Dispersome IP ApS

Dispersome IP ApS (DIP) is a 50:50 joint venture between HOVIONE FARMACIÊNCIA, S.A., a Portuguese corporation, having its registered office at Quinta de São Pedro, Sete Casas, 2674-506 Loures, Portugal (hereafter referred to as "Hovione"), and ZERION PHARMA A/S, a Danish corporation, having its registered office at Fruebjergvej 3, 2100 Copenhagen Ø, Denmark (hereafter referred to as "Zerion"). ​ ​Structuring DIP as a joint venture company followed an agreement between the partners to pool the intellectual property (IP) portfolio protecting the Dispersome Technology platform in a separate legal entity for the joint management of prosecution and maintenance of this IP and joint financing of related expenses. To keep the company structure and cost as lean as possible, the company is operating without staff. ​ ​Dispersome IP ApS holds the IP Rights to the Dispersome Technology, which targets the enhancement of the solubility and bioavailability of poorly soluble drugs using beta lactoglobulin as pharmaceutical excipient. The technology aims to improve therapeutic outcomes by increasing drug solubility and bioavailability and reducing the dose of API. ​ ​The execution of the promotion and commercialization of the Dispersome Technology is performed by Hovione and Zerion, respectively, under license agreements signed with DIP. To compensate Hovione and Zerion for their high efforts to promote and commercialize the Dispersome Technology, which is not remunerated by DIP directly,​the major share of license income achieved from license agreements between DIP and third-party customers will be paid out to Hovione and Zerion. DIP will retain a portion of the license income as fee for administrative efforts.​ ​The management of the Company believes in the business concept of Company and the tremendous value of the​Company’s intellectual property portfolio. With more and more drug products using the Dispersome technology entering the market, the value of the Company intellectual property will increase and provide a steady revenue stream from license income. ​ ​Service Level Agreements between DIP and its shareholders ensure that all necessary business activities are performed. ​​Business Environment and Potential​Oral dosage forms remain a growing market segment. With more and more sophisticated drug discovery methods the number of active pharmaceutical ingredients (APIs) for oral dosage forms which display low or very low water solubility and hence low bioavailability is steadily keeping a ratio of >60% of registered APIs. Pharmaceutical companies are constantly looking for new drug delivery and formulation technologies for enhancing solubility and bioavailability. ​ ​Dispersome is addressing this formulation challenge and high market need. By formulating poorly soluble drugs with the Dispersome Technology, using beta-lactoglobulin (BLG) as pharmaceutical excipient, Zerion and Hovione have achieved superior and dramatic increases in solubility and corresponding bioavailability with a high number of model and customer APIs. ​ ​The Dispersome Technology is amongst superior drug delivery technologies due to its ability to yield improved solubility and bioavailability and tablets with high drug-load. The formulation techniques applied is the creation of amorphous solid dispersions (ASDs) of APIs in a BLG matrix. In many cases, BLG is the only excipient used. If required, additional excipients can be used as matrix component. The preferred manufacturing technology is spray drying, forming particles of amorphous solid dispersions (ASDs) of APIs. Hot Melt Extrusion (HME) is an alternative technique to manufacture ASDs. Such ASDs not only allow for the production of tablets with higher drug load, thereby reducing the size of tablets or the amount of tablets to be swallowed to achieve a therapeutically efficacious dose. The Dispersome ASDs as well lead to a better solubility and ultimately bioavailability of the API in the body as shown by in vitro dissolution and clinical testing. ​ ​In addition to the technological advantages, the Dispersome Technology is protected by a very solid and large patent portfolio of pending and granted patents. Licensees can benefit from an additional IP protection or patent life-time and market exclusivity extension for their drug formulations. ​ ​In the recent months, Zerion’s customer Insud has advanced a Dispersome formulation of a generic API into late-stage clinical testing. It is the management’s expectation that Insud will request a license from DIP for the commercialization of its Dispersome product starting in 2027, leading to license income in the same year. ​ ​Zerion is entertaining additional partnerships and supporting additional drug development programs with the potential to lead to further license agreements. ​ ​In FY25, Hovione, using the license from DIP, has made significant progress in developing nutraceutical product formulations, including a curcumin product formulation, using the Dispersome Technology. In pre-clinical and clinical studies this curcumin formulation has shown a performance that is comparable to high-selling marketed products. DIP considers receiving license income from Hovione’s out-licensing activities related to this product formulation. ​ ​Further, Hovione has continued its development of beta lactoglobulin as excipient for spay dried formulations used in respiratory drugs. Data indicate that the Dispersome Technology has significant potential in the respiratory drug area to become one of the few excipients used for lung and nasal delivery. These findings open up a new business field and commercialization opportunity for Dispersome.