NICE has approved tobramycin inhalation powder, and the inhaler used to apply it, for treatment of a dangerous complication of cystic fibrosis (CF).

The TOBI Podhaler from Novartis has received final approval from NICE as a cost-effective therapy for Pseudomonas aeruginosa (Pa) lung infection in CF patients aged six and older.

The dry powder therapy is approved as part of a patient access scheme and when the standard treatment, nebulised colistimethate, is not tolerated or not effective.

Tobramycin inhalation powder saves the patient half an hour treatment time per day relative to the nebulised version of the same drug.

Pa infection is the main cause of premature death in people with CF, a genetic disorder that makes the lungs susceptible to infections. CF affects more than 9,000 people in the UK, and only half of CF patients live beyond the age of 41.

The Podhaler delivers tobramycin inhalation powder via a small hand-held inhaler, taking only six minutes for each dose compared to 20 minutes for each nebuliser dose. In addition, the inhaler does not need a power source, and the dry powder capsules do not need to be refrigerated.

Trials have shown the dry powder to have similar clinical efficacy to the nebulised drug, with clear benefits in terms of patient convenience. It was launched in the UK in 2011.

Dr Diana Bilton, Consultant Respiratory Physician at Royal Brompton Hospital, London, said: “Our experience is that patients really benefit from this antibiotic inhaler in terms of a reduction in treatment burden and being able to get on with life instead of spending time on a nebuliser.”

Generic manufacturer Mylan has agreed a $17.5 million deal with Pfizer for the exclusive rights to develop, manufacture and commercialise a portfolio of respiratory products.

As part of the deal, Mylan will have licensing rights to Pfizer’s generic equivalent to GSK’s Advair and Seretide.

Heather Bresch, Mylan President, says the agreement offers a “significant opportunity for our generics business”.

The agreement will also see Mylan retaining staff at Pfizer’s respiratory inhalation development team at Discovery Park in Sandwich, Kent. Other former Pfizer staff will be located in Cambridge.

Under the terms of the agreement Mylan will have rights to Pfizer’s dry powder inhaler (DPI) technology platform, as well as the opportunity to negotiate on existing compounds during different stages of their development in the Pharma giant’s pipeline.

Mylan will have to pay the costs for any remaining development and commercialisation for the transferred products. Additional payments will also be made once the deal is completed, depending on the regulatory and commercial success of the portfolio.

Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol which are delivered via a DPI and used to treat asthma and COPD.

On completion of the deal, Mylan with gain the exclusive commercialisation rights for Seretide in the US, Canada, Australia and New Zealand, as well as in the EU and European Free Trade Association countries. The two companies will have the co-promotion rights to the product in the rest of the world.

Pharmaxis has received a positive opinion from the CHMP for Bronchitol to treat adults with cystic fibrosis (CF) in Europe.

The drug’s indication is to help clear mucus, improve lung function and reduce exacerbations in CF patients over the age of 18, which represents approximately two thirds of those who could benefit from the therapy.

Dr Alan Robertson, CEO of Pharmaxis, said that the positive opinion “is good news for the CF community, which has supported us throughout the development of Bronchitol”.

The treatment consists of mannitol administered as a dry powder in a hand-held inhaler and is to be used as an add-on therapy to standard medications already in use.

Professor Stuart Elborn, President of the European Cystic Fibrosis Society, said that the medication will be the first approved therapy in Europe to improve both lung function and reduce exacerbations when added to standard medications in use today.

“Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies,” he added.

Bronchitol’s approvals in Australia and Europe are based on two Phase III clinical trials involving more than 600 CF patients.

Bronchitol was developed in Australia and will be commercialised through the EU in collaboration with the company’s marketing partner, Quintiles.

Pharmaxis plans to undertake a clinical trial in children aged 6-17, with a view to extend the drug’s licence.

Pharmaceutical company Pharmaxis researches, develops and commercialises therapeutic products for chronic respiratory disorders.

The first antibiotic inhaler device has been launched in the UK to treat chronic lung infections in adults and older children with cystic fibrosis (CF).

The TOBI Podhaler (pictured) from Novartis is a hand-held inhaler that delivers a new dry powder form of tobramycin to fight chronic Pseudomonas aeruginosa (Pa) lung infections, a common cause of death in people with CF.

The new device is estimated to save almost half an hour treatment time per day in people with CF over the age of 6, increasing their independence and quality of life.

CF affects 9,000 people in the UK. A life-threatening condition, it makes the lungs vulnerable to chronic infections.

Clinical studies have shown that treatment with tobramycin inhalation powder reduces treatment time by 72% compared with the nebulised drug.

Professor Stuart Elborn, Professor of Respiratory Medicine at Queen’s University, Belfast, commented: “People with CF have to endure a lengthy regimen of treatments and physiotherapy every day, so the time saved using tobramycin inhalation powder is significant.”

The new tobramycin inhalation powder has been produced using Novartis’ patented PulmoSphere technology. In trials, it was successfully inhaled in 5–6 minutes, whereas the nebuliser solution takes 20 minutes. For a twice-daily regimen, this saves approximately 28 minutes per day.

The dry powder inhaler is also less vulnerable to bacterial growth than the nebuliser, and needs no battery.

“We are proud to be launching TOBI Podhaler: a product that clearly demonstrates how we are applying innovative technology to better meet the needs of people with CF, helping them to lead independent and active lives,” said Dr Tim Cave, Medical Director of Novartis Pharmaceuticals UK.

Based in Basel, Switzerland, Novartis supplies a diversified portfolio of healthcare products including pharmaceuticals, diagnostics and drug delivery devices.