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AstraZeneca continues appeal against US court ruling over asthma drug

AstraZeneca said it will continue to "vigorously" defend the intellectual property rights protecting its Pulmicort Respules medicine.

AstraZeneca said it will continue to "vigorously" defend the intellectual property rights protecting its Pulmicort Respules medicine.

The company is appealing against a US court ruling that the patent protecting Pulmicort from rival drugs in the US is invalid.

The US Court of Appeal has issued a temporary injunction blocking generic manufacturers from distributing generic versions in the US until the court rules on AstraZeneca's appeal.

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As a condition of the injunction, the court has also ordered that AstraZeneca post a bond in the amount of $72m.

"We intend to vigorously defend the intellectual property rights protecting Pulmicort Respules," said Executive Vice President of the company's North America division, Paul Hudson.

The patents protecting the drug expire in 2018, with paediatric exclusivity extending into 2019.

Separately, the group also announced that it has entered into a definitive agreement to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, New Jersey.

Under the agreement, AstraZeneca will acquire Omthera for $12.70 per share, or $323m.

Omthera is focused on the development of new therapies for abnormal levels of lipids in the blood, a condition known as dyslipidemia.

Its investigational product, Epanova, for the treatment of patients with very high triglycerides, has been shown to bolster levels of eicosapentaenoic acid and docosahexaenoic acid significantly in the blood.

The third phase of clinical studies have been completed on Epanova, a coated soft gelatin capsule containing a mixture of polyunsaturated free fatty acids derived from fish oils.

The studies revealed the drug helped to lower high levels of triglycerides and reduce non-high density cholesterol in combination with a statin for patients with high triglycerides.

Omthera is expected to file a new drug application (NDA) in the US for Epanova in mid-2013 for patients with severe hypertriglyceridemia.

"The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes," said AstraZeneca's Chief Executive Officer, Pascal Soriot.

"There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events.

"This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas."

RD

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