NVS » Topics » Gleevec/Glivec

This excerpt taken from the NVS 6-K filed Feb 9, 2010.
Gleevec/Glivec (USD 3.9 billion, +12% lc), a targeted therapy for some forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals. The latest approval in 2009 was for use in adjuvant (post-surgery) GIST patients, which is now approved in more than 55 countries in North America, Europe and Asia-Pacific.

 

This excerpt taken from the NVS 6-K filed Jan 26, 2010.
Gleevec/Glivec (USD 3.9 billion, +12% lc), a targeted therapy for some forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals. The latest approval in 2009 was for use in adjuvant (post-surgery) GIST patients, which is now approved in more than 55 countries in North America, Europe and Asia-Pacific.

 

This excerpt taken from the NVS 6-K filed Oct 27, 2009.
Gleevec/Glivec (USD 2.9 billion, +12% lc), a targeted therapy for some forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), has achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals. The latest approval was for use in adjuvant (post-surgery) GIST patients, which is now approved in more than 25 countries in North America, Europe and Asia-Pacific.

 

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This excerpt taken from the NVS 6-K filed Jul 17, 2009.
Gleevec/Glivec (USD 1.9 billion, +15% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), has achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals. Glivec received European regulatory approval in May 2009 as a post-surgery (adjuvant setting) therapy for GIST following Swiss (February 2009) and US (December 2008) approvals.

 

This excerpt taken from the NVS 6-K filed Apr 27, 2009.
Gleevec/Glivec (USD 894 million, +13% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), was a top driver of incremental sales growth in the first quarter based on leadership positions in treating these cancers. Gleevec was approved as the first post-surgery (adjuvant setting) therapy for GIST in the US (December 2008) and in Switzerland (February 2009), and also recommended for approval in Europe (March 2009). Data on these benefits in adjuvant GIST patients were published in “The Lancet” medical journal.

 

This excerpt taken from the NVS 6-K filed Feb 9, 2009.
Gleevec/Glivec (USD 3.7 billion, +15% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), sustained solid double-digit growth in 2008 based on strong clinical data and its status as the leading therapy for these and other life-threatening forms of cancer. In December 2008, Gleevec became the first FDA-approved treatment for use after GIST surgery (adjuvant setting). Similar submissions were made in the EU, Switzerland and other countries, with additional launches for this indication expected in 2009. Data from the landmark IRIS study at the American Society of Hematology meeting showed nearly 90% of CML patients in the study were still alive seven years after diagnosis when treated with Gleevec, demonstrating the longest overall survival observed to date in this disease area.

 

This excerpt taken from the NVS 6-K filed Jan 29, 2009.
Gleevec/Glivec (USD 3.7 billion, +15% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), sustained solid double-digit growth in 2008 based on strong clinical data and its status as the leading therapy for these and other life-threatening forms of cancer. In December 2008, Gleevec became the first FDA-approved treatment for use after GIST surgery (adjuvant setting). Similar submissions were made in the EU, Switzerland and other countries, with additional launches for this indication expected in 2009. Data from the landmark IRIS study at the American Society of Hematology meeting showed nearly 90% of CML patients in the study were still alive seven years after diagnosis when treated with Gleevec, demonstrating the longest overall survival observed to date in this disease area.

 

This excerpt taken from the NVS 6-K filed Oct 20, 2008.
Gleevec/Glivec (USD 2.8 billion, +16% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), has sustained solid double-digit growth during 2008 based on its status as the leading therapy for these and other life-threatening forms of cancer. Glivec has received priority review status from the FDA as the first therapy to be assessed for use after surgery for GIST (adjuvant setting). Phase III results published in 2007 showed a dramatic 89% reduction in risk of GIST returning after surgery in patients treated with Glivec compared to placebo. A decision by the FDA is expected by the end of 2008. Similar submissions have been filed in the EU and Switzerland, and will be filed in other countries.

 

This excerpt taken from the NVS 6-K filed Jul 18, 2008.
Gleevec/Glivec (USD 1.8 billion, +17% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), generated double-digit growth based on its status as the leading therapy for these and other life-threatening forms of cancer.

