(Tromsø, 30. June 2016) Biotec Pharmacon ASA (“Biotec”, OSE: BIOTEC) is
continuing to focus on their short and medium term goals presented at the
Capital Markets Day in February and the Q1 presentation in April.
This week, Biotec will file the 510K application for the important US market.
The process normally takes 6-9 months and expects feedback from the authorities
late in 2016 or early 2017. Registering Woulgan® in this way will form the
foundation for the commercially valuable registration and reimbursement work to
follow. The company is accelerating development of its strategy for the
commercialization of Woulgan® in this strategic market.
The UK Drug Tariff application is progressing as outlined in the Q1 2016 report.
Biotec is responding to questions from the NHS Drug Tariff as they work through
Earlier in June, Biotec held a clinical review meeting with several UK
evaluation sites. The results from the evaluations are encouraging and in line
with earlier studies, confirming Woulgan® as a product with impressive
capabilities in wound healing. The results are being processed for publication
in a UK wound care journal later this year.
Sales of Woulgan® have begun in the Nordic region resulting from the actions of
our partner Navamedic. While early sales are modest, it is an important step for
the brand. Woulgan has been submitted for inclusion onto several tenders with
more planned as they are announced. When Woulgan® is listed on a tender it makes
ordering the product in volume significantly more convenient and is thus a key
requirement for larger market share in any region. Navamedic continues to focus
on product evaluations with key opinion leaders to accelerate and extend the
adoption of Woulgan®.
Biotec signed a distribution agreement with Rogg Verbandstoffe for the German
market. Product sales training of selected Rogg key account managers is
scheduled before the summer with more of the team to be trained immediately
afterwards. Biotec has hired an experienced marketer to coordinate commercial
initiatives in this attractive market.
ArcticZymes continues to secure funding for its R&D program. In addition to the
Horizon 2020 funding received earlier this year, ArcticZymes together with
Vectron received BIA funding for the project “XPress – Mitigating Bottlenecks in
recombinant enzyme production”. The project will be important in enabling more
cost-efficient production processes for its molecular enzymes by increasing
yield and scalability. The grant will cover up to 40 % of the project costs, and
ArcticZymes part of the grant is NOK 5,0 million over the next 4 years.
For more information
Svein Lien, CEO
+47 922 89 323