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PARI Granted Orphan Drug Designation for Inhaled Cyclosporine – Potential New Therapy for Lung Transplant Patients While
lung transplants are a common treatment for patients suffering from incurable
lung disease and related diseases causing degradation of the lungs (such as
emphysema and cystic fibrosis), only about 45% of transplant patients survive
more than five years. Currently,
cyclosporine is used as a standard oral therapy to systemically create high
doses of medication in the body and a desired concentration in the lungs.
PARI believes that in the form of an inhaled treatment, cyclosporine can reach
desired concentration levels in the lung without the high systemic penetration.
This provides the potential for reduced side effects that today include kidney
and brain damage and vulnerability to infection. Historically,
cyclosporine has poor solubility in water. This has created varied drug
concentrations in lung tissue when prepared for routes differing from oral
dosages. PARI has found a way to combat these issues with eFlow. PARI’s
eFlow, an electronic, portable nebulizer, enables a very efficient
aerosolization of liquid medications via a vibrating, perforated membrane.
Compared to other nebulizer systems, eFlow can produce aerosols with a high
density of active ingredients, a defined droplet size, and a high proportion of
respiratable droplets in a shorter amount of time. Its silent mode of operation,
small size (it fits in the palm of your hand), light weight and possibility of
battery use make this device extremely user-friendly. In
clinical studies, PARI’s scientists aim to prove the safety and efficacy of
cyclosporine when given as inhalation therapy with eFlow. Based on
laboratory tests with artificial lung models, PARI believes that the desired
therapeutic effect can be achieved with notably reduced drug doses when given
via inhalation, compared to oral therapies. The result could be improved
quality of life and survival chances for lung transplant patients. PARI
sought Orphan Medicinal Product designation for inhaled cyclosporine to fulfill
an unmet medical need. With the Orphan Medicinal Product designation, PARI
receives market exclusivity for 10 years and has access to European Union
incentives that include protocol assistance, access to the centralized procedure
of the European Agency for the Evaluation of Medicinal Products, potential fee
reductions and possible EU funded research. To qualify for orphan status,
medicinal products must diagnose, prevent, or treat life-threatening or very
serious conditions that are rare and affect not more than 5 in 10,000 persons in
the EU. PARI’s
decision to seek market approval for inhaled cyclosporine is a new direction for
the company. For many years, PARI has worked closely with pharmaceutical
companies to bring inhaled products to market and has established competence in
the development and testing of drugs. ”We
are very interested in developing tailor-made products for nasal and pulmonary
application that seek to improve medication treatment and quality of life for
patients,” said Dr. Manfred Keller, Director of PARI Business Unit Pharma.
“In cooperation with lung transplant specialists, we will create a clinical
development program for the cyclosporine project and begin the pharmacokinetic
and clinical studies as soon as possible.” PARI
will also continue to work closely with pharmaceutical companies to develop
other customized drug-device therapies with eFlow. Because eFlow provides
the potential for significantly reduced medication doses and treatment times,
PARI is in the unique position of helping pharmaceutical companies develop
innovative new medication formulations with customized drug-device matching.
The potential for creating super-generics, or new uses for approved active
ingredients, is also greater with eFlow due to its innovative technology
platform. About
PARI PARI
is a leading worldwide manufacturer of fast and efficient aerosol delivery
products for patients with asthma, chronic lung disease, and cystic fibrosis.
PARI's primary focus is to provide patients with innovative products and
services that help control disease. PARI is headquartered in Starnberg,
Germany and has offices in the United States, Japan, United Kingdom, and Canada.
Additional information on eFlow is available by contacting Kirsten Ayars at
805-898-0567 or Geoff Hunziker at 408-892-2097. ### Contacts:
Kirsten
Ayars, 805-898-0567 TynanGroup
Public Affairs
Geoff
Hunziker, 408-892-2097 PARI
Aerosol Research Institute
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