Ranbaxy Laboratories Limited has received import permission for marketing the US FDA approved product Gliadel (polifeprosan 20 with carmustine implant) Wafer for the treatment of newly diagnosed high-grade malignant gliomas & recurrent glioblastoma multiforme. Ranbaxy has signed an exclusive licensing agreement with BioPro Pharmaceutical, Inc, (BioPro) USA to promote and market Gliadel Wafer in India.
Commenting on the development, Sanjeev I Dani, senior vice president & regional director, Asia & CIS, Ranbaxy said, "We are pleased to bring this lifesaving, high technology product to Indian patients. We are working with BioPro to create a productive relationship by complementing each other's strengths. The licensing agreement, and subsequent launch approval, should enable Ranbaxy to further strengthen its position in the Oncology Segment."
"We are pleased with the professional and rapid processing of our regulatory application of Gliadel by the Drug Controller General India's Office," reported Peter Huang, chairman and CEO of BioPro. "We have an excellent product in Gliadel and excellent partners in Eisai Inc and Ranbaxy India. Now, so many brain cancer patients in India will have access to an excellent therapy option."
Gliadel Wafer is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. It is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery. Gliadel is the only FDA-approved chemotherapeutic implant for use during surgical resection, providing localized delivery of chemotherapy directly into the cavity created when a brain tumour is removed during surgery.
Gliadel is an off-white to pale yellow, roughly dime-sized wafer made up of a biocompatible polymer that contains the chemotherapeutic drug, carmustine (BCNU). After a neurosurgeon removes a high-grade malignant glioma, up to eight wafers are implanted along the walls and floor of the cavity where the tumor was previously located. Once implanted, Gliadel slowly dissolves, releasing high concentrations of BCNU into the tumor site, which minimizes drug exposure to other areas of the body.
The product is manufactured by MGI Pharma and BioPro retains the marketing rights in some Asian countries including China, Hong Kong, Taiwan, Korea, Singapore, Indonesia, the Philippines, Malaysia, Thailand, and India. Gliadel is approved in a number of countries globally including USA, many countries of Europe, Australia, Canada, South Africa, Israel, Korea, Taiwan, Hong Kong, Singapore, Malaysia and Thailand.
Though there is very limited data available on the incidence of brain tumours in India, according to unofficial sources, the estimated prevalence of CNS tumours in India is 2-5 new cases per 100000 per year. Another source estimates the total number of cases to be around 21,000 per year. Glioblastoma multiforme constitutes about 60-65% of these primary brain tumours.
BioPro Pharmaceutical is an oncology specialty biopharmaceutical company focused on the commercialization of products in the Pan Asian pharmaceutical markets.