It is not yet known if Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) will exclusively launch generic Risperdal on Sunday. Ethical Risperdal, a treatment for schizophrenia and some symptoms of autism made by Johnson & Johnson (NYSE: JNJ) unit Janssen, had $2.5 billion in US sales in 2007.
In 2001, Teva first applied to the US Food and Drug Administration (FDA) to market a generic version of Risperdal under Paragraph IV, i.e. a patent challenge. The FDA refused to grant Teva a 180-day exclusivity period because the patent had been removed from the Orange Book (patent registry). Teva then filed a citizen's petition, and when the FDA rejected it, Teva filed a lawsuit and won.
In April, Teva announced that the US Federal District Court for the District of Columbia had ordered the FDA to reregister the patent and award Teva an exclusivity period beginning on June 29. The FDA meanwhile appealed the ruling, and a hearing is set for August.
Leader Capital Markets analyst Yoav Burgan says, "On the face of it, it seems that Teva is more likely to launch the drug than to wait for the appeal. Teva invested heavily in reversing the FDA decision, and it is no small matter for a court to reverse an FDA decision. It therefore seems that the scales are tipped in the direction of a launch, and there's a good chance that it will happen next week."
Burgan does not think that Teva included generic Risperdal in its annual guidance. "When Teva published its first quarter financial report, it didn’t change its annual guidance. When it published its original guidance, Risperdal did not appear concrete enough for inclusion, even if it were risk-adjusted." He predicts that Risperdal could add $0.10-0.15 to Teva's earnings per share for 2008.
Published by Globes [online], Israel business news - www.globes-online.com - on June 26, 2008
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