(By Mani) Celgene Corp. (NASDAQ: CELG) said its Apremilast product significantly improves signs and symptoms of psoriatic arthritis (PsA) in biologic-treatment-failure patients when it presented the results of a late-stage study at American College of Rheumatology annual meeting in Washington.
All efficacy endpoints were met, and activity was shown among both patients previously exposed to biologics and patients who have failed biologics.
Given Apremilast's good safety profile, it has a high probability of approval, and it is also anticipated by an advisory committee for Apremilast since it is a novel compound for chronic use.
"In our view efficacy was consistent with expectations and it appears that apremilast's efficacy falls between TNF inhibitors and methotrexate," Oppenheimer analyst Boris Peaker wrote in a note to clients.
Apremilast is targeting markets totaling about 7 million patients in the US and EU across multiple indications. According to Celgene, these markets are comprised of 1 million PsA patients, 2.5 million moderate-to-severe psoriasis patients, and 2.5 million ankylosing spondylitis patients.
There is significant interest among patients and physicians in new therapies, especially safe and efficacious oral drugs like Apremilast as the available treatments includes only nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, disease-modifying antirheumatic drugs (DMARDs) and Tumor necrosis factor (TNFs).
"Therefore, if successful, we believe that Apremilast may eventually become a blockbuster drug. However, we also believe that the existing therapies set a high bar for any new oral drug, and the key commercial question is how will docs view Apremilast given its efficacy and safety profile," Peaker said.
Summit, New Jersey-based, Celgene has not determined if it will partner the product, but it believes a targeted specialty sales force could effectively cover the roughly 7,200 prescribers in rheumatology and 10,919 prescribers in medical dermatology within the US. This is a smaller prescriber target than Celgene presently covers with its hematology/oncology portfolio.
"We believe Celgene is capable of covering the prescriber base given its size, but expect the company to evaluate partnering options once all data is available," the analyst added.
Celgene, which discovers, develops, and commercializes treatments for cancer, has a key sales driver in the form of Revlimid. Revlimid, an oral immunomodulatory drug for the treatment of patients with multiple myeloma and myelodysplastic syndromes, has a strong growth outlook, and analysts estimate a 14 percent sales growth over the next three years. Recently, Celgene announced that its Abraxane showed a statistically significant survival benefit in pancreatic cancer patients in Phase III trial.