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Inhalation Sciences Sweden AB

Concept Development
Prototype
Development
Product
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Project:

The Challenge

Technologies to facilitate drug discovery and early development of inhaled drugs currently limit development of drugs that can be administered to the lungs.  

Inhalation Sciences’ Solution

Inhalation Sciences Sweden has developed a research platform which may provide pharmacokinetic and dynamic data at an early stage, i.e. for very early selection of drug candidates. The company's goal is to introduce a new patented technology for development of inhalation drugs. The key is to be able to generate data that effectively allows either a go or no-go decision to be reached at an early stage in the development process.

Competitive Advantages

The technology platform requires only minimal pre-processing of a compound before testing. Only small amounts – often less than 100 mg – of a substance/new chemical entity are needed to generate all aerosol exposures necessary in order to complete the critical first screening of a lead compound for its potential as an inhalable drug.

The pharmacokinetic data derived enables poor-performing NCEs and new formulations to be discarded early on in the development process. Hence, the most promising projects can be advanced into the clinic at a much earlier stage than previously possible. Also, the risk of expensive late-stage product attritions, due to poor PK & ADME performance in the clinic, is substantially reduced.

Inhalers can be selected early in the development phase of new inhalation therapies for achieving optimal pharmacological features.

The company is also developing its own pipeline of inhalation drugs.

The Market

Recent growth in the asthma and chronic obstructive pulmonary disease (COPD) market, within the seven major markets, has been driven mainly by the uptake of more expensive inhaled corticosteroid/long acting combination products. The asthma/COPD market is expected to reach sales of almost USD 25bn in 20171

Systemic delivery by inhalation of small-molecular-weight drugs aimed at treating systemic disease represent an area of significant opportunity. This is of particular advantage for diseases that require treatments with fast onset of action, dose reliability and titration, minimal side-effects, and/or a means by which to bypass first-pass metabolism in the liver. Conditions such as migraine, nausea, anxiety and sexual dysfunction may benefit from rapid adsorption of drug and immediate therapeutic effect.

Status

  • Pharmacokinetic validation studies on generic and biologic drugs in the isolated perfused lung (IPL) have been successfully completed
  • Development of the first spray dryer prototype for micronizing small amounts of substance with high yields has been completed and is now ready for commercialization
  • Three collaboration agreements have successfully been completed with larger pharmaceutical companies

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Planned Milestones

  • Develop an in vitro system for early screening of inhalation drugs
  • Significantly expand current collaborations with pharmaceutical and biotech companies for screening drug candidates in the IPL and in vivo in rats
  • Carry out indicative kinetic studies in human volunteers

Patent Status

Four patent applications have been filed in the US, EU, Canada, Russia, China, India and Japan covering the important aspects of the technology.

Commercialization

The company's strategy is to seek collaborations with leading global pharmaceutical companies for further development and validation of the entire technology platform. This will form a solid foundation for further commercial activities such as out-licensing or a possible M&A transaction. The company also welcomes opportunities to work in collaboration with biotech and pharmaceutical companies for the co-development of new inhalation drugs intended for out-licensing.

 

  1. Source: Datamonitor, Forecast Insight: Asthma/COPD, 8/2008

 

 

Contact: Staffan Söderström, CEO | +46 8 508 845 80 | staffan.soderstrom@inhalation.se | www.inhalation.se