MS and NSCLC targeted
GENEVA, SwitzerlandóMerck Serono and Ono Pharmaceutical Co. Ltd. of Osaka, Japan, have signed two separate agreements to strengthen Merck's multiple sclerosis (MS) and cancer franchises.
The first license grants Merck worldwide exclusive rights (except in Japan, Korea and Taiwan) for the development and commercialization of ONO-4641, a novel investigational sphingosine-1- phosphate (S1P) receptor modulator currently in Phase II trials. The compound was originally discovered and developed by Ono for the potential treatment of multiple sclerosis. Under the terms of the agreement, Ono will receive about $20 million as an upfront payment. In addition, Ono could receive additional payments based on the achievement of certain development, regulatory and commercial milestones. No further financial terms were disclosed.
"Merck Serono is committed to building on our leadership franchise in multiple sclerosis and we are excited about adding a potential oral treatment, ONO-4641, to our pipeline," says Dr. Stefan Oschmann, president of Merck Serono. "We also believe that Ono will bring a wealth of experience in developing innovative therapies and understanding
regulatory requirements in Japan."
MS is a chronic, inflammatory condition of the central nervous system and is the most common, non- traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
The second license agreement provides Ono with co-development and co- marketing rights in Japan for Stimuvax (BLP25 liposome vaccine), an investigational cancer therapeutic designed to stimulate the body's immune system to target cancer cells that express the tumor antigen MUC-1. Under the terms of this agreement, Ono will pay Merck nearly $7 million as an upfront payment.
Merck Serono is investigating the use of Stimuvax in the treatment of non-small cell lung cancer (NSCLC). Merck Serona's parent, Merck KGaA, obtained the exclusive worldwide licensing rights from Seattle-based Oncothyreon Inc. Stimuvax is being developed in Europe by Merck Serono. In the United States and Canada, Stimuvax is being developed by EMD Serono, an affiliate of Merck.
The START study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,500 patients in approximately 30 countries. The primary endpoint of the START study is overall survival (OS). The almost identical INSPIRE study is designed to evaluate the efficacy, safety and tolerability of Stimuvax in approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.
"We are very glad to partner with Merck Serono for the development and marketing of ONO-4641, given Merck Serono's commitment to developing treatments for people living with multiple sclerosis," says Gyo Sagara, Ono's president and representative director. "Moreover, we are delighted to collaborate in Japan on Stimuvax and, together with Merck Serono, to offer a potential future medicine for people suffering from non-small cell lung cancer."
Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono. With an annual R&D expenditure of about $1.4 billion, Merck Serono focuses on neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in rheumatology. The Merck family holds an approximately 70 percent interest in Merck KGaA. In 1917, the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.