Pipeline & Platform
Using proprietary particle sciences and manufacturing technology, Pearl is developing a broad portfolio of products in the metered dose inhaler (MDI) format for the treatment of COPD and asthma. MDIs are the most widely used drug delivery format for inhaled treatments for respiratory diseases. Of the total inhaled medicine doses delivered each year worldwide, 70 percent are administered via MDI.
Respiratory companies attempting to develop MDIs have faced significant formulation challenges. For example, with the switch away from environmentally-damaging chlorofluorocarbon (CFC)-based propellants in the early 1990s, existing products needed to be reformulated and new ones created using novel, ozone-friendly HFA propellants. However, this has posed chemistry and manufacturing challenges that have been further compounded by the highly potent actives. This has been even more difficult to achieve with combination therapies.
Pearl Proprietary Particles
Pearl's world-class scientists and engineers have solved fundamental chemistry, manufacturing and control (CMC) issues associated with MDIs by advancing a proprietary formulation approach that uses porous particles to create stable suspensions in HFA propellants, and high performance aerosols upon actuation. Whether delivering one active in the case of a monotherapy, or multiple actives in a combination product, the porous particles dominate the behavior of the resulting suspension and aerosol. They provide predictable dosing performance and enhanced aerodynamics of a slower, "softer" aerosol plume that carries the drug more efficiently into the patient's lungs. In addition, Pearl’s technology obviates the need to use special additives such as co-solvents (ethanol), or other suspension modifying agents.
Pearl’s proprietary platform technology of porous particles in propellant works well with all classes of respiratory therapeutics, and offers unprecedented performance consistency and reliability. Pearl can rapidly create MDI products that encompass a wide range of monotherapies and combinations of even the most potent active drugs used to treat COPD and asthma, including unique combinations that until now have not been possible to formulate. This positions Pearl well to provide patients with chronic respiratory diseases an ability to transition seamlessly across treatments at all stages of severity, and to use a high performance version of the familiar MDI dosage format across all therapies.
Pearl has advanced multiple HFA-MDI products into the clinic in only seven to nine months from start of formulation in a format suitable for future commercialization. We believe that our robust formulation and manufacturing platform, our development team, and our development systems provide a high probability of clinical, regulatory, and technical success.
Summary of Advantages of Pearl’s Innovative Platform Technology
Pearl's novel HFA-MDI technology has the potential to offer many advantages over existing technology to patients and healthcare professionals. We expect these advantages to result in therapies that provide better drug delivery, and that give patients the full benefit of the therapy.
Pearl's technology provides:
- Reproducible dosing, from puff to puff, at all doses, including with single digit microgram doses of highly potent active drugs
- Rapid development of early development candidate in a format suitable for further development
- High lung dose and lower oral deposition - drug is deposited where it is needed for therapeutic benefit, less where it is not, and potentially results in a more favorable side effect profile
- Slower and softer plume than achieved by many HFA MDIs - breath coordination is less critical
- Uniform stable suspensions -- more tolerant of patient mis-handling and provide uniform dosing with each actuation
- Allows two or more active drugs to be combined in a single dose without each individual drug affecting the dose delivered of the other drug - no drug interaction in the dosage form or during delivery to the patient
- Chemically and physically stable across classes (LAMA, LABA, ICS) even for highly potent actives
- Enables the use of the most widely-used inhalation delivery format, the metered-dose inhaler
- Highest quality products that meet stringent regulatory standards, and provide the best therapies possible to patients.