Associate

Celgene Corp. formed a promotion and distribution deal with GlaxoSmithKline plc for the pharmaceutical company's multiple myeloma product, Alkeran, now giving Celgene an official reason to be in contact with physicians in that disease arena.

The deal calls for Celgene, of Warren, N.J., to buy Alkeran tablets and Alkeran for injection from London-based GSK and then distribute the product under Celgene's label. Celgene will have no manufacturing or quality assurance responsibility. Financial details of the arrangement were not disclosed, but Brian Gill, Celgene's director of investor relations and public relations, said the deal opens doors for Celgene's sales force.

"Strategically, what this does for Celgene is, the sales force now has a legitimate, approved product for multiple myeloma," Gill told BioWorld Today.

He said no increase is expected in Celgene's existing sales force to handle the new drug. The sales force totals about 140, with 105 of them selling in the field. They call on oncologists, mostly those treating multiple myeloma.

Celgene's lead product, Thalomid (thalidomide), is approved for the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) in leprosy. It also is approved for maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. It is not approved for multiple myeloma, but the product is being used off-label for the disease, as well as in other cancers. Revimid, an analogue of Thalomid, is in pivotal trials in multiple myeloma, an indication for which it has been granted fast-track status, and metastatic melanoma.

In March, Celgene said clinical investigators presented data from pilot, open-label trials of Thalomid in complex regional pain syndrome at the annual meeting of the American Pain Society. Celgene initiated the trials based on a report of a patient with a three-year history of the disease who experienced a complete resolution of symptoms while receiving Thalomid in a multiple myeloma clinical trial at the Mayo Clinic.

Late in 2002, Celgene said it licensed Rockville, Md.-based EntreMed Inc.'s thalidomide analogue program for about $27 million. The companies had been in legal battles over patent issues surrounding thalidomide, but through the license agreement all suits were dropped and the matter settled. Celgene originally licensed thalidomide in 1998, but only for angiogenesis-related uses. (See BioWorld Today, Jan. 3, 2003.)

Now, while marketing and selling Alkeran, Celgene will be in the position to establish working relationships in the oncology community. Alkeran, a bifunctional alkylating agent, beyond being approved for multiple myeloma, is active against selective human neoplastic diseases and against both resting and rapidly dividing tumors. While "not a blockbuster by any means," Gill said, it generates about $15 million in revenue.

Celgene expects Thalomid to earn between $170 million and $180 million in 2003, an increase of 40 percent to 50 percent over 2002's figure of $119 million. It expects full-year earnings in the range of 5 cents to 10 cents per diluted share.

Celgene said it plans to investigate the use of Alkeran in other indications, and Gill said it has been suggested that using Alkeran with Thalomid "could optimize the effectiveness of both," so the company will explore that area. While Thalomid "has been meeting all our expectations," Gill said, he pointed to other areas inside Celgene as further reasons for the Alkeran deal.

Celgene has placental stem cell technology, including private umbilical cord and placental stem cell banking it got through the acquisition of Anthrogenesis Corp. That $45 million deal was disclosed in November. Alkeran is "used in stem cell transplant procedures," and Gill said Celgene would look at developing the product in that indication as well. (See BioWorld Today, Nov. 15, 2002.)

Celgene's stock (NASDAQ:CELG) rose 36 cents Monday to close at $25.55.