Partner Release:
GILEAD’S HEAD-TO-HEAD STUDY OF CAYSTON® VERSUS TOBRAMYCIN INHALATION SOLUTION IN CYSTIC FIBROSIS PATIENTS ACHIEVES CO-PRIMARY EFFICACY ENDPOINT OF NON-INFERIORITY– Cayston Data Meet Statistical Definition of Superiority –
Valencia, Spain, June 18, 2010 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that its head-to-head Phase III clinical trial of Cayston® (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second (FEV1) percent predicted after 28 days of treatment. Patients receiving Cayston had a mean increase in FEV1 percent predicted from baseline to Day 28 of 8.35 percent compared to 0.55 percent for patients receiving TIS, which meets the statistical definition of superiority. Safety results were similar across both arms of the study, with lower incidence of cough in patients receiving Cayston. These data were presented during a late-breaker oral session today at the 33rd European Cystic Fibrosis Conference (ECFC) in Valencia, Spain. [more]
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Partner Release:
ARIKACETM DEMONSTRATES SUSTAINED BENEFIT IN THE TREATMENT OF CYSTIC FIBROSIS PATIENTS WHO HAVE PSEUDOMONAS LUNG INFECTIONS - Data Presented at the European Cystic Fibrosis Society Conference
MONMOUTH JUNCTION, NJ, June 17, 2010 – Transave, Inc., today reported interim results from a multi-cycle Phase II open label clinical trial in cystic fibrosis (CF) patients on its lead investigational drug, ARIKACETM (liposomal amikacin for inhalation). The data indicated that ARIKACE, delivered once daily for 28 consecutive days followed by 56 days off-treatment for four cycles demonstrated statistically significant improvement in lung function that was sustained during the 56 days off study drug. ARIKACE was well-tolerated during the four cycles. Results were presented today at the 33rd European Cystic Fibrosis Society (ECFS) Conference in Valencia, Spain, by Predrag Minic, MD, Professor of Pediatrics and Head of Pediatrics Pulmonology Department, Mother and Child Health Institute, Belgrade, Serbia, and co-lead investigator of the study. [more]
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Partner Release:
We're pleased to share the following positive news from Transave re: a composition of matter patent for ARIKACE delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH) TRANSAVE ISSUED KEY COMPOSITION OF MATTER PATENT FOR ARIKACE™
MONMOUTH JUNCTION, NJ, May 24, 2010 - Transave Inc. today announced that the United States Patent and Trademark Office has issued an important composition of matter patent (U.S. Patent No. 7,718,189) for liposomal aminoglycoside formulations including its lead compound, ARIKACE™ (liposomal amikacin for inhalation). The company expects that the patent will provide exclusivity for ARIKACE until October 1, 2026. [more]
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Partner Release:
Mpex Pharmaceuticals Presents Positive Phase 2 Clinical Trial Results
of AeroquinTM (MP-376) Treatment in Cystic Fibrosis Patients
- Data Presented at the American Thoracic Society Annual Meeting -
San Diego, CA, May 17, 2010 - Mpex Pharmaceuticals, Inc. today announced the
presentation of data from its Phase 2b clinical trial with AeroquinTM (a proprietary erosol formulation of levofloxacin, MP-376) in cystic fibrosis (CF) at the American Thoracic ociety (ATS) Annual Meeting in New Orleans. Trial results demonstrated statistically ignificant improvements in bacterial load, respiratory function and time to need for anti- seudomonal antibiotics (a measure of exacerbations) versus placebo in a heavily treated patient population. The results were presented by Dr. Douglas Conrad from the niversity of California at San Diego School of Medicine, the principal investigator for the study. [more]
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PARI Pharma’s Altera Delivers Gilead’s Cayston, Approved by the U.S. FDA for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
MONTEREY, CALIFORNIA, FEBRUARY 23, 2010 – Altera, which uses eFlow Technology, was cleared to market today by the FDA as the first drug-specific nebulizer for use in the treatment of patients with cystic fibrosis and has been specifically developed to deliver Gilead Sciences’ Cayston (aztreonam for inhalation solution) 75 mg. Cayston is a new inhaled antibiotic that received marketing approval from the U.S. Food and Drug Administration (FDA) yesterday as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). The safety and efficacy of Cayston have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV1) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia. [more]
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Partner Release:
U.S. Food and Drug Administration Approves Cayston(R) (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
- First New Inhaled Anti-Pseudomonal Therapy Approved for Cystic Fibrosis Patients in More Than 10 Years -
