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NICKOLAS BUZAID
Clolar patient, Connecticut, U.S.A.
Nick was diagnosed with acute lymphoblastic leukemia (ALL) at age three, and over the next 17 years endured chemotherapy, an allogeneic bone marrow transplant (BMT) and three relapses. After Nick's third relapse at age 20 in 2004, his doctors used Clolar to get him into remission for another BMT. Today, Nick is a college business major in Maryland.  |
Oncology/
Endocrinology
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› CAMPATH®/MABCAMPATH® / alemtuzumab
› CLOLAR®/EVOLTRA® / clofarabine
› THYROGEN® / thyrotropin alfa for injection
Genzyme's Oncology and Endocrinology businesses comprise a number of important, novel therapies for leukemia and thyroid cancers. Each made significant progress in 2007.
The acquisition of Bioenvision, Inc. in 2007 brings us exclusive worldwide rights to clofarabine, creating a broader global platform for Genzyme cancer therapies. Clofarabine is marketed under the Clolar brand in North America and as Evoltra in Europe for the treatment of relapsed and refractory pediatric acute lymphoblastic leukemia (ALL). In 2007, we completed enrollment of a pivotal trial in the United States for clofarabine in adult acute myeloid leukemia (AML)-we expect to submit for FDA approval in the second half of 2008 and hope to begin marketing for this much-larger indication in 2009. A separate phase 3 pivotal study of clofarabine in adult AML patients aged 55 and over is underway.
Campath is the first and only humanized monoclonal antibody approved by the FDA for the treatment of B-cell lymphocytic leukemia (B-CLL). In 2007, we received marketing approval for Campath as a first-line treatment of B-CLL patients in the United States and Europe. This opens the potential for Campath to make a greater difference through use earlier in the course of the disease, more than tripling the number of patients who could benefit.
Genzyme's oncology pipeline contains a number of promising therapies, including several for solid-tumor cancers. In 2007, Genzyme clinical researchers completed enrollment in a phase 1 study in melanoma and renal cell cancer for TGFbeta antagonist GC1008, and we expect to complete phase 3 enrollment for a study of Campath in combination therapy with fludarabine for B-CLL in 2008. We also treated our first patient in a study of an oral formulation of clofarabine in myelodysplastic syndromes (MDS).
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JOAN SHEY
Thyrogen patient, New Jersey, U.S.A.
After undergoing a 1995 thyroidectomy related to thyroid cancer, Joan dealt with the effects of hypothyroidism during annual treatments for metastasies in her lungs. In 1998, Thyrogen changed that, making a major difference in the way she feels. Joan founded the Light of Life Foundation in 1997 to educate patients and promote thyroid cancer awareness.  |
In our Endocrinology business, Thyrogen, an important adjunct to thyroid cancer therapy, continued to expand and grow revenues globally. In 2007, Thyrogen received U.S. regulatory approval for use in thyroid cancer remnant ablation. This new indication significantly expands the patient population that can benefit from Thyrogen-of the approximately 35,000 thyroid cancer cases in the United States each year, an estimated 80 to 90 percent are candidates for ablation. We also expect to complete a phase 2 study of a new formulation of recombinant human TSH in goiter in 2008.
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