Technology

PLATFORM TECHNOLOGY

NanoZolid® – a unique proprietary technology

LIDDS has developed NanoZolid®, a proprietary technology that helps solve some of the main problems with the way drugs work in the body and affect the patients’ quality of life. NanoZolid retains the efficacy of the original drug compound but reduces the side effects. Frequent dosing and severe side effects can be avoided by delivering effective drugs locally to the disease area.

The NanoZolid® technology provides flexible, controlled and sustained release of drug substances. This allows effective treatment and low side effects based on local administration in the disease area. The unique patented technology uses 13 different steps to provide the controlled and extended release of the drug. It is based on nanocrystalization, using a combination of water, heat and pressure. Partnering with Recipharm, we are now producing substance for Liproca® Depot in industrial scale.

With NanoZolid LIDDS can tailor a sustained (6 months) or shorter drug release locally, we can avoid minimal passage of drugs across the blood-brain barrier, and we can achieve high local efficiency quite comparable with systemic drugs. NanoZolid can be used with traditional small molecule compounds as well as with large biological molecules, providing major opportunities in immuno-oncology.

NanoZolid is:
• The only drug delivery technology that can achieve a controlled sustained release for up to six months.
• Addressing many of the side-effect problems that patients experience with current drugs.
• Giving local effect with high drug load.
• Patented in all major markets.
• Tissue friendly and safe, as the matrix is dissolved without residuals.
• Eliminating the risk for dose dumping.
• Validated by the clinical efficacy shown in Liproca Depot phase II studies.

TECHNOLOGY DESCRIPTION

A technology with many uses

LIDDS unique proprietary drug carriers can be used to develop new locally acting drugs for a wide range of cancers, such as tumors of the prostate, lung, ovarian, liver, brain, abdominal cavity, spine, head / neck, bone, uterus, kidney and bladder . Moreover, new treatments are developed to other intractable diseases that currently require systemic therapy to achieve high local drug concentrations. LIDDS has a unique and patented technology for local drug delivery that creates several advantages: The formulation provides controlled release of drugs in the desired time up to six months. Pharmaceutical preparation reabsorbed completely into the tissue due to its water solubility. The drug is not adversely affected by the integration of LIDDS technology. The formulation reduces the risk of accidental so-called dose-dumping, i.e. the drug is leaking uncontrollably.

Manufacturing Process and Technology

LIDDS NanoZolid® has developed a unique manufacturing process for its drug products which schematically can be described with three main steps, according to the figures below:

Patent portfolio

Thus far, a total of 89 national patents have been granted within eight patent families and LIDDS now has comprehensive patent protection for the NanoZolid® platform in all major markets. There are only a few remaining countries where the application has not yet been granted. These are markets where the processing time for patent applications usually is long.

The patent portfolio is judged to be sound and includes methods for controlling drug release, the manufacturing process, injection devices/aids, the method for controlling the solidification rate and the principle for treating prostate cancer with the NanoZolid technology. In addition to patent protection, which for LIDDS’s first five patent families applies until between 2027 and 2030, data exclusivity can be granted, which results in up to 10 years of additional market exclusivity after product registration.

A new patent application for the NanoZolid technology was submitted in 2016, which, upon approval, provides patent protection until 2037 for both the LIDDS technology platform and for the drugs developed in combination with NanoZolid.

During the first quarter of 2017, LIDDS filed a patent application to protect the development of NanoZolid with immune-modulating drugs and immunotherapy methods, as initial research demonstrated that the technology can integrate antibodies and larger biomolecules. Another patent application was submitted in October 2017 regarding the method of local treatment with cytostatics in combination with immunotherapy.

PATENTPATENTUSEUREST OF THE WORLD
1 / 2004Bioceramic compositionsApprovedApprovedNot filed
2 / 2006Method to treat prostate cancerApprovedApprovedAus, Can, Chi, Jap, Mex, Russ, S Kor, Nor, Afr, Isr, Ind,
3 / 2007Slow local drug releaseApprovedApprovedAus, Can, Chi, HK, Jap, Mex, Russ, S Kor, Isr, S. Afr, Ind,
4 / 2009Mixing tool suspensionsApprovedFiledAus, Can, Chi, Russ, Isr, Jap, Mex, S Korea, Ind, S. Afr
5 / 2009Steering of curingApprovedApprovedAus, Can, Russ, Jap,
HK, Mex, S.Kor,
Ind, Isr, S. Afr
6 / 2016Manufacturing process-Filed PCT-
7 / 2017NanoZolid + Biomolecules-Filed-
8 / 2017NZ-cytostatics + Immuno theraphy-Filed-