Mumbai: Ranbaxy today said it had 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 and recurrent glioblastoma multiforme.
The Indian pharmaceuticals company has signed an exclusive licensing agreement with BioPro Pharmaceutical, Inc, to promote and market Gliadel Wafer in India.
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 tumor 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 tumour site, which minimises 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 100,000 per year. Another source estimates the total number of cases to be around 21,000 per year. Glioblastoma multiforme constitutes about 60 per cent-65 per cent 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, with subsidiary operations in greater China, including Beijing, Hong Kong and Taipei, as well as in Korea.