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Strattera sales fall back over continuing safety concerns

Published on 26/04/05 at 04:18pm

Lilly say it expects sales of Strattera to fall in 2005 because of continuing concerns over the safety of ADHD treatments.

The US company issued the warning to investors during the presentation of its first quarter earnings, which showed a 15% fall to $120 million in sales of the attention deficit disorder treatment, compared to the same period last year.

The drug, launched in the US in 2002 is a first-in-class non-stimulant treatment for ADHD, but reports of serious liver problems in a small number of patients have scared off parents of children with the condition.

Earlier this year the MHRA warned UK health professionals about the rare but serious hepatic problems linked to the drug, although the incidence reported is less than 1 in 50,000 patients.

The MHRA advised the drug should be discontinued in patients with jaundice or laboratory evidence of hepatic injury, and should not be restarted.

The UK regulator, however, advised prescribers against routine liver function monitoring of patients, as the reaction had not formed an identifiable pattern.

More than two million patients have taken Strattera worldwide, with 41 reports of hepatic disorders recorded, including two cases of severe acute hepatitis.

Lilly also highlighted its restructuring programme to reduce wholesale inventories as a further reason why sales for the drug would suffer in 2005.

The company had hoped Strattera would offset its reliance on Zyprexa, its antipsychotic drug, which is also experiencing falling sales because of side-effect concerns.

Zyprexa's first quarter global sales fell to $1.04 billion, a 5% decline from 2004. US sales of the drug fell by 17% to $517.4 million although this was partially offset by a 9% sales growth in international markets.

Despite the setbacks, Lilly reported solid first quarter sales of $3.5 billion, driven by impressive sales of other new medicines.

Lilly launched five new drugs in 2004 in addition to six new indications for medicines already on the market, with its newer products accounting for 14% of its total sales.

Cialis, its male impotence drug, launched in the US last year, registered global first quarter sales of $150.1 million, a 38% increase from 2004, with its US sales now representing nearly a quarter of its sales.

Lilly said the drug recently overtook Pfizer's Viagra for the number one position in France. But Viagra still retains market leadership in the US, with around four times more sales at $1.5 billion.

The company's new depression drug Cymbalta, launched in the US in August 2004, generated first quarter sales of $106.8 million, with Lilly chief executive Sidney Taurel predicting a bright future for the drug, despite it being launched amid safety concerns about antidepressants.

Commenting on the negative press surrounding the antidepressant market, Taurel said: "We don't feel Cymbalta's long-term potential will be constrained in this environment. We believe Cymbalta is one of the most important and exciting new drugs in our portfolio."

Lilly will be hoping that Cymbalta's recent launch in Europe will boost its sales, particularly in the lucrative German and UK markets.

Speaking of Lilly's short-term pipeline, Taurel said that Arxxant (ruboxistaurin) was an exciting new drug with  potential as a first-in-class treatment for several serious complications of diabetes.

"We expect the first approved indication to be for the symptoms of diabetic peripheral neuropathy. We're also investigating it for treatment of diabetes-related damage to the eyes and kidneys," Lilly's Taurel said.

Taurel was also optimistic about another diabetes treatment, Exanatide, a drug it was co-developing with Amylin for the treatment of type II diabetes.

Currently under review by the FDA, Taurel said that trials showed the drug improved patients' blood glucose levels as well as reducing their weight.


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