Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, and Helsinn Group (“Helsinn”), a Swiss pharmaceutical group focused on building quality cancer care products, are pleased to announce that they have entered into an exclusive licensing agreement to introduce AKYNZEO® in India and Nepal.
AKYNZEO®, an oral fixed combination of netupitant 300mg and palonosetron 0.5mg in capsule form, is used for prevention of chemotherapy-induced nausea and vomiting (CINV). The licensing agreement with Glenmark for AKYNZEO® represents Helsinn’s first such agreement in India. Glenmark will have exclusive marketing rights for AKYNZEO® in India and Nepal.
Glenmark has received marketing approval for AKYNZEO® from the Central Drugs Standard Control Organization (CDSCO).
AKYNZEO® is the first and only combination anti-emetic prophylaxis with high complete response rates for five days in cancer chemotherapy-treated patients, having demonstrated 90% complete response rates through five days compared to 77% for oral palonosetron in patients receiving HEC cisplatin-based chemotherapy. It has been included among the recommended options in the MASCC/ESMO, ASCO and NCCN antiemesis guidelines. Delayed nausea is still a problem for up to 82% of patients receiving MEC (Moderately Emetogenic Chemotherapy) and HEC (Highly Emetogenic Chemotherapy), representing a significant unmet medical need.
The safety profile of AKYNZEO® was evaluated in 1169 cancer patients receiving at least one cycle of highly emetogenic or moderately emetogenic cancer chemotherapies in three double-blind, active-controlled studies. Common adverse reactions reported with AKYNZEO® were headache (3.6%), constipation (3.0%) and fatigue (1.2%). None of these events was serious (please refer to SmPC (Summary of Product Characteristics) for Full Safety Information).
AKYNZEO® was developed by Helsinn and it is currently marketed in EU, in the U.S., and several other leading markets of the world.
“We are happy to partner with Helsinn, a leader in cancer supportive care. AKYNZEO® will help Indian patients undergoing chemotherapy and struggling to manage CINV to address this issue in a much better manner. I am sure the launch of AKYNZEO® will fortify our presence in oncology, which is a key therapeutic focus area for the company,” said Sujesh Vasudevan, President – India Formulations, Middle East and Africa at Glenmark.
Andrea Meoli, Helsinn Group Chief Commercial Officer, commented: “We are excited to begin our first collaboration agreement in India with our new partner Glenmark Pharmaceuticals. Glenmark’s renowned expertise in sales, marketing and distribution in this region will mean that AKYNZEO®, a key anti-emetic product, will be made available to more patients suffering from the side effects of cancer treatment in the important markets of India and Nepal.”