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Pharma news in brief

Our weekly round-up of news affecting the industry

High interest speeds Boots deal

The level of interest in Boots' over-the-counter business, Boots Healthcare International, has been so strong that the firm is gearing up to reach a sale by the end of September - some six to seven months earlier than CEO Richard Baker had originally planned. The company has reportedly whittled the list of potential buyers down to just six, which are thought to include GlaxoSmithKline, Bayer and Reckitt Benckiser. BHI has been valued at between £1.05bn and £1.3bn, though speculation centres on a final figure nearer to £1.5bn or £1.6bn. A Lehman Brothers research note hinted that Reckitt Benckiser could afford such a stretch and its shareholders are keen to buy.

Fluarix accelerated onto US market

Good news for GlaxoSmithKline came in the form of a marketing approval from the Food and Drug Administration for Fluarix, its influenza vaccine for people aged 18 and over. The vaccine was the first such product to be cleared through the FDA's accelerated approval process, which is designed to allow certain products onto the market quickly - that treat serious or life-threatening illnesses. The FDA based its decision on safety and efficacy data from four clinical studies, involving approximately 1,200 adults, in combination with post-marketing data from countries where the product was already available. GSK will undertake further trials to verify the clinical benefit - that the vaccine can generate protective levels of antibodies against influenza virus types A and B.

AZ rules out a GSK merger

Outgoing AstraZeneca CEO Sir Tom McKillop has nipped in the bud growing speculation of a potential merger with British pharma leviathan GlaxoSmithKline (GSK) after rumours of a permanent tie-up circulated on the back of his resignation. Some industry analysts have suggested that following AZ's pipeline setbacks the company could benefit by joining forces with GSK, which would in turn enjoy a more powerful presence in key cardiovascular and cancer markets. The move would also keep tabs on the rising French contingent in Europe, after the merger of Sanofi and Aventis. Yet, McKillop has denied all rumours and reiterated AZ's commitment to achieving organic growth.

US action on counterfeit Lipitor

Further to the recent security breaches of the UK's supply chain, where two cases of fake Lipitor broke through the safety net, the US Food and Drug Administration (FDA) has announced the indictments of 11 individuals, including a drug repacker and two wholesale distributors. The charges include conspiracy to sell counterfeit, illegally imported and misbranded drugs, which includes the manufacture of counterfeit Lipitor at a facility in Central America, as well as conspiracy to sell stolen drugs, the purchase of genuine Lipitor for distribution in South America and illegal importation of both versions into America. The announcement follows an earlier one from the FDA assuring Americans some weeks ago that the UK's Lipitor-related supply breaches would not be duplicated stateside. It is understood that any non-legitimate Lipitor has now been withdrawn from the US market.

BMS seeks to fill COX-2 gap

Bristol-Myers Squibb is hoping to fill the hole in the rheumatoid arthritis market left by the withdrawal of, and unfavourable disposition towards, several COX-2 inhibitors. The firm has applied to market abatacept, which will be branded Orencia, for the treatment of moderately to severely active rheumatoid arthritis in the US. The drug, a selective T-cell co-stimulation modulator, is understood to be a first-in-class product. A Food and Drug Administration arthritis advisory committee panel is due to assess the firm's biologics licence application this week. Separately, BMS has affirmed the completion of the sale to Novartis of its consumer medicines arm.

30th September 2008


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