AstraZeneca Granted Temporary Restraining Order in Pulmicort Respules Patent Litigation
LONDON, Nov. 20, 2008-On 19 November 2008, AstraZeneca was granted a Temporary Restraining Order (TRO) by the United States District Court for the District of New Jersey, halting sales of Teva’s budesonide inhalation suspension product, a generic version of AstraZeneca’s PULMICORT RESPULES treatment.
The TRO freezes supply of Teva’s product to prevent any future sales and requires Teva to send a letter to its customers, along with a copy of the TRO, requesting that they comply with the terms of the Court’s Order. As part of the same ruling, AstraZeneca and its partner Par Pharmaceuticals are to suspend distribution of AstraZeneca’s own authorised generic and send a similar letter to customers who purchased that product.
The marketing and distribution of branded PULMICORT RESPULES is unaffected.
The TRO remains in force until further order of the Court. A preliminary injunction hearing in this matter is scheduled to begin on Tuesday 25 November. The full court case is due to commence on 12 January 2009. AstraZeneca has full confidence in the strength of the patents protecting PULMICORT RESPULES and will continue to defend them vigorously.
AstraZeneca confirms that it continues to expect Core earnings per share in the range of $4.90 to $5.05 for the full year 2008. Actual performance within this range is dependent upon the performance of the business for the remainder of the year and further developments in the PULMICORT situation, including the outcome of the preliminary injunction hearing on 25 November 2008.
As a reminder, the company's full year guidance reflects actual results for the first nine months, combined with guidance for the fourth quarter based on the original assumptions for currency, being fourth quarter 2007 average exchange rates.
About Pulmicort Respules
PULMICORT RESPULES is a preventive, maintenance asthma medicine indicated for use in children 12 months to 8 years of age in the United States. Full-year US sales for PULMICORT in 2007 totalled $964 million, about 90 percent of which is accounted for by PULMICORT RESPULES. Patents covering PULMICORT RESPULES expire in 2018 with paediatric exclusivity extending to 2019.
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
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20 November 2008
Posted: November 2008