Cantargia AB: Cantargia: FDA tilldelar särläkemedelsstatus (Orphan Drug Designation) till nadunolimab för behandling av bukspottkörtelcancer
Cantargia AB meddelade idag att den amerikanska läkemedelsmyndigheten, Food and Drug Administration (FDA), har beviljat särläkemedelsstatus i USA till nadunolimab (CAN04) för behandling av bukspottkörtelcancer. Detta ger möjlighet att utnyttja flertal incitament vid den fortsatta kliniska utvecklingen av nadunolimab i bukspottkörtelcancer
Cantargia AB meddelade idag att den amerikanska läkemedelsmyndigheten, Food and Drug Administration (FDA), har beviljat särläkemedelsstatus i USA till nadunolimab (CAN04) för behandling av bukspottkörtelcancer. Detta ger möjlighet att utnyttja flertal incitament vid den fortsatta kliniska utvecklingen av nadunolimab i bukspottkörtelcancer
22/9 2021 17:46 Helge Larsen/PI-redaktør 3
97195 Cantargia: FDA grants Orphan Drug Designation to nadunolimab for treatment of pancreatic cancer
Cantargia AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer. This provides access to various incentives in the continued clinical development of nadunolimab in pancreatic cancer.
The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia's lead program and is investigated in multiple clinical trials evaluating combination with chemotherapy regimens in various forms of cancer, including pancreatic ductal adenocarcinoma, PDAC, which accounts for more than 90% of all cases of pancreatic cancer.
The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US. Orphan Drug Designation qualifies sponsors for incentives, including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval. More information about rare diseases and the Orphan Drug Designation Program is available on www.fda.gov.
Nadunolimab is currently evaluated in ongoing clinical trials for treatment of PDAC. In CANFOUR, a phase I/IIa study, nadunolimab is investigated in approximately 70 patients with gemcitabine and nab-paclitaxel as first line combination in advanced PDAC, and in the phase Ib trial CAPAFOUR together with FOLFIRINOX as first line therapy in patients with metastatic PDAC. Interim efficacy data from 33 PDAC patients in the CANFOUR study show that the nadunolimab combination therapy results in durable responses or pseudoprogression, leading to prolonged progression-free survival (iPFS) and overall survival (OS) compared to historical control data. Preparations are ongoing for late-stage development in PDAC, to be initiated during 2022.
"The Orphan Drug Designation by FDA provides several strategic advantages and is a valuable step forward in the development of nadunolimab. The designation also confirms Cantargia's strong commitment to provide new effective treatment options to patients with pancreatic cancer." said Göran Forsberg, CEO of Cantargia.
For further information, please contact:
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com
This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16.30 CET on 22 September 2021.
Cantargia AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer. This provides access to various incentives in the continued clinical development of nadunolimab in pancreatic cancer.
The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia's lead program and is investigated in multiple clinical trials evaluating combination with chemotherapy regimens in various forms of cancer, including pancreatic ductal adenocarcinoma, PDAC, which accounts for more than 90% of all cases of pancreatic cancer.
The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US. Orphan Drug Designation qualifies sponsors for incentives, including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval. More information about rare diseases and the Orphan Drug Designation Program is available on www.fda.gov.
Nadunolimab is currently evaluated in ongoing clinical trials for treatment of PDAC. In CANFOUR, a phase I/IIa study, nadunolimab is investigated in approximately 70 patients with gemcitabine and nab-paclitaxel as first line combination in advanced PDAC, and in the phase Ib trial CAPAFOUR together with FOLFIRINOX as first line therapy in patients with metastatic PDAC. Interim efficacy data from 33 PDAC patients in the CANFOUR study show that the nadunolimab combination therapy results in durable responses or pseudoprogression, leading to prolonged progression-free survival (iPFS) and overall survival (OS) compared to historical control data. Preparations are ongoing for late-stage development in PDAC, to be initiated during 2022.
"The Orphan Drug Designation by FDA provides several strategic advantages and is a valuable step forward in the development of nadunolimab. The designation also confirms Cantargia's strong commitment to provide new effective treatment options to patients with pancreatic cancer." said Göran Forsberg, CEO of Cantargia.
For further information, please contact:
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com
This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16.30 CET on 22 September 2021.
23/9 2021 11:55 Aps invest 097222 Redeye has a positive view of Cantargia's obtaining orphan drug status. It provides some benefits, the most important of which are described in our comment.
Yesterday, Cantargia announced that it has received an orphan drug designation from the FDA for CAN04 in pancreatic cancer. The main advantages of an orphan drug designation are:
Tax credits for qualified clinical trials
Exemption from user fees
Potential seven years of market exclusivity after approval
The potentially most important advantage of these is market exclusivity. It provides intellectual property protection for up to seven years after market approval. As a comparison, CAN04 has a patent in the US that expires in 2035, independently of whether the product is approved or not (though an extension of up to 5 years is theoretically possible). We have assumed a sales launch of CAN04 in pancreatic cancer in 2025-2026. Therefore, the market exclusivity can be considered an additional insurance that does not affect our valuation at present.
On a general note, orphan drugs tend to have a higher price tag that is inversely proportional to the number of patients (the fewer the patients, the higher the price). Evaluate Pharma, based on the top 100 products in 2019, found that the mean cost per patient in the US for orphan drugs was USD 150,854 versus USD 33,654 for a non-orphan drug. Furthermore, authorities tend to require smaller pivotal trials in orphan drugs and the designation is an advantage when discussing partnerships.
To be qualified for the Orphan drug designation in the United States, the prevalence (i.e. people living with the disease) has to be below 200,000. According to Datamonitor, the incidence of pancreatic cancer is about 57,000 in North America (about 460,000 worldwide). Since the disease is most often detected late and the median survival very short, the prevalence and incidence and are similar.
Yesterday's news does not render any changes to our valuation. Nonetheless, we observe that the share is trading below our Bear Case of SEK 25. We reiterate our Base Case of SEK 48 per share with a Bull Case of SEK 95.0.
Yesterday, Cantargia announced that it has received an orphan drug designation from the FDA for CAN04 in pancreatic cancer. The main advantages of an orphan drug designation are:
Tax credits for qualified clinical trials
Exemption from user fees
Potential seven years of market exclusivity after approval
The potentially most important advantage of these is market exclusivity. It provides intellectual property protection for up to seven years after market approval. As a comparison, CAN04 has a patent in the US that expires in 2035, independently of whether the product is approved or not (though an extension of up to 5 years is theoretically possible). We have assumed a sales launch of CAN04 in pancreatic cancer in 2025-2026. Therefore, the market exclusivity can be considered an additional insurance that does not affect our valuation at present.
On a general note, orphan drugs tend to have a higher price tag that is inversely proportional to the number of patients (the fewer the patients, the higher the price). Evaluate Pharma, based on the top 100 products in 2019, found that the mean cost per patient in the US for orphan drugs was USD 150,854 versus USD 33,654 for a non-orphan drug. Furthermore, authorities tend to require smaller pivotal trials in orphan drugs and the designation is an advantage when discussing partnerships.
To be qualified for the Orphan drug designation in the United States, the prevalence (i.e. people living with the disease) has to be below 200,000. According to Datamonitor, the incidence of pancreatic cancer is about 57,000 in North America (about 460,000 worldwide). Since the disease is most often detected late and the median survival very short, the prevalence and incidence and are similar.
Yesterday's news does not render any changes to our valuation. Nonetheless, we observe that the share is trading below our Bear Case of SEK 25. We reiterate our Base Case of SEK 48 per share with a Bull Case of SEK 95.0.
