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Genentech Builds Case For Rituxan In Pemphigus With Comparator Study Data

 
• By Joseph Haas

Genentech reports that Rituxan yields better results over 52 weeks in pemphigus patients than off-label use of CellCept. Principia, meanwhile, unveils positive Phase II data for its pemphigus candidate.

A case of pemphigus foliaceus. Pemphigus foliaceus infographics elements. symptoms and prevention for Pemphigus. health care and medical infographics design. vector illustration. - Vector
Pemphigus has seen few treatment advances in recent decades

Genentech Inc. succeeded in adding pemphigus vulgaris to US and EU labeling for its biosimilar-threatened Rituxan (rituximab) within the past year, but is still working to build evidence around the biologic’s efficacy in the rare autoimmune disease. On 12 October, the Roche division unveiled data from the Phase III PEMPHIX study showing that Rituxan yields superior results in pemphigus patients at 52 weeks than off-label use of its own CellCept (mycophenolate mofetil, aka MMF).

While Genentech tries to encourage use of Rituxan in its fifth labeled indication, however, potential competitor Principia reported positive data on 10 October from part B of a Phase II trial for its PRN1008 in pemphigus. The South San Francisco-based firm partnered PRN1008 with AbbVie Inc. in 2017, but regained all rights to the oral, covalent Bruton’s tyrosine kinase (BTK) inhibitor this past March after the pharma deemed the candidate as not a strategic fit

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.