Aurinia faces choppy waters amid lower-than-expected 2022 guidance and patent challenge on Lupkynis
Beth Snyder Bulik
Senior Editor
from 'Endpoints News' March 3, 2022 01:09 PM EST PharmaFDA+Marketing
A new patent challenge to Aurinia Pharmaceuticals’ lupus nephritis drug Lupkynis is adding to the biopharma’s woes this week. Sun Pharmaceutical is challenging Aurinia’s “treatment protocol” patent, the company revealed in a 10-K filing this week first reported by STAT.
Aurinia pushed back on the news report, pointing out, in a statement to Endpoints News, that the patent has already been through “significant review” with the US Patent and Trademark Office before Lupkynis was approved by the FDA in January 2021.
“We are confident in our process to prosecute all of our patents. We’re putting together our reply and will vigorously defend this patent and any other challenges that any party may bring to any of our patents,” Aurinia said.
Sun’s intellectual property challenge was filed Feb. 24 with the USPTO’s Patent Trial and Appeal Board. It asks for an inter partes review (IPR) on claims it presented as reasons why “the ’036 patent are not patentable.” Lupkynis’ ‘036 patent is a specific dosing and administration schedule, granted by the FDA on the drug’s label, that extends the drug’s exclusivity to 2037.
Lupkynis’ original drug patent is set to expire in 2027, but the dosing approved and included on its label is key to extending the drug’s exclusivity out for 15 years.
In the wild and woolly world of drug patents, this is not the first entanglement for Aurinia and Sun around voclosporin, the generic name for Lupkynis.
Aurinia was studying voclosporin ophthalmic solution (VOS) as a dry eye treatment but dropped development of it in 2020 when VOS did not meet Phase II/III primary endpoints.
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However, Aurinia is suing Sun and its Cequa dry eye medicine approved in 2018 over two patents from its voclosporin ophthalmic solution. Aurinia revealed the suit in December 2020 claims Sun’s dry eye med Cequa, or cyclosporine, infringes on two of its patents and is asking for an injunction to stop Sun from selling Cequa and monetary relief including cost. Sun has denied the charges and said the two patents at issue are invalid. That case is expected to go to trial in March 2023.
Lupkynis was approved to treat lupus nephritis in people with systemic lupus erythematosus. About 40% of people with lupus will develop the kidney inflammation condition. Its chief competitor is GlaxoSmithKline’s Benlysta, an existing lupus treatment that got a nod for lupus nephritis the month before Lupkynis was approved. Aurinia is working with Otsuka outside the US to market Lupkynis and expects European approval in the second half of 2022.
Bloomberg reported last year that Bristol Myers Squibb was eyeing Aurinia as a takeover target, however, Stat’s new report cast doubt on the smaller biotech’s attractiveness to suitors (it named Biogen as another) with the patent cloud now overhead.
Still, it’s been a tough week for Aurinia which was already dealing with a declining stock price after its fourth-quarter report on Monday resulted in analysts dropping forecasts for the year. While sales for 2021 and Q4 were on target at $45.5 million for the year, Aurinia’s lower-than-expected sales forecast for Lupkynis in 2022 caused analysts to drop estimates and stock price targets. Aurinia projected Lupkynis sales of $115 to $135 million for 2022 which was considerably lower than industry consensus at around $180 million.
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SVB Leerink laid out the issue as a potential disconnect between management and the Street, pointing to its own healthcare conference in early February where Aurinia told analysts to expect “aggressive numbers.”
As SVB Leerink wrote in a Q4 earnings note Monday:
When we asked AUPH about these prior comments on the call just ended, management noted that 150-200% YoY growth is worthy of the term aggressive. This divergence from consensus reminds us of the first couple quarters of Lupkynis’ launch when management was focused on the longer-term trajectory, rather than the initial ramp which was the focus of investors.
Oppenheimer analyst Justin Kim also tackled the disconnect explaining its stock price target cut to $18 from $31. He wrote that “consensus estimates (including our own) perhaps now unrealistically relied upon commercial inflection over steady incremental growth.”
