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Pharma news in brief

Our weekly round-up of news affecting the industry

FDA asks for more info on Avastin
The US Food and Drug Administration has asked US biotech firm, Genentech, for more information before it will approve its colon cancer drug, Avastin, for an additional indication for breast cancer. Shares in Genentech fell when the company said it would probably resubmit the application by mid-2007, which would initiate a new six-month review period. Genentech and development partner, Roche, filed for US approval in May based on a study that showed combining Avastin with chemotherapy doubled the time women lived without their disease worsening. It is not the first time that Avastin, seen as one of the brightest stars in Genentech's pipeline, has suffered a setback. In June, Genentech stopped a trial of the drug for the treatment of pancreatic cancer after results found it failed to boost overall survival over standard therapy.

Health insurer pulls Nexium reimbursement
AstraZeneca (AZ) has been hit by the news that the second largest health insurance firm in the US has decided to discontinue reimbursement for its best-selling ulcer drug, Nexium. United Healthcare said it plans to halve its $300m bill for proton-pump inhibitors by no longer paying for Nexium, in a staggered move that should be completed by the end of this year. Tim Heady, chief executive of United Healthcare's pharmacy benefit management arm, told the Financial Times that after a careful review of the drug category, coupled with AZ's refusal to lower the drug's price, the health insurer had decided patients could ìsafely manage their conditions with other, less expensive medicationsî. AZ said it would not be adjusting its forecasts as a result of the decision, which has so far not been mirrored by other insurers.

Bayer reaches 'squeeze out' level
Bayer has announced it now owns more than 95 per cent of shares in fellow German firm Schering, taking it over the coveted `squeeze out' level required to oust minor shareholders. The firm said in a statement that it had bought more shares on the stock market to reach the level at which minority shareholders can usually be forced to sell their stock to a majority shareholder. ìWe will now arrange a further meeting of Schering shareholders as soon as possible to finalise the full takeover,î said a Bayer spokesman. Bayer did not say whether it would squeeze out minority shareholders, but revealed that the next step would be a decision by Schering shareholders at an extraordinary meeting today (September 13) on an agreement with Bayer. Shareholders will be asked to vote on a so-called 'domination and profit and loss transfer' agreement that would allow Bayer to transfer profit out of Schering, restructure its near Ä17bn takeover, and integrate operations with its own.

Boehringer HIV drug gets SMC approval
The Scottish Medicines Consortium has approved the use of Boehringer Ingelheim's Aptivus (tipranavir) for the treatment of HIV-1 infection in highly pre-treated adult patients with a virus resistant to multiple protease inhibitors. The positive assessment was based on outcomes from 48 week analyses of two pivotal, open label phase III trials. ìIt's good news that the SMC has accepted Aptivus and that patients in Scotland will now have easier access to it. This is a very effective drug for people living with HIV who have struggled to control their HIV,î said Brian West, information and development officer at HIV Scotland.

30th September 2008


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