FDA resumes review of DiviTum®TKa submission
|SEK 000s||Q3 20/21||Q3 19/20||May-Jan 20/21||May-Jan 19/20||Full year 19/20|
|Operating profit (loss)||-11,062||-7,433||-28,012||-19,520||-29,816|
|Profit (loss) for the period||-10,909||-7,515||-27,491||-19,540||-30,318|
|Earnings per share, after dilution||-0.38||-0.32||-0.97||-0.83||-1.29|
Significant events during the third quarter
Significant events after the end of the period
When: 18 March 2021 at 10.00 CET
Phone numbers: SE: +46850558357, DK: +4578150109, UK: +443333009034, US: +18332498404
Broadcast language: in English
For Biovica, the third quarter has been filled with intensive preparations for our market launch of DiviTum®TKa in the USA. At the end of January, we received good news from the FDA that it has appointed a lead reviewer and resumed its review process of Biovica’s 510(k) application. We are pursuing our schedule for being able to launch DiviTum®TKa in the USA during 2021 and utilizing the time prior to approval in the best way possible.
We have made progress with our plan for the launch of DiviTum®TKa. A key factor for successful commercialization of DiviTum®TKa is convincing oncologists and payers in the USA of its value. One important part of that effort was hiring Amy Williams as our new Scientific Director, working from our office in Boston. She most recently held the position of Scientific Associate Director at Novartis Oncology, where she worked with leading oncologists and opinionmakers in breast cancer, which is precisely the group we are targeting. Her recruitment is an important addition that further strengthens our organization.
During the quarter, we also continued our work with preparations for obtaining reimbursement from payers in the USA. One of Biovica’s strengths is all of the positive results from clinical trials using the assay. By creating economic models based on these excellent clinical results, it will be possible to calculate the assay's social benefits through cost savings. We will be presenting the results of this work during the year.
Four abstracts based on studies using DiviTum®TKa were presented at San Antonio Breast Cancer Symposium (SABCS), which is the world's largest breast cancer symposium, in early December. One of the abstracts included results from the SWOG study, which is the backbone of our application for market approval. We carried out the study in collaboration with SWOG Cancer Research Network. The results confirm DiviTum®TKa’s monitoring capabilities and reveal impressive data on progression free survival and overall survival, as well as supporting prior evidence that DiviTum®TKa can be used as a prognostic tool. It introduces a new possible prediction capability with the assay, meaning that, already prior to starting treatment, it could provide information on how the patient is expected to respond.
The other three abstracts presented at SABCS are based on the European multicenter study (PYTHIA), the study conducted at Mayo Clinic (PROMISE), and a dosing study of Palbociclib at Washington University School of Medicine in the USA. In each of those studies, DiviTum®TKa was used to monitor the response from treatment with CDK 4/6 inhibitor for women with metastatic breast cancer. The presentations at SABCS serve as an important validation of DiviTum®TKa as a potential standard tool for evaluation of the treatment effect on metastatic breast cancer. The attention that we drew at SABCS is also an important piece of the puzzle for our commercialization. Wide knowledge of DiviTum®TKa at the time of the launch will facilitate quicker progress in the test reaching its full commercial potential.
Our collaborations with the laboratory divisions of major cancer institutes are also very important, in that they could later become important commercial partners to us. Because of the COVID-19 pandemic, oncology labs have been used for COVID-tests, which has affected our discussions. Nevertheless, we made progress with those discussions during the quarter. The good news that the FDA has resumed its review of our application means that we are getting closer to an approval, and because of that, laboratories have given a higher priority to their discussions with us.
Sales in the third quarter grew to a total of SEK 1.4 million. Most of that is attributable to the first partial deliveries on two major orders that came in during the quarter. It is satisfying that new pharmaceutical companies are starting to see the value of using DiviTum®TKa when developing new cancer drugs. Also, one of our existing customers has placed a new order.
During the quarter, we were also happy to announce that DiviTum®TKa has been selected for inclusion in two new studies.
The first is a prospective study in the UK involving around one hundred women diagnosed with hormone-receptor-positive breast cancer. It will investigate whether the test can be used for monitoring standard treatment using a CDK4/6 inhibitor in combination with an aromatase inhibitor. The objective is to verify that patient monitoring using DiviTum®TKa will reduce costly medical imaging diagnostics.
The other study where DiviTum®TKa has been chosen is the prospective clinical study TIRESIAS. It is a multi-center study that will collect samples from 150 patients with hormone receptor positive metastatic breast cancer who receive the first-line standard treatment: a CDK4/6 inhibitor and an aromatase inhibitor. The aim is to demonstrate that DiviTum®TKa can predict progression free survival from samples taken as early as two weeks into treatment.
It currently takes three to six months to see whether a particular line of treatment is effective, which is unfortunate. We very much hope, based on the study results that we have presented, that DiviTum®TKa will help improve the current standard of care.
DiviTum®TKa fulfills a significant need in a market that is both large and attractive. In summary, it has been yet another intensive quarter, where we’ve taken additional steps towards achieving our goal: that patients with metastatic breast cancer will receive the best possible treatment from day one.
We are working diligently to prepare for commercialization and look forward to soon being able to make a meaningful difference for patients with metastatic breast cancer. A successful launch in the USA for use of DiviTum®TKa in treating metastatic breast cancer is the first step towards realizing the product’s full potential. I am excited and optimistic about what the future holds and look forward to reporting our next successes.
This information was distributed by MFN https://www.mfn.se/