PCI Biotech receives US Orphan Drug Designation for fimaporfin in the treatment of bile duct cancer (cholangiocarcinoma)
Tekst
Oslo, 4 October 2017 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company today announced that the U.S. Food and Drug
Administration (FDA) has granted Orphan Drug Designation to its lead product
candidate, fimaporfin, for the treatment of patients suffering from
cholangiocarcinoma (bile duct cancer). This patient population has no approved
treatment alternatives today and fimaChem (fimaporfin) has the potential to play
a role in this area of high unmet medical need.
"Receiving orphan status from the FDA is a crucial step in the development of
this important new medicine for cancer patients in need of better local
treatments. PCI Biotech’s fimaChem treatment is well suited for treatment of
bile duct cancer, with easy light access through routine endoscopic methods."
said Dr. Per Walday, CEO of PCI Biotech. “Orphan designation is a significant
regulatory milestone and recognises the therapeutic benefits we seek to bring to
the patients. It supports our further development of fimaChem in this indication
and provides important development and commercialisation benefits.”
Contact information:
Per Walday, CEO
pw@pcibiotech.com
Mobile: +47 917 93 429
About Orphan Drug Designation
Under the U.S. Orphan Drug Act, the FDA’s Office of Orphan Products Development
provides special status and incentives to encourage the development of drugs for
diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation
conveys up to seven years of marketing exclusivity if the drug receives
regulatory approval from the FDA and offers various development incentives,
including an exemption from the FDA user fee and FDA assistance in clinical
trial design. The receipt of Orphan Drug Designation status does not change the
regulatory requirements or process for obtaining marketing approval and
designation does not mean that marketing approval will be granted.
About bile duct cancer (cholangiocarcinoma)
The bile duct drains bile from the liver into the small intestine. Biliary tract
sepsis, liver failure and/or malnutrition and cachexia due to locoregional
effects of the disease are the most important causes of death. Currently,
surgery is the only curative option for these patients; yet the majority of the
tumors are inoperable at presentation. Inoperable patients are treated with
stenting to keep the bile duct open and with chemotherapy. The combination of
gemcitabine and cisplatin has shown promising results and has become standard
treatment in some regions, but there is still a need for better treatments to
increase overall survival and quality of life.
