Kamada Announces Successful Completion of Phase I Studies With Aerosolized AAT for...
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Kamada Announces Successful Completion of Phase I Studies With Aerosolized AAT for the Treatment of Lung Diseases
EMEA Has Already Approved the Company's Clinical Plans for Phases
II-III Enabling the Company to Move Forward With the Development of
Its Flagship Product
WEIZMANN SCIENCE PARK, Israel--(Business Wire)--Kamada (TASE:KMDA), a biopharmaceutical company (www.kamada.com)
developing, producing and marketing specialty life-saving
therapeutics, has successfully concluded Phase I clinical studies
designed to test the safety and tolerability of the aerosolized
version of its flagship product, Alpha-1 Antitrypsin (AAT) using an
optimized eFlow(R) Electronic Nebulizer (PARI Pharma GmbH) to treat
various lung diseases.
According to David Tsur, Kamada's CEO, "we are very pleased with
the successful completion of Phase I clinical trial with Kamada's
aerosolized AAT product and the eFlow(R) device. This next generation
AAT product holds numerous advantages over current products, among
them: providing greater patient convenience, reduced treatment costs,
larger treatment population and additional potential indications, all
pending successful completion of the company's clinical development
plan for aerosolized AAT." Tsur added that "Kamada is strategically
progressing towards registration of its AAT formulations in the
European and US markets."
Kamada has already obtained Orphan Drug Designation (ODD) from
both the US FDA and the EMEA for aerosolized AAT for the treatment of
Congenital Emphysema and Cystic Fibrosis. ODD designation, and
subsequent ODD status, present significant commercial advantages
during the development process, registration and distribution of the
product throughout its lifecycle, notably exclusive distribution
rights for periods of 7 years in the U.S. and 10 years in Europe,
should Kamada be the first to successfully complete the clinical
trials and obtain regulatory approvals for these indications.
About eFlow
eFlow(R), an electronic, portable nebulizer, enables extremely
efficient aerosolization of liquid medications via a vibrating,
perforated membrane. Compared to other nebulizer systems, eFlow(R) can
produce aerosols with a very high density of active drug, a precisely
defined droplet size, and a high proportion of respirable droplets
delivered in the shortest possible amount of time. Combined with its
silent mode of operation, small size (it fits in the palm of your
hand), light weight, and battery use, eFlow(R) helps reduce the burden
of taking daily inhaled treatments.
About PARI Pharma
PARI Pharma develops aerosol delivery devices and inhaled
therapies. Based on PARI's 100-year history working with aerosols,
PARI Pharma specializes in treatments for pulmonary and nasal
administration optimized to advanced delivery platforms, such as
eFlow(R).
About Kamada
Kamada is a public biopharmaceutical company (TASE:KMDA)
developing, producing and marketing a line of specialty life-saving
therapeutics using its proprietary chromatographic purification
technologies. Licensed and marketed in more than 15 countries, several
of these specialty therapeutics hold registered and pending patents
and are currently in advanced clinical trials.
For additional information, please visit www.kamada.com.
Kamada
Sivan Shatil, 972-52-666-5762
Business Development
sivans@kamada.com
Copyright Business Wire 2008
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