AstraZeneca loses US patent; MedImmune buys AlphaCore

Hannah Blake

pharmaphorum

The United States District Court for the District of New Jersey has ruled that AstraZeneca’s patent No. 6,598,603, which was protecting Pulmicort Respules in the United States, is invalid. Pulmicort Respules (budesonide inhalation suspension) is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.

This ruling comes after AstraZeneca filed patent infringement lawsuits against Apotex Inc., Apotex Corp., Watson Laboratories and Breath Limited, and Sandoz, Inc., for infringement of US patents directed to methods of use and formulation and form of active ingredient (budesonide) for Pulmicort Respules.

“AstraZenca strongly disagrees with the Court’s decision. AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES. AstraZeneca is considering next steps, including an appeal of the Court’s decision.”

Paul Hudson, Executive Vice President, North America.

The Court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca’s second patent, US Patent No. 7,524,834. The decision is limited to the US and has no impact on the validity of patents related to Pulmicort Respules in other countries.

The patents protecting Pulmicort Respules expire in 2018, with paediatric exclusivity extending into 2019.

In other news, the global pharmaceutical company has also announced its biologics research and development unit, MedImmune, has acquired AlphaCore Pharma. AlphaCore Pharma is a biotech company focused on the development of ACP-501, a recombinant human lecithin-cholesterol acyltransferase (LCAT) enzyme. Cardiovascular and metabolic disease is a core therapy area for AstraZeneca’s small and large molecule research.

"As the science in this area continues to evolve, we are committed to exploring unique pathways that could lead to new combination or standalone therapies for patients living with chronic and acute cardiovascular diseases.

"Cardiovascular disease is projected to remain the single leading cause of death worldwide over the next decade and beyond. Through novel approaches like LCAT, we hope to shift the treatment paradigms in this area to help prevent and treat these conditions."

Dr. Bahija Jallal, Executive Vice President, MedImmune.

This acquisition is in line with the plans for a major R&amp,D overhaul, including job cuts, announced by AstraZeneca's CEO Pascal Soriot last month.