FOSTER CITY, Calif., Feb 22, 2010 (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston(R)(aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). Cayston's safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV1) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia. [more]
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Alnylam Initiates Phase IIb Clinical Trial of ALN-RSV01 in Adult Lung Transplant Patients Infected with Respiratory Syncytial Virus (RSV) Infection
– Primary Endpoint is Reduction in Incidence of New or Progressive Bronchiolitis Obliterans Syndrome (BOS), a Life-Threatening Complication of RSV Infection in Lung Transplant Patients –
Cambridge, Mass., February 22, 2010 – Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has initiated a Phase IIb trial in adult lung transplant patients with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. RSV infection in lung transplant patients represents an important unmet medical need; the condition is associated with significant morbidity, including the development of acute lung transplant rejection in 10% to 20% of infected patients. Lung transplant patients infected with RSV are also at risk for an increase in frequency of new or progressive bronchiolitis obliterans syndrome (BOS), a life-threatening complication representing an irreversible disease of the transplanted lung resulting in approximately 50% mortality within three to five years of onset. [more]
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PARI’s Altera Delivers Gilead’s Cayston, Approved by European Commission to Treat Cystic Fibrosis
MONTEREY, CALIFORNIA, SEPTEMBER 23, 2009 – PARI Pharma’s Altera, which uses eFlow Technology, is the first drug-specific nebuliser for cystic fibrosis and has been specifically developed to deliver Gilead Sciences’ Cayston. Cayston, aztreonam lysine 75 mg powder and solvent for nebuliser solution, is a new antibiotic that received conditional marketing approval from the European Commission as a suppressive therapy for cystic fibrosis patients, 18 years and older, who have chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) infection. [more]
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Mpex Reports Positive Phase II Results with Aeroquin, Delivered by PARI Pharma’s eFlow Technology
MONTEREY, CALIFORNIA, SEPTEMBER 14, 2009 – Mpex Pharmaceuticals, Inc. reported positive top line results from a Phase 2b clinical trial with Aeroquin, a novel aerosol formulation of levofloxacin delivered by an optimized Investigational eFlow Nebulizer System from PARI Pharma. In the Mpex cystic fibrosis trial, nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa in sputum after 28 days of dosing versus placebo. [more]
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PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans
MONTEREY, CALIFORNIA, JUNE 2, 2009 – This month’s Journal of Aerosol Medicine and Pulmonary Drug Delivery features positive Phase Ib clinical trial results for PARI Pharma’s L-CsA, inhaled liposomal cyclosporine A. In May, PARI Pharma received Orphan Drug Designation from the Food and Drug Administration for L-CsA, delivered via an Investigational eFlow Nebulizer System, for the prevention and treatment of bronchiolitis obliterans, a devastating, incurable disease of the small airways affecting approximately 60,000 patients worldwide. [more]
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PARI Pharma’s Nebulized DSCG Shows Results Similar to Inhaled Steroids in Asthma Studies Presented at ATS
Positive Results Based on New DSCG Formulation & eFlow Technology Delivery
MUNICH, GERMANY and MONTEREY, CALIFORNIA, May 20, 2009 – This week, Swiss researchers presented positive data from an ongoing Phase II clinical study at the American Thoracic Society (ATS) International Conference that compared PARI Pharma’s inhaled IsoCrom, an isotonic 1% disodium cromoglycate (DSCG) solution, to inhaled corticosteroids (ICS) in 28 children with atopic asthma. Results showed decreases in mean asthma symptom scores without a change in lung function for both groups. These results were achieved with IsoCrom administered via a customized small droplet Investigational eFlow Nebulizer System designed to deliver drugs to the deep lungs. One of the benefits of DSCG is the long track record as an extremely safe drug. [more]
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PARI Pharma Receives 2nd ODD from EMEA; Moves Inhaled Tobramycin – eFlow Technology Program Forward
MUNICH, GERMANY and MONTEREY, CALIFORNIA, May 7, 2009 – PARI Pharma GmbH received an Orphan Drug Designation (ODD) by the European Commission based on a positive recommendation by the EMEA for inhaled PARI Tobramycin 100 delivered via a customized Investigational eFlow Nebulizer System. This is the second ODD designation that PARI Pharma has received for a product in its proprietary drug pipeline; the first ODD was granted for PARI’s inhaled cyclosporine delivered via an eFlow Technology device. [more]
