2019 Review and Looking Forward
Last year began with a strategic review of our brands, capabilities and international partners, which ultimately led to a restructured product portfolio, a host of new international partnerships and an expansion of our corporate, sales and medical teams.
In 2019, we received FDA approvals for our Next Generation Caldolor® product, featuring an improved package and formulation in a ready-to-use presentation, and our new RediTrex™ line of injectable methotrexate products. Some other highlights from last year include:
- Vibativ® (telavancin) was the subject of two clinical publications in 2019. One study showed numerically superior cure rates of telavancin (compared to vancomycin within a subset of patients who had hospital-acquired pneumonia). The other detailed the positive clinical outcomes that resulted from treating multiple infection types with Vibativ, including complicated skin and skin structure infections, bone and joint infections, bacteremia and endocarditis and lower respiratory tract infections.
- We were awarded $1 million from the FDA to support a Phase II clinical program to study ifetroban for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD).
- We completed our study of Caldolor® in patients ranging from newborn to six months of age, which shows no safety concerns and similar blood levels to that of older children. We are now finalizing the study report for submission to the FDA.
Some of our top news coverage from the past year includes our new licensing and distributions arrangements for China that was covered by Pharma Journalist and the Nashville Business Journal.
Also, The Pharmacy Times reported that methotrexate received FDA approval for treatment of Rheumatoid Arthritis and Nashville Medical News announced the addition of Vibativ® and our $1 million grant to support the clinical trial of ifetroban.
While we are proud to reflect on our company’s accomplishments in 2019, we are equally aware that the current situation in the world is not one to celebrate. Our thoughts go out to those suffering from the COVID-19 pandemic, especially the patients whose illnesses have led to life-threatening conditions. Even in these uncertain times, we remain focused on and look forward to advancing our mission of improving patient care through the development and delivery of high-quality medicines.
For more information on our products, including full prescribing information, please visit the individual product websites, links to which can be found on our corporate site.
