Bayer discontinues phase II Liplong study

Bayer Schering Pharma has announced that an independent Data Safety and Monitoring Board (DSMB) has

The DSMB concluded that the study will not be able to achieve the predetermined efficacy endpoint (non-inferiority).

However, no safety concerns were raised. As a result of the DSMB findings and recommendation, the company has decided to discontinue the study.

Liplong is a randomized, double-blind active comparator controlled study designed to demonstrate the non-inferiority of BAY79-4980 infused in hemophilia A patients once a week, as compared to Kogenate FS, antihemophilic factor (recombinant), which is infused three times per week

Kemal Malik, member of the board of Bayer Schering Pharma and head of global development, said: "While we are disappointed with the outcome of the analysis, we remain committed to developing our long-acting recombinant factor VIII compounds. It is our goal to enable once weekly prophylaxis dosing as well as other factor therapies, such as BAY VII, a modified recombinant factor VII therapy for hemophilia A and B in patients with inhibitors."

Furthermore, Bayer has sought scientific advice from regulatory agencies for the clinical development of a directly PEGylated recombinant factor VIII molecule, which in preclinical models has a doubled half-life. Proof of concept trials in humans are scheduled to start in late 2010.

Further analysis of the Liplong data will be carried out over the next months.

Show Hide image

Geoffrey Howe dies, aged 88

Howe was Margaret Thatcher's longest serving Cabinet minister – and the man credited with precipitating her downfall.

The former Conservative chancellor Lord Howe, a key figure in the Thatcher government, has died of a suspected heart attack, his family has said. He was 88.

Geoffrey Howe was the longest-serving member of Margaret Thatcher's Cabinet, playing a key role in both her government and her downfall. Born in Port Talbot in 1926, he began his career as a lawyer, and was first elected to parliament in 1964, but lost his seat just 18 months later.

Returning as MP for Reigate in the Conservative election victory of 1970, he served in the government of Edward Heath, first as Solicitor General for England & Wales, then as a Minister of State for Trade. When Margaret Thatcher became opposition leader in 1975, she named Howe as her shadow chancellor.

He retained this brief when the party returned to government in 1979. In the controversial budget of 1981, he outlined a radical monetarist programme, abandoning then-mainstream economic thinking by attempting to rapidly tackle the deficit at a time of recession and unemployment. Following the 1983 election, he was appointed as foreign secretary, in which post he negotiated the return of Hong Kong to China.

In 1989, Thatcher demoted Howe to the position of leader of the house and deputy prime minister. And on 1 November 1990, following disagreements over Britain's relationship with Europe, he resigned from the Cabinet altogether. 

Twelve days later, in a powerful speech explaining his resignation, he attacked the prime minister's attitude to Brussels, and called on his former colleagues to "consider their own response to the tragic conflict of loyalties with which I have myself wrestled for perhaps too long".

Labour Chancellor Denis Healey once described an attack from Howe as "like being savaged by a dead sheep" - but his resignation speech is widely credited for triggering the process that led to Thatcher's downfall. Nine days later, her premiership was over.

Howe retired from the Commons in 1992, and was made a life peer as Baron Howe of Aberavon. He later said that his resignation speech "was not intended as a challenge, it was intended as a way of summarising the importance of Europe". 

Nonetheless, he added: "I am sure that, without [Thatcher's] resignation, we would not have won the 1992 election... If there had been a Labour government from 1992 onwards, New Labour would never have been born."

Jonn Elledge is the editor of the New Statesman's sister site CityMetric. He is on Twitter, far too much, as @JonnElledge.