Novartis’ Cox-II challenger suffers set back
pharmafile | October 28, 2003 | News story | |Â Â Â
Prexige, the new challenger to the established Cox-II drugs from Novartis has been dealt a serious blow after the FDA issued it with a non-approvable letter.
The US authority rejected the company new drug application and is requesting further data, which is likely to result in a mid-2006 launch for Prexige (lumiracoxib), two years later than the company had hoped.
The FDA said its final decision would hinge on the 18,000 patient TARGET study due in July next year, as well as dosing for acute pain and an additional hip osteoarthritis study.
The rejection came as a surprise to analysts, with Deutsche Bank cutting in half its forecast sales for the drug in 2007 from just over $1 billion to $500 million, representing around 5% of the Cox-II market.
Jorg Reinhardt, Head of Global Development at Novartis said: "We will work very closely with the FDA to provide all necessary data and are committed to making this medicine available to patients. We believe the full analysis of TARGET as well as the additional clinical data will provide insights into the appropriate treatment of arthritis and pain and the risk/benefit profile of lumiracoxib."
The news was particularly unexpected because Novartis has already conducted the biggest ever clinical trial in the class, using data from 13,000 patients.
The US rejection is in direct contrast to the UK, where the drug has been granted its first licence, which will be adopted across the EU through the mutual recognition system.
The UK's MHRA has approved the drug for osteoarthritis pain relief (100-200mg) and short-term treatment of moderate to severe pain associated with primary dysmenorrhoea, dental surgery and orthopaedic surgery (400mg).
Novartis had hoped that its extensive studies would help it win market share from the two dominant players in the Cox-II market: Pfizer, who lead sales globally with Celebrex and Bextra, and Merck, who lead in Europe with Vioxx and Arcoxia.
Cox-IIs were one of the fastest-growing new drug classes in the 1990s but have been hit by regulatorsconcerns in Europe and the US over their safety profile, including worries that they are not as beneficial to the heart as aspirin.
Both second generation Cox-IIs have been held back by regulators because of clinical data queries, with Merck still awaiting final FDA clearance for Arcoxia, expected before the end of this year.
Meanwhile in Europe, Pfizer Bextra became the fourth Cox-II to reach the market this summer after an EMEA-enforced delay, and has yet to make a significant impact in the wake of Arcoxia's UK launch.
Analysts had singled out Prexige as Novartis' single biggest product launch over the next two years, but nevertheless still rate the company long-term future as one of the brightest in the industry.
Novartis expect to launch up to four new products over the next 2-3 years, but none are expected to reach the same blockbuster status as Prexige.
