Pearl is developing a pipeline of bronchodilator therapies for major chronic respiratory diseases. Our lead product is a bronchodilator combination in the simple press and breath metered dose inhaler (MDIs), administered twice a day to mimic the disease profile of patients with chronically obstructed airways. The majority of world`s half a billion pulmonary disease patients require multiple medicines to breath better. Most patients do so via different inhalers, which are often not universally usable in various regions of the world, complicated, time-consuming, or require use of inhalation effort by inhalation-compromised patients for drug delivery. Over 70% of inhaled doses are given by MDIs, yet many products are not available as MDIs. Pearl has invented a suite of novel, safe and efficient formulation and manufacturing technologies to allow MDIs to be available as highly stable, robust and reliable single, double and triple drug combinations for the first time in five decades of their existence. Pearl`s formulations provide the potential of better targeting and distribution of drug throughout the lungs, dose after dose under a wide range of patient use scenarios, without the need for complex devices. Offering these therapies in the most familiar delivery format to patients will reinforce compliance, and allow patients to seamlessly transition across all treatments and stages of disease, while potentially offering improved clinical outcomes over existing therapeutics via our improved aerosols.
Pearl has an experienced team of inhalation product development experts with a proven track record of developing and commercializing innovative respiratory products. We have raised $102.5M in venture financing since our start in May 2007, hired a work-force of about 60 professionals at three US locations, and engaged over 150 additional scientists, engineers, non-clinical and clinical contract researchers worldwide.
Pearl was a TiE50 Biosciences winner in 2010, one of the top 10 Fierce Financings in 2010, and a Fierce Biotech Fierce 15 company in 2011. This recognition is driven by Pearl’s world class team executing in an extraordinarily productive manner since its start in 2007. Pearl has completed eight clinical studies on its lead combination product and its two monotherapy components (5 Phase IIb, 2 Phase I/IIa, and 1 Phase I), and will complete two additional Phase 2b studies before end of 2012. This clinical evidence sets Pearl apart in the respiratory field, given the comprehensiveness of its dose ranging, safety evaluation, comparative assessment of monotherapy versus combination, and demonstration of superiority against current market leaders. This includes an unprecedented nano-dose study just started with a muscarinic antagonist, when the industry has struggled to formulate this class of drug in MDIs or break the microgram dose barrier.
To augment the clinical progression, Pearl has also completed fourteen comprehensive non-clinical studies to cover the safety requirements for late stage development, filed three INDs with significant regulatory dialog completed for confidence in its late stage work, invented a brand new particle formulation platform and filed brand new patent applications in all major markets worldwide to protect its products up to 2030. In parallel, Pearl scientists have generated abundant chemistry, manufacturing and controls (CMC) data to prepare a commercial image of the product for use in Phase 3, which de-risks the entire bronchodilator portfolio against the traditional hiccups in the regulatory process for respiratory products. En route, Pearl has achieved several industry firsts in respiratory product development, e.g., developed a long acting muscarinic antagonist MDI by fixing one of the most difficult MDI formulations; taken an average of just 6 months from first formulation to first patient dosed regardless of the type of clinical trial; developed combination therapies that do not change the delivery of the drugs when they are combined; and placed clinical development on the critical path of respiratory product development, which is the way pharmaceutical development should be.
In less than about 55 months after its first financing, the Pearl bronchodilator portfolio is projected to be ready for Phase 3 work, while its competitors have seen significant delays in their programs. Pearl has the potential of being the first to market with the best-in-class double bronchodilator combination product, giving it an opportunity to advance an equally unique triple therapy combination closely behind it.
For our stockholders, we believe Pearl is well-positioned to realize a return on their investment. As a first step in this process of providing our investors a return, Pearl plans to establish a partnership with an established commercial player in the respiratory field in the near future.