Zerion Pharma and Insud Pharma announce collaboration to develop Dispersome formulations of marketed drug products
The Danish pharmaceutical company Zerion Pharma A/S (ZERION) and the Spanish pharmaceutical group Insud Pharma, SL today are announcing their collaboration to develop and commercialize drug products applying ZERION’s solubility enhancing Dispersome technology. ZERION will develop Dispersome formulations of marketed drug products while INSUD PHARMA will be responsible for the finished product dosage form, the clinical development as well as global marketing and sales of the final products.
INSUD PHARMA and ZERION started working together in 2021 and the partnership has now resulted in the first Dispersome drug product being ready for upscaling, GMP manufacture and human clinical trials. ZERION has granted INSUD PHARMA a worldwide exclusive license to this first Dispersome drug formulation. Under the terms of the license agreement, INSUD PHARMA will pay ZERION license fees, as well as milestone fees and royalties on product sales. INSUD will cover all clinical and other development costs.
“I am truly excited by our partnership with Insud Pharma that I consider a very innovative and dynamic pharma company with global commercial reach. We appreciate Insud’s readiness to explore innovative approaches to improve existing drug products”, says Ole Wiborg, CEO of ZERION, adding: “This partnership also provides early validation of an important element in our business strategy, that is to improve solubility and bioavailability of already marketed drug products. ZERION has a number of internal development programs in this field but we did not expect to complete commercial partnerships this soon.”
The two companies are working together on a second product candidate and expect more products to be included in the collaboration. A large number of solid drug products (typically tablet formulations) on the market suffer from poor solubility and low bioavailability. Applying the Dispersome technology to these products may lead to a reduced amount of the active drug ingredient and provide true benefits to patients in the form of lower dosing, or smaller and fewer tablets.
With a global organisation employing 7,000 people with a presence in more than 40 countries, INSUD PHARMA is very well positioned to effectively market the Dispersome drug product on a global scale.
“We are striving to launch innovative medicinal products that in addition to being price-competitive provide additional benefits to the patients”, says Alejandro Delgado, Global Director of Portfolio Management & Business Development. “We believe that ZERION’s technology can offer such benefits and have been very pleased with the results, we have seen thus far. We are happy to announce this collaboration that highlights the capabilities of ZERION in the field of drug formulation and the great team that makes it possible.”
The Dispersome technology
ZERION has pioneered the Dispersome technology that addresses poor drug solubility, one of the most recognized drug development challenges. Here, the API (Active Pharmaceutical Ingredient) is formulated with novel protein-derived excipients, into amorphous solid dispersions (ASDs) by Spray Drying. These protein-derived excipients aim to replace traditionally used polymers, achieving a higher increase in solubility and drug bioavailability.
The use of Dispersome technology has shown to enable drug loadings even above 50% w/w while maintaining amorphous stability and improving API solubility. These results have been demonstrated and proven with a wide diversity of drug entities.
Beta-Lactoglobulin (BLG), the main component in whey protein isolate (WPI), is the key excipient used in the Dispersome technology. BLG is a natural and biodegradable ingredient used in food and nutrition products, offering a safe and easy-to-integrate alternative to be used in existing applications.