Botulinum Toxin Type B Studies Demonstrate Long-Term Stability and a Consistent and Pure Formulation

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Botulinum Toxin Type B Studies Demonstrate Long-Term Stability and a Consistent and Pure Formulation
    PHILADELPHIA, May 10 /PRNewswire/ -- Elan Pharmaceuticals announced today
that the positive results from the long term stability studies conducted on
MYOBLOC(TM) (Botulinum Toxin Type B) Injectable Solution were presented at the
53rd Annual American Academy of Neurology meeting. These studies show that
MYOBLOC is stable for 30 months when refrigerated and nine months at room
temperature. Equally important, this new formulation was found to maintain the
potency, consistency and purity of the botulinum toxin complex throughout
these time periods. Maintaining a consistent, pure and stable complex is
important when injecting patients with botulinum toxin to minimize the risk of
antibody formation. MYOBLOC is the first new botulinum toxin therapy in a
decade and the only botulinum toxin formulated as a ready-to-use solution.
Type B is an antigenically distinct serotype from botulinum toxin type A.

    Stability in Botulinum Toxin Therapy
    The pH of botulinum toxin formulations helps determine the stability,
integrity and activity of the therapy. The higher the pH, the greater the
chance of the protein complex breaking down leading to loss of stability and
toxin activity. In the MYOBLOC stability studies, botulinum toxin type B was
tested at pH of 5.0, 5.5, 6.0 and 6.5 to determine the optimal pH; Type B was
extremely stable at pH of 5.0 or 5.5. Type B is manufactured with this optimal
pH of 5.6. The pH of commercially available Type A botulinum toxin is 7.3.
    "The MYOBLOC stability data are important because they highlight some of
the advantages of this new solution formulation" said Dr. James Callaway, VP
Pharmaceutical Development, Elan Pharmaceuticals. "MYOBLOC is produced using a
manufacturing process that does not require lyophilization (vacuum-drying) and
assures no loss of potency during the final production stages."

    Highly Convenient, Maximum Flexibility
    "MYOBLOC is a much needed treatment option for patients in need of
botulinum toxin therapy," said Dr. Richard Trosch, Clinical Associate
Professor of Neurology at Wayne State University. "Botulinum toxin type B is
easy for the physician to store and use, and is highly consistent and
effective."
    MYOBLOC is available in three convenient vial configurations of 2,500
units, 5,000 units and 10,000 units, providing maximum flexibility for dosing.
MYOBLOC was FDA approved in December 2000 to reduce the severity of abnormal
head position and neck pain associated with cervical dystonia. Studies are
underway to test MYOBLOC in a number of additional potential uses.
    MYOBLOC is generally safe and well-tolerated. The most frequently reported
adverse events associated with MYOBLOC treatment were dry mouth, dysphagia
(difficulty swallowing), dyspepsia (upset stomach), and injection site pain.
These side effects are generally mild to moderate, temporary, clear up on
their own, and more common with higher doses. If patients experience any side
effects during treatment with MYOBLOC, they should contact their physician.
    Caution should be exercised when administering MYOBLOC to individuals with
peripheral motor neuron diseases (e.g., amyotrophic lateral sclerosis, motor
neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or
Lambert-Eaton syndrome). Patients with neuromuscular disorders may be at
increased risk of clinically significant systemic effects including severe
dysphagia and respiratory compromise from typical doses of MYOBLOC.

    Elan Pharmaceuticals is a division of Elan Corporation, plc. Elan is a
leading worldwide fully integrated pharmaceutical company headquartered in
Ireland, with its principal research, development, manufacturing and marketing
facilities located in Ireland, the United States and Israel. Elan is focused
on the discovery, development and marketing of therapeutic products and
services in neurology, pain management, oncology, infectious disease and
dermatology and on the development and commercialization of products using its
extensive range of proprietary drug delivery technologies. Elan shares trade
on the New York, London and Dublin Stock Exchanges.

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SOURCE Elan Pharmaceuticals
http://www.elan.ie
CONTACT:
Leslie Harrison of Ketchum, 646-935-4029, for
Elan Pharmaceuticals