STARNBERG, Germany, April 7, 2015 /PRNewswire/ -- PARI Pharma's Vantobra®, a new highly concentrated tobramycin nebuliser solution for inhalation delivered by a Tolero® nebuliser, was granted Marketing Authorisation from the European Commission in mid-March. Vantobra is a breakthrough for cystic fibrosis patients as it offers reduced treatment times of 4 minutes with treatment effects comparable to TOBI® as concluded by the Committee for Medicinal Products for Human Use (CHMP). The CHMP also concluded that Vantobra is clinically superior to the orphan medicinal product TOBI Podhaler® due to greater safety in a substantial portion of the target population.
"In clinical trials, patients were able to take a full treatment of Vantobra within 4 minutes. This is a major benefit for cystic fibrosis patients that have been used to 15-minute treatment times with TOBI and already have a long list of other therapies. Saving time and making it easier for patients is a major goal for PARI. We believe that reducing the treatment burden leads to increased adherence to antibiotic therapy and addresses a key issue for patients and physicians," said Dr. Oliver Denk, vice president at PARI Pharma.
"When PARI Pharma developed customisable eFlow Technology, our hope was to reduce nebulisation time while delivering full medicinal benefits. Vantobra's highly concentrated tobramycin solution along with Tolero's drug-specific eFlow technology combine technological advancements. This is science working for patients," said Dr. Martin Knoch, president of PARI Pharma. "Vantobra delivered via the Tolero is PARI Pharma's first approved drug/device combination and joins a suite of other novel medicines delivered via customisable eFlow technology in development with our pharmaceutical partners or already on the market, such as Gilead's Cayston®."
In two clinical trials, Vantobra and TOBI showed comparable safety and efficacy profiles. The major difference is the time saved for patients. For twice-daily treatment with Vantobra, more than 10 hours of inhalation time per month can be saved compared to TOBI. Vantobra may also present a fast and well-tolerated alternative to tobramycin dry powder inhalation.
Vantobra is a proprietary aqueous solution of 170 mg tobramycin/1.7 ml for inhalation use via an optimised, drug-specific Tolero nebuliser handset. Vantobra and the Tolero handset are packaged together for patient convenience. PARI Pharma developed Vantobra and Tolero for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis.
Vantobra and the Tolero nebuliser are currently approved in Europe only.
About the Tolero Nebuliser and eFlow Technology
Tolero is an optimised nebuliser designed for Vantobra and uses eFlow Technology to enable highly efficient aerosolisation of highly concentrated tobramycin inhalation solution. Compared with other nebulisation technologies, eFlow Technology produces aerosols with a very high density of active drug, precisely defined droplet size, and high proportion of respirable droplets delivered in the shortest possible period of time. The eFlow Technology offers a silent operation, small size, light weight, and battery use to reduce the burden of taking daily inhaled treatments.
About PARI Pharma
PARI Pharma focuses on the development of aerosol delivery devices optimised together with drug formulations. Based on PARI's over 100-years history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimised with advanced delivery technologies, such as eFlow Technology.
PARI Pharma partners with pharmaceutical companies to develop new or improved therapies with eFlow Technology and other advanced delivery platforms. Investigational eFlow nebuliser systems are customised per investigational drug product and currently used in the development of aerosol therapies for cystic fibrosis, chronic obstructive pulmonary disease, non-tuberculous mycobacteria lung infections, alpha-1 antitrypsin deficiency, ventilator associated pneumonia, pulmonary alveolar proteolysis, and bronchiolitis obliterans after lung transplantation among other indications.
SOURCE PARI Pharma