Upsher-Smith Laboratories Adds ITI-111 (Nasal Midazolam) to CNS Development Pipeline
By Upsher-smith Laboratories Inc., PRNESunday, June 27, 2010
Second Deal in Six Months Expands CNS Portfolio to Four Programs
MAPLE GROVE, Minnesota, June 28, 2010 - Upsher-Smith Laboratories, Inc. today announced an agreement with Ikano
Therapeutics, Inc. to obtain exclusive global rights to ITI-111, Ikano's
nasal midazolam. Under terms of the agreement, Upsher-Smith will assume all
further development, testing and clinical study of nasal midazolam as an
orphan drug for the management of acute repetitive seizure (ARS) in patients
with epilepsy. Upon successful completion of development and regulatory
approval, Upsher-Smith will commercialize the product, initially in the U.S.
market.
"Currently, epilepsy patients experiencing cluster seizures or acute
repetitive seizures have limited options for treatment," said Dr. Jacqueline
French, Professor of Neurology at the New York University Comprehensive
Epilepsy Center. "A product such as nasal midazolam could represent an
additional treatment option for these patients, and has the potential to
address a significant unmet need."
Some patients with epilepsy periodically experience episodes of ARS that
are distinct from their usual seizure pattern. There have been no new
FDA-approved products targeting ARS in nearly 15 years.(1)
"The addition of nasal midazolam to our growing development portfolio
represents a significant milestone in helping us achieve our vision of
building a leadership position in the central nervous system field," said
Mark Evenstad, President of Upsher-Smith. "We will continue to focus our
efforts on the development of products that address significant unmet needs
for patients with epilepsy, Parkinson's disease and Alzheimer's disease."
Upsher-Smith's development programs for the management of epilepsy
include USL255 (extended-release topiramate) and tonabersat. USL255 is an
internally developed program that recently entered a Phase III clinical trial
for the adjunctive treatment of partial onset seizures in adults. USL255 is
designed to provide convenient once-daily dosing and reduce fluctuations in
topiramate blood levels observed with currently available immediate-release
topiramate options. Tonabersat is a first-in-class neuronal gap junction
modulator that may have applicability in a variety of neurological
conditions, including migraine and epilepsy.
About Epilepsy and Acute Repetitive Seizures (ARS)
Epilepsy is a neurological condition that produces seizures affecting a
variety of mental and physical functions.
ARS may be defined as a predictable component of a patient's seizure
disorder which is historically distinct from the patient's other seizures in
type, frequency, severity or duration with an onset which is easily
recognized by the patient's family and physician.(2) An ARS episode may last
from minutes to hours and may have a consistent, predictable component such
as an aura or prodrome which is temporally linked to subsequent seizures.
Episodes of ARS may progress to prolonged seizure or status epilepticus in
some patients and may diminish the function and quality of life for both
patients and their families.(2)
About Upsher-Smith
Upsher-Smith Laboratories, Inc., founded in 1919, is a rapidly growing,
privately held pharmaceutical company that manufactures and markets branded
and branded generic prescription and over-the-counter products.
Upsher-Smith's product portfolio focuses in the areas of women's health,
dermatology, cardiology, and central nervous system diseases. The company's
growing CNS pipeline concentrates on diseases with significant unmet need,
including epilepsy, Parkinson's disease, and Alzheimer's disease. Its leading
CNS products in development are USL255 (extended-release topiramate) and
tonabersat for epilepsy, and PRX1 for the symptomatic treatment of
Parkinson's disease. To expand its CNS pipeline, Upsher-Smith seeks alliances
and co-development programs, pursues licensing and acquisitions, and
leverages the development of its core competency in formulation development.
For more information, visit www.upsher-smith.com.
About Ikano Therapeutics Inc.
Ikano Therapeutics Inc. (ITI) is a specialty pharmaceutical company
focused on developing innovative specialty therapeutics, with an emphasis on
drugs in areas for which there is proven, unsatisfied medical and patient
need. ITI's goal is to apply formulation and development expertise across
selected therapeutic areas to create new and differentiated products that
improve safety, efficacy and clinical utility for patients, caregivers and
health care professionals. For more information, please visit the ITI web
site at www.ikanotherapeutics.com.
1. Martin J. Acute repetitive seizures and seizure emergencies: weighing
your treatment options. March 3, 2005. Accessed 6/1/10 at
www.epilepsy.com/articles/ar_1109872672.
2. Cereghino JJ. Identification and treatment of acute repetitive
seizures in children and adults. Curr Treat Options Neurol. 2007 Jul;
9(4):249-55.
Daina Cardillo, Kovak-Likly Communications, +1-203-762-8833, dcardillo at klcpr.com
Tags: June 28, Maple Grove, Minnesota, Scandinavia, Upsher-smith Laboratories Inc., Western Europe