Genzyme

November 16, 2009 -- Genzyme Corporation (Nasdaq: GENZ) announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme™ (alglucosidase alfa) for the treatment of Pompe disease. In its letter, the agency stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved.

Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed.    » read more »

November 13, 2009 -- Genzyme Corp. (Nasdaq: GENZ) announced today that it has issued letters to U.S. healthcare providers regarding its enzyme replacement products Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta), Myozyme® (alglucosidase alfa), Aldurazyme® (laronidase), as well as Thyrogen® (thyrotropin alfa for injection), filled at its Allston Landing manufacturing facility. The letters remind providers of the U.S. product labeling recommendations advising both visual inspection of vials and in-line filtration of enzyme replacement products to address the potential presence of foreign particles.    » read more »

October 6, 2009 -- CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.    » read more »

June 16, 2009 -- Genzyme Corporation (NASDAQ: GENZ) today announced that it has detected a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility. The company has decided to temporarily interrupt bulk production at the plant to sanitize the facility. Genzyme is collaborating with regulatory agencies as it works to resume production. The company expects the plant to be fully operational by the end of July.    » read more »

June 12, 2009 -- Genzyme Corporation (Nasdaq: GENZ) today announced that the European Commission has approved Renvela® (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels ≥ 1.78 mmol/L (5.5 mg/dL), and covers both the tablet and powder formulations.

“With this marketing authorization, Renvela is the first phosphate binder for patients not on dialysis approved through the centralized procedure in Europe,” said Dan Regan, Senior Vice President and General Manager of Genzyme’s renal business. “This is an important step toward improved patient care, and we are pleased that CKD patients in Europe will now have access to this proven therapy.”    » read more »

Assumes Primary Responsibility for Alemtuzumab in Multiple Sclerosis; Expands Hematologic Oncology Portfolio

June 2, 2009 -- Genzyme Corp. (Nasdaq: GENZ) announced today that it has completed the transaction with Bayer HealthCare to acquire the worldwide rights to Campath®/MabCampath® (alemtuzumab), giving Genzyme primary responsibility for the development and commercialization of this promising multiple sclerosis (MS) therapeutic candidate. Genzyme is conducting two rapidly progressing phase 3 studies of alemtuzumab in relapsing-remitting MS patients.    » read more »

May 29, 2009 -- Genzyme Corp. (Nasdaq: GENZ) today announced that the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has adopted a positive opinion on the marketing authorization application for Mozobil ® (plerixafor injection).

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.    » read more »

Genzyme Delivers Solid Financial Performance While Building for the Future

July 23, 2008 -- Genzyme Corporation (NASDAQ: GENZ) today reported strong sales and profit growth in the second quarter, along with significant progress in its commercial and clinical programs.

Revenue increased 25 percent to approximately $1.171 billion from $933.4 million in last year’s second quarter. The increase was driven by growth across all areas of the business.

GAAP net income was $69.6 million, or $0.25 per diluted share, compared with $83.8 million, or $0.31 per diluted share, in the second quarter a year ago. GAAP net income reflects the fee for the license to mipomersen, a highly promising cholesterol-lowering drug in late-stage development.    » read more »

October 4, 2007 -- Genzyme Corp. (NASDAQ: GENZ) announced today that it has received approval to market Elaprase® (idursulfase) in Japan for the treatment of Hunter syndrome. Elaprase is an enzyme replacement therapy developed by Shire Human Genetic Therapies Inc., and Genzyme is commercializing the product in Japan and other Asia Pacific countries under an agreement with Shire. Genzyme intends to launch Elaprase this quarter, following reimbursement approval.    » read more »

September 26, 2007 -- Genzyme Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).    » read more »

Project to Support the Increasing Global Need for Genzyme Products

September 18, 2007 -- Genzyme Corp. (Nasdaq: GENZ) today broke ground on a significant expansion of its flagship manufacturing facility at Allston Landing in Boston. The $150 million project is focused on adding space for manufacturing support functions, and will allow for the creation of 90 jobs.    » read more »

August 29, 2007 -- Genzyme Corporation today announced that results from the Dialysis Clinical Outcomes Revisited (DCOR) trial, the largest outcomes study ever conducted in the hemodialysis population, have been published in Kidney International. The three-year trial involving more than 2,100 patients compared the difference in outcomes for patients receiving Renagel® (sevelamer hydrochloride) with those using calcium-based phosphate binders.    » read more »

August 9, 2007 -- Genzyme Corp. (Nasdaq: GENZ) today announced that it has reached an agreement in principle to settle a class action lawsuit brought by a group of shareholders following the consolidation of Genzyme’s tracking stock structure in 2003.    » read more »