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Pharma news in brief

Our weekly round-up of news affecting the industry

SkyePharma signs key Flutiform marketing deal
SkyePharma has finally signed a US marketing agreement for its key asthma treatment, Flutiform, with Kos Pharmaceuticals, a deal which could be worth up to $165m. The UK firm said it had received $25m in upfront payments, and could receive a total of $165m in milestone payments on achievement of all regulatory and revenue targets, plus royalties. It is hoping to secure a European marketing deal in the next few months. SkyePharma had been pursuing a Flutiform deal since 2003, a fact that was not lost on disgruntled investors who succeeded in forcing the firm's former chairman, Ian Gowrie-Smith, to resign. In March, their proposal to oust chairman Jerry Karabelas was narrowly defeated in a shareholder vote.

Roche boosts HDL pipeline
Roche has acquired exclusive rights to Trimeric Apo A-I, an experimental drug to raise HDL cholesterol, being developed by privately owned Danish biotech firm, Borean Pharma. The drug is an early-stage preclinical compound and is a version of the naturally occurring protein apolipoprotein A-I, the major protein component of High Density Lipoprotein (HDL) or “good cholesterolâ€. The HDL market is growing, with some researchers predicting that such treatments will become very effective in preventing heart attacks and strokes. Roche licensed rights to another HDL cholesterol drug from Japan Tobacco in October 2004.

Elan bullish on Tysabri re-launch
Irish firm, Elan, is bullish about its chances of re-launching multiple sclerosis drug, Tysabri, in the European Union and the US in the third quarter of this year. Sales of the drug were suspended in the US last year, after three patients on combination therapy including Tysabri, contracted a rare neurological disease called progressive multifocal leukoencephalopathy (PML). The US Food and Drug Administration's advisory committee has advised that the treatment be introduced as a monotherapy in the US; its decision is due by June 28. The European Medicines Agency's advisory committee has recommended Tysabri only be used as a treatment for relapsing MS patients. Elan markets the drug with Biogen in the US.

Sanofi vaccines sales offset generic impact
Growing sales of vaccines at sanofi-aventis have helped to soften the negative impact of generic competition to some of the company's biggest-selling drugs. Sanofi reported net income of €1.51bn ($1.92bn) for the quarter, including charges of €661m resulting from its takeover of Aventis in August 2004. Excluding these charges, the company said profit for the quarter increased 54 per cent from €1.42bn a year earlier. Total pharmaceutical sales rose by 3.3 per cent to €6.5bn, with two top drugs, Allegra and Amaryl were hit by generic competition.

FDA gives warning to Pliva
Croatian firm, Pliva, has been warned by the US Food and Drugs Administration that it must take 'corrective action' after the regulator inspected its plant in Zagreb. “The management is addressing this issue very seriously and is in the process of implementing a corrective action plan, which was submitted to the FDA in April,†said Pliva in a statement. The company added that it would not receive any new approvals for new treatments “while these issues are being addressedâ€, but said the management did not expect any material impact on its 2006 financial outlook.

30th September 2008


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