Genzyme related Press Releases

Genzyme Seeks U.S. Approval for Clolar® to Treat Adult AML

Calisha Myers — Mon, 24 Nov 2008 13:51:04 -0500

Genzyme Seeks U.S. Approval for Clolar® to Treat Adult AML

Indication Would Address Significant Unmet Medical Need and Expand Product Use

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ) announced today that it has filed a supplemental New Drug Application with the U.S. Food and Drug Administration for the use of Clolar® (clofarabine) to treat adult patients with acute myeloid leukemia (AML). The company has requested priority review of its application and, if granted, Clolar could be approved for this indication in the first half of 2009.A

Clolar is currently approved in the United States and Europe for the treatment of acute lymphoblastic leukemia (ALL) in relapsed and refractory pediatric patients one to 21 years old who have received at least two prior treatments, and it is now a standard of care in this setting. Genzyme is developing clofarabine globally for the treatment of adult AML, earlier-line pediatric ALL, and myelodysplastic syndromes (MDS), broader indications that the company estimates could drive peak annual sales of the product to approximately $600 million.

"Clolar has an important role in the treatment of pediatric leukemia and has great potential to help a broader set of patients with hematological disorders," said Beth Trehu, M.D., vice president and general manager for Clofarabine. "We are committed to fulfilling the potential of this product by expanding its indications and securing approvals globally."

Supplemental NDA filing

AML is a cancer characterized by the rapid proliferation of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The condition is the most common acute leukemia affecting adults.

Genzyme's supplemental NDA seeks approval for Clolar's use as a single agent in previously untreated adults aged 60 years or older with AML who have at least one unfavorable prognostic factor. Many older AML patients with unfavorable prognostic indicators currently have poor outcomes using available induction chemotherapy. Clolar, if approved, would fulfill an unmet need for this difficult to treat patient population. Approximately 30 percent of older adult patients with AML receive any form of chemotherapy.

According to the American Cancer Society, in 2008 approximately 13,290 people will be diagnosed with acute myeloid leukemia (AML) in the United States, and most AML patients will be adults. The median age of a patient with AML is about 67 years.

The median survival for those patients receiving the current available induction chemotherapy-which is associated with high mortality-can vary from 1 to 13 months, and the 5-year survival rate over the past three decades remains at less than 10 to 15 percent. Older AML patients often have disease features such as an adverse cytogenetics profile or pre-existing blood disorders such as MDS that result in lower response rates and worse treatment outcomes compared to younger patients treated with conventional combination chemotherapy. In addition, current therapies are poorly tolerated in older patients with unfavorable risk factors, such as advanced age and poor performance status.

Genzyme will use the results of the CLASSIC II study to support its label expansion filing. This large Phase 2 clinical trial demonstrated that patients with at least one pre-specified unfavorable prognostic factor who received single agent Clolar achieved a 45 percent overall remission rate, including a 40 percent complete remission rate and a 5 percent complete remission rate with incomplete platelet recovery. These data were presented in June at the American Society of Clinical Oncology meeting. Updated data will be presented in December at the American Society of Hematology (ASH) meeting in San Francisco.

Importantly, the 30 day all-cause mortality, one of the study's secondary endpoints, was 9.6 percent, which compares favorably to conventional induction chemotherapy, known as the "7 + 3" regimen, where the 30 day induction mortality ranges from 10-30 percent up to 50-80 percent with increasing age and worsening performance status.

These patients had manageable treatment-related side effects. The most commonly occurring adverse reactions included nausea, febrile neutropenia, vomiting, diarrhea, rash, increased alanine aminotransferase, increased aspartate aminotransferase, fatigue, pneumonia, fever, headache, neutropenia, anorexia, mucosal inflammation, pruritus, and thrombocytopenia.

"The therapeutic outcomes for older AML patients have not improved in the past 30 years," said Michael Vasconcelles, M.D., group vice president, Oncology Clinical Research. "These data highlight the potential of clofarabine to become an innovative and much needed treatment option for this group."

Updated CLASSIC II trial data from the independent response review panel, including disease free survival, will be presented next month in an oral presentation at the ASH annual meeting by Harry P. Erba, M.D., Ph.D., of the University of Michigan, a co-principal study investigator along with Hagop Kantarjian, M.D., of the University of Texas M.D. Anderson Cancer Center.

Product Expansion

Genzyme is working to expand clofarabine's availability worldwide. In Europe, where Clolar is sold under the trade name Evoltra® and where the incidence of adult AML is similar to that of the U.S., Genzyme anticipates filing for an expanded label in adult AML in 2009. Genzyme's European filing will include the CLASSIC II study as well as longer-term follow-up data. Genzyme is seeking approval for pediatric ALL and will seek approval for Clolar in adult AML in multiple countries throughout the world where the company has built an infrastructure base in the Hematology market through other products such as Thymoglobulin.

Clolar is also being evaluated in Phase 3 clinical trials to test its single agent efficacy and safety as a front-line therapy in adult AML, as well as in combination therapy for newly diagnosed and relapsed patients. Three Phase 2 study abstracts (#964,1936, and 2964) with Clolar in relapsed/refractory AML patients will be presented at ASH.

Genzyme is also pursuing indications for MDS, a group of conditions caused by abnormal blood-forming cells of the bone marrow. About 30 percent of MDS cases progress into acute myeloid leukemia. MDS incidence ranges from 12,000 to 20,000 cases per year in the U.S. and Europe. About 80 to 90 percent of MDS patients are older than 60 years of age. Genzyme is currently conducting MDS trials with an oral formulation of clofarabine to confirm the optimal dose and schedule, and is supporting other MDS cancer trials. An oral presentation (#222) of the MDS study results will be given at ASH.

In the pediatric setting, there are several ongoing studies exploring the usage of Clolar as combination therapy in relapsed/refractory ALL patients and in earlier lines of therapy. In the United States, the average incidence of ALL in pediatric patients is roughly 3,000 cases per year, and in the EU it is nearly 2,000. An abstract (#2925) on a Phase 1 and 2 trial using Clolar in combination in patients with relapsed/refractory acute leukemia will be presented at ASH.

About Clolar

Clolar has Orphan Drug designation for adult and pediatric ALL, and seven years of market exclusivity in the United States for relapsed/refractory pediatric ALL. The FDA also granted six months of extended market exclusivity to Clolar under the Best Pharmaceuticals for Children Act.

