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Pharma news in brief

Our weekly round up of news affecting the industry

AZ withdraws Exanta from market
AstraZeneca (AZ) has withdrawn its controversial anticoagulant Exanta from the market and terminated its development due to links with liver injury. The drug, which has only been approved in Europe, failed to gain US Food and Drug Administration approval in late 2004 because of safety concerns. AZ said its own trials had recently indicated ìa potential risk of severe liver injury, with an observation of rapid onset of signs and symptoms in the weeks following the end of the 35 days treatmentî. David Brennan, AZ chief executive, said the company had decided to take action ìin the interests of patient safetyî. The company estimates around 400 people are being prescribed Exanta in just 11 countries. It amassed sales of $575,000 last year.

GSK profits up
GlaxoSmithKline said it was preparing for a number of filings and approvals in 2006 as strong sales of asthma and diabetes drugs helped it to record a 16 per cent rise in 2005 net income to £6.7bn. GSK said seven products were set for launch this year while a further seven would be filed for approval during 2006. Sales of top-selling respiratory product Seretide (Advair in the US) were up by nearly 25 per cent in 2005, while sales of diabetes treatment Avandia/Avandamet rose 18 per cent. Results were in line with expectations and GSK's shares closed 13p higher at £14.57. GSK chief executive Jean-Pierre Garnier has not ruled out the possibility of the firm buying Swiss biotech outfit, Serono. ìI can't comment on specific deals,î he said. ìWe keep an eye on what's for sale and we will take a look at everything. You have got to have the right opportunity at the right price.î

Pfizer predicts flat growth
Pfizer has revised its outlook to the disappointment of analysts and investors, forecasting flat growth for the next two years. In 2006, the world's largest pharma firm said it expects earnings, adjusted for exceptional items, to remain at about $2 per share compared with 2005, with revenue staying at around $51.3bn. ìValue and growth take place when people anticipate the future and move to create it,î Pfizer chief executive Hank McKinnell told investors. ìWe will transform this company to create new value for all who work with us, depend on us and invest in us.î The company moved to allay investor fears that generic competition would bite into profits of Lipitor, its top-selling lipid-lowering agent. Pfizer said Lipitor sales would increase by 7 per cent to $13bn this year. Meanwhile, Pfizer said it was considering spinning off its consumer products division, which generated sales of $3.9bn in 2005. German firm Bayer is thought to be among those interested in acquiring the unit.

FDA calls for stronger warnings on ADHD drugs
A US Food and Drug Administration advisory panel has recommended that attention deficit hyperactivity disorder drugs should carry `black box' warnings about an increased risk of sudden death and serious cardiovascular problems. The panel recommended warning labels for methylphenidate drugs, such as Ritalin, Concerta, Methylin and Metadate, as well as the amphetamines Adderall and Adderall XR. The recommendation comes after the release of a 2004 FDA review, which showed that 81 deaths and 54 non-fatal cardiovascular events were possibly linked to such drugs between 1999 and 2003. A spokesman for Shire, which sells Adderall and Adderall XR, said it wanted further studies to determine if there were possible adverse effects from its drug. ìWhile we fully support disclosure and adequate warning, Shire believes that the interests of physicians and patients would be better served by further study to determine whether there is, in fact, a relationship between these medicines and cardiovascular events,î Shire said in a statement.

Indian firms compete for Betapharm
Two Indian generic companies appear to be fighting it out to acquire German firm Betapharm Arzneimittel, according to the Wall Street Journal. Anji Reddy, chairman of Dr Reddy's Laboratories, said his company was competing against fellow Indian rival Ranbaxy Laboratories to buy Germany's fourth largest generics manufacturer. A Ranbaxy spokesman would neither ìconfirm nor denyî interest in the German firm. Betapharm reported Ä161m in revenue in 2004, compared with Ä50m in 1999.

30th September 2008

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