Mozobil(TM) (plerixafor injection)
Potential health benefits   December 2008
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ALL RIGHTS RESERVED ZHION 2008. DO NOT TRANSFER THIS ARTICLE TO OTHER
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APPROVAL / USE / INDICATIONS

The Food and Drug Administration approved Genzyme's stem cell transplant drug
Mozobil and granted the treatment special status protecting it from competition for
seven years. [1]

STRENGTHS

-

MECHANISM / TREATMENT

Mozobil is a novel small molecule CXCR4 chemokine receptor antagonist. It has
been shown in multiple studies to rapidly and effectively increase the number of stem
cells in circulation in the blood in patients with non-Hodgkin's lymphoma and multiple
myeloma. [3]

Hematopoietic stem cells transplants are commonly used to treat patients with blood
cancers. Prior to the procedure, a minimum number of about two million stem cells
per kilogram (2.2 pounds) of body weight must be collected, Genzyme said. [2]

Mozobil is used for stem cell transplants in patients with the blood cancers
non-Hodgkin's lymphoma and multiple myeloma. Mozobil is approved for use with
blood growth factor stimulating agents, which help bone marrow cells to become
mature and begin circulating in the blood stream. [2] Current treatments often
involve chemotherapy or growth factors to achieve the same movement. [1]

COMMON SIDE EFFECTS/SAFETY/CONTRADICTION

There is a potential for tumor cell mobilization in leukemia patients, increased
circulating leukocytes and decreased platelet counts, splenic enlargement, and fetal
harm when administered to pregnant women. [3]

The most common adverse side reactions reported in patients who received Mozobil
in conjunction with granulocyte-colony stimulating factor that were more frequent
than in patients who received placebo were diarrhea, nausea, fatigue, injection site
reactions, headache, arthralgia, dizziness and vomiting.[3]

MANUFACTURER

Genzyme

SALES/MARKET/COMPETITION

In addition to its expected benefits for patients with non-Hodgkin's lymphoma and
multiple myeloma, Mozobil may offer economic benefits for transplant centers. The
product has the potential to decrease the number of apheresis days and provide
transplant centers with predictable and efficient use of the apheresis center. Mozobil
may also reduce the number of patients who require a second mobilization
procedure due to a failure to mobilize sufficient numbers of cells with current therapy
of granulocyte-colony stimulating factor alone. [3]

The company expects European approval of the drug in the second half of 2009. It is
also seeking approval in Australia and Brazil, and said approval applications in up to
60 countries were planned. [2]

Genzyme said peak annual sales of Mozobil for transplants could reach $400 million.
[1]

Reference
[1] Genzyme gets FDA OK on stem cell transplant drug Associated Press, 12.16.08,
07:30 [2] UPDATE 1-Genzyme says FDA OKs stem cell transplant drug Reuters Mon
Dec 15, 2008 5:52pm EST [3] FDA Approves Genzyme's Mozobil
Product provides enhanced mobilization of stem cells for autologous transplantation
in Non-Hodgkin's Lymphoma and Multiple Myeloma patients MarketWatch.com Last
update: 4:59 p.m. EST Dec. 15, 2008