Clolar should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Suppression of bone marrow function, which is usually reversible and dose dependent, should be anticipated and is likely to increase the risk of infection, including severe sepsis.

Administration of Clolar results in a rapid reduction of peripheral leukemia cells. Patients should be evaluated and monitored for signs and symptoms of tumor lysis syndrome and cytokine release (e.g., tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome (SIRS), capillary leak syndrome, or organ dysfunction. Clolar should be discontinued immediately in the event of clinically significant signs or symptoms of SIRS or capillary leak syndrome, either of which can be fatal. The use of prophylactic steroids may be of benefit in preventing signs and symptoms of cytokine release.

The most common side effects seen after Clolar treatment, regardless of causality, were gastrointestinal tract symptoms, including vomiting, nausea, and diarrhea; hematologic effects, including anemia, leukopenia, thrombocytopenia, neutropenia, and febrile neutropenia; and infection.

Liver and kidney function should be assessed prior to and during treatment with Clolar, as the liver is a target organ for Clolar toxicity and Clolar is excreted primarily through the kidneys. Concomitant use of medications known to induce hepatic toxicity should be avoided.

Clolar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant and avoid breast feeding while receiving treatment with Clolar.

For more information about Clolar, please call 1-800-RX CLOLAR or visit www.CLOLAR.com.

About Genzyme

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 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

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 regarding Genzyme's future business plans and strategies, including statements regarding: the potential for receipt of U.S. marketing approval for Clolar for treatment of adult AML in the first half of 2009; Genzyme's assessment of the sales potential for Clolar in AML and MDS; plans to expand the approved indications for Clolar and secure global approvals for the product; plans to file for an expanded label in adult AML in the EU in 2009 and the expected timing for receipt of approval; and planned presentations of several Clolar trials at the upcoming ASH meeting. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. These risks and uncertainties include, among others: the timing and outcome of discussions with the FDA and EMEA regarding approval of Clolar in adult AML; the actual safety and efficacy of Clolar for the indications in which it is being tested, including MDS; Genzyme's ability to secure global approvals for adult AML and MDS; and the risks and uncertainties described in reports filed by Genzyme with the U.S. Securities and Exchange Commission, including without limitation the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.

Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.

Genzyme Reports Strong Third-Quarter Sales and Earnings Growth

Calisha Myers — Wed, 22 Oct 2008 10:15:17 -0400

Genzyme Reports Strong Third-Quarter Sales and Earnings Growth

Company Expects 2009 Non-GAAP EPS of Approximately $4.70

October 22, 2008--CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (NASDAQ: GENZ) announced today that third-quarter revenue rose 21 percent to $1.160 billion, compared with revenue of $960.2 million in the same period a year ago. The increase was driven by double-digit growth in every Genzyme business unit.

GAAP net income was $119.6 million, or $0.42 per diluted share, compared with $159.3 million, or $0.58 per diluted share, in last year's third quarter. Net income in this year's third quarter reflects a $100 million licensing fee for rights to PTC124, a promising genetic disease drug in late-stage development.

Non-GAAP net income rose 20 percent to $289.8 million from $241.3 million in the third quarter last year. Non-GAAP earnings grew 16 percent to $1.04 per diluted share compared with $0.90 per diluted share.

During the third quarter, Genzyme generated approximately $481 million in cash from net income prior to one-time events and proceeds from the issuance of common stock. The company has increased its cash position to approximately $1.5 billion while making investments to support long-term growth, including investments to expand manufacturing capacity, to offset dilution by repurchasing shares, and to complete strategic transactions that strengthen its late-stage pipeline.

"The third quarter was a very strong quarter financially and also extremely productive in terms of building for the future," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "Our broad geographic diversification, solid cash position, and group of market-leading products will allow us to sustain our growth through the current financial environment and over the longer term."

Genzyme is on track to meet its goal of 20 percent compound average non-GAAP earnings growth from 2006 through 2011. For 2009, the company expects non-GAAP earnings to increase to approximately $4.70 per diluted share. Non-GAAP earnings are projected to rise to approximately $7.00 per diluted share by 2011.

These estimates include the impact of Genzyme's redemption of its convertible senior notes. The company plans to redeem all $690 million of these notes as of December 1, 2008. The notes are redeemable in cash or can be converted to common stock at the option of the noteholders at a conversion price of $71.24 per share.

Near-Term Catalysts

Genzyme anticipates a number of potential approvals for new products or broader indications for existing products over the next several quarters. These catalysts will provide significant near term momentum:

FDA action on the BLA for Myozyme® (alglucosidase alfa) produced at the 2000L bioreactor scale is expected by November 29, 2008. An FDA advisory committee yesterday affirmed that the Late Onset Treatment Study established the clinical effectiveness of alglucosidase alfa produced at this scale.
European approval for 4000L-scale production of Myozyme is expected in the first half of next year.
FDA action is expected by December 16, 2008, on Genzyme's marketing application for MozobilTM (plerixafor), a product intended to prepare patients with certain types of cancers for a stem-cell transplantation. The application has priority review status. European approval of Mozobil is anticipated during the first half of next year.
Genzyme expects that the U.S. labeling for Clolar® (clofarabine) will be expanded by the middle of next year to include the treatment of adults with acute myelogenous leukemia. E.U. approval for this expanded indication is expected later in 2009.
In addition, Genzyme continues to work with the FDA toward a label expansion in mid-2009 for Renvela® (sevelamer carbonate) to include the treatment of chronic kidney disease. European approval of Renvela is also expected by the middle of next year.
FDA action on Genzyme's marketing application for Synvisc-ONETM (hylan G-F 20) is anticipated by December 23, 2008. The agency is expected to convene an advisory committee in December to discuss the marketing application.
Genzyme also anticipates achieving a number of important milestones within its late-stage pipeline that will have a significant near-term business impact. These include the initiation or completion of pivotal clinical studies and the publication of key study results. These milestones are detailed after the following summary of third-quarter sales.

Third-Quarter Product Sales

Within the Therapeutics business, Myozyme revenue increased to $76.7 million, 43 percent greater than revenue of $53.6 million in the same period last year. U.S. Myozyme sales have been constrained by the delay in approval for 2000L-scale production. Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee affirmed by a vote of 16-1 that the LOTS study established the clinical effectiveness of alglucosidase alfa produced at the 2000L scale. Genzyme expects FDA action on its BLA for this product by the PDUFA date of November 29. Approval of 2000L-scale production is needed to provide broader access to treatment for patients with late-onset Pompe disease in the United States.

