J&J’s blockbuster prostate cancer drug Zytiga has just been pushed perilously close to the edge of the patent cliff. And with its franchise teetering on the brink, the pharma giant is left scrambling for an OK of a successor therapy that may soon find itself going head-to-head with Pfizer’s Xtandi.
The US Patent Trial and Appeal Board ruled that a patent covering the administration of Zytiga was improperly allowed as the approach was obvious, Reuters reported Wednesday night. The company immediately put out a statement that it was reviewing its options for a rehearing on the inter partes reviews decision, or a shift to a federal appeals court.
You can be sure that J&J $JNJ won’t roll over easily on this one.
The action was brought by Argentum Pharmaceuticals, a generics outfit which has been stripping away the patents that guard a franchise worth more than $2 billion a year.
If J&J loses this battle, it still has a late-stage drug in front of the FDA — apalutamide, or ARN-509 — it’s hoping can protect the big revenue stream it gets from Zytiga (abiraterone), an oral drug that has helped revolutionize prostate cancer treatment over the last 5 years.
J&J won a priority review of apalutamide for nonmetastatic castration resistant prostate cancer, an early designation. And it’s fielding Phase III data that is slated to be revealed at the ASCO Genitourinary Cancers Symposium on February 8. The accelerated PDUFA date is in April.
But Pfizer $PFE is also in the hunt to gain an approval for Xtandi — a drug partnered with Astellas and picked up in the $14 billion Medivation buyout — in the same indication. After a changeup in its trial design that cut the chase for pivotal data by two years, the pharma giant headlined topline data last September that showed that Xtandi combined with androgen deprivation therapy beat ADT alone on metastasis-free survival rates for nonmetastatic prostate cancer. And now it’s looking for a label expansion.
The final numbers on both studies will be carefully watched as the two giants hustle for an approval. Billions rest on the outcome of that race.
J&J’s statement this evening notes:
“We are disappointed in and strongly disagree with the U.S. Patent and Trademark Office’s (USPTO) decisions relating to Zytiga as part of the Inter Partes Reviews. We are evaluating our options with respect to a request for rehearing and/or appeal to the Court of Appeals for the Federal Circuit. We believe the ‘438 patent is valid and will continue to vigorously defend it.”
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