Advanced Life Sciences: Addressing Antibiotic Resistance in Infectious Disease Market

Traditional antibiotics are losing their effectiveness against bacterial infections such as community-acquired bacterial pneumonia (CABP), a type of lower respiratory tract infection that is the sixth leading cause of death in the U.S. An estimated 5.6 million cases of CABP occur annually in the United States. With the resistance rates for penicillin and macrolide antibiotics approaching 60 percent and 40 percent in the U.S., respectively, a new treatment option is clearly needed.

That new option could come from Advanced Life Sciences (OTC BB: ADLS), a biopharmaceutical company focused on the discovery, development and commercialization of drugs in the areas of infection, oncology and respiratory disease. The company’s lead product is Restanza (cethromycin), a novel once-a-day antibiotic for the treatment of life-threatening bacterial infections and bioterror pathogens. Restanza has shown 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. Cethromycin binds to two sites on the pathogen, where other agents only bind to one site, reducing the potential of resistance with cethromycin. The drug is currently in late-stage development. ADLS achieved a Special Protocol Assessment Agreement with the U.S. Food and Drug Administration in August on the design of a Phase III study of Restanza.

ADLS has developed both oral and intravenous forms of Restanza to capitalize upon the community and hospital markets. According to the company, $2 billion worth of prescriptions to treat CABP are written in the U.S. annually. Markets such as Europe and Southeast Asia, which have a significantly higher incidence of pneumonia than the U.S., may be double or even triple the size of the U.S. market.

Restanza has also demonstrated effectiveness against bioterror pathogens and has been granted Orphan Drug Designation by the FDA for the prophylactic treatment of inhalation anthrax post-exposure, plague and tularemia. Inhalation anthrax is usually fatal if left untreated. The company offered its bioterror expertise in Washington D.C. on Monday, giving testimony at a Senate hearing on defending against public health threats.

The company is developing two additional drugs: ALS-886 for the treatment of tissue damage associated with adult respiratory distress syndrome, a lung condition that affects an estimated 200,000 million people in the U.S. annually and for which there is no known effective treatment; and ALS-357 for the treatment of malignant melanoma.

The company is seeking government and pharmaceutical partners to help advance ADLS’ oral Restanza CABP program. The company has partnered with the University of British Columbia to develop novel antibiotics against gram-negative pathogens. “We believe this program will nicely complement our internal antibiotic R&D platform and advances our strategy to expand our research efforts into the development of novel antibiotics to address unmet medical needs in treating clinically important infections caused by Gram-negative pathogens,” Michael Flavin, Chairman and CEO of ADLS, stated in a July announcement. The team at Advanced Life Sciences has 20 years of experience working in the biotechnology field.

In the video below, Michael T. Flavin, Ph.D., CEO & Chairman of Advanced Life Sciences, and John Flavin, MBA, President, CFO, & Director discuss their lead product Restanza and their plans for the future.