We are pleased to report several significant milestones that reinforce our mission of working together to
provide unique products that improve the quality of patient care. Our latest updates include important
research findings, growing Medicaid coverage and expanded product access.
• In October, we announced new real-world outcomes research comparing Caldolor® to its key
competitor – ketorolac, analyzing 17 million patient records and focusing on over 150,000 adult
and pediatric patients who receive either product. The findings demonstrate that Caldolor is
associated with a lower incidence of adverse drug reactions and improved healthcare utilization.
• The FDA has granted our request for Orphan Drug and Rare Pediatric Disease designations for
our Ifetroban product designed to treat patients with Duchenne Muscular Dystrophy – a
devastating genetic disorder affecting young boys. These designations not only recognize the
urgent need for effective treatments, but also provide hope for the families involved and a
pathway to bring a potential new medicine to a vulnerable patient population more quickly and
efficiently.
• We also recently announced two new developments at Cumberland Emerging Technologies
(CET), where we are building a long-term pipeline of innovative biopharmaceutical products in
collaboration with academic research groups. We were excited to share the top-line results
from the MENDING Study – a Phase II investigator-initiated trial evaluating the safety and
efficacy of a new treatment for delirium in critically ill patients.
CET also entered into a Development Agreement with a corporate partner to fund a new product
designed to locate sites of internal bleeding.
• During the third quarter, we launched a revised sampling program for Sancuso®, our oncology
support medication, that broadens access to the product, allowing more patients to try it and
experience its benefits. We also introduced a new HUB services capability to provide enhanced
patient support, ensuring patients receive comprehensive assistance throughout their
treatment journey.
• Additionally, we are working to bring our potent antibiotic, Vibativ®, to new market both in the
U.S. and overseas. A new WHO report has identified antimicrobial resistance as an urgent global
health crisis, with rising antibiotic resistance diminishing many antibiotics' effectiveness. Unlike
many antibiotics that are losing the battle to fight bacteria, Vibativ’s unique dual method of
action was specifically designed to address drug-resistant bacteria and we therefore believe it
has the potential to help many patients amid this growing resistance crisis.
As we close out 2024, we remain focused on our mission and look forward to sharing additional
accomplishments in the coming months. We thank the entire Cumberland team for their hard work and
commitment to improving patient care.