Novartis' Zometa finally wins FDA approval

Novartis has received approval from the US Food and Drug Administrationfor Zometa (zoledronic acid) as an intravenous treatment for hypercalcemia of malignancy.

Zometa, which has been under FDA review since 1999, is a follow-up to Novartis' bisphophonate Aredia (pamidronate disodium) which is due to lose its patent protection shortly and, as a result, sales to generic competitors. Turnover of Aredia amounted to $240 million in the first half of 2001. However, the threat of generic competition to Aredia is not the only blow Novartis has faced of late. In June, the FDA rejected the company's irritable bowel syndrome drug Zelnorm (tegaserod) on the grounds that it it is linked to a higher rate of abdominal operations (in particular gall-bladder surgery) compared to placebo (Marketletter June 25). FDA actions have also led to the delay of the launch of its asthma drug Xolair (omalizumab) by at least two years, asking for additional data in its review of the firms Biologics License Application (Marketletter July 16), and further to this, sales of its type 2 diabetes drug Starlix (nateglinide) have been weaker than expected.

Despite the recent series of setbacks, Novartis is aiming to compensate for the loss of Aredia sales to generaic competition with the launch of Zometa, which is not only more effective than its precedent but has a more favorable administration schedule; it can be delivered in 15 minutes, compared to hours required for the administration of Aredia. Analysts believe Zometa has the potential to be a blockbuster, according to the UK Financial Times, in which analyst Nicholas Draeger of Cheuvreux is quoted as saying "we are looking for peak sales [of Zometa] of 2 billion Swiss francs ($1.2 billion) plus."