Glenmark inks pact with Lubrizol arm Particle Sciences to develop generic cancer drug

Glenmark Pharmaceuticals has formed a strategic alliance with the US-based Particle Sciences Inc, a Lubrizol company, for development and marketing of generic version of Abraxane, a cancer drug.

“The company has entered into a strategic development, license and commercialisation agreement with Particle Sciences Inc to develop and market a generic version of Celgene’s Abraxane product - paclitaxel protein (albumin)-bound particles for injectable suspension,” said Glenmark Pharmaceuticals in a press release.

Abraxane, marketed globally by Celgene, has reported sales of $ 967 million world-wide and $ 654 million in the US in the calendar year 2015. 

As per the terms of the agreement, Glenmark has obtained global exclusive marketing and distribution rights of the product upon commercialisation. 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 (ANDA) in FY19. The product will be subsequently filed in other key markets across the globe.

“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. This is a challenging product to develop and we expect it to remain a limited competition opportunity,” said Robert Matsuk, president - North America and global API, Glenmark Pharmaceuticals Limited.

Abraxane is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. It is also prescribed for 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. In addition, Abraxane is indicated for metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Particle Sciences, a part of the Lubrizol Corporation (a Berkshire Hathaway company), is an integrated provider of drug development services. The company focuses on BCS II/III/IV molecules, biologics and highly potent compounds through a variety of technologies including emulsions, gels, micro and nano-particulates, drug/device combination products, solid solutions and others.