Interim Report May-January 2018/2019
Significant events during the third quarter
- Abstract was presented at San Antonio Breast Cancer Symposium
- New office and staff in USA
Significant events after the end of the period
- Abstract to be presented at AACR in April
- Shares now traded on Nasdaq First North Premier
- Lars Holmqvist elected as new Chairman
- Two new customers, a pharmaceutical company and a CRO, and sales of SEK 1.5 million.
Continued focus on commercialization of DiviTum®
The focus of Biovica’s business plan is commercialization of DiviTum®, which will provide cancer patients with more personalized treatments leading to better outcomes while ensuring that society uses it resources in the most efficient way. We have targeted the US and European market, where Biovica’s market potential for DiviTum® is estimated at SEK 6 billion.
We took significant steps towards that goal in the third quarter:
- Progress in the efforts aimed at FDA approval in accordance with plan
- Additional positive study results that provide the foundation for commercialization of DiviTum®
- New employees fortify the organization for the pending commercialization
Progress in our efforts to obtain FDA approval
Biovica has concluded the development project for the product to meet the requirements for FDA approval. These improvements are currently being verified in accordance with the agreed specification with the FDA in the supplement 1 stage.
Additional positive study results
Our clinical development program documents the benefits of DiviTum® to both patients and society. It also provides the foundation for successful commercialization of the product. The study results are a necessary component of the regulatory process and for obtaining reimbursement. They are also very important in generating demand and for establishing commercial partnerships for sales.
We are thus very pleased with the study results we received in February 2019 showing that DiviTum®, as the first blood-based biomarker, can be used to evaluate the effects on metastatic breast cancer following treatment with Palbociclib (a CDK4/6 inhibitor). The results will be presented at the AACR Annual Congress in April 2019.
Fortified organization as we prepare for commercialization
Biovica held an extraordinary general meeting on 20 March 2019 to elect Lars Holmqvist as the company’s new Chairman of the Board. Lars Holmqvist will contribute his unique expertise of the commercialization process. He also has an extensive international network that will be of great value to Biovica during the ongoing commercialization process for DiviTum®. Lars replaces Göran Brorson, who has made a valuable contribution to Biovica and was a driving force in its development.
Biovica also established an office and staff in Boston, USA. It is another important part of the ongoing commercialization process, bringing us closer to both partners and customers.
New customers and sales of SEK 1.5 million
The great potential for the product exists in the market for clinical use, which requires regulatory approval. Additional potential for DiviTum® exists in the research market, where the test is used to help develop new cancer drugs. Two new customers, a pharmaceutical company and a CRO, haves been added and they've also placed their first orders. Their orders for the DiviTum® kit total approximately SEK 1.5 million. Two global pharmaceutical companies that develop new cancer drugs and see the benefits of DiviTum® are behind these orders.
Biovica has a unique product that fulfills a great need in the market. We are following our plan for product launch. We have obtained good results from our studies with DiviTum® and our interaction with the FDA has been positive. On the whole, I am optimistic about the future and confident that the day is approaching when we can feel proud of having contributed the best possible treatment from day one to cancer patients all over the world, while creating great significant value to our shareholders.
Anders Rylander, CEO Biovica.
Phone: +46 (0)18 444 48 35,
Cecilia Driving, CFO
Phone +46 (0)73 125 92 47
The information was submitted for publication, through the agency of the contact person set out above, at 08:00 pm CET on March 21, 2019.
In the event of contradictions or differences between the Swedish press release and this English version the Swedish text will prevail.
Biovica develops and commercializes blood-based biomarker assays that improve monitoring of modern cancer therapies and predict patient outcome. The company’s DiviTum® assay, a test for accurately measuring cell proliferation, has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. Biovica aims to make best-possible-treatment from day one a reality.
Biovica collaborates with world-leading cancer institutes as well as pharmaceutical companies launching next-generation therapies. The company is ISO 13485 certified for Quality Management Systems. DiviTum® is CE-labeled and MPA-registered. Appointed Certified Adviser to the company is FNCA Sweden AB, email@example.com, +46 8 528 00 399.
Read more: www.biovica.com