Genzyme is also preparing to seek clearance from European authorities for 4000L-scale production of Myozyme at its manufacturing facility in Belgium. The company has successfully completed the required three consecutive process validation runs. In addition, preliminary data on the comparability of 4000L product with 2000L product are encouraging. Genzyme anticipates submitting an application for 4000L production in early January, and EMEA approval is anticipated during the first half of next year. Approval of 4000L-scale production will be necessary to meet the anticipated global demand for Myozyme. Product supply is expected to remain tight until the 4000-L process is approved.

Third-quarter sales of Fabrazyme® (agalsidase beta) increased 20 percent to $125.6 million from $104.6 million, driven primarily by an increase in the number of patients beginning therapy. Enrollment has begun in the post-marketing FIELD study of Fabrazyme, which is exploring additional dosing options that may facilitate early treatment of Fabry disease. Third-quarter sales of Cerezyme® (imiglucerase for injection) rose 8 percent to $309.3 million, compared with $286.1 million in last year's third quarter. Sales of Aldurazyme® (laronidase) were $38.2 million, 18 percent higher than sales of $32.3 million in the same period a year ago. Aldurazyme sales in last year's third quarter were recorded as joint venture revenue.

Sales of Thyrogen® (thyrotropin alfa for injection) rose 42 percent to $38.2 million from $26.8 million, driven by a significant increase in the use of the product in thyroid remnant ablation procedures and substantial international growth.

Within the Renal business, sales of sevelamer therapies Renagel® (sevelamer hydrochloride) and Renvela grew 11 percent to $171.0 million from $154.2 million in the third quarter of last year. Sevelamer's share of the competitive U.S. market for phosphate binders continues to grow, with slightly more than half of all prescriptions within this market now written for sevelamer therapies. The March launch of Renvela in the United States is contributing to this growth. The product is now included in most health plan formularies. Discussions with the FDA continue regarding broadening Renvela's use to patients with chronic kidney disease. Genzyme, along with two other companies, submitted a position paper to the FDA in June regarding the expanded use of phosphate binders. Genzyme is continuing to provide the FDA with additional information and anticipates that this indication will be added to Renvela's labeling by the middle of next year. Also next year, Genzyme expects to begin the international introduction of Renvela and to initiate enrollment in a clinical study of its next-generation advanced phosphate binder.

Within the Transplant business, third-quarter sales of Thymoglobulin® (Anti-thymocyte Globulin [Rabbit]) and Lymphoglobuline® (Anti-thymocyte Globulin [Equine]) rose 11 percent to $45.5 million from $41.0 million in last year's third quarter. Construction is well underway on a new manufacturing plant for Thymoglobulin in France to meet the anticipated long-term demand for the product. Regulatory approvals of the facility are expected beginning in 2010, and production at the plant is expected to begin in 2011.

Preparations continue for the 2009 launch of Mozobil in the United States and Europe. Genzyme expects FDA approval of the product by December 16, and European approval is expected next year. Mozobil is designed to mobilize stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for patients with lymphoma or multiple myeloma to receive a successful transplant.

Upon approval, Mozobil will be sold by Genzyme's newly formed bone marrow transplant sales force, with support from the company's Oncology sales force. Approximately 55,000 stem cell transplants are performed each year globally for multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma, and other conditions. Genzyme expects that, over time and with further clinical development, Mozobil will be used in the majority of these procedures, and peak sales of the product in the transplant setting are projected to reach $400 million annually. In addition to its expected benefits for patients, Mozobil may offer significant economic benefits for transplant centers. The product has the potential to decrease the number of apheresis days and provide transplant centers with more predictable and efficient use of the apheresis center, while reducing the number of patients who require a second mobilization procedure after failing to mobilize sufficient numbers of cells initially. More than 900 patients have already received Mozobil through a compassionate use program in the United States, and similar compassionate use programs have recently begun in Europe.

Oncology revenue rose 49 percent to $34.0 million, compared with $22.7 million in the third quarter last year, driven primarily by increasing sales of Clolar. The growth also reflects the addition of European sales of Clolar, which Genzyme began recording following its acquisition of Bioenvision Inc. late last year. Genzyme is working to introduce Clolar worldwide as well as expand its indications. The product is currently approved as a third-line treatment for pediatric patients with acute lymphoblastic leukemia. Genzyme is developing the product for use globally as a first-line therapy for adult AML and myelodysplastic syndromes, significantly larger indications that are expected to drive peak annual sales of the product to approximately $600 million. The company expects to submit a supplemental biologic license application this year to expand Clolar's U.S. labeling to include adult AML. FDA action is expected by the middle of 2009. A similar submission in Europe is expected during the first half of 2009. Within the Biosurgery business, sales of Synvisc® (hylan G-F 20) and Synvisc-ONE rose 10 percent to $67.5 million from $61.2 million in last year's third quarter. This growth was driven primarily by the increasing strength of Synvisc in the U.S. market. Genzyme is introducing Synvisc-ONE in a growing number of European and Southeast Asian countries. The product is designed to simplify osteoarthritis pain management and thereby reach a broader set of patients. Genzyme's marketing application for Synvisc-ONE will be the subject of an FDA advisory committee meeting in December. The panel is expected to discuss the clinical data Genzyme submitted to support the approval and labeling of the product. The FDA is expected to act on the application by December 23.

Also within the Biosurgery business, third-quarter sales of Sepra® products rose 25 percent to $33.0 million, compared with $26.4 million in the same quarter a year ago. Sales have been consistently strong over recent quarters, driven by the expanded use of Seprafilm® adhesion barrier in C-section and other gynecological procedures.

Third-quarter revenue for the Genetics business increased 12 percent to $82.1 million, compared with $73.1 million in last year's third quarter. This growth was driven in part by the continuing demand for prenatal screening for genetic conditions. Additionally, Genzyme is experiencing increasing demand for its diagnostics tests that assist oncologists in selecting the appropriate treatment for patients with certain types of cancer. The increasing recognition of the value of diagnostics in personalized medicine will continue to fuel organic growth in the Genetics business.

Operating Expenses

Third-quarter non-GAAP SG&A expenses were $306.9 million, compared with $245.2 million in the same period last year. GAAP SG&A expenses in this year's third quarter were $331.2 million. Non-GAAP R&D spending in the third quarter rose to $190.6 million, or 16 percent of revenue, compared with $162.3 million, or 17 percent of revenue, in the third quarter last year. GAAP R&D spending in this year's third quarter was $305.2 million.

