A number of biotech or biopharmaceutical companies have succeeded in the past couple of years in changing their statuses from clinical stage to revenues-generating firms. A number of these firms reside in the Prohost Portfolio, picked up before they generated revenues from their newly approved products’ sales. We are following up on these firms’ news as they come out of their new journeys towards marketing their approved products, stretching their markets for more revenues, selecting their distributors, attracting new partners to help develop other products in their pipelines and more.
One of these firms is Array Biopharma (ARRY). We take advantage of Array’s reporting results for its first quarter of fiscal 2019, and other updates, to learn about this firm’s achievements during the first quarter.
Array started its release by referring to its robust U.S. launch of its combination products Braftovi (encorafenib) + Mektovi (binimetinib) for BRAF-mutant melanoma. Array has witnessed strong demand for Braftovi + Mektovi. It continues to receive positive feedback, from healthcare providers, payers and the melanoma community, regarding the combination.
In its reporting, Array reminded of the following:
– The combination, Braftovi + Mektovi, received European Commission approval in September for adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test.
– This approval is applicable to all 28 European Union member states, as well as, Liechtenstein, Iceland and Norway.
– The COLUMBUS phase 3 trial overall survival (OS) results, which were published online on September 12, 2018 by The Lancet Oncology demonstrate that the median OS was 33.6 months for patients treated with Braftovi + Mektovi compared to 16.9 months for patients treated with vemurafenib as a monotherapy. The combination was said to reduce the risk of death compared to treatment with vemurafenib.
It is important to learn about safety information in the manuscript and in the Important Safety Information and the full Prescribing Information
BEACON CRC Phase 3 Trial
On August 7, 2018, Array announced that the FDA granted Breakthrough Therapy Designation to Braftovi, in combination with Mektovi and cetuximab for BRAFV600E-mutant metastatic colorectal cancer (mCRC) after failure of one to two prior lines of therapy for metastatic disease.
It is important to note that, BRAFV600E-mutant mCRC patients have more than double mortality risk of mCRC patients without the mutation and that there are no therapies specifically approved for this high unmet need population.
Following consultation with the FDA and the European Medicines Agency, Array has initiated an amendment to the BEACON CRC protocol to allow for an interim analysis of trial endpoints.
Array plans to use it to seek accelerated approval in the U.S based primarily on confirmed overall response rate (ORR) and durability of response.
Array anticipates topline results from this analysis in the first half of 2019.
The BEACON CRC trial continues to enroll well, and Array expects to complete enrollment of the trial around the end of 2018.
ANCHOR CRC TRIAL
In October 2018, ANCHOR CRC, an international trial designed to assess the efficacy and safety of the combination of encorafenib, binimetinib and cetuximab in patients with BRAFV600E-mutant mCRC in the first-line setting, was posted to clinicaltrials.gov.
The ANCHOR CRC trial is being conducted in collaboration with Pierre Fabre and Ono Pharmaceutical, with support from Merck KGaA, Darmstadt, Germany.
The trials are advancing with Bristol-Myers (BMY), Merck (MRK) and Pfizer (PFE). Array’s binimetinib in combination with PD-1/PD-L1 checkpoint inhibitors, in separate, strategic collaborations . Each collaboration is pursuing a different rationally designed clinical approach in several solid tumor populations including metastatic colorectal cancer patients with microsatellite stable tumors (BMY and MRK), and patients with non-small cell lung and pancreatic cancer (PFE). These approaches are focused on earlier lines of therapy and the addition of a third regimen.
Net product sales revenues for Braftovi + Mektovi was $14.0 million.
Total revenue for the first quarter of fiscal 2019, increased by $27.2 million compared to the same quarter of fiscal 2018.
Research and development expense increased by $2.3 million, with an increase over fiscal 2018.
Net loss, for the first quarter of fiscal 2019, was $24.8 million or ($0.12) per share compared to $38.0 million or ($0.22) per share, for the same quarter in fiscal 2018.
The decrease in net loss was primarily due to new product sales and increased milestone revenues from Pierre Fabre and Loxo Oncology, which was partially offset by reduced reimbursement revenue from Novartis.
As of September 30, 2018, CASH, cash equivalents and marketable securities, were $415 million.
Array has just launched its approved products which are being used in combination treatment for unresectable or metastatic melanoma with a BRAFV600 mutation, a severe type of melanoma with no available specific treatment. In the meantime, Array is conducting trials with Braftovi, in combination with Mektovi and cetuximab, for mCRC after failure of one to two prior lines of therapy for metastatic disease. This is important as colorectal cancer is still a big problem for oncologists. In spite of the increased colonoscopy that saved many people from developing colorectal cancer, colorectal cancer is still killing thousands of people each and every year.
Array did not take rest or celebrate its approved drugs, but went further into immuno-oncology collaboration, advancing trials with the leaders of immuno-oncology, Bristol-Myers, Merck and others, with its binimetinib in combination with their PD-1/PD-L1 checkpoint inhibitors for various strategic collaborations. The aim is to treat other solid cancers, including metastatic colorectal cancer, microsatellite stable tumors, non-small cell lung cancer and pancreatic cancer.
Array has already demonstrated its solid fundamentals. Now it is using its capability to stretch its approved products’ markets, hence, grow its revenues and generate earnings.
Its CASH is enough to help finance its ambitious projects and we believe this $415 million will grow rather than shrink.