Views of Ms. Sarabjit Kour Nangra (VP-Research, Pharma) on Sun Pharma announces settlement of litigation for generic Gleevec in US
"Sun Pharmaceutical Industries Ltd., today announced that one of its subsidiaries has executed a settlement agreement with Novartis Pharmaceuticals Corporation stipulating a dismissal of the lawsuits filed in the United States against the Company regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Gleevec, Imatinib Mesylate tablets. These tablets are indicated for the treatment of chronic myeloid leukemia. Under the terms of the settlement agreement, Sun Pharma's subsidiary may launch its version of generic Gleevec in the United States on February 1, 2016. The other terms of the agreement are kept confidential. The agreement is subject to customary regulatory approvals. Sun Pharma's subsidiary holds a tentative approval from the US FDA for its ANDA for a generic version of Gleevec. As per IMS, Gleevec had annual sales of approximately US $2bn in the US. The deal has put the clarity on the launch of the product and would fully reflect in the FY2017 financials. On a conservative basis, the product can contribute around US$250mn and US$75mn for the 6-month exclusivity period. We remain neutral on the stock."