NIPER Hyderabad bags patent for nano formulation of lung cancer drug osimertinib

New Delhi, February 21, 2023 :

The Indian Patent Office has granted patent to National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad for its nano formulation of lung cancer drug osimertinib mesylate, which claims to address the risk of acquired resistance against the therapy in the first year of treatment.

Osimertinib is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) drug developed by AstraZeneca Pharmaceuticals and sold under the brand Tagrisso to treat metastatic non-small cell lung cancer (NSCLC). Tagrisso is one of the blockbuster drugs of AstraZeneca.  

NIPER, in its complete specification submitted with the Patent Office, said that one of the major concerns with the use of osimertinib mesylate and other TKIs is development of acquired resistance against the therapy, typically occurring within eight to 12 months of beginning of the treatment. This has resulted in a need to develop a delivery system which could demonstrate higher efficacy at lower dose as to eliminate or delay acquired resistance. It said that the nanoparticle technology is one of the strategies to Eli Nina the acquired resistance with small dose and enhanced efficacy.

The researchers have successfully addressed the existing drawbacks and formulated a nano formulation of osimertinib mesylate PLGA nanoparticles with ligands, through the claimed invention, said the institution.

The institution filed the patent application in February, 2020 and the first examination report was issued by the patent office in July, 2022. In a hearing notice issued in January, this year, the patent office raised an objection including that the formal requirements such as the permission from the National Biodiversity Authority (NBA) has not been provided. The institution said that an approval is being taken from the NBA and later submitted the copy of the NBA approval in February, 2023.

Observing that the formal objection raised in the hearing notice has been overcome, the Assistant Controller of Patents and Designs, Kolkata, granted the patent application with nine claims filed as per the relevant section of the Patents Act.

AstraZeneca has announced in 2017 that it received US Food and Drug Administration (FDA) full approval for Tagrisso 80 mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy.

Tagrisso, said the company during the time, was the first approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients. Eligibility for treatment with Tagrisso is dependent on confirmation that the EGFR T790M mutation is present in the tumour, it added. The company has been conducting research on the use of the drug, also in combination with other drugs, for additional indications across the world.

According to AstraZeneca’s annual report for the fiscal year 2022, sales of Tagrisso was at $5.44 billion is one of the major drugs in its $14.63 billion oncology division, and registered an actual growth of nine per cent during the year. PharmaBiz