 

This excerpt taken from the NVS 6-K filed Apr 22, 2008.
Gleevec/Glivec (USD 888 million, +20% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), again delivered double digit growth and strengthened its leadership position in helping patients with these and other often-fatal forms of cancer. Data showing that 88% of Gleevec/Glivec patients with newly diagnosed Philadelphia chromosome-positive CML (Ph+ CML) were still alive after six years of treatment along with greater use in patients with metastatic GIST and various rare diseases led to strong growth in the US, where net sales rose 32%.

 

This excerpt taken from the NVS 6-K filed Feb 8, 2008.
Gleevec/Glivec, our pioneering anticancer medicine. In 2006 an Indian patent court rejected an application from Novartis seeking a patent for
This excerpt taken from the NVS 6-K filed Jan 23, 2008.
Gleevec/Glivec (USD 3.1 billion, +14% lc), a therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), reinforced its leadership in helping patients with these and other often-fatal forms of cancer. New data from the IRIS study in patients with newly diagnosed Philadelphia chromosome-positive CML (Ph+ CML) showed Gleevec/Glivec halted disease progression to more advanced stages completely in the sixth year of treatment and that 88% of Gleevec/Glivec patients in the trial were still alive. Gleevec/Glivec has also benefited from wider use in patients with GIST and in various rare diseases. Competition in the CML market in 2007 had little impact on underlying demand.

 

This excerpt taken from the NVS 6-K filed Oct 22, 2007.
Gleevec/Glivec (USD 2.2 billion, +14% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), expanded net sales based on improved survival rates for patients, expansion of the GIST market and use in rare diseases. Competition has also expanded the CML market, but it had little impact on underlying demand. During the third quarter, the FDA approved updated labeling that includes five years of data demonstrating an estimated overall survival rate of 89.4% in CML patients, confirming the generally well-tolerated safety profile in these patients.

 

This excerpt taken from the NVS 6-K filed Jul 19, 2007.
Gleevec/Glivec (USD 1.4 billion, +14% lc), a targeted therapy used in patients with certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) as well as other rare cancers, maintained strong growth thanks to improved survival rates for patients, expansion of the GIST market and use in newly-approved rare diseases. New competition had little impact on underlying demand. Data presented at the American Society of Clinical Oncology (ASCO) meeting showed one year of treatment with Gleevec/Glivec led to an 82% reduction in the risk of cancer returning in patients who underwent surgery for GIST tumors. These findings may lead to changes in clinical practice recommendations, and regulatory submissions are planned for 2008. Development of Gleevec/Glivec for use in an aggressive brain tumor known as glioblastoma multiforme was halted in the second quarter after study results showed no improvement in progression-free survival.

 

This excerpt taken from the NVS 6-K filed Apr 26, 2007.
Gleevec/Glivec (USD 674 million, +16% lc), a targeted treatment used primarily in patients with certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), grew rapidly despite new competition in both disease areas. Growth was driven mostly by increased survival of CML and GIST patients, expansion of the GIST market as well as new indications approved for various rare diseases. Positive interim data made public in April showed GIST patients treated after surgery with Gleevec/Glivec were significantly less likely to experience a return of their cancer over those not taking this medicine. Global submissions are planned.

 

This excerpt taken from the NVS 6-K filed Feb 14, 2007.
Gleevec/Glivec (USD 2.6 billion, +17% lc), a targeted treatment for patients with certain forms of chronic myeloid leukemia (CML) and gastro-intestinal stromal tumors (GIST), continued to expand at a rapid rate through ongoing penetration of the CML and GIST markets. New landmark data showed nearly 90% of CML patients in a five-year study taking Gleevec/Glivec were still alive after five years. Gleevec/ Glivec also received four EU and five US approvals for treating various rare diseases during 2006.

This excerpt taken from the NVS 6-K filed Jan 24, 2007.
Gleevec/Glivec (USD 2.6 billion, +17% lc), a targeted treatment for patients with certain forms of chronic myeloid leukemia (CML) and gastro-intestinal stromal tumors (GIST), expanded at an rapid rate through ongoing penetration of the CML and GIST markets. New landmark data showed nearly 90% of CML patients in a five-year study taking Gleevec/Glivec were still alive after five years. Gleevec/Glivec also received four EU and five US approvals for treating various rare diseases during 2006.

