Pearl Therapeutics Issued US Patent on Co-Suspension Formulation Technology

Pearl Therapeutics Inc. recently announced that the US Patent and Trademark Office has issued a patent on its novel co-suspension formulation technology for inhaled combinations. US Patent No. 8,324,266, titled Compositions, Methods & Systems for Respiratory Delivery of Two or More Active Agents was issued on December 4, 2012, and covers methods for treating pulmonary disease using Pearl’s co-suspension technology in metered-dose inhalers (MDIs).

This technology effectively prevents the sedimentation of drug crystals inside MDI canisters, minimizes interaction of active agents either with canister components or with each other, and keeps active agents stable over long periods of time. These characteristics allow for consistent dosing of each of the co-suspended active agents, even where the active agents are delivered at ultra low doses. Pearl’s co-suspension technology is used in its lead bronchodilator combination candidate PT003, a fixed dose combination of glycopyrrolate (GP) and formoterol fumarate (FF), as well as PT010, a triple-combination of GP, FF, and an inhaled corticosteroid.

“We believe our co-suspension formulation technology, as described in this patent, is a key differentiator of Pearl’s combination product pipeline. Using this technology, we have accomplished three important goals: reproducibly combined drugs and doses at unprecedentedly low levels in MDIs; advanced a dual bronchodilator combination PT003 through a rigorous clinical development program; and formed a stable triple combination of two bronchodilators and a corticosteroid,” said Sarvajna Dwivedi, PhD, Pearl’s Co-founder and Executive Vice President, Research and Development. “The issuance of this patent is a testament to the scientific innovation and engineering excellence of the Pearl team.”

“This patent marks the rapid evolution of Pearl’s intellectual property beyond the patent portfolio in-licensed in 2007,” added Chuck Bramlage, Pearl Therapeutics’ Chief Executive Officer. “The patent protection into 2030 afforded by this issuance gives the company greater control of the long-term commercial value of its combination product portfolio, including PT003. With the recent completion of PT003’s Phase II program, we are preparing to advance it into Phase III in 2013, and subsequently to bring to market this valuable therapy for the millions of individuals whose COPD is inadequately controlled with current medications.”

Pearl Therapeutics is a privately held company developing combination therapies for the treatment of highly prevalent respiratory diseases, including chronic obstructive pulmonary disease and asthma. Pearl is rapidly advancing a pipeline of products including PT003, an inhaled, fixed-dose combination bronchodilator product composed of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) delivered via a metered dose inhaler (HFA MDI); and PT010, a triple-combination product that combines the LAMA and LABA components of PT003 with an inhaled corticosteroid (ICS) for twice-daily administration from an HFA MDI for the treatment of severe COPD. Both PT003 and PT010 are developed with Pearl’s proprietary porous particle co-suspension technology, which allows the formulation of multiple products in the MDI format, with highly stable, robust, and aerodynamically efficient drug delivery. For more information, please visit www.pearltherapeutics.com.