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Pharma news in brief

Our weekly round-up of news affecting the industry

Older products spur Novartis growth

Novartis says growth from older medicines such as heart drug Diovan and cancer pill Gleevec have fuelled a 13 per cent rise in third quarter profits. Net income for Europe's second largest drugmaker by market value rose to $1.67bn, or 71 cents a share, from $1.47bn, or 62 cents, a year earlier, above analysts' expectations. Novartis has spent about $9bn this year on acquisitions to add products to its generic and OTC drug units, including the purchase of Germany-based Hexal. The company reduced its estimate of the negative effects of these purchases on this year's net income. Profit will be reduced by between $175m and $250m from an earlier estimate of between $250m and $350m, it said.

Parallel traders lodge Pfizer complaint with EU

The European Association of Euro-Pharmaceutical Companies (EAEPC) has filed a complaint with the European Commission, accusing Pfizer of implementing an illegal dual-pricing system and an export ban in Spain. The parallel traders' association says the world's biggest pharma firm has signed contracts with a select group of Spanish wholesalers to ìexert control over distributionî in other EU states. ìThis is clearly in breach of Article 81 of the EU Treaty,î said Thilo Bauroth, head of the EAEPC legal affairs team. ìThis strategy also has a European rather than solely national impact and so should be investigated at a European level.î

Tysabri safety fears ease

Shares in Elan soared after a new safety study of its multiple sclerosis drug Tysabri showed no new cases of a potentially fatal brain disorder. The study in patients with Crohn's disease and rheumatoid arthritis (RA) showed no new confirmed cases of progressive multifocal leukoencephalopathy (PML), Elan and its US marketing partner Biogen said in a statement. The two companies are seeking to get Tysabri back on the market after its withdrawal in February following the death of an MS patient from PML. Two further cases were later confirmed, one of which also proved to be fatal.

OFT to look at cartels

The Office of Fair Trading (OFT) says it fears branded pharmaceutical manufacturers could be agreeing deals with generic drug companies to delay the arrival of cheaper drugs or keep price levels higher. Speaking to the Financial Times, new OFT chairman Philip Collins said that restricted access to distribution or long-term agreements with existing manufacturers could mean new products were finding it harder to break into the market. ìSo much in healthcare is about innovation, new products and new forms of treatment,î he said. ìYou don't want good ideas to be forestalled from coming to market because of misuse of market power or because of agreements between different manufacturers.î

Exubera closer to EU approval

A European Medicines Evaluation Agency committee has recommended the use of Pfizer and sanofi-aventis' inhaled diabetes treatment Exubera for the treatment of type 1 and type 2 diabetes in adults. Recommendations for marketing by the Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within 90 days. The European move follows a similar decision by the US Food and Drug Administration last month. Exubera has been touted as a possible blockbuster, although its path to market has been troubled by concerns about possible adverse effects on lung function.

Pfizer wins UK Lipitor patent case

The UK High Court of Justice has upheld a patent on Pfizer's blockbuster anti-cholesterol drug Lipitor, meaning that the active ingredient will remain protected from generic copies until 2011. However, the court sided with Indian generics company Ranbaxy Laboratories' argument that a more specific but secondary patent on a component of the same drug was invalid. Both companies said they would appeal the rulings they lost. Attention is now turning to a similar case in the US where a decision is expected to come from the District Court of Delaware in the coming months. More than half of Lipitor's $10.9bn in worldwide sales last year came from the US market.

30th September 2008


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