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Kamada Completes
Last Patient Visit in Phase II Bronchiectasis
Study with its Inhaled AAT
March 17, 2009 09:00 AM Eastern Daylight Time
NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada, a
bio-pharmaceutical company (www.kamada.com)
engaged in the development, manufacturing and
marketing of specialty life-saving therapeutics,
announced today that it has completed the last
patient visit in a Phase II bronchiectasis study
with its Inhaled Alpha-1 Antitrypsin (AAT),
delivered via an optimized Investigational eFlow
Nebulizer System (PARI Pharma GmbH). Preliminary
results indicate that the product continues to
demonstrate a good safety profile; final
analysis of airway inflammation and secondary
endpoints is expected to be available by
mid-year. [more]
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PARI Pharma
Completes Successful Clinical Trials for
Tobramycin 100 & Investigational eFlow for CF
MONTEREY, CALIFORNIA, NOVEMBER 10, 2008 – PARI
Pharma GmbH has successfully completed Phase I
and Phase II clinical trials comparing its
proprietary PARI Tobramycin 100
(150mg/1.5mL)formulation delivered via a
customized Investigational eFlow Nebulizer
System to TOBI (tobramycin300mg/5mL) delivered
with the PARI LC PLUS jet nebulizer. While key
deposition and safety thresholds were maintained,
the marked difference was a reduction in the
average inhalation time to 4 – 4 1/2minutes for
the PARI Tobramycin 100, down from 16 - 17
minutes for the TOBI therapy. PARI Tobramycin
100 is an investigational therapy for cystic
fibrosis patients with Pseudomonas
aeruginosa infections. [more]
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Technologyat Medical Plastics
Conference
MONTEREY, CALIFORNIA, OCTOBER 6, 2008 – Today, PARI Pharma
GmbH will unveil a prototype Closed System using eFlow
Technology that uses single dose ampoules to control
medication used in the nebulizer system. By creating a
proprietary, unit-dose ampoule that is required to operate
the nebulizer, the Closed System using eFlow Technology
meets an unmet need by reducing the risk of using the wrong
medication in the delivery device, simplifying filling
procedures, improving dose uniformity and hygiene. [more]
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Mpex Initiates a Phase 2 Clinical Trial of Aerosol
MP-376 in the Treatment of Chronic Bacterial Infections in
Cystic Fibrosis Patients
Mpex Pharmaceuticals, Inc. today announced that it has
initiated a Phase 2 clinical study with MP-376 for the
treatment of pulmonary infections due to Pseudomonas
aeruginosa and other bacteria in patients with cystic
fibrosis. MP-376 is Mpex's proprietary aerosol formulation
of levofloxacin, an antibiotic that has potent activity
against key bacterial pathogens, including Pseudomonas
aeruginosa. Delivery of levofloxacin directly to the lungs
of CF patients by the aerosol route can potentially provide
a number of safety and efficacy advantages compared to oral
or IV administration. MP-376 is delivered using a customized
configuration of PARI's highly efficient eFlow® electronic
nebulizer.
[more]
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TRANSAVE ANNOUNCES POSITIVE PHASE II RESULTS FOR
ONCE-DAILY ARIKACE™ IN THE TREATMENT OF CYSTIC FIBROSIS
PATIENTS WHO HAVE PSEUDOMONAS LUNG INFECTIONS
Transave, Inc., reported positive results from a Phase II
clinical trial on its lead investigational drug, Arikace™
(liposomal amikacin for inhalation). The compound is being
developed for the treatment of cystic fibrosis (CF) patients
who have lung infections due to the bacterium Pseudomonas
aeruginosa. The Phase II data indicated that Arikace,
delivered once daily for 28 consecutive days, produced a
significant improvement in lung function, was
well-tolerated, and had a side-effect profile comparable to
placebo. The Phase II trial was a randomized, double-blind,
placebocontrolled study of 64 patients from 15 centers in
Europe. Results were presented today at the 31st European
Cystic Fibrosis Society (ECFS) Conference in Prague, Czech
Republic, by Lieven Dupont, MD, Associate Professor of
Respiratory Medicine at the Katholieke Universiteit, Leuven,
Belgium, and co-lead investigator of the study.
[more]
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Kamada
Announces Successful Interim Results of Phase II Deposition
Study with Aerosolized AAT
Weizmann Science Park, Ness Ziona, Israel, June 04 2008 -
Kamada, a bio-pharmaceutical company (www.kamada.com)
engaged in the development, manufacturing and marketing of
specialty life-saving therapeutics, announced today of
successful interim results in a Phase II deposition study
with its Aerosolized AAT product delivered by PARI's
optimized eFlow® electronic nebulizer to treat Alpha-1
Deficiency and other respiratory diseases.
