Lugano, Switzerland and Mumbai, India,July 9, 2018: Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, today announced the launch of AKYNZEO®, a fixed combination drug for the prevention of chemotherapy-induced nausea and vomiting (CINV), on to the Indian market under an exclusive licensing agreement with Helsinn.
AKYNZEO®, an oral fixed combination of netupitant 300mg and palonosetron 0.5mg, is to be administered in a single capsule that acts on both the two main pathways associated with acute and delayed phases of CINV. The product has been developed by Helsinn and Glenmark has exclusive marketing rights for AKYNZEO® in India and Nepal.
“Oncology is a key area of focus for Glenmark, and we are committed to bringing in new treatment options for Indian patients. Nausea and vomiting associated with chemotherapy has a significant impact on quality of life of cancer patients that can influence a patient’s adherence to the treatments being undertaken. AKYNZEO® is a convenient single-dose for each chemotherapy cycle oral capsule with an activity that covers both the acute and delayed phase of CINV, avoiding multiple drug antiemetic options and thereby improving patient compliance,” said Sujesh Vasudevan, President – India Formulations, Middle East and Africa at Glenmark.
Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “We are very pleased to announce that the oral fixed combination AKYNZEO® has now been launched in India and Nepal, providing a new prophylactic option for patients suffering from chemotherapy-induced nausea and vomiting. Helsinn is focused on helping people with cancer get the best out of every day and is pleased to be expanding its availability. Glenmark is a trusted partner with an excellent footprint in this region and a commitment to providing the best treatment options for people with cancer and we are delighted to be working alongside them on this.”
In the EU:
AKYNZEO® (netupitant 300mg/palonosetron 0.5mg) capsules for oral use was approved in May 2015 in the EU. AKYNZEO® oral is indicated in the EU for adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.
For additional information please see the EU Summary of Product Characteristics
Oral NEPA has been recommended by various international antiemetic guidelines: the National Comprehensive Cancer Network (NCCN) antiemetic guidelines, both in Highly Emetogenic Chemotherapy (HEC; inclusive of AC and carboplatin AUC≥4)) and in Moderately Emetogenic Chemotherapy (MEC) for selected patients with additional risk factors or who have failed previous cycles of CINV prevention with steroid plus setron; the American Society for Clinical Oncology (ASCO) guidelines, in HEC, including AC, and carboplatin (AUC≥4) regimens and the MASCC/ESMO Guidelines in HEC, AC and carboplatin-based chemotherapy. Helsinn currently has 20 licensing partners for AKYNZEO® in 167 countries.
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.
To learn more about Helsinn Group please visit www.helsinn.com
About Glenmark Pharmaceuticals Ltd:
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2017). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory.
The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.
For more information:
Helsinn Group Media Contact
Group Head of Communication
Tel: +41 (0) 91 985 21 21
Glenmark Media Contact
Glenmark, Mumbai, India
Tel: +91 22 4018 9999 (Extn: 1801)