Tax Rate

The non-GAAP tax rate for the third quarter was 27 percent, reflecting some benefit from Genzyme's investment in manufacturing infrastructure outside the United States. Going forward, the company expects the full-year non-GAAP tax rate to be 29 percent. The GAAP tax rate for the third quarter was 34 percent.

Key Pipeline Highlights

Alemtuzumab

Genzyme continues to enroll patients in two ongoing Phase 3 trials of alemtuzumab for the treatment of multiple sclerosis. Final results from the Phase 2 CAMMS 223 study comparing alemtuzumab with Rebif® (interferon beta-1a) for the treatment of relapsing-remitting multiple sclerosis are expected to be published imminently in a top medical journal. Publication of the study results underscores the potential of alemtuzumab for patients with MS and should support enrollment in the two ongoing Phase 3 studies.

Mipomersen

Genzyme and Isis Pharmaceuticals Inc. are developing the novel lipid-lowering drug mipomersen for patients with high-cholesterol who are at high risk for cardiovascular disease. The companies have completed enrollment in the Phase 3 trial involving patients with homozygous familial hypercholesterolemia, a genetic disorder that causes exceptionally high levels of LDL cholesterol. Results from the study are expected in mid-2009, and the submission of a U.S. marketing application for this indication is anticipated during the second half of 2010. The companies in August began a Phase 3 study of mipomersen that involves patients with heterozygous familial hypercholesterolemia, and three additional trials evaluating mipomersen's safety and efficacy in reducing LDL cholesterol in high-risk patients are expected to begin by the end of this year. Data from the trials will also inform the design of a morbidity and mortality outcome study.

GENZ-112638

Genzyme expects to begin two Phase 3 studies during the first half of next year of GENZ-112638, an investigational oral therapy for Gaucher disease. Final results from the open-label Phase 2 study of the compound are expected to be available early next year. Preliminary results from an interim analysis were consistent with those observed for patients beginning enzyme replacement therapy, and they highlight the potential of this compound to provide a convenient treatment alternative for patients and a broader range of treatment options for physicians.

PTC124

Genzyme and PTC Therapeutics formed a global collaboration in July to develop and commercialize PTC124, PTC's novel oral therapy in late-stage development for the treatment of genetic disorders due to nonsense mutations. PTC124 is currently being evaluated in a Phase 2b trial for Duchenne muscular dystrophy. A Phase 2b trial in cystic fibrosis is expected to begin by the end of this year, following the August publication of a proof of concept study in the Lancet.

Gene therapy for cardiovascular disease

Genzyme anticipates presenting final results from its Phase 2 study of HIF-1a for patients with peripheral arterial disease at a major medical meeting early next year. The study enrolled nearly 300 patients at approximately 40 medical centers in the United States and Europe and explored the treatment's potential to promote the growth of new blood vessels and improve circulation in patients' limbs.

Gene therapy for Parkinson's disease

Genzyme is collaborating with Ceregene Inc. on CERE-120, a treatment intended to preserve neuronal function in Parkinson's disease patients. Results from a Phase 2 study of CERE-120 are expected in early 2009. In a complementary program, Genzyme has also completed enrollment in a Phase 1 study of a treatment designed to restore the therapeutic effectiveness of levodopa, the primary treatment for Parkinson's disease.

On September 22, Genzyme opened its new Science Center in Framingham, MA. The facility serves as a central site for early stage research. In addition, for the sixth consecutive year, Genzyme was selected by scientists as a top employer in a survey ranking the reputations of biotechnology and pharmaceutical companies. Genzyme placed third among 500 companies included in the survey, its highest ranking to date. The survey is managed by the journal Science and the American Association for the Advancement of Science.

This press release contains forward-looking statements regarding Genzyme's financial outlook and business plans and strategies, including without limitation: its 2009 and 2011 earnings guidance and 2006-2011 CAGR guidance; its expectations for FDA action in the US on aglucosidase alfa produced at the 2000L-scale, and the timing thereof; its plans to submit an application in the EU for Myozyme produced at the 4000L-scale, its expectations for receipt of approval of that application, and the timing thereof; its assessment of the adequacy of Myozyme product supply; its plans to seek regulatory approvals of existing products for use in new indications, including Renvela for CKD patients not on dialysis and alemtuzumab for MS, the timetables therefore and the impact of such approvals on the company; its plans and estimated timetables of the receipt of clinical trial results, commencement of new trials, submission of regulatory filings, receipt of regulatory responses and product launches for new and next generation product candidates, including for Mozobil, Clolar, Synvisc-ONE, mipomersen, GENZ-112638, PTC124, HIF-1a, CERE-120 and the next generation APB; its estimate of the sales potential of Mozobil and benefits for patients and transplant centers; its estimate of the non-GAAP 2008 tax rate; its expectations for the receipt of regulatory approvals and commencement of production of Thymoglobulin at its new manufacturing plant in France, and the timing thereof; and its estimate of the sales potential for Clolar. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: Genzyme's ability to obtain and maintain regulatory approvals for products and manufacturing facilities and processes, including aglucosidase alfa produced at the 2000L scale in the US and at the 4000L scale in Europe, the timing of receipt of such approvals and the scope of such approvals; Genzyme's ability to successfully complete clinical development of its product candidates, including Mozobil, Clolar, mipomersen, Genz-112638, PTC124, HIF-1a, CERE-120 and the next generation APB; Genzyme's ability to expand the use of current and next-generation products in existing and new indications by receiving positive regulatory responses, including for Renvela and Synvisc-ONE; Genzyme's ability to manufacture its products, including Thymoglobulin and its LSD therapies in a timely and cost effective manner and in sufficient quantities to meet demand; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's 2008 Quarterly Report on Form 10-Q for the quarter ended June 30, 2008. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today's date and Genzyme undertakes no obligation to update or revise the statements.

Genzyme®, Myozyme®, Fabrazyme®, Cerezyme®, Thyrogen®, Renagel®, Renvela®, Thymoglobulin®, Synvisc®, Campath®, Clolar®, Sepra®, Seprafilm®, and Lymphoglobuline® are registered trademarks of and MozobilTM and Synvisc-ONETM are unregistered trademarks of Genzyme or its subsidiaries. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. All rights reserved.

About Genzyme

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 diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, cardiovascular disease, and other areas of unmet medical need.

