Norway's PCI Biotech sees promising data from cancer drug study - CEO (updated)

PCI Biotech Holding ASA

24/04/2018 05:45

* PCI develops fimaCHEM bile duct cancer drug treatment
    * Pivotal second-phase study to start in H2
    * Needs extra capital or partnership to finish study
    * Brokerage Arctic predicts revenues from 2022

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    By Camilla Knudsen
    OSLO, April 24 (Reuters) - Norwegian drug maker PCI Biotech
 PCIB.OL  has seen promising results from its bile duct cancer
study ahead of a key second phase, but will need extra capital
or a partnership to finalise a treatment, its chief executive
told Reuters.
    Developing the fimaCHEM platform, combining light-based,
photochemical technology with its fimaporfin drug, PCI seeks to
treat patients who have inoperable tumours.
    "We are currently in an extension of phase one, scheduled to
be finished in the second half of 2018, and then we are ready to
start the pivotal phase two almost immediately," Chief Executive
Per Walday said in an interview at the company's headquarters.
    "Data from the first phase looks promising, and we know that
strong results may allow for accelerated conditional approval
from an interim analysis. We strongly believe in this, but we
only have results from a few patients so far, so there are no
guarantees," Walday added.
    PCI's cash position covers preparations for the second
phase, but the company will need either a partnership or to
raise money in a share issue to finish the work, he said.
    "We do not have sufficient resources to complete the study
today, so we would have to either raise more money or bring in a
partner," Chief Financial Officer Ronny Skuggedal said.
    With bile duct cancer is classified as a rare disease, the
European Medicines Agency and the U.S. Food and Drug
Administration have granted PCI so-called orphan drug status,
providing development benefits and a high-price potential.
    "We estimate around 3,000 patients (per year) in Europe and
the U.S. eligible for our treatment, with no other approved
treatment (available now)," the CEO said.
    Oslo-based brokerage Arctic Securities has forecast an
average price for full fimaCHEM treatment of $95,000 per
patient, with estimated revenues rising from $37 million in 2022
to $267 million by 2026.
    PCI also sees a potential for expanding sales to Asia, where
bile duct cancer has a higher prevalence, Walday said.
    The company also develops a platform for therapeutic cancer
vaccines, known as fimaVACC, and works with biotech firms,
including RXi Pharmaceuticals  RXII.O  and Germany's BioNTech on
fimaNAc, evaluating potential partnerships within gene therapy.
    "The advantage is that we benefit from research and
documentation synergies across all three focus areas, but if one
should fail, the other entities could still move forward,"
Walday said.
    PCI's shares have doubled in value since mid-December,
trading at 57 Norwegian crowns. Brokerage Arctic, with a 'buy'
rating, has set a target of 78 crowns for the stock.

 (Reporting by Camilla Knudsen; Editing by Terje Solsvik and
Gopakumar Warrier)
 ((camilla.knudsen@thomsonreuters.com; +47 2331 6595; Reuters
Messaging: camilla.knudsen.thomsonreuters.com@reuters.net))