FDA approves Teva's generic Pulmicort

AstraZeneca's asthma prevention drug has annual US sales of nearly $1 billion.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced this morning that the US Food and Drug Administration (FDA) had granted approval for the company’s abbreviated new drug application (ANDA) to market its generic version of AstraZeneca’s asthma treatment Pulmicort.

Pulmicort is budesonide, a corticosteroid. It prevents asthma attacks by preventing the release of substances in the body that cause inflammation.

The approval is for 0.25 mg/2 ml and 0.5 mg/2 ml doses.

Teva said that shipment of these products had commenced.

According to Teva, on the basis of IMS data, total annual sales of these strengths of the brand product were approximately $996 million in the US for the twelve months to the end of September.

Teva is currently involved in patent litigation over this product in the US District Court for the District of New Jersey. A trial has been scheduled for January 12, 2009.

Commenting on the approval, Yoav Burgan of Leader Capital Markets said today, "This is an at-risk launch with potential of $100 million in sales and an addition of $0.06 to Teva's earnings per share during the exclusivity period, of which about $0.015 will come in 2008. It may be that this lay behind Teva's raising of its 2008 EPS guidance. In its conference call on the third quarter results at the beginning of the month, Teva raised its EPS guidance for 2008 by $0.10 to $2.79-2.85, with $0.08 of the rise being non-business related, arising from the write-back of a write-down on Teva's ARS portfolio."

On the Tel Aviv Stock Exchange, Teva shares are down slightly, at NIS 170.20. In New York yesterday, the shares closed at $42.19, giving a market cap of $32.82 billion.

Published by Globes [online], Israel business news - www.globes.co.il - on November 19, 2008

© Copyright of Globes Publisher Itonut (1983) Ltd. 2008

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