Advanced Life Sciences Holdings, Inc. has announced the submission of a new drug application (NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP). Advanced Life Sciences also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.
CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5.6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.
Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.
"We are excited to make our NDA submission for cethromycin in mild-to- moderate CAP," said Michael T. Flavin, Ph.D., the Company's chief executive officer. "Our team has worked tirelessly to complete this important objective for the cethromycin program. We look forward to advancing the cethromycin NDA through the FDA review process."
The NDA submission is based on a full clinical development and manufacturing program for cethromycin. The program included two global Phase III pivotal studies for the treatment of mild-to-moderate CAP in which cethromycin was dosed at 300 milligrams once daily for seven days compared to the standard of care therapy, Biaxin, which was dosed at 250 milligrams twice daily for seven days. The data from these trials showed that cethromycin was non-inferior to Biaxin with a similar safety profile. The most common adverse reactions for cethromycin were taste disturbance, diarrhea, nausea and headache.
More than 5,000 patients have been treated with cethromycin in 53 clinical trials to date.
In conjunction with the NDA submission, the Company has received a commitment to increase availability under its loan facility with Leaders Bank from $4 million to $10 million. The commitment provides that the loan would mature on January 1, 2011 and contain substantially similar terms and conditions as the existing loan agreement between Advanced Life Sciences and Leaders Bank. Advanced Life Sciences has also agreed to issue to Leaders as a closing fee warrants for the purchase of 65,000 shares of its common stock at an exercise price of $1 per share. Consummation of the increased loan facility is subject to entering into definitive agreements and other customary closing conditions.
Advanced Life Sciences has also entered into a standby equity distribution agreement (SEDA) with YA Global Investments, L.P. (Yorkville) for the sale of up to $15 million of shares of the Company's common stock over a two-year period.
"The SEDA is an instrument that allows us financial flexibility while we advance our ongoing regulatory, partnering and pre-commercial activities for cethromycin," said John L. Flavin President and CFO of Advanced Life Sciences. "Our ability to choose if, and when, to access funds under the SEDA facility provides us with flexibility and the potential to minimize dilution for our stockholders."