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From Oranienburg to the rest of the world: global market launch of Daxas® (Roflumilast) kicks off in Germany
Stefan Brinkmann, Managing Director of Nycomed GmbH, kicked off the German market launch of Daxas® (Roflumilast) in Oranienburg today, making Germany the first country to market the medicine. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that was developed by Nycomed to treat the progressive, life-threatening lung disease COPD.

  • First new substance class in the area of chronic obstructive pulmonary disease (COPD) in more than a decade
  • New treatment option for 700,000 patients in Germany with severe COPD and chronic bronchitis
  • Improves lung function and reduces exacerbation in combination with bronchodilator treatment
  • Daxas® – a German success story: research and development in Konstanz; worldwide production in Oranienburg
“This is a very special day for Nycomed in Germany, as Daxas allows us to offer a new treatment option to 700,000 patients in Germany. However, Daxas is also a success story for the German pharmaceutical industry. The product was researched and developed at our research facility in Konstanz and we are pleased that Nycomed Oranienburg was selected as the production site to supply the global market,” said Managing Director Stefan Brinkmann.
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Data from Mipomersen Phase 3 Trial in heFH Patients Presented at ESC
Genzyme Corp. and Isis Pharmaceuticals Inc. announced that data from the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) were presented today at the European Society of Cardiology’s Congress 2010 in Stockholm, Sweden. The study met its primary endpoint with a 28 percent reduction in LDL-cholesterol, compared with an increase of 5 percent for placebo (p<0.001). The trial also met all of its secondary and tertiary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in other mipomersen studies.
This double-blind, placebo-controlled phase 3 study was designed to test the efficacy and safety of adding mipomersen to stable lipid-lowering therapy. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. The trial included 124 adult heFH patients at 26 sites in the United States and Canada. All of the patients had pre-existing coronary artery disease and LDL-C levels greater than 100 mg/dL, and were taking a maximally tolerated dose of a statin, as well as additional lipid-lowering drugs in most cases. Prior to study enrollment, 78 percent of patients had previously experienced at least one cardiovascular event and 49 percent had more than one previous cardiovascular event.
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Women’s saris may save lives in Pakistan
The colourful garment, the sari, which is worn by the majority of women in South-East Asia may be a powerful tool in the fight to save the victims of the floods in Pakistan from life-threatening cholera infections. Research from Bangladesh has shown that filtering polluted water through an old used sari almost removes the cholera bacteria and thereby reduces the incidence of cholera substantially. This simple and low-tech solution may be of great importance to people’s health and survival in remote areas hit by floods.
Pakistani women’s cotton saris can be used to filter the water to remove dangerous – potentially deadly – cholera bacteria from the water so that it can be used as drinking water.
"The flooding has contaminated the drinking water with organisms that cause diseases such as cholera”, says Anders Dalsgaard, professor at LIFE - Faculty of Life Sciences at University of Copenhagen. For a large number of years he has been demonstrated through DNA fingerprint techniques how potentially toxic cholera bacteria spread between countries and continents during epidemics.
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Biotage Introduces Resolux™ Peptides Purification HPLC Columns to Address Increasing Global Demand
Biotage, a leading supplier of tools and technology for medicinal and analytical chemistry, has launched a new range of HPLC columns optimized for peptide purification. The Resolux™ line was introduced during the ACS Fall 2010 National Meeting & Exposition in Boston, Massachusetts USA and will be premiered at the 31st European Peptide Symposium on September 5th in Copenhagen, Denmark.
The new Resolux line from Biotage delivers purification solutions for very short peptides up to large chains by offering consumables in three different pore sizes. The new line will be available in three different surface chemistries, covering the range from hydrophobic peptides to hydrophilic. Resolux products are engineered to provide the selectivity and high resolution required for the most demanding peptide purification. The products include analytical, semi-prep and preparative HPLC columns from 2.1 mm to 30 mm diameter, for predictable scale-up from micro-gram to multi-gram scale.
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Genzyme rejects Sanofi-Aventis offer
Biotechnology company Genzyme Corp. said Monday it rejected Sanofi-Aventis SA's $18.5 billion buyout offer because it undervalues the company.
On Sunday, French drug developer Sanofi-Aventis offered $69 per share for Genzyme ( GENZ - news - people ), which has been struggling in the aftermath of manufacturing problems for key drugs.
In a letter to Sanofi-Aventis, Genzyme Chairman and CEO Henri A. Termeer said the board unanimously rejected the offer. He said the board is "not prepared to engage" in negotiations with an "unrealistic" starting price.
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