[more]
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PARI’s eFlow delivers Alnylam
RNAi Therapeutic in Phase II study
MONTEREY, CALIF., APRIL 17, 2008 – An optimized PARI eFlow
platform nebulizer will be delivering Alnylam’s ALN-RSV01 in
a Phase II human clinical trial that has begun enrolling
patients. ALN-RSV01 is a RNAi therapeutic being developed as
a treatment for respiratory
syncytial virus (RSV) infection, the leading cause of
pediatric hospitalization in the U.S. and a
prevalent infection in immune-compromised adults. RSV
currently does not have a viable treatment option. [more]
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PARI
and Kamada Announce Successful
Phase I Results for Aerosolized Alpha-1
Antitrypsin (AAT)
Monterey, California,
JANUARY 15, 2008 – Successful results of
Kamada’s (TASE: KMDA) Phase I clinical trial
were announced for their inhaled Alpha-1
Antitrypsin (AAT) liquid drug candidate that was
delivered by PARI’s optimized eFlow® electronic
nebulizer. Dosage levels studied resulted in
good safety profiles and patient tolerability,
leading the way to continued clinical
development of AAT for administration via an
optimized eFlow to the lungs.
[more]
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PARI’s eFlow
delivers Alnylam RNAi Therapeutic in Phase I
study
Monterey, Calif., December 13, 2007 – PARI’s
eFlow, an advanced electronic nebulizer, was
optimized and used to deliver Alnylam’s
ALN-RSV01 in a Phase I human clinical trial.
Results of the Phase I trial were announced
today at the 18th Annual Drug Delivery to the
Lungs meeting held in Edinburgh, U.K. ALN-RSV01
is an RNAi therapeutic being developed as a
treatment for respiratory syncytial virus (RSV)
infection, the leading cause of pediatric
hospitalization in the U.S. and a prevalent
infection in immune-compromised adults. RSV
currently does not have a viable treatment
option. The Phase I study represents the
first-ever clinical study of an RNAi therapeutic
administered via inhalation.
[more]
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PARI’s eFlow
included in Gilead’s NDA Submission for
Aztreonam Lysine for Inhalation
Monterey, California, November 26, 2007 – PARI
Pharma’s eFlow electronic nebulizer was included
in Gilead’s (Nasdaq: GILD) recent New Drug
Application (NDA) submittal to the U.S. Food and
Drug Administration (FDA) for marketing approval
of aztreonam lysine for inhalation (75 mg three
times daily). Aztreonam lysine for inhalation,
delivered by eFlow, is an investigational
therapy in development for people with cystic
fibrosis (CF) who have pulmonary Pseudomonas
aeruginosa (P. aeruginosa) infection.
[more]
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Pediatric Asthma Programs featuring PARI
Pharma’s eFlow
Acquired by
AstraZeneca
MONTEREY, CALIFORNIA, SEPTEMBER 24, 2007 –
Today, the rights to Verus Pharmaceuticals’
pediatric asthma development programs that
utilize PARI’s eFlow electronic nebulizer for
aerosol delivery were acquired by AstraZeneca.
Following Gilead Sciences’ acquisition of Corus
Pharma in August 2006, this is the second major
pharmaceutical acquisition where a licensed
eFlow is featured prominently in the development
pipeline.
[more]
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PARI
Pharma Presents Study Results of Sinus Delivery
and Inhaled Liposomal Ciclosporin A at European
Cystic Fibrosis Conference
MUNICH, GERMANY, JUNE 14, 2007 - PARI Pharma
will present in-vivo study results for their
PARI SINUS pulsating drug delivery system as
well as lung deposition and pharmacokinetic data
of their proprietary inhaled liposomal
Ciclosporin A formulation in lung transplant
patients at the European Cystic Fibrosis
Conference (ECFC) in Belek, Turkey this week.
