Abbott surprised by early Humira approval
pharmafile | October 27, 2003 | News story | |
Abbott Laboratories says US approval of its rheumatoid arthritis product Humira has come earlier than expected, and will now increase spending on its launch in 2003.
Dr Jeffrey Leiden, President and COO of the pharmaceutical division, said: "The approval comes only nine months after submission, and nearly six months ahead of our original target date for launch."
The company has now lowered its profit forecasts for 2003 because of the launch costs but nevertheless welcomed the news.
"Humira is the single most important new product Abbott has produced in its 115-year history," said Dr Leiden. "From a corporate perspective, the new drug is a significant milestone in the strategic positioning of our pharmaceutical business."
Humira (adalimumab) was discovered as part of a broad collaboration between Abbott and UK biotech company Cambridge Antibody Technology, and is the first ever human monoclonal antibody treatment approved for rheumatoid arthritis.
The speedy approval now means Abbott will begin shipping the drug this month, and expects it to reach sales of $150 million this year, $500 million in world-wide sales by 2004 and peak sales of an estimated $1 billion.
"With any new drug the size of Humira we would invest heavily upfront to ensure we realise its full commercial potential. That investment will be brought forward to support sales and marketing for a full 12 months against our previous assumption of six months," said Dr Leiden.
Humira is the latest drug in the tumour necrosis factor (TNF) blocker class, and will now compete with Wyeth Enbrel and Johnson & Johnson/Schering-Plough Remicade.
The company will also investigate further clinical uses for the drug, with five possible indications, including Crohn disease, already identified.
"These could add several hundred million of incremental revenues in addition to the peak of $1 billion of sales," Dr Leiden said. "That is equivalent to having five new late-stage products in our pipeline."
The company submitted the drug for EMEA approval in April 2002, and expects its approval by mid-2003.
