Revenue from marketed dermatology products increased 28% for full-year 2020 compared to 2019
Our partner company, Cyprium Therapeutics, and Sentynl Therapeutics, a wholly-owned subsidiary of the Zydus Group, signed a Development and Asset Purchase Agreement for CUTX-101 for the treatment of Menkes disease
Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is expected to begin in the second half of 2021
NEW YORK, March 31, 2021 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, today announced financial results and recent corporate highlights for the full-year ended December 31, 2020.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We are delighted with our continued progress, and achievement of significant milestones throughout 2020 and in recent months. Notably, our partner company, Cyprium Therapeutics (“Cyprium”), and Sentynl Therapeutics, a wholly-owned subsidiary of the Zydus Group, signed a Development and Asset Purchase Agreement for CUTX-101 for the treatment of Menkes disease, in February 2021. Also, our full-year 28% revenue growth during the pandemic shows the resilience of the Fortress business model. Since the company’s management took over in 2014, Fortress and our partner companies have built a growing portfolio of six marketed dermatologic pharmaceutical products and more than 25 product candidates in our pipeline across multiple therapeutic categories, including oncology, gene therapy, dermatology, and rare diseases. We are on track to submit our second New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) later this year."
Dr. Rosenwald continued, “As we look ahead to 2021, Fortress expects to deliver further top-line growth through a diversified, long-term revenue stream, and we and our partner companies anticipate multiple key value-creating milestones throughout the year. We have four product candidates in five ongoing pivotal clinical trials, with multiple other earlier-stage clinical trials progressing as well. Additionally, we intend to continue to in-license promising drugs and drug candidates, and to seek partners for late-stage programs to maximize each opportunity to its full potential. We continue to demonstrate the ability of our business model to generate meaningful value creation opportunities with the potential to produce life-changing therapies for people in need.”
2020 and Recent Corporate Highlights1:
Marketed Dermatology Products
- Our six dermatology products are marketed by our partner company, Journey Medical Corporation (“Journey”).
- Our products generated net revenues of $44.5 million for full-year 2020, compared to full-year 2019 net revenues of $34.9 million, representing growth of 28%. Our products generated $13.7 million in revenues in the fourth quarter of 2020, compared to $11.1 million in the fourth quarter of 2019, representing growth of 23%. While we generated revenue growth year-over-year in 2020, sales of our products were impacted by the COVID-19 pandemic, which caused a temporary supply shortage and impacted the ability of our sales force to make in person calls, due to states slowly re-opening.
- We in-licensed and recently launched our sixth prescription dermatology product.
- We intend to launch up to two additional new prescription products this year and expect to generate further sales growth in 2021.
- We currently have 42 sales representatives dedicated to the dermatology product portfolio and we expect that number to continue to grow this year.
CUTX-101 (Copper Histidinate for Menkes disease)
- In January 2020, the FDA granted Rare Pediatric Disease Designation to CUTX-101 for the treatment of Menkes disease.
- In June 2020, we announced the publication of a study, “Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database (gnomAD),” in Molecular Genetics and Metabolism Reports. Assuming Hardy-Weinberg genetic equilibrium, the allelic frequency of loss-of-function variants suggests a minimum birth prevalence for Menkes disease of 1 in 34,810 males, higher than previously recognized. If likely pathogenic missense variants are included, the estimated birth prevalence could potentially be as high as 1 in 8,664 live male births. The study can be accessed here.
- In July 2020, we announced the publication of a study, “Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease” in Molecular Genetics and Metabolism Reports. The study assessed the analytic validity of an ATP7A targeted next generation DNA sequencing assay as a potential newborn screen for Menkes disease. The study can be accessed here.
- In July 2020, we announced that the European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products issued a positive opinion on our application for Orphan Drug Designation for CUTX-101 for the treatment of Menkes disease. In August 2020, the European Commission granted Orphan Drug Designation to CUTX-101. EMA Orphan Drug Designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and 10 years of market exclusivity.
- In August 2020, we reported positive top-line clinical efficacy results for CUTX-101. The study demonstrated statistically significant improvement in overall survival for Menkes disease subjects who received early treatment (ET) with CUTX-101, compared to an untreated historical control (HC) cohort, with a nearly 80% reduction in the risk of death (Hazard Ratio = 0.21, p