Periodic Reporting for period 2 - NO-GO (NO-GO: UNVEILING THE POWER OF C-08 FOR THE TREATMENT OF OVER ACTIVE BLADDER)
Okres sprawozdawczy: 2020-05-01 do 2021-10-31
Overactive Bladder (OAB) syndrome is defined by a group of urinary symptoms: urinary urgency, with or without urinary incontinence, increased urinary frequency and nocturia. OAB affects 10% of the adult population under 50, with similar rates in both men and women. OAB affects over 500 million people worldwide and is expected to increase with the ageing trend of our society. No definitive solution exists to cure OAB and the current palliative treatments are far from being effective, on top of inducing multiple side effects such as disorientation, nausea and drug-to-drug interactions. OAB carries an important socio-economic burden for patients and healthcare bodies. In response to this necessity, we at SAGANATURA have developed NO-GO, a revolutionary treatment for OAB that has been proven with a clinical trial and real life use in patients since 2005. The treatment is 100% natural product with no side effects and safe. The solution for the treatment is orally consumable nutraceutical, containing a compound which our research has identified as the active compound of the herbal supplement SagaPro which SagaNatura has sold since the year 2005. NO-GO is based on the successful product SagaPro. The product has been very popular in Iceland since 2005 and has reached international markets but has suffered from both the lack of data from large clinical trials and a lack of know-how of the method of action. These factors are needed to convince key opinion leaders, distributers and pharmaceutical companies to include the product in their portfolio.
The first half of project NO-GO has been finalized. The objectives of the project were technical and commercial based. The technical objectives included designing a final composition of NO-GO with a standardized amount of the active compound C-08, securing manufacturing capability, scale up production and validate the NO-GO formula in a clinical setting on a large number of participants. For the commercial objectives we aimed to prepare documentation for EFSA health claims, implement GMP in the manufacturing facility, secure exploitation by getting a patent for the new formula to treat OAB and to design and implement a sale- and marketing plan that would result in global reach of NO-GO and sales reaching over 1.5 million packets in 5 years.
The first half of project NO-GO has been finalized. The objectives of the project were technical and commercial based. The technical objectives included designing a final composition of NO-GO with a standardized amount of the active compound C-08, securing manufacturing capability, scale up production and validate the NO-GO formula in a clinical setting on a large number of participants. For the commercial objectives we aimed to prepare documentation for EFSA health claims, implement GMP in the manufacturing facility, secure exploitation by getting a patent for the new formula to treat OAB and to design and implement a sale- and marketing plan that would result in global reach of NO-GO and sales reaching over 1.5 million packets in 5 years.
The project has been very successful, and we are already ahead of our plans in commercialization because of the work that has been performed during the project. We have managed to go from the formula SagaPro which was mostly based on mg total plant extract and a certain range of multiple chemicals in the HPLC fingerprint of the formula to a new and well-defined formula. The new NO-GO formula is based on a standardized content of the compound C-08 per capsule within a specific background of a chemical fingerprint. We have also centralized production of NO-GO, a capsulation machine is up and running, an extract dryer has been built and in-house angelica cultivation is started, and we now have 5 hectares of land that has been sowed using specific angelica seeds from areas high in C-08. Although due to Covid-19, the clinical trial did not reach the intended number of participants, the results are still good, statistically significant and show that NO-GO is a valid treatment method for overactive bladder.
We have implemented GMP in our finished product facility by designing and building a new capsulation and final product packaging facility. A method of use patent for NO-GO has been submitted domestically and internationally, as a PCT application. Finally, a commercial and tactical plan has been prepared and has already been put to good use with international distributers resulting in new customers ahead of plan.
The aim of the project is to create 21 new jobs and profits of €108 Million with ROI of 16.6 after 5 years on the market. End users will benefit from improvement of symptoms, no side effects, and ability to lead a normal everyday life. Doctors will be able to recommend NO-GO to their OAB patients, a product with no side effects, and healthcare bodies will save costs on expensive OAB prescription drugs with high dropout rates. Finally, with our sustainable approach for cultivating Angelica Archangelica we will seize this business opportunity while also preserving the Icelandic landscape, using natural resources and minimizing the impact to the ecosystem.
We have implemented GMP in our finished product facility by designing and building a new capsulation and final product packaging facility. A method of use patent for NO-GO has been submitted domestically and internationally, as a PCT application. Finally, a commercial and tactical plan has been prepared and has already been put to good use with international distributers resulting in new customers ahead of plan.
The aim of the project is to create 21 new jobs and profits of €108 Million with ROI of 16.6 after 5 years on the market. End users will benefit from improvement of symptoms, no side effects, and ability to lead a normal everyday life. Doctors will be able to recommend NO-GO to their OAB patients, a product with no side effects, and healthcare bodies will save costs on expensive OAB prescription drugs with high dropout rates. Finally, with our sustainable approach for cultivating Angelica Archangelica we will seize this business opportunity while also preserving the Icelandic landscape, using natural resources and minimizing the impact to the ecosystem.
Expected result of the project is to increase life quality for millions of people suffering from OAB and eliminate or reduce symptoms with no side effects and provide ability to lead a normal everyday life. Creating a good night sleep, which is rear among OAB patients, has numerous health benefits creating both strong social and economic impact from the project. Impact for Doctors & Healthcare bodies includes better management and awareness about OAB and lower total healthcare costs. Positive impact for the environment is to use natural wild grown plants to increase life quality vs. using chemically produced medicine with side effects on people and polluting effect on nature. SAGANATURA aims at creating 20 new jobs and increase both revenue and profits from increased production and sales.