 

This excerpt taken from the NVS 6-K filed Oct 24, 2006.
Gleevec/Glivec (USD 1.9 billion, +18% lc), a targeted treatment for patients with certain forms of chronic myeloid leukemia (CML) and gastro-intestinal stromal tumors (GIST), received EU approval for treating another form of leukemia (Philadelphia chromosome positive acute lymphoblastic leukemia) and a hard-to-treat solid cancer tumor known as dermatofibrosarcoma protuberans (DFSP). Use of Glivec as a treatment for three other rare diseases remains under EU review. US review for all five rare cancers is ongoing. Penetration of the CML and GIST markets and the increasing number of patients thanks to improved survival have been key growth drivers. In the US, the first competitor product for patients with CML emerged in the third quarter.

 

This excerpt taken from the NVS 6-K filed Jul 18, 2006.
Gleevec/Glivec (USD 1.2 billion, +19% lc), for patients with all stages of Philadelphia-chromosome positive (Ph+) chronic myeloid leukemia (CML) and for certain forms of gastro-intestinal stromal tumors (GIST), maintained robust growth. New data at the American Society of Clinical Oncology (ASCO) showed nearly 90% of patients treated with Gleevec/Glivec for five years for CML were still alive and the yearly risk of progression to advanced disease declined the longer patients took the medicine. Growth has been driven by ongoing penetration of the CML and GIST markets, an increase in the average daily dose and the increasing number of patients thanks to improved survival.

 

This excerpt taken from the NVS 6-K filed Apr 27, 2006.
Gleevec/Glivec (USD 559 million, +18% lc), for patients with all stages of Philadelphia-chromosome positive (Ph+) chronic myeloid leukemia (CML) and for certain forms of gastro-intestinal stromal tumors (GIST), kept delivering double-digit sales growth. Ongoing penetration of the CML and GIST markets, an increase in the average daily dose and an increasing number of patients thanks to improved survival have supported sales. US and EU submissions for approval as a treatment for four rare types of cancer have been completed.

 

This excerpt taken from the NVS 6-K filed Jan 20, 2006.
Gleevec/Glivec has been submitted in the US, EU and Japan for Ph+ acute lymphoblastic leukemia (ALL).

 

This excerpt taken from the NVS 6-K filed Sep 21, 2005.
Gleevec/Glivec (imatinib mesylate), indicated for all stages of Philadelphia chromosome positive (Ph+) chronic myeloic leukemia (CML) and certain forms of gastro-intestinal stromal tumors (GIST), has recently received approval from the EMEA for increasing the average daily dose to 600 mg or 800 mg from 400 mg in patients with chronic phase CML and GIST. Gleevec is on track to be submitted by the end of 2005 in the US, EU and Japan as a treatment for Ph+ acute lymphoid leukemia (ALL) and other rare diseases. A registration program in glioblastoma multiforme, the most common and aggressive of the primary brain tumors, has been initiated.

 

                 

This excerpt taken from the NVS 6-K filed Feb 4, 2005.

Gleevec/Glivec

        Often, reaching patients in distant corners of the globe requires the same creativity and tenacity that drives scientists in our research labs. For the breakthrough cancer therapy Gleevec/Glivec, Novartis cooperated with the Max Foundation to develop one of the most generous and far-reaching patient assistance programs yet implemented on a global scale. These patient assistance initiatives in more than 70 countries have provided Gleevec/Glivec free of charge to more than 10 000 people who otherwise would not have had access to the drug to treat their life-threatening disease.

The Gleevec/Glivec International Patient Assistance Program (GIPAP), established for patients outside North America, is based on a "patient-direct" approach—ensuring deliveries to patients through a network of more than 500 registered physicians and more than 130 qualified treatment centers worldwide. The Max Foundation serves as administrator for GIPAP.

In India, GIPAP had to navigate financial, regulatory, legal and importation barriers to reach the eligible patient population. More than 3 000 people—an estimated 98% of patients who receive Gleevec/Glivec in India—have obtained the drug at no cost through the GIPAP program.

By contrast, Argentina's national health-care reimbursement scheme ensures full coverage for oncology treatment. However, patients still face life-threatening delays during the months needed to approve insurance reimbursement applications. Novartis has partnered with physicians—and Argentina's Ministry of Health—to provide eligible patients with interim access to Gleevec/Glivec until reimbursement is processed and approved. About 20% of the country's CML and GIST patients(1) have been unable to obtain Gleevec/Glivec in a timely manner through their healthcare provider, and turned to GIPAP for support.


(1)
Chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST).
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