Healthcare Industry News: Monaco
News Release - May 15, 2007
Solstice Neurosciences, Inc. Announces Commercialization Agreement
MALVERN, Pa., May 15 (HSMN NewsFeed) -- Solstice Neurosciences, Inc. and Eisai Co, Ltd., Tokyo, Japan have entered into a commercialization agreement for NeuroBloc® (Botulinum Toxin Type B) Injectable Solution, a purified formulation of the neurotoxin produced by the bacterium Clostridium botulinum for treatment of cervical dystonia (CD). This agreement includes the 27 European Union countries, as well as Norway, Iceland, Liechtenstein, Monaco, Switzerland, Croatia, Turkey, and Russia.In January 2001, the European Commission granted Marketing Authorization valid throughout the European Union (EU) for NeuroBloc, also known as Myobloc® (Botulinum Toxin Type B) Injectable Solution in the United States, for the treatment of cervical dystonia.
Solstice Neurosciences, Inc. will receive up to euro 41 million from Eisai which includes an up-front payment as well as incremental payments for development milestones. Solstice Neurosciences, Inc. and Eisai will jointly develop the product for additional therapeutic indications in the territory.
"With the EU being one of the world's largest markets, we are extremely excited about this agreement with Eisai. This partnership will help bolster Solstice Neurosciences' long-term, global strategy to increase the use of NeuroBloc/MYOBLOC for its current indication in CD," explained Shawn Patrick O'Brien, President & CEO of Solstice Neurosciences, Inc. "In addition," said Mr. O'Brien, "partnering with Eisai, a global leader in neuroscience, enables us to build upon their expertise to collaboratively, effectively and efficiently enter the European market with new therapeutic indications for NeuroBloc. This agreement builds on an established relationship that began in 2000 when Eisai licensed the brand for development and marketing in Japan."
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops, and markets products throughout the world. Eisai focuses its efforts in three areas of therapeutic focus: Integrative neuroscience including neurology and psychiatric medicines; gastrointestinal disorders; and integrative oncology including oncotherapy and supportive-care treatments. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 9,000 people worldwide and forecasts the group sales of 668 billion yen in FY2006. More than 50% of the group sales are derived from overseas business. For more information, visit http://www.eisai.co.jp .
About NeuroBloc/MYOBLOC
NeuroBloc, known as MYOBLOC in the United States and Canada, was the first drug approved in the US to reduce the severity of abnormal head position and the neck pain associated with cervical dystonia. When injected into an affected muscle, botulinum toxin type B inhibits the release of the neurotransmitter, acetylcholine, at the motor nerve terminals to allow it to relax.
Regulatory approvals in the US, EU and Canada were based on the results from randomized, multi-center, double-blind, placebo-controlled studies in adult patients with cervical dystonia.
NeuroBloc/MYOBLOC is supplied as a ready-to-use, injectable solution in three single-dose vial sizes of 0.5 mL (2500 U), 1.0 mL (5000 U), and 2.0 mL (10,000U). Unopened vials of NeuroBloc/MYOBLOC has demonstrated stability when stored at 2-8 degrees C, and is approved for a 36-month shelf life in the EU, and a 48-month shelf-life in the US and Canada.
About Solstice Neurosciences, Inc.:
Founded in 2004, Solstice Neurosciences, Inc. is a biopharmaceutical company focused on the development, manufacturing, sales and marketing of specialty products. Solstice's first product, MYOBLOC, represents the only botulinum toxin type B currently available to physicians and patients worldwide. MYOBLOC is sold in the United States and approved in Canada. It is also distributed and sold in the EU as NeuroBloc. MYOBLOC is indicated for the treatment of patients with cervical dystonia (CD) to reduce the severity of abnormal head position and pain associated with CD. For more information about Solstice Neurosciences, Inc., visit http://www.solsticeneuro.com
About Cervical Dystonia
Cervical Dystonia (CD), also known as spasmodic torticollis, is a condition that primarily affects the muscles of the head and neck (the cervical area of the spine). Cervical dystonia is the most common dystonia requiring referral to movement disorder clinics. While the exact cause of CD is unknown, scientists believe the problem originates in the basal ganglia area of the brain that is instrumental in movement. In general, there are three main approaches to the treatment of CD: oral medications, toxin therapy and surgery.
Myobloc® and NeuroBloc® are registered trademarks of Solstice Neurosciences, Inc.
Source: Solstice Neurosciences
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