AstraZeneca stops release of Teva generic
FDA had given OK, but the drug giant won the temporary halt. Also, it will cut jobs in Europe.
LONDON - Pharmaceuticals giant AstraZeneca P.L.C. won the first round of a legal fight over the release of a generic version of its child asthma medication Pulmicort Respules by rival Teva Pharmaceutical Industries Ltd. yesterday as it also announced job cuts in Europe.
AstraZeneca, which employs about 4,600 in the Philadelphia region with its U.S. headquarters in Wilmington and a manufacturing facility in Newark, Del., was granted a temporary restraining order by the U.S. District Court in New Jersey that halts the supply and distribution of Teva's generic drug.
The Israeli-based company, which employs 1,500 at four locations in the Philadelphia suburbs, including its North American headquarters in North Wales, began U.S. shipments of the drug Tuesday, just hours after receiving approval from the U.S. Food and Drug Administration for the generic version.
Teva went ahead with the launch despite an ongoing patent-infringement case brought by AstraZeneca, which has patents covering Pulmicort Respules that expire in 2018, with pediatric exclusivity extending to 2019.
The patent case is to begin Jan. 12. But strong earnings potential provided an incentive. AstraZeneca's full-year U.S. sales for Pulmicort totaled $964 million in 2007, about 90 percent of which is accounted for by Pulmicort Respules.
The temporary order granted yesterday freezes supply of Teva's product to prevent future sales and requires Teva to send a letter to its customers requesting they comply with the order, which remains in place until at least Tuesday, when there will be a court hearing on the injunction.
Yesterday on the New York Stock Exchange, AstraZeneca's American depositary shares closed at $34.74, down $2.10 (5.70 percent).
Teva closed yesterday at $41.91, up 11 cents (0.26 percent), in Nasdaq trading.
Meanwhile, AstraZeneca announced that it would close three European operations and eliminate 1,400 jobs through 2013.
The facilities to close are in Spain, Belgium and Sweden, the company said.
AstraZeneca employs 67,000 people globally - about half of whom work in Europe.
AstraZeneca will expand a packaging and formulation plant in China. The restructuring "moves the supply process closer to the customers," said David Smith, executive vice president of operations.
Other drug giants, including Merck & Co. Inc., which employs about 12,000 in the Philadelphia region, have announced recent employee cutbacks as they struggle with a weak economy and generics.