After losing race for first to market in lupus nephritis, Aurinia taps Otsuka for voclosporin licensing pact abroad
Tiny biotech Aurinia Pharmaceuticals is looking to slay a giant in GlaxoSmithKline’s Benlysta — which just scored a big approval in lupus nephritis — with its late-stage voclosporin on the cusp of an FDA approval. Looking to take its commercial plans global, Aurinia has tapped a Japanese pharma to accelerate its potential voclosporin launch.
Aurinia will hand over licensing rights for lupus nephritis candidate voclosporin in the EU, Japan and elsewhere to Otsuka Pharmaceutical as the late-stage drug rapidly approaches its FDA review date, the companies said Thursday.
The commercial tie-up comes within hours of British drugmaker GlaxoSmithKline getting the FDA greenlight for its Benlysta as the first-approved therapy for LN. Aurinia’s $AUPH share prices were trading down 12.7% on Thursday to around $13.24 at press time, underscoring investors’ negative reaction to the news.
Aurinia will receive an upfront cash payment of $50 million as part of its deal with Otsuka as well as the possibility for an additional $50 million contingent on sales and regulatory milestones. Aurinia will then pull in tiered royalties of 10% to 20% on sales in the EU, Japan, UK, Russia, Norway, Switzerland, Belarus, Iceland, Lichtenstein and Ukraine.
To meet its end, Otsuka expects to file a marketing application for voclosporin with the EMA in the second quarter and plans to submit in Japan “at a later date,” the companies said. Voclosporin is facing an FDA review date of Jan. 22.
Aurinia, a biotech with no approved therapies in its portfolio, has a lot riding on LN, a severe form of lupus that can lead to end-stage renal failure, dialysis and kidney replacement. But being second to market after Big Pharma GSK and Benlysta, a nine-year veteran in lupus with established relationships with nephrologists, will be no easy task.
After earlier testing marred by patient deaths, Aurinia released Phase III data in December 2019 showing voclosporin in combination with mycophenolate and low-dose corticosteroids improved the speed of and overall renal response rates in patients with LN over placebo.
Patients given voclosporin recorded renal response of 40.8%, while those on the control arm experienced a rate of 22.5% — meeting the main goal of the study (p < 0.001) at 52 weeks. Voclosporin also posted statistically significant improvements across all pre-specified secondary endpoints, including renal response at 24 weeks, partial renal response at different time points and time to achieve urinary protein-to-creatinine ratio.
Six deaths occurred in the study, one in the voclosporin arm and five in the control group. Serious adverse events were reported in 20.8% of voclosporin patients, versus 21.3% in the control arm.
Aurinia has had a rough go of it this year, cutting another late-stage program for voclosporin ophthalmic solution (VOS) in November after flopping a Phase II/III study in dry-eye disease. Aurinia portrayed that formulation as a next-gen follow-up to Restasis, but the drug couldn’t make its mark in improving patients’ condition.
A win in LN would help turn the tide in Aurinia’s favor, but it’s also racing time as another big player, Roche’s Gazyva, looks to enter the market. In June 2019, Roche posted Phase II data showing Gazyva on top of standard-of-care therapy bested standard of care alone in achieving complete renal response for lupus nephritis patients. The drug earned the FDA’s breakthrough tag in September 2019.