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DisperSol Technologies, a clinical-stage pharmaceutical company developing new treatments for oncology and rare diseases, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced a strategic manufacturing collaboration to accelerate the development of multiple DisperSol pharmaceutical products. The collaboration will see the installation of a commercial-scale KinetiSol® technology manufacturing line at Catalent’s oral solids development and manufacturing facility in Somerset, New Jersey.
The KinetiSol platform is a disruptive innovation in amorphous solid dispersion manufacturing owned by DisperSol that is often the best and sometimes the only method to turn molecules with great clinical promise but poor bioavailability into viable medicines for patients. KinetiSol technology underlies all of DisperSol’s pipeline programs including Phase 3 ready KDFX for iron overload disorder, and KABE, which recently commenced Phase 2 studies against prostate cancer.
As part of the agreement, DisperSol will tech transfer its proprietary equipment, software and know-how to a dedicated suite in Catalent’s Somerset facility. In turn, Catalent will provide staff for development, scale up, and commercial stage KinetiSol production, as well as associated capabilities including process engineering, Quality Control and Assurance.
“This strategic collaboration with Catalent is integral to our company as we now move into late clinical-stage development and commercial-scale manufacturing of our products,” said Dr. Edward M. Rudnic, DisperSol’s Chief Executive Officer. “The commercial amorphous solid dispersion manufacturing expertise of Catalent’s team and their globally accredited quality systems make them a perfect partner for DisperSol.”
“Catalent is thrilled to partner with innovators to accelerate development of novel disruptive technologies to scale. Our Somerset development center has a track record of introducing and industrializing new oral technologies such as the KinetiSol platform,” commented Jeremie Trochu, Vice President, Operations, Early Phase Development at Catalent. “We look forward to working together to accelerate DisperSol’s pipeline of medicines, so that patients can benefit from the wide-ranging treatments that it has developed.”
ABOUT DISPERSOL
DisperSol is a clinical-stage drug development company focused on developing new treatments for patients utilizing its proprietary KinetiSol® technology platform. KinetiSol has proven capable of creating novel therapeutics from poorly bioavailable drugs to deliver unique clinical benefits to patients. The platform enables a drug development path forward to patients when other options fail to make a difference. DisperSol’s active programs include, DST-0509 about to enter Phase 3 for iron overload disorder, DST-2970 in Phase 2 for refractory metastatic prostate cancer and DST-8294 for treatment of clotting disorders. Additional earlier-stage programs include, DST-0058 and DST-5407 for idiopathic pulmonary fibrosis and non-squamous non-small cell lung cancer, respectively.
ABOUT CATALENT
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 15,000 people, including over 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.
