As Celgene Corp presented the breadth and quality of its portfolio at the JPMorgan healthcare conference in San Francisco, the firm presented more positive clinical data for apremilast, this time for psoriasis.
The company announced that statistical significance for the primary endpoint of achieving 75% improvement in the psoriasis area-and-severity index (PASI 75) at week 16 was achieved for patients receiving apremilast 30 mg twice-daily in both the ESTEEM 1 and 2 Phase III studies. Patients on the oral small-molecule inhibitor of phosphodiesterase 4 also achieved a statistically significant benefit over placebo in the major secondary endpoint of static physician global assessment (sPGA).
A New Drug Application for psoriasis, based on the data which involved 1,250 patients, is expected to be submitted in the second half of 2013 and Celgene previously announced it expects to file an NDA for psoriatic arthritis in the first quarter of 2013. A combined filing for psoriasis and PsA in Europe in the second half of the year.
Apremilast is just one of a number of compounds that should drive growth at Celgene. At the JPMorgan meeting, chief executive Bob Hugin said the results are highly statistically significant, claiming that "the market opportunity is in the millions for this product".
He noted that "we're rapidly accruing our Phase III study in ankylosing spondylitis, and we're going to move into other indications with apremilast throughout the course of 2013".
Pomalyst set to be a blockbuster
In his presentation (the transcript for which is on Seeking Alpha), Mr Hugin noted that as well as expanding its already-approved treatments, such as Abraxane (nanoparticle albumin-bound -'nab' - paclitaxel) and Revlimid (lenalidomide), Celgene is particularly excited about the potential for its new multiple myeloma drug Pomalyst (pomalidomide), which could be "the next blockbuster product in our haematology franchise".
A decision on Celgene’s NDA for the latter treatment is expected by February 10. Mr Hugin said that Pomalyst has "a very differentiated mechanism and has strong, strong data", noting that "we're developing other indications". These including myelofibrosis where a Phase III trial is fully accrued and data expected in the coming months, and systemic scleroderma.
Celgene anticipates product sales of $6 billion in 2013, roughly an 11% increase on last year, and earnings per share of $5.50-$5.60. By 2017, it expects those figures to soar to $12 billion and $13-$14 per share; the company's fourth-quarter and full-year 2012 results will be published on January 24.