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.