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Pharma news in brief

Our weekly round-up of news affecting the industry

Double boost for MabThera
The European Commission has approved Roche's top-selling cancer drug, MabThera, as a treatment for patients with rheumatoid arthritis.

The drug has been indicated as a combination treatment for adults with severe active rheumatoid arthritis, who have had an inadequate response or are intolerant to current treatment options, the Swiss company said.

MabThera has also won EC approval as maintenance therapy for European patients with relapsed or refractory follicular Non-Hodgkin's Lymphoma.

The recommendation was based on study results that showed MabThera maintenance therapy reduces the risk of death by almost 48 per cent compared to standard disease management.

Plavix deal under threat
A deal proposed by Bristol-Myers Squibb (BMS) and sanofi-aventis to end patent litigation over their blood-thinning drug, Plavix, could be thwarted by a previous legal agreement forbidding BMS from entering into such a settlement.

The two firms are negotiating with the Federal Trade Commission (FTC) over their deal with Apotex, which would provide the Canadian generics firm with a payment as well as permission to begin selling a generic version of Plavix almost a year before a key patent expires in 2012.

However, BMS's 2003 agreement with the FTC forbade it from entering into such an agreement without seeking the commission's opinion.

Altana opens tablet production plant
German firm, Altana, has opened a new pharmaceutical production facility in Cork, Ireland. The Ä67m plant currently employs 56 people, although the company said it expects to employ 150 people at full operational level.

The plant will primarily support production of Altana's most successful pill, Pantoprazole, for the treatment of acid-related gastrointestinal disorders, which has seen a rise in demand.

ìThe facility in Cork means that in addition to Oranienburg (Germany), Altana will have a second state-of-the-art, high-quality manufacturing site for solid formulations meeting the strictest international standards,î said Altana CEO, Dr Hans-Joachim Lohrisch.

Roche files Avastin for breast cancer
Roche has filed for its cancer drug, Avastin, for use in previously untreated breast cancer in European patients, following positive late-stage trial data.

The phase III study showed that adding Avastin to standard chemotherapy as a primary treatment for advanced breast cancer doubled the time women lived without the disease advancing, compared to chemotherapy alone.

Avastin was initially approved for use in advanced colorectal cancer in early 2005 in Europe and in 2004 in the US, and has also been filed for lung cancer use in the US.

Rebif gets EU green light for early MS use
The European Union has approved Serono's top-selling multiple sclerosis drug, Rebif, for use at an earlier stage of the disease.

Previously, doctors could only prescribe Rebif if patients had had two attacks - they can now do so if patients have had just one attack.

Analysts at Kepler Equities described the approval as ìgood newsî for Serono, even if it would not lead to a major boost in sales. Rebif had sales of $1.3bn, about half of Serono's overall sales.

30th September 2008


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