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Glaxo to Shift Away From Antidepressant Research 5 Feb 2010

GlaxoSmithKline PLC said it will stop research into new antidepressants and focus on diseases for which it believes it can develop more valuable drugs, a major shift for a company that developed some of the biggest-selling antidepressants of the past 20 years.

Profits at the U.K. drug giant, which posted a 66% increase in fourth-quarter earnings Thursday, were long fueled by the antidepressants Paxil and Wellbutrin, which at their peak generated billions of dollars a year in sales. Similar medicines, such as Eli Lilly & Co.'s Prozac and Pfizer Inc.'s Zoloft, also generated big sales for those companies.

Andrew Witty, CEO of GlaxoSmithKline, spoke at the Council on Foreign Relations in New York in January.

However, low-cost generic copies have eroded demand for name-brand antidepressants, which accounted for just 2.3% of Glaxo's total sales last year, down from 14% in 2002. Chief Executive Andrew Witty said Thursday that the company thinks further investment in the market wouldn't be prudent.

Part of the reason is financial risk. Clinical trials of antidepressants are among the "most expensive and highest-risk" of all drug trials, Mr. Witty said, because companies often don't know until the end of very large studies whether a drug works. It is also hard to prove that a depression drug is working, he said, because patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.

That's a drawback in an era when insurers and other health-care payers want to see clear value for their money, Mr. Witty said.

Payers "want big benefits to make it worth their while to invest their resources," he said, adding that Glaxo would scrap research into pain drugs for the same reasons, focusing instead on diseases including Alzheimer's, Parkinson's, multiple sclerosis and a clutch of rare diseases.

Other companies, such as Lilly, Sanofi-Aventis SA and AstraZeneca PLC, continue to invest in antidepressant research. In December, AstraZeneca paid a biotech company $200 million for the rights to develop an experimental antidepressant. But companies generally are more eager to invest in cancer and diseases tied to aging, where the need for new treatments is greater.

Mr. Witty announced the changes as Glaxo reported that quarterly profit rose to £1.63 billion ($2.59 billion) fom £982 million a year earlier, helped by a £296 million gain from placing its HIV activities into a joint venture with Pfizer. The results also were flattered by big restructuring charges that cut net profit in the fourth quarter of 2008. The charges stemmed from a cost-cutting program and acquisitions.

Sales grew 17% to £8.1 billion from £6.9 billion, aided by H1N1 vaccine and other pandemic-flu products. Full-year sales of H1N1 vaccine were £883 million, mostly coming in the fourth quarter, and Glaxo said it expects the same level of H1N1 vaccine sales this year. Some countries, such as Germany and France, have cut their orders for the vaccine, partly because the pandemic hasn't been as bad as feared.

Sales of the antiviral drug Relenza for the full year soared to £720 million from £57 million in 2008 as countries stockpiled the drug to treat people infected with the H1N1 virus.

Weighing on earnings were £392 million of legal charges in the fourth quarter. Mr. Witty would say only that these related to "quite a number of cases," declining to add whether they were tied to a federal investigation of the company's drug-marketing practices in the U.S.

Mr. Witty said Glaxo aims to invest even more of its research funds in experimental drugs discovered by outside academic groups and biotech companies, which he said would improve the company's return on investment. Overall it aims to boost its return on investment in late-stage drug development to 14% from a current 11%.

GSK shifts away from antidepressants

By Andrew Jack

Published: February 4 2010 

GlaxoSmithKline is to stop researching antidepressant medicines as part of a shake up in research and development designed to strengthen productivity.

Andrew Witty, chief executive, said the pharmaceutical company would cease discovery work in depression, a pivotal part of its historical neuroscience activity, in an effort to save £500m a year in costs by 2012.

Andrew Witty

Andrew Witty: introducing productivity into R&D

The move came as he unveiled an 18 per cent rise in full-year pre-tax profits to £7.9bn on sales up 16 per cent to £28.4bn in the 12 months to December 31.

It marks a symbolic shift for GSK, which as recently as 2006 generated more than £2bn from sales of its antidepressants Wellbutrin and Seroxat or Paxil, a drug that has sparked criticism from regulators and a series of litigations against the company.

Other large pharmaceutical groups including AstraZeneca and Pfizer have also unveiled significant cost- cutting and a shift towards more licensing of drugs at the expense of in-house drug development.

GSK on Thursday became the first pharmaceutical company to disclose a measure of productivity in R&D, saying the estimated return on investment from its late-stage pipeline had risen in recent years from an industry average of 7 per cent to 11 per cent, with a future “aspiration” of 14 per cent.

Mr Witty said 2009 was “the year when our strategy really started to demonstrate its value”, with a more globalised and diversified business.

He rejected suggestions that the closure of depression R&D as well as pain research had anything to do with past litigation problems, saying that antidepressants were “among the most expensive, high-risk” drugs with weak “endpoints” that made it difficult to measure likely success until late in the development process.

Half of GSK’s latest £500m in annual savings will come from R&D, much from the closure of the two neuroscience areas as well as broader efforts to reduce the fixed costs that account for a third of R&D spending.

That should particularly affect GSK’s depression research centres in Harlow in the UK as well as Verona in Italy, although Mr Witty said the impact on jobs in the UK would be in “the hundreds”.

He stressed that other neuroscience research, such as into neurodegenerative and neuro-inflammatory diseases, would continue.

GSK also unveiled a new structure reflecting its recent interest, like other large companies such as Pfizer, in treatments for extremely rare but high- priced “orphan” diseases, such as Duchenne Muscular Dystrophy, Hunter syndrome and Fabry and Gaucher disease.

Professor David Nutt from Imperial College in London, a leading expert on antidepressants, called GSK’s decision to withdraw from the field “bad news”.

 

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