Advanced Life Sciences (OTC BB: ADLS) took two steps this week toward advancing its lead drug candidate, Restanza. The Illinois-based biopharmaceutical company, which is engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases, announced Tuesday that it has entered into a Cooperative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research. Under the terms of the agreement, Walter Reed will perform advanced animal efficacy testing of Restanza, ADLS’ novel oral antibiotic, against various Plasmodium species that cause malaria. In previous in vitro and in vivo studies with Walter Reed, Restanza demonstrated significantly greater efficacy compared to azithromycin.
On Wednesday, ADLS announced that it had been awarded a cash grant of more than $244,000 to further the development of Restanza. The grant comes in the form of a tax credit and was awarded to ADLS under the Qualifying Therapeutic Discovery Project, which was created by Congress as part of the Patient Protection and Affordable Care Act of 2010. ADLS was awarded the maximum amount that is allocated per project.
The grant is awarded to projects that have the potential to address unmet medical needs, and Restanza definitely falls under that category. Restanza is currently in late-stage development for the treatment of respiratory tract infections including community-acquired pneumonia (CAP) and biodefense pathogens including anthrax, plague and tularemia. Pneumonia is the sixth leading cause of death in the U.S., and it’s becoming increasingly difficult to treat with currently available antibiotics. The resistance rates for penicillin and macrolide antibiotics are approaching 60 percent and 40 percent in the U.S. According to ADLS, an office visit that results in an effective prescription only costs about $200, but the cost of treating patients who don’t respond to penicillins or macrolides comes out to approximately $15,000 per patient. There is a growing need for drugs that address the issue of antibiotic resistance.
Restanza has demonstrated 14 times higher potency than macrolide antibiotics against gram-positive bacteria and appears to be effective against bacteria that are resistant to other types of antibiotics, including penicillin and macrolides. The Company estimates that $2 billion in prescriptions to treat CAP are written each year in the U.S. The market could be two to three times larger in Europe and Southeast Asia, where CABP is more common than in the U.S. (More information can be found on the company's CAP Fact Sheet.) Restanza has also shown efficacy against biodefense agents, and the FDA has designated Restanza as an orphan drug for the prophylactic treatment of plague, anthrax, and tularemia.
In addition, the company is developing drug candidates for melanoma and respiratory conditions such as adult respiratory distress syndrome, which affects approximately 200,000 people in the U.S. each year and is potentially fatal. To learn more about ADLS, watch the video below featuring Michael T. Flavin, Ph.D., CEO & Chairman of Advanced Life Sciences, and John Flavin, MBA, President, CFO, & Director. In this video, Michael and John Flavin discuss Restanza and the Company’s plans for the future.