by IainBate
5. February 2013 11:47
The European Commission has granted a marketing authorisation in the EU for Zaltrap to treat adults with metastatic colorectal cancer that is resistant or has progressed after initial treatment.
The decision was based upon evidence from Phase III trial data which showed Zaltrap to be the first and only agent to statistically significantly improve survival in combination with FOLFIRI chemotherapy after an oxaliplatin regimen.
Colorectal cancer is the most common cancer in both men and women in Europe and is the second leading cause of cancer death.
The treatment is marketed by Sanofi and Regeneron Pharmaceuticals.
Dr Debasish Roychowdhury, Senior Vice President and Head, Sanofi Oncology, thanked “physicians, patients and their families” for their efforts in getting the injection approved.
“We are thrilled to provide a new therapy that further extends the lives of patients with metastatic colorectal cancer and look forward to working with European health authorities to ensure patients have access to Zaltrap,” he said.
Dr George Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, added that the treatment “provides a new option to address the unmet medical need” across Europe.
Zaltrap received approval by the US FDA back in August 2012 following a priority review by the agency. It is also under review with other health regulators across the world.
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Tags: Zaltrap, European Commission, Zaltrap marketing authorisation, metastic colorectal cancer, European Union, Sanofi, Regeneron Pharmaceuticals, Dr Debahish Roychowdhury, Sanofi Oncology, Dr George Yancopolulous, FDA
Drugs
by emma
3. November 2011 14:27
Sales increased more than 10% at Sanofi in the third quarter to €8.7 billion, despite the loss of €471 million due to generic competition compared to the same period a year ago.
Total sales grew 10.1% along with an 11% increase in growth platforms after strong performances in its diabetes, vaccines and consumer health divisions.
Christopher A. Viehbacher, Sanofi CEO, says the return to growth in sales and earnings is an “important milestone as the company progressively puts the patent cliff behind it”.
Growth platforms and Genzyme accounted for 68.5% of total sales after the recently acquired business recorded sales up 6.9% to €768 million.
Pharmaceutical net sales were up a tenth to €6.9 billion and helped year-to-date net sales rise 5.5% to €20 billion, despite generic competition to Lovenox, Ambien CR and Taxotere in the US and Plavix (pictured) and Taxotere in the EU plus the impact of US healthcare reform and EU austerity measures.
Its diabetes division was driven by a strong US and Emerging Markets performance which resulted in a 12.4% increase in sales after Lantus recorded growth of 14.6% and 23.4%, in respective markets. Growth in Sanofi’s vaccine division also increased 16.7% after a solid demand for seasonal flu medication in the US.
The Sanofi Group now expects 2011 business net income to be between 2%-5% lower than last year’s total. “We continue to make strong progress in R&D with the submission of five new products and also in the tight control of our costs,” said Mr Viehbacher.
It was reported this week that Sanofi is set to overtake Pfizer as the world’s biggest pharmaceutical company by 2016.
Submissions have been recently filed for Lyxumia (lixisenatide) in the EU, Aubagio (teriflunomide) and Zaltrap (aflibercept) in the US; Visamerin/Mulsevo (semuloparin) in the US and EU; plus Kynamro (mipomersen) in the EU.
The company released its Q3 performance on the day it announced it was cutting jobs in its US R&D and sales divisions.
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