s stock has gained 16.3% in the year so far against the industry's decline of 0.8%.

The company’s performance so far this year has been impressive, propelled by solid sales of new drugs. Strong growth of Ocrevus, Perjeta, Tecentriq, Alecensa and Hemlibra combated biosimilar competition in Europe for Herceptin and MabThera from the likes of Novartis NVS and Amgen AMGN.

Zacks Rank & Stock to Consider

Roche currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the healthcare sector is Bristol Myers Squibb BMY, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bristol-Myers’ earnings per share estimates increased from $4.24 to $4.29 for 2019 over the past 60 days.

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