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Pharma news in brief

Our weekly round-up of news affecting the industry.

Shareholders at Merck to vote

Merck and Co will allow shareholders to vote for the appointment of eight directors at its annual meeting in late April, the first shareholder meeting since the company recalled COX-2 inhibitor, Vioxx, last September. After the election, the company will have a total of 12 directors, including the four whose present terms extend beyond the meeting. Shareholders will also have the opportunity to vote on the separation of chairman and chief executive roles, currently held by Raymond Gilmartin, who also holds the role of president.

An owner of 200 shares proposed that the separation of the chair and CEO roles would improve corporate governance and provide an independent oversight of both management and the CEO. However, the board is urging shareholders to oppose the resolution, stating that 11 of the 12 directors are independent and that it is unnecessary to require the chairman of the board to be an independent director. Shareholders will also be asked to vote on banning animal testing and the use of corporate resources for political purposes, among other subjects.

Reform in the FDA is needed, says Senator

A top Senate Republican has called for US drug regulator, the Food and Drug Administration (FDA), to employ an independent drug safety office with the power to issue warning labels on dangerous medicines as well as suspend TV advertising while potential side effects are being investigated. Charles Grassley, Senate finance committee chairman, said he was preparing legislation, which he hoped would be ready in two weeks, following the controversy surrounding the safety and withdrawal of drugs already on the market. The regulator's continued monitoring of approved drugs was called into question after two FDA scientists claimed that their warnings about the safety of certain drugs were ignored or suppressed. The new agency would have an independent director.

Pharma giants criticise EMEA

Two global pharmaceutical firms, Novartis and Wyeth, criticised methods used by the European regulators to approve new drugs by comparing them with existing treatments rather than placebos. Daniel Vasella, chief executive of Novartis, said the US regulator's approach to testing drugs was more meaningful and encouraged better treatment. He added that patients and doctors ìmay find another drug works better and would prefer four or five choices to one or twoî. Robert Ruffolo, head of research and development at Wyeth, agreed: ìThe Europeans have expanded Öfar beyond their remitÖ of safety, efficacy and risk benefits.î He added: ìIf you try to demand that every single drug is better, safer and brings more benefit than all the others, you'll never see another drug.î

However, industry critics and consumer advocates argue that drugs need to be compared with other treatments, otherwise patients are left at the mercy of drugmakers with little point of reference to weigh up a drug's effectiveness.

AZ sparks speculation over succession

AstraZeneca (AZ), Europe's third-largest pharma firm, has promoted the head of its US operations, David Brennan, to the company's main board, in a move that has fuelled speculation over the management succession. Brennan, who retains his current role as executive vice president of North America and Canada, becomes the fourth executive director to serve on the board. Chief executive, Sir Tom McKillop (aged 62), is due to retire, and Brennan could be a key internal candidate for the top job. McKillop built up the AZ name into an industry powerhouse following the merger of British Zeneca and Swedish Astra in 1999.

However, the group has suffered recently after the rejection of anticoagulant pill, Exanta, failed trials of lung cancer treatment, Iressa, and negative publicity over cholesterol-lowering drug, Crestor. In a turn of good fortune for AZ however, US regulators denied a Public Citizen (PC) petition to ban Crestor. The FDA said Crestor was no more of a risk than any other statin and there was no evidence to support PC's claims that the drug could seriously harm patients' kidneys.

30th September 2008


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