| It’s
beginning to look like Christmas for Millennium (NASDAQ:
MLNM)
as the company announced that it plans to submit a new drug
application (NDA) to the Food and Drug Administration (FDA) to
market its anti-cancer drug Velcade. Millennium said its
marketing application would be based on the final results from
Phase II patient testing. The company plans to release those
results from patients with relapsed/refractory multiple myeloma on
Monday, December 9th at the American Society of
Hematology (ASH) meeting. The presentation will demonstrate the clinical usage of Velcade in 202
patients and boosts earlier clinical data of Velcade in 78
patients.
ASH starts this
Friday, December 6th in Philadelphia and goes until
Tuesday, December 10th. Millennium will provide
important insights into the clinical profile of Velcade and
attention will be on the confirmation of the response rate
observed in the initial Phase II Velcade multiple myeloma study. Data from the previous Phase II clinical study of Velcade in multiple
myeloma patients demonstrated compelling anti-cancer activity with
47% of patients achieving a partial or complete response and 20%
achieving a complete response rate well above any other current
therapies. The second part of the study is the safety data,
which will be presented as well on Monday, December 9th.
If the new results are as encouraging as the previous data,
Millennium will redeem itself as a company with a viable and
marketable product, as multiple myeloma is extremely difficult to
treat.
Millennium said
that it plans to submit the NDA within the next few months to
market Velcade as a treatment for relapsed/refractory multiple
myeloma under a sub part H filing with the FDA. In other words, as
long as Millennium can provide clinical studies that are well
controlled and adequate, and support it with a larger random
trial, Velcade can be marketed. The drug gained FDA
"fast-track" status, which means it could be approved
six months after the application is submitted.
As we and others
see it Velcade is the key to Millennium’s success. Velcade is a
novel proteosome inhibitor and is being evaluated as a single
agent and in combination with other anti-cancer agents for a
variety of different malignancies. In addition to multiple myeloma,
Phase I/II trials are underway in lung, prostate, breast, ovarian,
melanoma, esophageal and gastric cancers. Currently,
Velcade is in Phase III study that began accruing patients in
July. According to the company, the study is on track and will be
completed.
Velcade appears to
work by causing cancer cells to self-destruct. The presentation of
data on Monday should give oncologist and investors a better
picture as to whether Velcade can pass the muster. We are betting
Velcade won’t disappoint investors.
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