Celgene will move forward with clinical studies for its oral Phase II lead TNF-alpha inhibitor CC10004 (apremilast) for treatment of psoriasis in light of positive proof of mechanism results reported earlier this year.

In announcing its second quarter results July 26, the firm said the next step in advancing its pipeline will be to meet with FDA to outline development for apremilast. That meeting is expected to take place later this year.

The Summit, N.J., biotech reported in May that a Phase II study of apremilast met its primary endpoint of superiority over placebo in two psoriasis scores after 12 weeks of treatment. The positive proof of mechanism results lead Celgene to believe that apremilast could be effective in a broad range of inflammatory diseases (¹ Also see "Celgene Reports Positive Psoriasis Results For Anti-Inflammatory Candidate" - Pink Sheet, 22 May, 2007.).

To date, Celgene has focused its development on hematology and oncology. However, one of the company's priorities is to "establish a new anti-inflammatory franchise," Celgene CEO Sol Barer said during a same-day conference call with investors.

"Our next steps include additional multi-center Phase II trials to determine the effect of extending duration of dosing of apremilast in the treatment of psoriatric arthritis ... open label trials in diseases such as recalcitrant psoriasis and [we] are currently evaluating possible protocol designs in psoriasis including moderate to severe disease and as the first systemic therapy after topical in combination with methotrexate," Celgene President Bob Hugin said.

Celgene has another TNF-alpha inhibitor, CC11050, which is in Phase I studies for multiple inflammatory diseases.

In earnings developments, Celgene reported a 76 percent increase in net revenues for the second quarter over the year-ago quarter. Its top product, Revlimid (lenalidomide), was the strongest driver of the net sales increase. Revenues from that product increased 187 percent year-over-year to $181 million for the quarter.

"Third-party market research indicates that physicians continue to move Revlimid to earlier lines of therapy with the largest market share growth in first and second-line treatment," Hugin said. "There was an approximately 25 percent increase in the number of patients receiving six or more dispenses in the second quarter as compared to the first quarter."

Revlimid is approved as a second-line treatment for multiple myeloma in the United States and is under investigation for first-line treatment (² Also see "Revlimid Data Could Support First-Line Use In Multiple Myeloma" - Pink Sheet, 5 April, 2007.). It is also approved for myelodysplastic syndromes. Celgene is exploring lenalidomide's activity in non-Hodgkin's lymphoma, chronic lymphocytic leukemia and T-cell lymphoma as well as solid tumors, including prostate cancers.

The European Medicines Agency approved Revlimid as a second-line treatment for multiple myeloma in April. Celgene said it expects to launch the drug in France and Ireland in the fall and in Italy and Spain in the first half of 2008.

-Pamela Taulbee (p.taulbee@elsevier.com)

Celgene Counts On Apremilast To Expand Inflammatory Disease Pipeline

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