* 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 (Adds quotes, background, bullets)
By Camilla Knudsen
OSLO, April 24 (Reuters) - Norwegian drug maker PCI Biotech 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 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)