Merck Specialties Private Limited, the Indian subsidiary of Merck KgaA, which introduced the colorectal cancer drug Erbitux in India, is planning to launch its UFT for colorectal cancer in India by early next year.
UFT (tegafur-uracil) is an oral chemotherapy agent that is used in combination with leucovorin (LV) for first-line treatment of patients with metastatic colorectal cancer. In 2005, Merck acquired the rights to UFT from the Japanese company Taiho Pharmaceutical for the treatment of colorectal cancer. Following transfer of the marketing authorizations to Merck, UFT has been re-launched by Merck in 16 countries like Germany, France, Denmark, Portugal, UK, Austria, Netherlands, Hong Kong, Thailand, Israel, Belgium, Sweden, Luxembourg, Bulgaria, Italy and the Philippines.
"We have applied to the Drug Controller General of India (DCGI) to launch UFT in India. We expect the approval soon and are likely to launch UFT in India by early next year", Dr Sudheirr Dhillon, head, oncology, Merck Specialities Ltd. told Pharmabiz.
Further, Merck KGaA's Stimuvax, a therapeutic vaccine being developed for non-small cell lung cancer (NSCLC), will undergo Phase IIIb clinical trials in India as part of an ongoing global clinical trial. Trials in India will be held at Jaslock Hospital, Tata Memorial and at select hospitals in Hyderabad and Delhi. Patients are being recruited and the study would be completed by December or early next year, informed Dr Suresh Advani, director, medical oncology, Jaslok Hospital, who heads the study in India. Stimuvax (L-BLP-25) is being developed in Europe by Merck KgaA and in North America by Biomira Inc and EMD Pharmaceuticals.
Erbitux is the first oncology product launched in India by Merck Specialties Private Limited from its parent's stable. The company has also applied to the DCGI to allow marketing of this drug indicated for treating neck and head cancer, common in India due to increased tobacco consumption.
"We have a promising R&D pipeline of about 30 compounds and many of these are undergoing clinical trials in various stages. Merck will definitely launch these products in India to benefit cancer patients in India," said Wayne Paterson, regional head of oncology-Asia Pacific, Merck Pte. Ltd.
Merck KGaA focuses its work in oncology on innovation in the treatment of cancer using targeted therapies designed to attack cancer cells specifically. Targeted therapies in development cover areas like inhibiting the epidermal growth factor receptor (EGFR), therapeutic cancer vaccines that stimulate the immune system against tumours, immunocytokines that provide local stimulation of the immune system, and angiogenesis inhibitors that starve the blood flow to tumours. At present, three compounds are in late stage development and eight are in earlier stages.