Conference Call Information

Genzyme will host a conference call today at 11:00 a.m. Eastern to discuss results for the third quarter of 2008. To participate in the call, please dial 1-773-799-3828 and refer to passcode "Genzyme." A replay of this call will be available by dialing 402-998-1342. This call will also be Webcast live on the investor events section of www.genzyme.com. Replays of the call and the Webcast will be available until midnight October 29, 2008.

Upcoming Events

Genzyme will host a conference call on February 11, 2009 at 11:00 a.m. Eastern to discuss financial results for the fourth quarter of 2008, and 2009 Guidance. To participate in the call, please dial 1-773-799-3828 and refer to pass code "Genzyme." A replay of this call will be available by dialing 402-998-1342. This call will also be Webcast live on the investor events section of www.genzyme.com. Replays of the call and the Webcast will be available until midnight on February 18, 2009.

GENZYME CORPORATION (GENZ)

Consolidated Statements of Operations

Three Months Ended

Nine Months Ended

(Unaudited, amounts in thousands, except per share amounts)

September 30,

September 30,

2008

2007

2008

2007

Total revenues

$
1,160,284

$
960,159

$
3,431,479

$
2,776,761

Operating costs and expenses:

Cost of products and services sold (1,2)

285,208

244,612

857,851

664,673

Selling, general and administrative (1,3)

331,170

270,306

996,861

878,807

Research and development (1,4)

305,242

175,800

949,900

540,362

Amortization of intangibles

55,295

49,819

166,558

149,301

Total operating costs and expenses

976,915

740,537

2,971,170

2,233,143

Operating income

183,369

219,622

460,309

543,618

Other income (expenses):

Equity in income (loss) of equity method investments (5)

-

(12,648
)

188

(1,091
)

Minority interest

566

5

1,592

3,932

Gain (loss) on investments in equity securities, net (6)

(14,129
)

1,105

(4,201
)

14,036

Other

(699
)

913

(840
)

110

Investment income

11,793

18,222

40,015

51,687

Interest expense

(792
)

(1,474
)

(3,596
)

(9,283
)

Total other income (expenses)

(3,261
)

6,123

33,158

59,391

Income before income taxes (1)

180,108

225,745

493,467

603,009

Provision for income taxes (1)

(60,512
)

(66,432
)

(159,036
)

(201,715
)

Net income (1)

$
119,596

$
159,313

$
334,431

$
401,294

Net income per share:

Basic

$
0.44

$
0.61

$
1.25

$
1.52

Diluted (1,7)

$
0.42

$
0.58

$
1.19

$
1.45

Weighted average shares outstanding:

Basic

269,176

262,775

267,767

263,387

Diluted (1,7)

288,179

279,206

286,003

279,898

(1)

In accordance with the provisions of Financial Accounting Standards Board, or FASB, Statement of Financial Accounting Standards No., or FAS, 123R, "Share-Based Payment, an amendment of FASB Statement Nos. 123 and 95," we recorded pre-tax charges for stock-based compensation expense and related tax benefits of:

Three Months Ended

Nine Months Ended

September 30,

September 30,

2008

2007

2008

2007

Cost of products and services sold

$
(6,926
)

$
(5,779
)

$
(19,751
)

$
(18,540
)

Selling, general and administrative expense

(24,222
)

(25,091
)

(79,015
)

(82,838
)

Research and development expense

(14,645
)

(13,518
)

(43,322
)

(44,973
)

Total pre-tax charges for stock-based compensation expense

(45,793
)

(44,388
)

(142,088
)

(146,351
)

Tax benefit

14,025

14,093

43,396

45,228

Stock-based compensation expense, net of tax

$
(31,768
)

$
(30,295
)

$
(98,692
)

$
(101,123
)

Diluted earnings per share and diluted weighted average shares outstanding for the three and nine months ended September 30, 2008 and 2007 were computed according to the provisions of FAS 123R.

(2)

Includes pre-tax charges of $(4,787)K recorded in September 2008 to write off one finished lot and $(11,773)K recorded in September 2007 to write off four finished lots of our Thymoglobulin inventory, which did not meet our specifications.

(3)

Includes a pre-tax charge of $(64,000)K recorded in June 2007 to settle the litigation related to the consolidation of our former tracking stocks.

(4)

In 2008, includes pre-tax charges of:

- $(100,000)K recorded in July 2008 for a nonrefundable upfront fee we paid to PTC Therapeutics, Inc. ("PTC") related to our collaboration agreement with PTC to develop and commercialize PTC124 for the treatment of nonsense-mutation-mediated Duchenne muscular dystrophy and nonsense-mutation-mediated cystic fibrosis;

- $(175,000)K recorded in June 2008 for a nonrefundable upfront license fee we paid to Isis Pharmaceuticals, Inc. ("Isis"); and

- $(69,900)K recorded in February 2008 for a nonrefundable fee we paid to Isis for the mipomersen license.

In 2007, includes a pre-tax charge of $(25,000)K recorded in June 2007 for an upfront milestone payment paid to Ceregene Inc. related to the development and commercialization of certain gene therapy products.

(5)

In 2007, includes a pre-tax charge of $(19,150)K for the three months ended September 30, 2007, related to our completion of the first step of the two step process under which we acquired Bioenvision, Inc. In July 2007, we acquired approximately 22% of the outstanding shares of Bioenvision common stock on an as-converted basis, including all outstanding shares of Bioenvision preferred stock, for $(72,229)K of cash. Subsequently, in October 2007, following a favorable merger vote by Bioenvision's shareholders, we completed the second step of the acquisition process and effective October 23, 2007, acquired the remaining outstanding shares of Bioenvision common stock. The full purchase accounting for the acquisition of Bioenvision, including the impact of the second step, was reflected in our consolidated financial statements in October 2007.

(6)

In 2008 includes:

- a net pre-tax charge of $(14,268)K recorded in September 2008, consisting of charges of $(10,000)K to write off our investment in ZyStor Therapeutics, Inc. and $(5,310)K to write down our investments in certain venture capital funds to fair value, offset in part by a gain of $1,042K representing cash formerly held in escrow from the sale of our investment in Therapeutic Human Polyclonals, Inc. ("THP") in March 2007; and

- a net pre-tax gain of $9,015K recorded in the second quarter of 2008, consisting of a gain of $10,304K resulting from the liquidation of our investment in the common stock of Sirtris Pharmaceuticals, Inc., offset in part by an impairment charge of $(1,289)K related to our investment in the common stock of GTC Biotherapeutics, Inc.

