NEW YORK—Ohr Pharmaceutical Inc., whose focus is on the development of novel therapeutics for large unmet medical needs, has acquired assets from privately held SKS Ocular LLC and its affiliate SKS Ocular 1 LLC (SKS Ocular). The transaction, which closed on May 30, will provide Ohr Pharmaceutical with a proprietary, patent-protected, sustained-release technology platform under development as well as a pipeline of preclinical sustained-release drug product candidates that address unmet medical needs in glaucoma, retinal disease and other ophthalmic indications. The lead development program is currently being pursued under a research collaboration with a large global pharmaceutical company, which Ohr declined to name. As part of the agreement, Ohr will also gain a strong research and development team and a state-of-the-art research laboratory in San Diego. In response to DDNews’ questions, Ohr noted that the two companies have not worked together previously.
Under the terms of the agreement, in exchange for substantially all the assets of SKS Ocular, Ohr will make an upfront payment of $3.5 million in cash and 1,194,862 shares of Ohr common stock. In addition, SKS Ocular will be eligible to receive up to 1,493,578 additional shares of Ohr common stock in contingent milestone payments. These payments will be made if the acquired platform and pipeline drug candidates are successful in meeting certain specified development and regulatory goals within a specified time frame. SKS Ocular will also be entitled to receive a portion of any cash payments to Ohr from further collaboration with the large global pharmaceutical company on the lead development program, up to a maximum of $5 million.
SKS Ocular is a biopharmaceutical company that is developing a sustained-release technology platform to develop best-in-class drug formulations for ocular disease. The SKS Ocular sustained-release technology employs microfabrication techniques to create nanoparticle and microparticle drug formulations that can provide sustained and predictable release of a therapeutic drug over a three- to six-month period. There are four active pipeline programs underway, in glaucoma, steroid-induced glaucoma, allergic conjunctivitis and protein delivery. The technology was designed to circumvent many of the challenges associated with current drug delivery technologies to deliver drugs including small molecules and biologics for extended durations. It can be applied via multiple ocular delivery routes.
The SKS Ocular sustained-release technology employs a hydrogel template approach to prepare nanoparticles or microparticles of predeﬁned size and shape and with homogeneous size distribution. The size of the particles can be adjusted, providing ﬂexibility in controlling the size and release rate in drug delivery formulations. The drug-loading capacity is reportedly 30 percent or more higher than that achieved by conventional methods, with a controlled initial burst release of drug that is minimal. Simplicity in processing makes the hydrogel template method useful for scale-up manufacturing of particles. The technology has significant advantages over currently available microparticle drug delivery systems prepared by emulsion methods. The limits of emulsion technology include low drug-loading capacity (usually much less than 10 percent of the total weight) and often signiﬁcant initial burst release of a drug. This technology platform is adaptable to multiple routes of ocular delivery.
SKS Ocular has an ongoing collaboration with a large global pharmaceutical company to develop a new formulation of a therapeutic agent that allows for a three-month release profile following a single administration into the subconjuctival space. If successful, this approach could potentially result in a significant improvement in glaucoma treatment where the current standard of care is frequent topical, patient-administered medications. It has been well established from multiple studies that the single greatest reason for treatment failure in glaucoma today is lack of compliance with medication due to the nature of the disease. Unlike retinal disease where patients, due to clearly evident visual symptoms and vision loss, are highly motivated to be compliant with therapy, glaucoma is typically asymptomatic until late in the disease process, and thus compliance is a significant issue. A physician-administered drug with a requirement for injections at intervals of several months would greatly improve patient compliance and could have a significant impact on reducing loss of vision from glaucoma.
“We are very excited to be acquiring SKS Ocular’s technology, which we see as complementary to our efforts to develop and commercialize Squalamine Eye Drops for retinal disease,” stated Dr. Irach Taraporewala, CEO of Ohr Pharmaceutical. “This acquisition is a continuation of our strategy to build out a robust pipeline with novel, innovative delivery technologies. Our expanded pipeline now includes both early and late stage clinical assets that address multibillion-dollar market opportunities for retinal disease, glaucoma and other ocular indications.” Squalamine is a small-molecule antiangiogenic aminosterol. As with other Ohr pipeline candidates, it is in preclinical development. The company provided no guidance on when clinical studies might commence.
“Our decision to join Ohr has been driven both by our conviction of their ability to leverage our technology platform and also by the high value we see in the Squalamine eye drop program,” stated Dr. Jason Slakter, co-founder of SKS Ocular and, upon closing, the chief medical officer of Ohr Pharmaceutical. “We look forward to taking an active role in managing the Squalamine clinical trials, in addition to advancing the pipeline of drug candidates we created. We are very pleased to become part of a company that shares our commitment to improving the lives of patients suffering from ocular disease.”