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Pharma news in brief

Our weekly round up of news from the industry.

Lilly goes public

Lilly has been accused of suppressing evidence that its blockbuster antidepressant, Prozac, could cause behavioural disturbances according to confidential Lilly documents published in the British Medical Journal (BMJ). The information, handed over to the BMJ by an anonymous source and now passed to the US Food and Drug Administration for review, alleges that officials at Lilly knew the drug could stimulate agitation, panic attacks and aggression, and sought to minimise the effects of such news going public.

In a statement the company responded: "It is important to point out that Lilly has published widely in the area of activation syndrome as it relates to fluoxetine (Prozac). Based on this, Lilly believes that there is no new scientific information to review on this topic." In addition, the company has taken action in making available on its website (www.lillytrials.com) clinical trial data for some of its prescription drugs including Prozac and its new antidepressant, Cymbalta. The data, which includes more than 40 phase I through phase IV trials, makes up nearly half of the information the company committed to making publicly available, with all data expected to be on the site by July.

Digging for dirt

The big pharma companies are preparing for a visit from a notorious film maker, Michael Moore, in the US who may be looking for inside information for a new film, provisionally entitled Sicko, according to the Los Angeles Times. The newspaper reported that at least six of America's largest pharmaceutical firms have issued internal notices to staff warning them to be on the lookout for a ìscruffy guy in a baseball capî.

Moore is said to have humiliated the Bush Administration and gun lobby in previous films; ìMoore's past work has been marked by negativity, so we can only assume it won't be a fair and balanced portrayal,î Rachel Bloom, executive director, corporate communications for AstraZeneca, told the Guardian. Moore is also said to have hired actors to portray pharmaceutical salesmen who offer gifts to doctors who promote their products. Following recent criticisms of the industry, Moore is creating a whirlwind of rumours concerning possible film-making tactics.

Former HealthSouth CEO trial begins

The trial of ex-HealthSouth CEO, Richard Scrushy, accused of a $2.7bn profit inflating accounting fraud and fraudulent activities against Medicare, the federal health insurance scheme, will open this week in Alabama. Scrushy has pleaded not guilty to 58 criminal charges. However, other former employees have already pleaded guilty to some of the charges and will provide testimonies at the trial. Further still, HealthSouth, one of the biggest healthcare firms in the US, has agreed to pay the US Department of Justice $325m to avoid prosecution for the alleged Medicare fraud.

The Swiss bank, UBS, may also face charges over its investment banking work for HealthSouth as chief US financial regulator, the Securities and Exchange Commission, considers civil action. Scrushy is the first chief executive of a large US firm to be indicted on such charges under the Sarbanes-Oxley law, introduced following the fraud scandal at Enron.

Proposal draws closer for Shire

Shire Pharmaceuticals is in final stage discussions with New River Pharmaceuticals concerning a deal to develop and market a new attention deficit hyperactivity disorder (ADHD) treatment for children. The drug is currently in phase III clinical trials and could reach the market by 2006, at the same time as its current ADHD drug, Adderall XR, faces the threat of generic competition. Shire has yet to sign the deal, expected to include royalty sharing arrangements and a one-off payment. ADHD drugs for children account for 50 per cent of Shire's turnover.

Pfizer shares rebounded

Shares in Pfizer bounced back as positive results from a new study found its arthritis drug Celebrex, a COX-2 inhibitor, did not increase cardiovascular problems. The National Institute of Health has reported in an Alzheimer's Disease prevention study that there was no increased risk in patients taking Celebrex. Just days before the report was published, Pfizer lost near $30bn in market capitalisation, as a large cancer-prevention study showed high doses of Celebrex more than doubled the risk of heart disease. UK regulator, the Medicines and Healthcare products Regulatory Agency, advised 600,000 British patients with heart problems to switch to another treatment as soon as possible, while all other users should make a non-urgent appointment to discuss the treatment with a doctor.

Critics have also claimed cardiovascular risks associated with Merck's withdrawn COX-2 inhibitor, Vioxx, are likely to be linked to other drugs in the class. Shares rose more than 3 per cent (78 cents to $25.07) as the Alzheimer's study showed the drug was unlikely to be withdrawn from market. Analysts still fear sales are most likely to fall.

30th September 2008

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