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Pharma news in brief

Our weekly round-up of news affecting the industry

Astellas profit down
Astellas, Japan's third biggest pharma firm, has posted a 64 per cent fall in quarterly recurring profit, due to substantial R&D costs. April-June recurring pre-tax profit, excluding one-offs, fell to 24.89bn yen ($216.9m) from 68.68bn yen a year earlier. The figures were attributed to lower Japanese drug prices as well as Astellas having to shell out to win rights to experimental anaemia drugs from US biotechnology firm, FibroGen. For the year to March 2007, Astellas kept its recurring profit estimate at 184bn yen, which would be a drop of 9 per cent from a year earlier. In April, the Japanese health ministry reduced prices of prescription medicines by an average 6.7 per cent to counter rising healthcare costs.

Lilly receives FDA rap over Alimta brochure
Eli Lilly has received a US Food and Drug Administration (FDA) warning for giving out misleading information regarding its cancer drug, Alimta, to consumers. In a brochure to patients, the US firm failed to say which specific conditions the drug treats, the FDA said in a letter dated July 27. Alimta is approved to treat non-small cell lung cancer or, in combination with cisplatin, to treat mesothelioma, but the brochure simply states that ìAlimta is a chemotherapy drug used to treat certain types of cancer.î According to the FDA letter, the brochure also includes information about a number of other kinds of cancer that Alimta is not approved to treat as well as failing to tell patients that there were no trials showing a clinical benefit such as improved survival or relief of symptoms in patients with non-small cell lung cancer. The FDA also said the brochure was misleading because it fails to reveal that Alimta may cause foetal harm when administered to a pregnant woman.

FDA considers OTC 'morning after' pill
The US Food and Drug Administration (FDA) says it is considering approving over-the-counter (OTC) use of the so-called `morning after' emergency contraceptive pill, Plan B. In a letter to the drug's manufacturer, Barr Pharmaceuticals, the FDA said it believed the appropriate age for OTC use of Plan B is 18 and older and that Barr would have to amend its latest application, which was for females aged 16 and over, to focus on adult women. Barr filed for OTC approval in March 2002 but its application has sparked fierce debate over whether its availability in pharmacies would make it easier for younger women to buy the product.

Bayer moves for remaining Schering shares
Bayer has moved to buy up the minority of shares that it does not already own of its recently-acquired subsidiary, Schering, by offering shareholders Ä89 per share. Bayer said it was offering the same amount as in its first tender offer and more than the `fair value' of Ä87.63 set down by auditors KPMG. Earlier, Bayer had warned speculative investors not to expect post-merger compensation above the tender offer, as has been the case in recent German takeovers when courts have awarded generous amounts. Under German law, Bayer must offer remaining shareholders compensation based on an audit; shareholders who refuse to sell at Ä89 per share have the option to go to court or agree to an annual dividend of Ä3.62. Bayer currently controls about 92 per cent of the stock.

30th September 2008


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