Abbott looks to seize lion’s share of RA market with Humira
pharmafile | October 28, 2003 | News story | |Â Â Â
Abbott Laboratories has launched its new rheumatoid arthritis treatment Humira in Europe claiming its biggest ever product could eventually become the number one product in the market.
Humira is the third entrant in the TNF-blocker class, following Amgen and Wyeth's co-marketed Enbrel and Schering-Plough's Remicade, but is expected to challenge strongly because of its user-friendly profile, with some analysts forecasting peak sales of $1 billion.
Erik von Borcke, General Manager of Immunology for Abbott International says he expects the drug efficacy and relative convenience of use to win it "The lion's share" of the disease modifying rheumatoid arthritis market
"After a certain time, Humira could very well overtake the others," he said.
Patients are able to administer the drug themselves by subcutaneous injection every other week, whereas Enbrel patients must inject themselves twice a week and Remicade requires administration in hospital every eight weeks.
But the established TNF-blockers both have a significant lead over Humira, with market leader Remicade increasing its sales in 2002 to 337 million. In May, the drug added Crohn's disease to its European indications which also includes ankylosing spondylitis, a painful and potentially progressive inflammatory disease affecting joints and ligaments.
Enbrel has also just received preliminary approval for an EU licence to treat the disease, and became the first to gain a US licence for the condition in July.
Abbott confirmed that the company's pricing of the drug will be at parity with the established blockbusters. "Humira will be competitively priced globally, and will be in-line with competitors' pricing," a spokesman said.
The company top management says Humira is the single most important new product it has ever produced, and invested heavily in its promotion the US, including a direct-to-consumer campaign.
"Our Chief Executive always calls this product pipeline in a drug," says von Borcke "because the same product, with the same mode of action, can serve unmet needs in five different diseases."
The drug's current EU licence is for the treatment of moderate to severe active RA in adults who have not responded to disease modifying anti-rheumatic drugs (DMARDs) including standard treatment methotrexate. But the company is seeking to expand the drug indications, both within RA and into other disease areas.
Three other RA indications are in various stages of development to assess the drug for the treatment of early RA, juvenile RA and improving physical function in RA. The company is also developing the drug to treat Crohn disease, ankylosing spondylitis, psoriatic arthritis and psoriasis, the latter opening the product up as a dermatological treatment.
Approved in the US last December, sales in the first quarter reached a better-than-expected $26 million, with Humira capturing 20% of new prescriptions. The drug has now been launched in the UK and Germany, with other European markets to follow shortly.
Following the drug's approval in the EU, the company has revised its forecast for 2003 global sales to $250 million, predicting a doubling in 2004 to $500 million.
The approval is also good news for UK biotech company Cambridge Antibody Technology, which co-developed the drug with Knoll, now part of Abbott.
CAT is, however, currently in dispute with Abbott over the payment of royalties, the dispute impacting on the biotech company share price earlier this year.
An Abbott spokesman commented: "We are still continuing to discuss the interpretation of the royalty provision, under the agreement through which we developed Humira. CAT will receive a royalty based on Humira sales, but it is subject to applicable offsets, so we are still in discussion."