In 2007 includes a pre-tax gain of $10,848K recorded in March 2007 on the sale of our entire investment in the common stock of THP, which had a zero cost basis.

(7)

In accordance with the provisions of Emerging Issues Task Force Issue No. 04-8, "The Effect of Contingently Convertible Debt on Diluted Earnings Per Share," the shares issuable upon conversion of our $690.0 million in principal of 1.25% convertible senior notes are included in diluted weighted average shares outstanding for purposes of computing diluted earnings per share, unless the effect would be anti-dilutive. Accordingly, interest and debt fees related to these notes of $1.9 million, net of tax, for the three months ended September 30, 2008 and 2007, and $5.7 million, net of tax, for the nine months ended September 30, 2008 and 2007, have been added back to net income in the applicable period and the 9,686K shares issuable upon conversion of these notes have been included in diluted weighted average shares outstanding for each of those periods for purposes of computing diluted earnings per share.

GENZYME CORPORATION (GENZ)

Condensed Consolidated Balance Sheets

September 30,

December 31,

(Unaudited, amounts in thousands)

2008

2007

Cash and all marketable securities

$
1,473,373

$
1,460,394

Other current assets

1,757,902

1,661,740

Property, plant and equipment, net

2,268,854

1,968,402

Intangibles, net (1)

3,338,605

2,959,480

Other noncurrent assets (2)

480,226

251,725

Total assets

$
9,318,960

$
8,301,741

Current liabilities

$
1,429,252

$
1,502,406

Noncurrent liabilities (1)

655,794

186,398

Stockholders' equity

7,233,914

6,612,937

Total liabilities and stockholders' equity

$
9,318,960

$
8,301,741

(1)

Effective January 1, 2008, in connection with the restructuring of BioMarin/Genzyme LLC, our joint venture with BioMarin Pharmaceutical Inc., we licensed certain rights to commercialize Aldurazyme from the joint venture and, in accordance with the provisions of FASB Interpretation No. 46R, "Consolidation of Variable Interest Entities," began consolidating the results of the joint venture at fair value. As of September 30, 2008, intangibles, net, includes $480,500K for the fair value of the joint venture's manufacturing and commercialization rights to Aldurazyme, offset by $(18,019)K of related accumulated amortization. Our noncurrent liabilities as of September 30, 2008, includes $462,481K of additional net liabilities related to the fair value of these rights. Excluding these rights, the fair value of the assets and liabilities of the joint venture as of September 30, 2008 was not significant.

(2)

As of September 30, 2008, other noncurrent assets includes $80,100K for the fair value of the five million shares of Isis common stock that we purchased in February 2008.

GENZYME CORPORATION

RECONCILIATION OF GAAP TO NON-GAAP EARNINGS

For the Three Months Ended September 30, 2008

(Amounts in thousands, except percentage and per share data)

Dilution

Due to

Common Stock

License

Gain (Loss) on

FAS 123R

GAAP

NON-GAAP

Equivalents

Fee

Investments

Amortization

Expense

As Reported

Income Statement Classification:

Total revenues

$
1,160,284

$
1,160,284

Cost of products and services sold

$
(278,282
)

$
(6,926
)

$
(285,208
)

Gross margin

76
%

$
882,002

$
(6,926
)

75
%

$
875,076

Selling, general and administrative

$
(306,948
)

$
(24,222
)

$
(331,170
)

Research and development

$
(190,597
)

$
(100,000
)

$
(14,645
)

$
(305,242
)

Amortization of intangibles

$
-

$
(55,295
)

$
(55,295
)

Purchase of in-process research and development

$
-

$
-

Equity in income (loss) of equity method investments

$
-

$
-

Minority interest

$
566

$
566

Gains (losses) on investments in equity securities

$
139

$
(14,268
)

$
(14,129
)

Other

$
(699
)

$
(699
)

Investment income

$
11,793

$
11,793

Interest expense

$
(792
)

$
(792
)

Summary:

Income (loss) before income taxes

$
395,464

$
-

$
(100,000
)

$
(14,268
)

$
(55,295
)

$
(45,793
)

$
180,108

(Provision for) benefit from income taxes

27
%

$
(105,671
)

$
-

$
8,750

$
3,673

$
18,711

$
14,025

34
%

$
(60,512
)

Net income (loss)

$
289,793

$
-

$
(91,250
)

$
(10,595
)

$
(36,584
)

$
(31,768
)

$
119,596

Net income (loss) per share:

Basic

$
1.08

$
-

$
(0.34
)

$
(0.04
)

$
(0.14
)

$
(0.12
)

$
0.44

Diluted (1)

$
1.04

$
(0.03
)

$
(0.32
)

$
(0.03
)

$
(0.13
)

$
(0.11
)

$
0.42

Weighted average shares outstanding:

Basic

269,176

269,176

Diluted (1)

278,493

9,686

288,179

(1)

GAAP As-Reported diluted earnings per share and diluted weighted average shares outstanding reflect the adoption of EITF 04-8. In accordance with the provisions of EITF 04-8, interest and debt fees related to our 1.25% convertible senior notes of $1,885K, net of tax, have been added back to net income and approximately 9,686K shares have been added to diluted weighted average shares outstanding for purposes of computing GAAP As-Reported diluted earnings per share.

GENZYME CORPORATION

RECONCILIATION OF GAAP to NON-GAAP CASH GENERATED

For the Three Months Ended September 30, 2008

(Amounts in thousands)

NON-GAAP Cash Generated of $481,269K includes NON-GAAP net income of $289,793K less depreciation, net of tax, of $23,881K plus proceeds from the issuance of common stock of $167,595K.

FDA Advisory Panel to Discuss Genzyme's Myozyme BLA on Tuesday

Calisha Myers — Fri, 17 Oct 2008 15:34:23 -0400

FDA Advisory Panel to Discuss Genzyme's Myozyme BLA on Tuesday

Meeting Will Focus on Clinical Data Supporting 2000 L Process

CAMBRIDGE, Mass.--(BUSINESS WIRE)--October 17, 2008--Genzyme Corporation (Nasdaq: GENZ) today announced that its U.S. Biologic License Application (BLA) for Myozyme® (alglucosidase alfa) produced at the 2000 L bioreactor scale will be discussed this Tuesday, October 21^st, at a public meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in Silver Spring, Maryland. This product is intended for the treatment of Pompe disease, a progressive, debilitating and life-threatening inherited disorder affecting approximately 2,000 people in the United States. The meeting will focus on the clinical outcomes of the Late Onset Treatment Study (LOTS), including statistical analyses of the study results, safety and the indication for alglucosidase alfa.

