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Upsher-Smith Laboratories Adds ITI-111 (Nasal Midazolam) to CNS Development Pipeline

June 28, 2010 By Bio-Medicine.Org

MAPLE GROVE, Minn., June 28 /PRNewswire/ — 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
epile

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SOURCE

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