{"id":12703,"date":"2022-01-28T15:42:50","date_gmt":"2022-01-28T14:42:50","guid":{"rendered":"https:\/\/kapitalpartner.dk\/ascelia-pharma-comparative-data-for-key-product-surpportive-for-commercial-potential\/"},"modified":"2022-02-26T12:29:06","modified_gmt":"2022-02-26T11:29:06","slug":"ascelia-pharma-comparative-data-for-key-product-surpportive-for-commercial-potential","status":"publish","type":"post","link":"https:\/\/kapitalpartner.dk\/en\/ascelia-pharma-comparative-data-for-key-product-surpportive-for-commercial-potential\/","title":{"rendered":"ASCELIA PHARMA – COMPARATIVE DATA FOR KEY PRODUCT SURPPORTIVE FOR COMMERCIAL POTENTIAL"},"content":{"rendered":"\n

With good prospects for Orviglance<\/a>(previously known as Mangoral) we expect coming phase 3 data due in H1\u20192022 will have significant positive impact on the share price. Orviglance is the first contrast agent in development for use in MRI scans of the liver, especially in adults with severe renal impairment (approx. 4% of the market) and is globally worth approximately USD 500-600 million a year.<\/p>\n\n

SMALL STUDY BUT STRONG DATA<\/h2>\n\n

The company recently presented results from a small comparative study with Orviglance and a gadolinium contrast agent, which showed that Orviglance-enhanced MRI scan was as effective as the gadolinium contrast agent, gadobenate dimeglumine, in visualizing lesions and the number of lesions detected. Two out of three independent readers reported a higher score for Orviglance enhancing the MRI scan.The results also showed that Orviglance-enhanced MRI scans provide improved diagnostic efficiency compared to MRI scan without contrast agent using identical end-points as in the ongoing pivotal phase 3 study, SPARKLE.<\/p>\n\n

However, it is worth noting that only 20 patients with liver metastases were included in the study and that the results are not static sufficient to conclude that Orviglance is superior to gadolinium.<\/p>\n\n

Gadolinium-based contrast agents increase the visibility of a tumor and these agents have been used for imaging in more than 300 million patients worldwide. Orviglance is the first contrast agent in development for use in MRI scans of the liver in adults with severe renal impairment (approx. 4% of the market). <\/p>\n\n

These patients are at risk of developing the severe and potentially fatal condition nephrogenic systemic fibrosis (NSF) if they use the gadolinium-based contrast agents currently available in the market. Orviglance aims to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors).<\/p>\n\n

The global market for Orviglance, which is targeted at patients with renal impairment undergoing an MRI scan of the liver, totals to approx. USD 500-600 million a year. Orviglance has received Orphan Drug Designation by the US Health Authorities FDA, which provide Ascelia Pharma with a number of economic and tax benefits.<\/p>\n\n

THE SHARE PRICE HAS EXPERIENCED DECLINE IN 2021<\/h2>\n\n

The share price is today (December 28, 2021) down by approx. 48% YTD. We expect that this driven by a combination of poor market sentiment around growth shares, capital increase and delay in recruitment of SPARKLE by up to 6 months due to the Covid-19 pandemic. However, the company has a solid cash portfolio that extends well into 2023. The next major price trigger is the upcoming announcement of the Phase 3 results for Orviglance in H1 2022.<\/p>\n\n