Genzyme's LOTS study was a randomized, double-blind, placebo-controlled clinical trial that enrolled 90 patients. The co-primary efficacy endpoints were the Six-Minute Walk Test (6MWT) and percent-predicted Forced Vital Capacity (FVC). These co-primary endpoints were prospectively agreed upon with the FDA and are considered the most clinically relevant measures of walking ability and pulmonary function, respectively, for patients with late-onset Pompe disease. The co-primary endpoints achieved statistical significance according to the statistical analysis plan for the primary efficacy endpoints.

The results showed that, at 18 months, patients treated with alglucosidase alfa increased their distance walked in six minutes by an average of 28 meters, as compared with the placebo group, which did not show any improvement from baseline (ANCOVA; p<0.035). Percent-predicted FVC, the co-primary endpoint, increased in the treated group by one percentage point at 18 months. In contrast, FVC declined by approximately three percentage points in the placebo group over the same period (ANCOVA; p<0.0055). The results for both efficacy endpoints were consistent across various prospectively defined subgroups.

Earlier this week, Genzyme learned that the FDA will use a sensitivity analysis as the primary analysis for the 6MWT for discussion at the panel meeting. Genzyme believes that the application of this sensitivity analysis is not appropriate for this trial. Genzyme believes that the pre-specified primary analysis demonstrates the efficacy of the 2000 L product.

Additionally, the LOTS safety data demonstrate that alglucosidase alfa produced at the 2000 L scale has an acceptable safety profile in late-onset patients. The number of patients with serious and treatment-emergent non-serious adverse events was similar in the alglucosidase alfa and placebo groups. Twenty-eight percent of patients in the treatment group compared to 23 percent in the placebo group experienced infusion-associated reactions. Allergic symptoms were more frequent during infusion-associated reactions in the treatment group. Similar to the 160 L experience, five percent of patients experienced anaphylaxis and two thirds of these were able to continue treatment. There was one death in the Myozyme group unrelated to treatment.

"Genzyme believes that the LOTS safety and efficacy data, in combination with additional clinical and post-marketing safety data, support a full approval of alglucosidase alfa produced at the 2000 L scale for patients with late-onset Pompe disease," said Genzyme Senior Vice President Alison Lawton. "We look forward to a productive discussion of these data at the advisory committee to facilitate a successful first-cycle approval for the 2000 L process and thereby assure a continued supply of alglucosidase alfa, the only treatment for patients with Pompe disease."

Genzyme currently has U.S. approval to sell Myozyme, manufactured at the 160 L scale, and the company has been seeking clearance from the FDA for 2000 L-scale production. Genzyme submitted a separate BLA for alglucosidase alfa produced by the 2000 L manufacturing process on May 30^th, following a determination by the FDA that alglucosidase alfa produced at the 160 L and 2000 L scales should be considered as two separate products because of comparability differences.

Genzyme is proposing the following indication for the product produced at the 2000 L scale: "Alglucosidase alfa is indicated for long-term use in patients with late-onset Pompe disease (GAA deficiency). Alglucosidase alfa has been shown to improve distance walked and stabilize pulmonary function in patients with late-onset Pompe disease." Late-onset patients are currently defined for the clinical studies as patients who develop clinical manifestations of the disease after two years of age, and who have no cardiac involvement.

Formal FDA action is expected on Genzyme's BLA by November 29, 2008. Genzyme anticipates that the FDA review process will culminate in the availability of two commercial versions of alglucosidase alfa in the United States: one produced at the 160 L scale and the other produced at the 2000 L scale. Production of Myozyme at the 2000 L scale has been approved for the use in all patients with Pompe disease in more than 40 countries. Approximately 1000 patients worldwide are on treatment.

To ensure that severely affected adults with Pompe disease in the United States have access to treatment, Genzyme, in collaboration with the FDA, created the Myozyme Temporary Access Program (MTAP) in May 2007. Through this program, the company is currently providing Myozyme produced at the 2000 L scale free of charge to approximately 160 patients. U.S. demand for alglucosidase alfa has now increased to the extent that it is no longer feasible for Genzyme to supply product to additional adult patients under the MTAP program. FDA approval of 2000 L production scale is needed to provide broader access to treatment for adult patients in the United States. There are approximately 50 - 100 patients identified who are waiting for access to treatment.

FDA and Genzyme briefing documents for Tuesday's advisory committee meeting are available on the FDA's Website.

Prior to the public advisory committee meeting, Genzyme and the FDA will meet with the advisory panel members in closed session to discuss proprietary manufacturing information. During this morning session, the discussion will focus around the biochemical characteristics of alglucosidase alfa produced at the 2000 L scale and its comparability to product produced at the 160 L scale.

About Pompe Disease

Pompe disease manifests as a broad spectrum of clinical symptoms. All patients typically experience progressive muscle weakness and breathing difficulty, but the rate of disease progression can vary widely depending on the age of onset and the extent of organ involvement. When symptoms appear within a few months of birth, babies frequently display a markedly enlarged heart and die within the first year of life. When symptoms appear during childhood, adolescence or adulthood, patients may experience steadily progressive debilitation and premature mortality due to respiratory failure. They often require mechanical ventilation to assist with breathing and wheelchairs to assist with mobility.

About Myozyme

Myozyme (alglucosidase alfa) is indicated for use in patients with Pompe disease (GAA deficiency). The U.S. product label includes a boxed warning with information on the potential risk of hypersensitivity reaction. Life-threatening anaphylactic reactions, including anaphylactic shock, have been observed in patients during Myozyme infusion. Because of the potential for severe infusion reactions, appropriate medical support measures should be readily available when Myozyme is administered. Full prescribing information for the product, including a complete list of the most common adverse reactions, is available on myozyme.com.

About Genzyme

This press release contains forward-looking statements regarding Genzyme's business plans and strategies, including without limitation: its expectations regarding receipt of FDA approval of the alglucosidase alpha 2000 L process BLA and the timing thereof; its expectations regarding the content of the discussions at the Advisory Committee meeting, including that no vote on whether to recommend approval of the BLA will be taken; and its expectation that both the 160 L scale and 2000 L scale materials will be commercially available in the US. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: Genzyme's ability to actually obtain FDA approval of the alglucosidase alpha 2000 L process in November 2008; that the Advisory Committee meeting is not positive or focuses on content different than what the Company anticipates; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10Q for the quarter ended June 30, 2008. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today's date and Genzyme undertakes no obligation to update or revise the statements.

