AstraZeneca has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA. The agreement settles the patent infringement litigation filed by AstraZeneca following Teva's submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Pulmicort Respules. Under the settlement agreement, Teva concedes that the patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Teva also concedes that its generic version of Pulmicort Respules infringes AstraZeneca's patents.
The settlement agreement will allow Teva to commence sales of budesonide inhalation suspension, a generic version of Pulmicort Respules, under an exclusive license from AstraZeneca beginning 15 December 2009. AstraZeneca will receive a significant undisclosed royalty on sales of Teva's product, with a marked step down in payments if additional at-risk generic products enter the marketplace. Teva also agrees to pay AstraZeneca an undisclosed sum in respect of damages resulting from the unauthorised launch of its generic budesonide inhalation suspension product on 18 November 2008. Except as described, the terms of the settlement are confidential. The agreement releases Teva from all past US sales of its generic budesonide inhalation suspension and provides that any product already shipped by Teva will remain in the market to be further distributed and dispensed.
AstraZeneca intends to continue to sell Pulmicort Respules, even after the licensed entry of Teva's product in December 2009. However, the separate agreement between AstraZeneca and Par Pharmaceuticals to make available an authorized generic version of Pulmicort Respules will be discontinued. AstraZeneca and Teva have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Teva has been dismissed.
With this announcement 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, including the potential negative impact on sales of Pulmicort Respules from Teva's generic product and the small amount of authorised generic already in trade channels. AstraZeneca will address the 2009 outlook for Pulmicort Respules as part of the full year 2009 guidance in January.
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.
"This agreement provides increased certainty and stability in our business and a clearer backdrop for our investment decisions while re-affirming the strength of our intellectual property," said David Brennan, Chief Executive Officer of AstraZeneca.
AstraZeneca's Pulmicort Respules patent infringement litigation against Breath Limited remains ongoing. In compliance with the Medicare Modernization Act of 2003, AstraZeneca will file all of the above agreements with the United States Federal Trade Commission and the United States Department of Justice.
AstraZeneca's patents protecting Pulmicort Respules have expiration dates that extend through 2018, with pediatric exclusivity through 2019.
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.
About AstraZeneca
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.