Celgene Corporation CELG presented long-term efficacy and safety data from analyses of the phase III ESTEEM studies on Otezla at the Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, CA.
Results from the ESTEEM 2 study showed continued improvement in difficult-to-treat areas such as nails, scalp and the palms of the hands and soles of the feet (palmoplantar psoriasis) at week 52 in patients who achieved a 50% reduction in Psoriasis Area and Severity Index (PASI) at week 32. Meanwhile, the ESTEEM 1 study revealed that no new safety signals were identified in patients treated with Otezla (30 mg twice daily) for up to two years.
Moreover, analysis of the phase IIb study (PSOR-005) on Otezla along with the ESTEEM 1 and ESTEEM 2 studies showed that Otezla improved palmoplantar psoriasis in a subset of patients suffering from moderate to severe chronic plaque psoriasis with prior experience of palmoplantar involvement.
Otezla is currently available in the U.S. for the treatment of adults suffering from active psoriatic arthritis and the treatment of patients suffering from moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Earlier in the year, Otezla was cleared in the EU.
In 2014, Otezla sales came in at $70 million with a major portion being recorded in the fourth quarter following approval of the plaque psoriasis indication. The drug is also being developed for additional indications like active Behçet’s disease (phase III) and ulcerative colitis (phase II). Celgene is expecting additional regulatory decisions on the drug later in the year.
Further label expansion of the drug will boost sales. Celgene expects the drug to contribute around $1,500 million to $2,000 million in 2017.
Celgene carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Acorda Therapeutics, Inc. ACOR, Cytokinetics, Inc. CYTK and Affymetrix Inc. AFFX. All three carry a Zacks Rank #1 (Strong Buy).