Glenmark Pharmaceuticals today said it has entered into an agreement with US-based Particle Sciences Inc to develop and market a generic version of Celgene’s ABRAXANE which is used in treatments of breast and lung cancers.
The agreement for strategic development, licence and commercalisation was signed between the company’s US arm Glenmark Pharmaceuticals Inc and Particle Sciences Inc.”
“As per the terms of the agreement, Glenmark has obtained global exclusive marketing and distribution rights of the product upon commercialisation,” the company said in a statement.
Particle Sciences will develop this product exclusively for Glenmark, and shall receive certain milestone payments during various stages of the product’s development from Glenmark, including royalties on sales, it added.
The company further said development of the product has been initiated for the US market and intends to file the ANDA in FY19.
The product will be subsequently filed in other key markets across the globe, it added.
Glenmark Pharmaceuticals Ltd President – North America and Global API, Robert Matsuk said: “The partnership is a significant development in Glenmark’s complex generics strategy and we are pleased to collaborate with Particle Sciences given their strong technical capabilities and understanding of particulate injection products.”
He added: “This is a challenging product to develop and we expect it to remain a limited competition opportunity.”
Glenmark said ABRAXANE, marketed globally by Celgene, has reported sales of USD 967 million world-wide and USD 654 million in the US in the calendar year 2015.
ABRAXANE is paclitaxel protein (albumin)-bound particles for injectable suspension indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
It is also used in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
The drug is also used for treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine, the company said.