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Velcade's Wider OK Could Pose Problems for Revlimid
(BioWorld Today Via Acquire Media NewsEdge) Cambridge, Mass.-based Millennium Pharmaceuticals Inc., now a subsidiary of Japanese firm Takeda Pharmaceuticals Inc., won U.S. marketing approval Friday to expand the labeling of Velcade (bortezomib) as a first-line treatment in patients with multiple myeloma.
The drug previously was approved to treat patients with the disease who have received at least one prior therapy. It also had gained approval in 2006 to treat patients with mantel cell lymphoma.
Velcade's expanded labeling is expected to put more pressure on its chief competitor, Summit, N.J.-based Celgene Corp.'s Revlimid (lenalidomide), which is approved for multiple myeloma only as a second-line combination therapy with dexamethasone.
Celgene's other multiple myeloma drug, Thalomid (thalidomide), however, is approved as a first-line treatment. But it, too, is expected to face rivalry from Velcade.
While Thalomid and Revlimid, an analogue of thalidomide, carry strict black-box warnings about the drugs' teratogenic effects to human fetuses - thalidomide has a notorious history of causing severe disfiguring birth defects - Velcade has not been shown to be a teratogen and does not have the boxed warning. However, Velcade's labeling warns that women should avoid becoming pregnant while using the drug.
Although the approval of Velcade's expanded use was largely anticipated by Wall Street, analysts were surprised by the broader-than-expected labeling, which allows the drug to be used in patients eligible and ineligible for transplants.
And even more importantly, said analyst Christopher Raymond, of Robert W. Baird & Co., the labeling does not specify any particular chemotherapeutic backbone with which the drug must be used.
With the broad labeling, he said, Velcade can be marketed for use with any chemotherapy combination, providing Millennium's and Takeda's sales forces with what will be significant advantage vs. Celgene's products.
In addition, Raymond noted that a front-line Velcade regimen costs roughly half that of Revlimid.
A front-line course of Revlimid can cost roughly $70,000 for about one year, whereas Velcade for the same course costs about $35,000, he said.
For its supplemental new drug application (sNDA) filing, Millennium examined Velcade in combination with melphalan and prednisone in patients with newly diagnosed multiple myeloma in an international, multicenter, open label, active-control Phase III trial, known as VISTA.
Patients were randomized to receive either nine six-week cycles of oral melphalan-prednisone plus Velcade or melphalan-prednisone alone - the control arm.
Results from VISTA showed that 30 percent of the 344 patients in the Velcade group experienced a complete remission compared with 4 percent of the 338 patients in the control arm. Patients treated with Velcade also experienced a survival benefit, according to Millennium.
However, Raymond noted, because VISTA used melphalan-prednisone, which is a less commonly employed regimen in the U.S., some observers at last year's annual meeting of the American Society of Hematology had postulated that Velcade's impact on the market might be limited.
But, he said, combining the expanded labeling with "what we think is a marked efficacy advantage and a significant cost advantage . . . we think it's plausible some private payers may begin to specify Velcade as the front-line agent of choice." Velcade also may have a lead with respect to physician profit margins, Raymond surmised.
"Given that physicians receive reimbursement for injectable agents and given our belief that reimbursement-based profitability contributes to physician decision making, we think that Velcade may also receive an advantage in this area over that of the oral Revlimid," he projected.
Raymond noted that Celgene has three Phase III trials examining Revlimid as a front-line therapy for multiple myeloma. If the firm were to file for an expanded approval of the drug under an accelerated process, it would more than likely do so in the second half of this year, he said.
However, Raymond noted, Celgene's MM-015 Phase III study, which is investigating Revlimid in combination with melphalan-prednisone vs. melphalan-prednisone alone, is still ongoing and may only finish enrollment this quarter.
If Celgene chooses to use that study for its sNDA filing, with final data likely available in the second half of 2009, the company would more than likely not submit its application until later in 2009, he said.
And if the sNDA for Revlimid were not filed until 2009 year-end, Raymond said, "we think that this timing may give Velcade an advantage in the front-line setting for quite some time."
But analyst Michael Aberman, of Credit Suisse Securities LLC, said that even if Celgene chooses to wait for the MM-015 data, which he said is the most likely scenario, he thinks Revlimid will be the "ultimate winner in the front-line setting."
Shares of Celgene (NASDAQ:CELG) closed at $59.74 Monday, up 16 cents. n
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