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2016-08-29

PCI Biotech Holding: PCI Biotech granted Orphan Drug Designation of fimaporfin for treatment of cholangiocarcinoma in EU

Oslo, 29 August 2016 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company today announced that the European Commission (EC)
has granted an Orphan Drug Designation for its lead product candidate,
fimaporfin, for the treatment of cholangiocarcinoma (bile duct cancer). The
EC's decision follows a positive opinion in July from the European Medicines
Agency's (EMA) Committee for Orphan Medicinal Products (COMP).

The orphan designation provides 10 years market exclusivity for the product
upon approval and several other incentives, including formal Protocol
Assistance and reduced regulatory fees with the EMA.

Per Walday, CEO of PCI Biotech, said: "Receiving orphan status from the EC is
a crucial step in the development of this important new medicine for cancer
patients in need of better local treatments. Bile duct cancer is an
indication well suited for PCI treatment, with easy light access through
routine endoscopic methods. Orphan designation is an important step as we
seek to bring this novel treatment to the market. It supports our further
development of fimaporfin in this indication and provides important
development and commercialisation benefits."

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.

About PCI Biotech

PCI Biotech is a cancer focused biopharmaceutical company headquartered in
Norway and listed on the Oslo Stock Exchange (Axess). The company is
developing therapeutic products based on its proprietary photochemical
internalisation (PCI) technology. The PCI technology works by inducing
triggered endosomal release and may be used to unlock the true potential of a
wide array of therapeutic modalities, such as small molecules, vaccines and
nucleic acids. The company has a clinical Phase I/II program in bile duct
cancer. The company is also developing PCI as a vaccination technology. When
applied in the emerging field of cancer immunotherapy, PCI can be used to
enhance the important cytotoxic effect of therapeutic cancer vaccines. The
PCI technology is also very well suited for intracellular delivery of nucleic
acids, such as RNA therapeutics. By releasing nucleic acid compounds from
endosomes where they are trapped following administration, PCI addresses one
of the major bottlenecks facing this emerging and exciting field. PCI
Biotech follows a strategy to create value by improving the effect of
existing cancer drugs and by realising the large potential in new
therapeutics.

Contact information:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo,
Norway.www.pcibiotech.com

Per Walday, CEO,pw@pcibiotech.no, Mobile: +47 917 93 429.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: PCI Biotech Holding via Globenewswire

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