Genzyme Receives Positive Opinion for European Approval of Mozobil.
The committee's opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The Commission has 66 calendar days to act on the CHMP's opinion.
In the EU, Mozobil would be indicated in combination with granulocyte-colony stimulating factor to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilize poorly.
"For many patients with lymphoma or multiple myeloma, moving on to a transplant is their only hope for remission or a cure," said Gerhard Ehninger, Professor of Medicine at Dresden Technology University and Chairman of the German Society of Hematology and Oncology. "Mozobil is an innovative treatment that, upon approval, can give these patients an opportunity to achieve a timely and successful transplant."
In order for a blood stem cell transplant to take place, a minimum number of such cells must be collected. For many patients, this process can take three or four hours over multiple days to complete. Even then, some patients are not able to mobilize enough cells, and a transplant is not possible. Mozobil has been shown in clinical studies to rapidly and effectively increase the number of stem cells in circulation in the blood in patients with lymphoma and multiple myeloma.
In Europe, patients have received Mozobil through compassionate use and named patient programs.
In addition to its benefits for patients, Mozobil offers potential economic benefits to transplant centers by decreasing the number of days needed to collect stem cells, a procedure known as apheresis. This can provide transplant centers with a more predictable and efficient use of their apheresis centers. Mozobil may also reduce the number of patients who require a second mobilization procedure because of a failure to mobilize a sufficient number of cells.
Genzyme received FDA approval of Mozobil in December 2008. The company plans to submit additional applications in up to 60 countries.
Mozobil, a novel small molecule CXCR4 chemokine receptor antagonist, has been shown in multiple earlier 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. Once circulating in the blood, stem cells can be collected for use in an autologous stem cell transplant.
Important Safety Information
Mozobil is indicated in the United States for use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma. Prescribing physicians and patients should be aware of the 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. The most common adverse reactions ( 10%) reported in patients who received plerixafor in conjunction with G-CSF that were more frequent than in patients who received placebo were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness and vomiting. For full prescribing information, please visit www.genzyme.com.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements, including the statements regarding: the anticipated timing of the European Commission's decision regarding product approval, the anticipated labeled indication, expectations with respect to stem cell collection for patients trying to advance to transplant, the possible economic benefits to transplant centers associated with the use of Mozobil and the anticipated submission of marketing approval applications in up to 60 countries. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the failure to receive regulatory approval to commercialize Mozobil in Europe or other countries, the timing of regulatory authority decisions, the failure to realize the potential economic benefits to transplant centers associated with Mozobil, and risks associated with commercial launch and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the Genzyme Quarterly Report on Form 10-Q for the quarter ending March 31, 2009. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.
Genzyme([R]) and Mozobil([R]) are registered trademarks of Genzyme Corporation or its subsidiaries. All rights reserved.
|Printer friendly Cite/link Email Feedback|
|Date:||May 29, 2009|
|Previous Article:||Timothy McQuay Appointed Chairman of the Board of BSD Medical Corporation.|
|Next Article:||Last Chance to Register for First-Ever Susan G. Komen Global Race for the Cure[R].|