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12:00 AM
Aug 16, 2004
 |  BioCentury  |  Finance

Ebb & Flow

Investors reacted badly to Monday's post-market news that Barr (BRL) will receive a license from Cephalon (CEPH) to sell generic oral transmucosal fentanyl starting Feb. 3, 2007.

CEPH was off $4.86 (10%) to $43 on Tuesday and closed the week down $6.07 (13%) at $42.01, even though the company said that were it not for the license, it probably would not have gone forward with its acquisition of Cima, which closed last week (see B3).

"All along, we've said that we would not close the deal if we would have had to divest either Actiq or Cima's OraVescent fentanyl" to satisfy FTC requirements, said CEPH spokesperson Chip Merritt.

Both products are for breakthrough cancer pain. CEPH gained Actiq oral transmucosal fentanyl when it acquired Anesta in 2000. Last quarter, Actiq posted sales of $85.6 million, up 63% from the 2003 period. Nevertheless, CEPH wanted to acquire Cima because it had OraVescent fentanyl in Phase III testing. That merger was announced last year (see BioCentury, Nov. 10, 2003).

CEPH believes ease of use is a potential advantage of the OraVescent version over Actiq. The latter is used as a lozenge on a stick, which could be of particular concern for cancer patients with mucositis, as transmucosal absorption is stimulated by rubbing the lozenge across the cheek. The CIMA product is a fast-dissolve transmucosal formulation.

In addition, Cima's version has patent coverage until 2019, while Actiq loses patent protection in March 2007, assuming it gets a pediatric extension. CEPH plans to seek the extension in 2005 based on a trial in children that it hopes to start this year.

CEPH initially will seek approval of OraVescent fentanyl for cancer pain, but said it may look at moving into breakthrough pain for a host of other conditions. The company hopes to receive FDA approval in late 2006, which would trigger BRL's license to Actiq.

Merritt said investors might be concerned about CEPH trying to launch OraVescent fentanyl during the same period that BRL starts selling its generic version of Actiq. "But we'll take one year of launch issues for twelve years of patent-protected growth any day," he said.

A bag too full

Despite having a significant presence in the rheumatology market with its Enbrel TNF inhibitor, Amgen (AMGN) last week decided there wasn't room in its reps' bags for rheumatoid arthritis (RA) drug Kineret anakinra. Thus, the company granted NPS (NPSP) exclusive rights to promote the IL-1 receptor antagonist to rheumatologists in exchange for a percentage of incremental revenues. "When we acquired Immunex, we decided to focus on Enbrel in the rheumatology market," said AMGN spokesperson Christine Cassiano. "Now, patients who can't receive a TNF inhibitor will have a sales force that is focused on Kineret."

AMGN doesn't break out Kineret sales. In the second quarter, Enbrel posted sales of $440 million, up 45% from second quarter 2003 sales of $304 million. In addition to RA, Enbrel is marketed for psoriatic arthritis and ankylosing spondylitis.

For NPSP, the deal will let it make inroads with rheumatologists and form a sales force in anticipation of FDA approval for its Preos recombinant human parathyroid hormone to treat osteoporosis. NPSP said it plans to submit an NDA for Preos by year end. The company plans to start detailing Kineret in the first quarter of 2005....

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