Head-to-Head Trial Shows that Myobloc®/NeuroBloc® Clinically Equivalent to Botox® in Cervical Dystonia

DENVER, June 21, 2005 – In a randomized, double-blind, head-to-head trial in 111 toxin-naïve subjects with cervical dystonia (CD), Myobloc® (Botulinum Toxin Type B) Injectable Solution (known as NeuroBloc® in the European Union) was found to be clinically equivalent to Botox® for efficacy as measured by the validated rating instrument known as TWSTRS and for duration of response.

The 56 toxin-naïve subjects in the NeuroBloc®/Myobloc® group received 10,000 U vs. 150 U for the 55 subjects in the Botox group. A statistical analysis demonstrated a clinical noninferiority endpoint, and both groups had similar adverse events.

This study is one of several Myobloc® studies being reported at the Denver Toxins 2005 meeting (officially called International Conference 2005 – Basic and Therapeutic Aspects of Botulinum and Tetanus Toxins) being held this week. The triannual Toxins meeting is held under the auspices of the Neurotoxicity Society and is targeted for physician specialists who use toxins to treat an ever growing list of conditions.

Solstice Neurosciences, Inc. ( Malvern, PA) purchased the manufacturing and marketing rights for Myobloc® in July 2004 and re-launched the product in the United States in April of this year. Myobloc® was previously owned by Elan Biopharmaceuticals, Inc. which originally brought the product to US market in early 2001.

“The FDA approved Myobloc® for CD after an extensive clinical trial program of 9 trials over 7 years. The current data support and expand on previously published reports demonstrating that Myobloc is a safe and effective first line treatment for patients with CD. Pain relief and muscle relaxation are key treatment objectives in patients with CD and Myobloc has a proven track record of efficacy.” said Mike Royal, MD JD, Chief Medical Officer for Solstice. Dr. Royal went on to say that “These new data demonstrate that Myobloc is clinically equivalent to Botox and with its superior clinical trial data set published in peer-reviewed literature, Myobloc® should be considered a first-line therapy for all patients with CD.”

Myobloc® Injectable Solution is sold in the United States and Canada and is also sold and distributed in Europe as NeuroBloc® (Botulinum Toxin Type B). Myobloc®/NeuroBloc® is indicated for the treatment of patients with cervical dystonia to reduce the severity of abnormal head position and pain associated with CD. Myobloc®/NeuroBloc® is given by physician injection every 3-4 months and relaxes the affected neck muscles while rapidly relieving the pain that so often plagues those suffering from CD. Myobloc®/NeuroBloc® is delivered as a premixed solution in three ready-to-use sizes with no reconstitution necessary and is the only botulinum toxin type B currently available to patients and physicians worldwide.

The most frequently reported adverse events with Myobloc® are dry mouth, dysphagia, dyspepsia, and injection site pain. These adverse events are generally mild to moderate, transient, self-resolving, and more common with higher dosages.

Solstice Neurosciences, Inc. is a privately held company focused on the development, manufacture, sales, and marketing of specialty biopharmaceutical products.

For more information: Roger Morris
Telephone: 610-274-8027
Email: londonbritain@msn.com

###