Celgene ($CELG) has put another brick in the wall of positive late-stage data for apremalist as a new therapy for psoriatic arthritis, building on its new drug application at the FDA. Treatment naïve patients in the study achieved the primary endpoint of ACR20--a 20% improvement in symptoms--after 16 weeks of treatment, adding to a mountain of data that is being used to seek an FDA approval for this oral drug, one of the most important late-stage drugs in the biotech's pipeline.
"Despite recent advances in the treatment of psoriatic arthritis, there remains a significant need for more oral DMARD (disease modifying) treatment options for DMARD-naïve patients," said Randall Stevens, VP of Clinical Research and Development for Inflammation & Immunology. "PALACE-4 is now the fourth major randomized apremilast Phase III study to provide promising results for patients with psoriatic arthritis."
The PALACE 4 study is ongoing, notes Celgene, and the study extension will remain blinded until all patients complete 52 weeks of therapy. Full data from this Phase III study will be submitted for presentation at an upcoming medical meeting. In the meantime, Celgene has already filed for an approval of apremalist for psoriatic arthritis in the U.S. And the biotech is planning a separate application for psoriasis in the U.S. as well as a combined app for psoriatic arthritis/psoriasis in Europe in the second half of this year.
Celgene has been building its NDA for psoriatic arthritis for months, ever since it nailed down positive data from its first clinical study for this indication last summer. But it hasn't been entirely smooth sailing for this drug. Apremalist failed a mid-stage study for rheumatoid arthritis, narrowing its commercial potential. And some of the data have left analysts distinctly unimpressed with the efficacy they're seeing--though most give it good odds of an approval.
Apremalist has been touted by JP Morgan analysts as a potential $500 million drug. And while Celgene believes it has a blockbuster on its hands capable of earning up to $2 billion a year, it's hard to find any analysts who agree with the in-house assessment. Cowen, for example, has estimated the sales potential at an underwhelming $300 million..
Celgene has been engaged in a frenzy of deal-making over the past year. Just today, it inked a $300 million collaboration with Concert Pharmaceuticals to develop more stable cancer drugs. Celgene, one of the top biotechs in the industry, likes to boast that the PALACE program "is the most comprehensive set of psoriatic arthritis studies to date intended for regulatory submission." Results from the PSA-001 phase II study of apremilast in psoriatic arthritis were recently published online in the journal Arthritis & Rheumatism.
- here's the press release