Cumberland Pharmaceuticals Inc.

11/17/2024 | News release | Distributed by Public on 11/18/2024 01:37

November 2024 Updates, Highlighting Key Clinical and Business Developments

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.