Glenmark Pharmaceuticals, headquartered in Mumbai, India, has entered into a strategic development, license, and commercialization agreement with Particle Sciences, a Bethlehem, Pennsylvania-based contract development and manufacturing organization and part of Lubrizol, to develop and market a generic version of Celgene’s anti-cancer drug, Abraxane (paclitaxel). The two companies will develop paclitaxel protein (albumin)-bound particles for injectable suspension.

As per the agreement, Glenmark has obtained global exclusive marketing and distribution rights of the product upon commercialization. Particle Sciences will develop this product exclusively for Glenmark and will receive certain milestone payments during various stages of the product’s development from Glenmark, including royalties on sales. Development of the product has been initiated for the US market, and Glenmark intends to file the abbreviated new drug application in 2019. The product will be subsequently filed in other key markets across the globe.

Abraxane is marketed globally by Celgene and had global 2015 sales of $967.5 million. In the US, the drug is indicated for: metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated; locally advanced or metastatic non-small cell lung cancer, as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Source: Glenmark