[more]
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PARI and Kamada Announce Positive
Intermediate Phase I Results for Inhaled Alpha-1
Antitrypsin
MONTEREY, CALIFORNIA, MAY 31, 2007 – The first
of two stages of the Phase I clinical trial show
positive results for Kamada’s Alpha-1
Antitrypsin (AAT) liquid drug candidate for
inhalation delivered with PARI’s eFlow
electronic nebulizer for the treatment of
patients suffering from AAT deficiency. Dosage
levels studied resulted in good safety profiles
and patient tolerability, leading the way to
continued drug development of aerosolized AAT
delivered with an optimized eFlow. [more]

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Gilead Announces Achievement of Primary
Efficacy Endpoint in Second Phase III Study of
Aztreonam Lysine for Inhalation in Patients with
Cystic Fibrosis
AIR-CF1 is First Phase III Clinical Trial in
Cystic Fibrosis to Evaluate Patient-Reported
Outcomes (PROs) as a Primary Endpoint
FOSTER CITY, CA, MAY 29, 2007 -- Gilead
Sciences, Inc. (Nasdaq: GILD) today announced
that its Phase III AIR-CF1 (CP-AI-007) study of
aztreonam lysine for inhalation for the
treatment of people with cystic fibrosis (CF)
who have pulmonary Pseudomonas aeruginosa (P.
aeruginosa) met its primary efficacy endpoint of
change at Day 28 from baseline in respiratory
symptoms, as assessed by the Cystic Fibrosis
Questionnaire-Revised (CFQ-R), a
patient-reported outcome (PRO) tool used to
measure health-related quality of life for
people with CF. [more]

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PARI Pharma, New Name of PARI Aerosol
Research Institute
MUNICH, GERMANY, MARCH 28, 2007 – To highlight a
greater focus on new and emerging drug therapies
developed in conjunction with their advanced
eFlow electronic nebulizer and formulation
technologies, PARI Aerosol Research Institute is
now PARI Pharma GmbH.
“For the last eight years, we have been
developing ways to improve respiratory therapies
for patients beyond what we can do on the device
side alone. We have a team of 75 scientists,
engineers, and technology specialists who focus
solely on drug and device optimization,
including inhalation formulation and device
development, as well as investigate new aerosol
therapies,” said Dr. Martin Knoch, President of
PARI Pharma. “The name change to PARI Pharma
communicates more accurately our core
competencies and business model. We are at a
very exciting point in our company history and
for the future of customized inhalation
therapies where drug and device are developed
together.” [more]
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PARI’s eFlow Wins Good Design Award
MONTEREY, CALIFORNIA, January 3, 2007 –
PARI’s eFlow was awarded a 2006 GOOD DESIGN
Award for medical equipment by The Chicago
Athenaeum: Museum of Architecture and Design
earlier this month. This is the second design
award eFlow has won this year, following the
Medical Design Excellence Award granted in
April. eFlow is a handheld, electronic nebulizer
that dramatically reduces treatment time for
aerosolized medications targeting the lungs. [more]

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Gilead Announces Preliminary Results From
Phase III Study of Aztreonam Lysine for
Inhalation in Patients With Cystic Fibrosis
Study of CF Patients With Pulmonary Pseudomonas
Aeruginosa Meets Primary Efficacy Endpoint
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19,
2006--Gilead Sciences, Inc. (Nasdaq:GILD) today
announced that its Phase III AIR-CF2 (CP-AI-005)
study of aztreonam lysine for inhalation for the
treatment of people with cystic fibrosis (CF)
who have pulmonary Pseudomonas aeruginosa
(P.
Aeruginosa) met its primary efficacy endpoint,
the time to need for inhaled or intravenous (IV)
antibiotics, which was assessed by the onset of
common symptoms predictive of a pulmonary
exacerbation. Data from the 247-patient study
demonstrated a significant improvement in time
to need for inhaled or IV antibiotics after a
28-day treatment course of aztreonam lysine for
inhalation compared to placebo, both following a
28-day treatment course of tobramycin inhalation
solution (pooled p-value=0.007 by log rank
test). The primary efficacy endpoint analyzed
the pooled data from both aztreonam treatment
arms, as pre-specified under a U.S. Food and
Drug Administration (FDA) Special Protocol
Assessment (SPA). Full study results will be
submitted for presentation at an upcoming
scientific meeting. [more]
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NIH using PARI’s eFlow in HIV/AIDS Vaccine
Research
Monterey, Calif., December 4, 2006 – The
National Institute of Allergy and Infectious
Diseases, part of the National Institutes of
Health, is currently conducting research using
PARI’s eFlow electronic nebulizer to study
aerosol delivery of vaccines to the mucosa. This
study evaluates immunogenicity of aerosolized
adenovirus- and DNA-based vaccines delivered to
the lungs to protect from HIV/AIDS and other
viral diseases. [more]
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PARI’s eFlow in Cystic Fibrosis Clinical
Trial of L-arginine
Monterey, California, November 29, 2006 –
PARI Pharma and The Hospital
for Sick Children (SickKids) in Toronto are
studying an inhaled L-arginine formulation
delivered by PARI’s eFlow to treat cystic
fibrosis.