Genzyme Begins Enrollment in Post-Marketing Study to Evaluate Use of Low Dose Fabrazyme Treatment for Fabry Disease

Calisha Myers — Wed, 15 Oct 2008 13:41:00 -0400

Genzyme Begins Enrollment in Post-Marketing Study to Evaluate Use of Low Dose Fabrazyme Treatment for Fabry Disease

CAMBRIDGE, Mass.--(BUSINESS WIRE)--October 15, 2008--Genzyme Corporation (Nasdaq: GENZ) announced today that the company has begun enrollment in a world-wide post-marketing clinical trial evaluating the efficacy and safety of treating pediatric male patients with mild Fabry disease symptoms with a low-dose regimen of Fabrazyme® (agalsidase beta). Data from the "Fabrazyme: Intervening Early at a Lower Dose (FIELD)" study may support supplemental submissions to regulatory agencies seeking additional dosing options that facilitate early treatment for Fabry disease.

"This treatment regimen might be more adapted for those patients with milder symptoms of the disease, providing them flexibility in their treatment options. The ability to provide a lower or less frequent dose of Fabrazyme for pediatric patients with milder symptoms may translate to some patients receiving the treatment early," said Dr. Uma Ramaswami, metabolic pediatrician at Addenbrooke's Hospital in Cambridge, UK, and co-principal investigator for the FIELD study.

Up to 20 institutions across Europe, the U.S., Canada and Latin America are expected to participate in the study. The trial will examine the efficacy and safety of two lower-dose regimens of Fabrazyme in male patients aged 5 to 18 years over the course of five years. Patients will receive either half the recommended dose of Fabrazyme every two weeks (0.5mg/kg of body weight) or a dose of 1mg/kg every four weeks. Fabrazyme at the recommended dose of 1mg/kg every two weeks has been approved in more than 40 countries, including the U.S. and Canada, as well as throughout the European Union, for the treatment of Fabry disease.

"We are very excited to be a part of this important study," said Dr. Paul Fernhoff from the Emory University School of Medicine and one of the clinicians conducting FIELD in the U.S. "We know that Fabry disease is a progressive disorder in which irreversible damage occurs, sometimes very early in life, and feel that intervention prior to this damage may be vital to improved patient outcomes."

About Fabry Disease

Fabry disease is one of a group of rare diseases called lysosomal storage disorders. It is characterized by excessive accumulation of the lipid GL-3 in various organs and tissues, which over time can cause renal, cardiac and cerebrovascular events. As a result, patients with Fabry disease typically have a shortened life span, and children must often cope with significant pain and disability. Fabry disease is an inherited and life threatening disease linked to the X chromosome which affects approximately 5,000 patients in the world.

Important Safety Information about Fabrazyme

Fabrazyme is indicated for use in patients with Fabry disease. Fabrazyme reduces GL-3 deposition in the capillary endothelium of the kidney and certain other cell types. The reduction of GL-3 inclusions suggests that Fabrazyme may ameliorate disease expression: however, the relationship of GL-3 inclusion reduction to specific clinical manifestations of Fabry disease has not been established.

The most serious and most common adverse reactions reported with Fabrazyme are infusion reactions. Serious and/or frequently occurring related adverse reactions consisted of one or more of the following events: chills, pyrexia, feeling hot or cold, dyspnea, nausea, flushing, headache, vomiting, paresthesia, fatigue, pruitus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, edema peripheral, myalgia, back pain, pallor, bradycardia, urticaria, hypotension, face edema, rash, and somnolence. The occurrence of somnolence can be attributed to clinical trial specified pre-treatment with antihistamines. Patients should be given antipyretics prior to infusion. Infusion reactions occurred in some patients after receiving pre-treatment with antipyretics, antihistamines, and oral steroids. Full prescribing information can be found at www.fabrazyme.com

About Genzyme

Science survey ranks top biopharma employers

Calisha Myers — Fri, 10 Oct 2008 10:42:43 -0400

Science survey ranks top biopharma employers

Science's annual survey of Top Employers polls employees in the biotechnology, biopharmaceutical, pharmaceutical, and related industries. Respondents to the web-based survey are asked to rate companies based on 23 driving characteristics, including financial strength, easy adaptation to change, and a research-driven environment.

This year, Genentech, Inc., of South San Francisco, California, regains top honors in a ranking of the world's most respected biopharmaceutical employers. The company placed first in the first five years that Science has carried out this survey. Monsanto of St. Louis, Missouri, comes in a close second, with Genzyme of Cambridge, Massachusetts, completing the top three.

This year's survey identified 17 other pharmaceutical and biotechnology companies, making up a top 20 of biopharma employers.

The rankings, determined from a study conducted by an independent research firm commissioned by the business office of the journal, will appear in a special business feature of the 10 October 2008 issue.

Like Science's 2007 ranking of biopharma employers, the 2008 survey sought to identify the companies with the best reputations as employers, based on almost 4,000 survey responses from readers of Science and other respondents in industry. Twenty percent of the respondents came from outside the United States, primarily Western Europe, and 92 percent worked in private industry.

Survey responses were analyzed by Senn-Delaney Culture Diagnostics & Measurement, which used a mathematical process to assign a unique score to rate the companies' employer reputation. Each company received a ranking, for example, on the basis of whether it treats its employees with respect, whether its work-culture values align with employees' personal values, and other factors.

###

For the complete business office feature with individual company rankings, go to http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2008_10_10/science.opms.r0800061. The article will not be posted at this URL address until the evening of 9 October 2008.

The American Association for the Advancement of Science (AAAS) is the world's largest general scientific society, and publisher of the journal, Science (www.sciencemag.org). AAAS was founded in 1848, and includes some 262 affiliated societies and academies of science, serving 10 million individuals. Science has the largest paid circulation of any peer-reviewed general science journal in the world, with an estimated total readership of one million. The nonprofit AAAS (www.aaas.org) is open to all and fulfills its mission to "advance science and serve society" through initiatives in science policy, international programs, science education, and more. For the latest research news, log onto EurekAlert! at www.eurekalert.org, the premier science-news Web site, a service of AAAS.