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Shares in Teva Pharmaceutical Industries continued to reach new highs on Sunday as the US District Court granted the company six months exclusivity for its generic equivalent of Bristol-Myers Squibb's Pravachol Tablets, for the treatment of cholesterol and the primary prevention of coronary problems.
The stock hit a record NIS 174.20 during Sunday trade in Tel Aviv, before closing 2.5 percent higher than its most recent trade on Thursday at NIS 173.60. The news sent the share 3.3% higher in Nasdaq Stock Market trading on Friday to close at $37.69.
The court granted Teva's request to prevent the US Food and Drug administration from approving competing generic drug maker ANDA's generic Pravastatin Sodium Tablets 10 mg., 20 mg. and 40 mg., until the expiration of Teva's 180-day exclusivity. It also overturns a previous ruling by the FDA regarding Teva's exclusivity period.
Analysts at CIBC World Markets explained that Teva received notification from the FDA earlier this year that its exclusivity period for the drug started on August 22, 2004, meaning that it would have already expired.
CIBC, who maintained its price target of $39 for Teva, noted that the FDA could yet appeal the court decision.
Deutsche Bank raised its forecast for Teva's 2006 earnings to $2.03 per share from $1.93 on news of the decision. It raised its outlook for the share to $41.
Teva told the court that its exclusivity on the drugs would "push its total sales receipts two to three times higher" during the first year that it markets the generic version of the drug. The tablets have a combined annual US branded sales of approximately $1.6 billion, it said.
Israel Markov, CEO and President of Teva, said that the company plans to launch the product in April next year, when Bristol-Myers' patent protection on Pravachol expires. Bristol-Myers' sales of Pravachol amounted to $2.6b. in 2004.
The decision followed a legal settlement Teva had with Wyeth, allowing Teva to sell a generic version of Wyeth's Effexor XR antidepressant, initiating the hike in its share price.