Pulmicort

RNS Number : 5169I

AstraZeneca PLC

19 November 2008

 



ASTRAZENECA ENTERS AGREEMENT FOR AUTHORIZED GENERIC PULMICORT RESPULES

AstraZeneca today announced that it has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of budesonide inhalation suspension in the United States in response to the launch 'at risk' of a generic version of this product by Teva.  Currently, the authorized generic product will be distributed in the 0.25 mg/2 mL and 0.5 mg/2 mL dosage strengths. Par Pharmaceutical began shipping the product today.

Additionally, AstraZeneca has filed a Temporary Restraining Order (TRO), seeking to stop Teva from launching its purported generic version of AstraZeneca's PULMICORT RESPULES 'at-risk', until the ongoing patent infringement case between the parties has been adjudicated. In October, AstraZeneca filed a preliminary injunction order with the court. We await the court's decision on these motions.

The ongoing patent infringement litigation brought by AstraZeneca against Teva for patent infringement will also continue, with the court case to commence on 12 January 2009.

AstraZeneca's branded version of budesonide inhalation suspension, PULMICORT RESPULES, will continue to be available in the United States.

Despite the launch of generic competition to PULMICORT RESPULES, the company remains on track to achieve its full year targets, although it is now likely that earnings per share will be near the bottom of the $4.90 to $5.05 range communicated with the third quarter financial results. This assumes that core EPS will be negatively impacted by approximately $0.16 per share as a result of lost sales contribution, one time charges associated with stock write-offs and provisions against inventory in the pipeline, and an immediate impairment of the PULMICORT-related intangible assets recognised in March 2008 under the terms of the Merck arrangements. 

As a reminder, the company's full-year guidance reflects actual results achieved in 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.

AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES and will continue to defend those rights.

PULMICORT RESPULES patients and their families should always consult with their health care professional if they have concerns about their medication. Patients should never disrupt or change their PULMICORT RESPULES dosing without first consulting their health care professional.

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.

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. For more Information visit www.astrazeneca.com

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19 November 2008

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