Dr. Felix Ratjen, chief of Respiratory Medicine
and senior scientist in Physiology &
Experimental Medicine at SickKids, is conducting
the multi-centre, double-blind, randomized,
placebo-controlled trial. The study evaluates
the safety, tolerability, and durability of
response to L-arginine therapy in cystic
fibrosis (CF) patients.
In CF patients, nitric oxide formation and
nitric oxide synthases, the enzymes responsible
for the synthesis of nitric oxide, are
decreased, which is believed to impair lung
function. Lab studies have shown that adding L-arginine,
the precursor of enzymatic nitric oxide
formation, relaxes the trachea. The hope is that
lung function in CF patients can be improved by
increasing L-arginine concentrations. [more]
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PARI and Kamada Collaborate to Develop Inhaled Alpha-1
Antitrypsin
MONTEREY, CALIFORNIA, November 20, 2006 – PARI and
Kamada Ltd. (TASE:KMDA) have signed a strategic
Collaboration Agreement to develop Kamada’s Alpha-1
Antitrypsin (AAT) liquid drug candidate for inhalation
through PARI’s eFlow for the treatment of patients suffering
from Alpha-1 Antitrypsin deficiency.
AAT, also known as Alpha-1 Proteinase Inhibitor (API), is
used for chronic replacement therapy in individuals who lack
AAT and have an inherited form of panacinar emphysema. Lack
of AAT leads to various health problems, including
significant reduction in lung function, lung inflammation,
shortness of breath, and recurrent exacerbations. This leads
to emphysema, which is marked by damage to the walls of the
air sacs in the lungs resulting in inefficient breathing and
shortness of breath. [more]
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The eFlow Electronic Nebulizer by Pari GmbH
Delivers Required Medications Quickly and is
Child Friendly
Getting There: It’s All in the Delivery
eFlow
Electronic Nebulizer. Aerosol medication
delivery is a popular method for diseases that
require pointed drug delivery, especially to the
lungs. As a rule, however, the design of these
life-saving devices still need much improvement.
Nebulizers are bulky and inefficient. With a
commonly used nebulizer, administration of drugs
that treat asthma, chronic obstructive pulmonary
disease, cystic fibrosis, pneumonia, and other
diseases can take anywhere from 8–30 minutes.
And, as the drugs often require several
administrations per day, patients often complain
about inconvenience. [more]
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PARI’s eFlow Receives Premier Design Award
The eFlow electronic nebulizer has been selected
as a winner in the 2006 Medical Design
Excellence Awards (MDEA) competition, the
premier awards program for the medical
technology community. The Award will be given at
the 2006 MDEA Awards Presentation on Wednesday,
June 7, in a ceremony in New York City. In
addition, the eFlow will be highlighted in the
MDEA issue of the publication Medical Device &
Diagnostic Industry (MD&DI) for April 2006.

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PARI Named Leading Nebulizer Company in
Cambridge Consulting Survey; Market Dominance
Also Visible with Frost & Sullivan Award for
Product Innovation
In its recently released study of the global
nebulizer
market, Cambridge Consulting named PARI the
market dominator for high-end, differentiated
nebulizers in the United States and Germany.
This follows the September Frost & Sullivan
Product Differentiation Innovation Award for
PARI’s TREK compressor nebulizer system. Both
the recognition as the market leader and the
award for innovative technology speak to PARI’s
continuing commitment to improve the lives of
people afflicted with respiratory disease.
[more]
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PARI to Celebrate 100 Year Anniversary
In May, PARI will celebrate 100 years of
innovation in the field of aerosol science and
inhalation technology. The celebration will kick
off in Starnberg, Germany at the Worldwide
headquarters.

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Recent eFlow Patient Survey Shows Promising
Results
101 patients with cystic fibrosis (CF) recently
completed surveys regarding their experience
with PARI’s eFlow SCF electronic nebulizer as
part of a disease intervention program initiated
by SourceCF (www.sourcecf.com). When asked to
rate their overall experience with eFlow, 88%
indicated that their experience was “excellent”
or “very good.”
Respondents indicated dramatically shorter
treatment times with eFlow. Seventy-two percent
of respondents reported that with eFlow,
treatment times were between one and six minutes
based on fill volume. Many patients had
previously used nebulizers other than eFlow and
reported that they yielded much higher treatment
times. Eighty-one percent of those who had used
other nebulizers reported treatment times of 10
minutes or more.
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