On September 19, 2016 Glenmark Pharmaceuticals, Inc., USA (Glenmark) reported that it has entered into a strategic Development, License and Commercialization 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 (Press release, Glenmark, SEP 19, 2016, View Source [SID:SID1234515301]).
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As per the terms of 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 shall 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 USA market and Glenmark intends to file the 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 marketed globally by Celgene has reported sales of USD 967 million world-wide and USD 654 million in the USA in the calendar year 2015. As per IMS MAT December 2015, ABRAXANE has registered sales of USD 990 million world-wide and USD 669 million in the USA.
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 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated
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
Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine