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Pharma news in brief

Our weekly round-up of news affecting the industry.

Blockbuster status

Crestor has become a blockbuster. Revenues for the controversial statin, manufactured by AstraZeneca, reached almost $1.1bn for the year ended March 31, despite countless problems in 2004, including allegations of potentially lethal side effects. Sales of Crestor fell from $312m in the last quarter of 2004 to $273m in the first quarter this year. However, in late April the number of new prescriptions for the drug rose from 5.8 per cent to 6.2 per cent after the Food and Drug Administration rejected calls from consumer watchdog, Public Citizen to withdraw Crestor from the market. AstraZeneca's net income was up 30 per cent to $1bn for the first quarter while sales increased by 13 per cent to $5.7bn. Research and development costs for the period were up $8m from $857m to $865m.

Illegal drug distribution

The Food and Drug Administration and the District Attorney for Utah have indicted seven drug distributors across the US for the illegal distribution of more than 40 drugs purchased in over 80 pharmacies nationwide. The FDA has posted a list of these diverted drugs - treatments bought, sold or circulated outside the established supply chains that assure their quality - on its website, which gives specific details of the drugs and the unauthorised distributors. Both the District Attorney and the regulator have warned patients who have purchased listed drugs from the pharmacies that are supplied by the named distributors to stop taking the medication immediately and see their doctor. They have also urged pharmacies that have received drugs from the indicted distributors to check their stock, cease dispensing affected products and notify any patient who may have received any of these drugs.

PDRX, Empire Pharmaceuticals, DRX Medical, PRNY Enterprises, AC Global, AC Healthcare and Afro Caribbean Healthcare have been named in the indictment.

A list of the drugs, pharmacies and distributors can be found at: www.fda.gov/bbs/topics/answers/2005/ ANS01353lists.html

GSK swallows Corixa

GlaxoSmithKline (GSK) is acquiring US-based biotech and vaccines specialist, Corixa, for $300m. Under the deal, which is due to be completed in the third quarter, GSK will pay $4.40 in cash for each share of its common stock and assume Corixa's convertible notes. GSK already owns 8 per cent of Corixa - once seen as one of the hottest biotech prospects with shares trading at $40-$60 in 2000 - which has been cutting staff and undergoing restructuring in recent months. The two companies have collaborated on a number of drugs, including a hepatitis B vaccine, which contains Corixa's MPL compound, and Bexxar, a treatment for non-Hodgkin's lymphoma developed by the biotech firm. According to Jean Stephenne, president of GSK biologicals, the transaction is an important strategic deal for GSK's vaccines division.

Shire profits falls

Shire Pharmaceuticals has posted a drop in first-quarter profits due, in part, to the high costs of new product launches and increased spending on research and development. Net income for the period, ended March 31, fell from $74.6m to $20.5m while pre-tax profits plummeted from $111.3m to $24.4m. The company is trying to reduce its dependency on hyperactivity disorder treatment Adderall XR, which is facing generic competition, and is ploughing money into the development of its pipeline. It has also recently launched Fosrenol, for kidney disease, and Equetro, for the treatment of bipolar disorder in the US.

More trouble ahead

Merck could face further problems as a potential delay to the first trial over Vioxx enables prosecution lawyers to build a stronger case. An Alabama state judge is due to hold a hearing today on whether to delay the trial scheduled for May 23. Both Merck and the plaintiff asked for a postponement after Judge Eldon Fallon of the US district court in New Orleans requested a delay as he considers an evidentiary process for hundreds of cases filed against Vioxx. The second trial over the COX-2 is scheduled for May 31. Merck, which has vowed to defend all cases bought against it, is the defendant in at least 2,400 lawsuits. Analysts estimate that the company's Vioxx liability could be in excess of $5bn.

PPRS: unravelled

The Association of the British Pharmaceutical Industry (ABPI) has published a guide that promises to explain the often complex processes and objectives behind the Pharmaceutical Price Regulation Scheme. The guide is available from ABPI Publications priced £10. For a copy email publications@abpi.org.uk or call 020 7747 1446.

30th September 2008

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