Aurobindo Pharma gains on positive Phase-3 results of breast cancer drug

This phase 3 study is a multi-centre, randomized, double-blinded study involving females with metastatic HER2- positive breast cancer, company said.

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Shares of Aurobindo Pharma gained in the early trade on July 5 after subsidiary CuraTeQ Biologics announced positive results in the phase-3 clinical trial of Trastuzumab biosimilar.

The breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by the wholly owned subsidiary Curateq Biologics Private Limited, has met its primary endpoint in the Phase-3 clinical trial, according to a statement from Aurobindo Pharma.

BP02 has shown equivalent efficacy to Herceptin in regard to its clinical response (overall response rate, ORR), in addition to demonstrating a comparable safety profile.

This Phase-3 study is a multi-centre, randomised, double-blinded study involving females with metastatic HER2- positive breast cancer, the company said.

The trial was carried out to demonstrate product equivalence in terms of efficacy vis-à-vis EU-sourced Herceptin. Additionally, the trial also compared pharmacokinetics, safety, and immunogenicity of BP02 vs originators product, it added.

The results demonstrated that BP02 met equivalence to Herceptin in terms of clinical response and the safety profiles of the two treatment arms were shown to be comparable during the treatment phase.

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Earlier, CuraTeQ completed a randomised, double-blind, parallel three-arm Phase-1 study (BP02-101) in healthy volunteers with BP02 and Herceptin sourced from the US and the EU.

“We are excited by this study outcome. CuraTeQ is in the process of initiating submissions to regulatory agencies starting this quarter. We hope to complete market authorization (MA) application submissions across all key regulated markets in a phased manner, by March 2024. Our first submission will be in India in July 2023,” said Dr Satakarni Makkapati, CEO, Biosimilars, Vaccines and Peptides.

On July 3, the company’s entity entered into an arrangement with Viatris Inc for an aggregate value of $48 million in relation to transfer from Viatris Inc of certain marketing and manufacturing related authorisations that will be subject to approval from applicable regulatory authorities and third parties.

The arrangement also contemplates participation in the supply system in relation to certain marketing and manufacturing related authorisations and sharing of the net economic benefits by Viatris Inc. to such group entity of the company, it added.

At 9:28am, Aurobindo Pharma was quoting at Rs 716.30, up Rs 3.65, or 0.51 percent on the BSE.

The share touched a 52-week high of Rs 741.40 and a 52-week low of Rs 397.30 on 28 June, 2023 and 03 February, 2023, respectively. It is trading 3.39 percent below its 52-week high and 80.29 percent above its 52-week low.