Pharmaero - Take a deep breath

Pharmaero was established in 2010 to develop inhaled antibiotics based on a proprietary aqueous droplet inhalation platform. The company is currently working on a number of compounds for the treatment of cystic fibrosis.

Pharmaero is a newly established development company focusing on pharmaceutical products delivered as aerosols for inhalation. Formed as a 50/50 joint venture between Xellia Pharmaceuticals and Scandinavian Health Ltd (SHL) in April 2010, the company is headed by general manager Tomas Norling.

Xellia, a global supplier of indispensable antibiotics (for example, vancomycin), is in transition from being a pure API supplier to a fully integrated specialty pharmaceutical company, operating predominantly in the injectable anti-infective field. SHL is the world's largest privately owned designer, developer and manufacturer of advanced drug-delivery devices, such as pen injectors, auto injectors and inhaler systems.

Pharmaero was established to develop inhaled antibiotics based on a proprietary aqueous droplet inhalation (ADI) platform. The company is working on a number of compounds, with the most advanced product being inhalable tobramycin for the treatment of cystic fibrosis (CF). The next product in line is inhalable colistin methane sulfonate (CMS), which is also for the treatment of CF.

CF is a congenital, recessively inherited disorder, which affects approximately one in 2,500 newborns in Caucasian populations. The most important bacterial pathogen associated with CF from the perspective of prevalence and pathogenicity is Pseudomonas aeruginosa, found in almost 80% of patients with CF by 18 years of age. If not treated, most CF patients die long before reaching the age of 30. If intensively treated, the mean lifetime of CF patients is currently 30 years, with life expectancy and quality of life continuously improving, for example due to availability of effective drugs such as nebulised tobramycin and colistin.

The common duration of treatment using nebulised tobramycin is 2×20 minutes daily, in addition to time spent on cleaning the nebulising device. Pharmaero's ADI device can do the job in 2×2 minutes, and since it can be discarded after use, re-infection is minimised and no time is spent on cleaning. Only ten deep inhalations in the morning and in the evening are required. The device is purely mechanical - no failure-prone electronics are included and no power supply is needed - implying great flexibility with regards to where and when it may be used.

This simple and easy treatment has important bearings on compliance with the prescribed dosing regime. It is a known fact that patients, of which teenagers constitute a large group, don't take their medication the way they should because it is timeconsuming and cumbersome. With the new treatment, all patients can take their inhaled antibiotic quickly, discretely and independently of any power supply.

The size of the nebulised droplets and particles carrying the antibiotic are important with regard to where they are deposited in the lungs. The optimal particle size for reaching the small airways is 1-5µm, but larger droplets can also be directed to the deeper lung if the airflow is adequately low. The ADI works particularly well with low inhalation flows.

One unique asset of the ADI device is the highly controllable particle size. Comparing ADI to the current PARI LC gold standard nebuliser on the market, ADI dosing achieves equivalent deposition and distribution of the drug across the respiratory and conductive zones of the lung at one-quarter of the PARI dose.

As well as inherent drug properties, other factors may affect the tolerability of inhaled antibiotics, including pH, preservative, osmolality and NaCl content. If these values are outside certain ranges, the drug may provoke coughing and bronchospasm. Compared with dry powder inhalers, wet mist formulations, as used with the ADI system, allow greater flexibility in selecting optimal formulation parameters, thus reducing cough reactions.

For this first, tobramycin-based ADI, TobrAir, a US submission study (phase III) is in preparation, with documentation to be filed as a 505(b)(2) application (timing under evaluation). Furthermore, an EU submission study (phase III) as a comparative efficacy study is in preparation with the intention of aiming at an application in 2015.

Pharmaero is already pursuing other opportunities where the company can make use of the unique aerosol technology, with CMS for treatment of Pseudomonas aeruginosa and vancomycin for treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections next in line.

Use of the ADI technology is not limited to antibiotics, however. Several respiratory tract afflictions treatable with other drugs, in addition to drugs that may be absorbed via the trans-pulmonary route, may also be targeted. The total market potential for such drugs is huge. As with typical development firms, Pharmaero's ideas outnumber its resources. For this reason, the company is open for discussions with investors and companies that possess product ideas and needs, in addition to companies providing a potential market outlet for products to come.

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Pharmaero's ADI device is purely mechanical, with no failure-prone electronics.
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